Express Pharma September 16-30, 2013 by Indian Express

VOL .8 NO.22 PAGES 78

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Market Better than statins Management Rupee’s fall from grace: A blessing in disguise Research A radio’logical’ solution 16-30 SEPTEMBER 2013, ` 40

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VOL 8. NO. 22 SEPTEMBER 16-30, 2013

CONTENTS

Chairman of the Board Viveck Goenka

Better

Editor Viveka Roychowdhury*

than

BUREAUS

Statins

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

Even as the statin market faces generic erosion, pharma companies are trying to figure out novel drugs and fixed dose combinations in the race to find the next generation drugs, that could spell market success. On the occasion of World Heart Day, Shalini Gupta analyses the statins vs non-statins debate

Bangalore Neelam M Kachhap Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

MANAGEMENT Boehringer Ingelheim India: Revving up

PAGE 42

RESEARCH Scientists from University of Strathclyde invents technology to treat major illnesses

PAGE 47

Almac Discovery and Queen’s launch £13 million cancer drug discovery partnership PAGE 48

Senior Manager Rajesh Bhatkal

PHARMA ALLY

PRODUCTION General Manager B R Tipnis

The future of DPIs: Aligning design with market demands PAGE 50

Manager Bhadresh Valia

Easing the instrument calibration load PAGE 53

Sr. Executive- Scheduling & Coordination Rohan Thakkar

PHARMA LIFE

Deputy Art Director Surajit Patro

Dr (Prof) Ranjit Roy Chaudhury

Chief Designer Pravin Temble

awarded FICCI’s Lifetime Achievement

Senior Graphic Designer Rushikesh Konka

Award 20133

PAGE 71

Photo Editor Sandeep Patil Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208,TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

September 16-30, 2013

MARKET

TURN TO PAGE 19 TO FIND SPECIAL DEALS

Ranbaxy completes 20 years in Russia PG 19 UKTI signs MoU with ABLE PG 20 FIS and IMCD in distribution partnership PG 21 Avesthagen signs license agreement with AvestaDHATM PG 22 US FDA accepts Boehringer Ingelheims supplemental new drug application PG 23 Bilcare starts field validation studies of its nonClonableID technology PG 24 Lupin receives US FDA approval for generic rifadin capsules PG 25 Expansion of product offerings with focus on cancer therapeutics drives M&A activity PG 26

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EDITOR’S NOTE Dose of reality

THE CURRENT SCENARIO COULD BE A DOSE OF REALITY SO THAT COMPANIES EMERGE STRONGER AFTER THIS CURRENT STORM

The free-falling rupee is manna for some, and for others, a manic hunt for operating capital. Export oriented companies are hopeful of better returns but whether this will be eroded by higher input costs is another matter. The market slow down has already forced pharma companies to pledge their shares to banks in lieu of loans to meet working capital needs. Elder Pharma (which has reportedly pledged over 95 per cent of its shares), Orchid Chemicals & Pharmaceuticals (over 80 per cent), and Wockhardt (87 per cent) are some of the companies who could be in dire straits if the currency falls even more drastically. given this reality, it is no wonder that Elder Pharma is reportedly close to selling its domestic formualtions business to Sanofi, which would settle its debts as well as allow a focus on the lucrative OTC market. Companies which have high debts in foreign currencies, like Glenmark Pharmaceuticals which has $100 million in foreign long term un-hedged debts, could be hit but in this company's case the repayment duration of three-four years is still manageable. Aurobindo Pharma with forex loans of around $600 million is also vulnerable while Jubilant Lifesciences, Shasun Pharma and Ranbaxy Laboratories too have significant forex loans on their balance sheets. But on the whole the pharma industry seems quite confident of riding out these swings, as our Management cover story, 'Rupee's fall from grace: A blessing in disguise?' finds out. Conditions also seem right for a consolidation drive among Indian pharma companies. The buzz is that Ahmedabad-based Cadila Health and Torrent Pharma are considering a

merger but whether anything comes of these talks, is another matter. Promoters of quite a few Indian pharma companies have been looking to exit the sector but many a deal in the past few years has unravelled due to high valuations. The current scenario could be a dose of reality so that companies emerge stronger after this current storm. With September 29 marking World Heart Day, the other major cover story in this issue, 'Rethinking statins', is an in depth analysis of the statins market and alternatives in the research and clinical pipeline. With heart disease causing 1 in 4 deaths among adults aged 25-69 years in India, there is no doubt that we need to tackle this risk on an urgent basis. But besides new molecules, there is also a strong case to use existing medicines more effectively and this is where Indian companies like Dr Reddy Laboratories (DRL) seem best positioned. The results of the first study of a polypill for cardiovascular disease which were released in early September, are a testament to the late Dr Anji Reddy's vision to provide an affordable, convenient treatment to heart disease patients in India and globally. The proportion of participants on the polypill — a fixed dose combination (FDC) of aspirin, cholesterol-lowering and blood pressure-lowering drugs — who were taking medications regularly was a third higher than in the group receiving usual care. The polypill group also had lower blood pressure and cholesterol measurements. It is a no-brainer: better adherence leads to better clinical outcomes and this study has proved once again that while all FDCs may not be good, a rational FDC like DRL's polypill can definitely help reduce the rising incidence of heart disease in India. Viveka Roychowdhury viveka.r@expressindia.com

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10 EXPRESS PHARMA

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September 16-30, 2013

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MARKET THE BUSINESS OF PHARMACEUTICALS

Better than

Statins Even as the statin market faces generic erosion, pharma companies are trying to figure out novel drugs and fixed dose combinations in the race to find the next generation drugs, that could spell market success. On the occasion of World Heart Day, Shalini Gupta analyses the statins vs non-statins debate

W H AT â&#x20AC;&#x2122; S INSIDE

MANAGEMENT 36 RESEARCH 44 PHARMA ALLY 50 PHARMA LIFE 71 September 16-30, 2013

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I If there is any drug class that has retained its stronghold in the cardiovascular disease market, it undoubtedly has to be statins. Atorvastatin(brand name Lipitor by Pfizer) and Simvastatin(brand name Zocor By Merck) together account for 57 percent of the cholesterol market itself. Patent expiration and the resulting erosion of the statin market by generic versions might have reduced the value but has hardly reduced the market share of these cholesterol lowering drugs. However, the future is open for debate even as efforts are on to develop drugs with new mechanisms to achieve better clinical results, and also develop combination drugs including polypills that combine statins with other drugs.

Lipid modulators, new mechanisms It is estimated that the dyslipidemia(abnormal cholesterol) patient population will grow steadily in the future increasing the need for cholesterol lowering drugs. While statins have so far been efficacious in addresing this need, so much so that it has been almost impossible for

PAM NARANG

VIJAYA VULAPALLI

Analyst, Decision Resources

Senior Analyst, GBI Research

CETP inhibitors will launch with long term outcomes data, and will likely be the most potent HDL-C raising agents available at this time. Furthermore, their ability to substantially reduce LDL-C levels somewhat offsets concerns about the therapeutic merits of raising HDL-C, on the back of dalcetrapib’s Phase III data

Simvastatin is already in the statins market as one of the key drugs and the Vytorin trial is to prove if combining both is going to yield better outcomes. Even if it gets approved, it may not gain in the market on the potential entry of new class of drugs that have different mechanism of action or pathways

Statins themselves are highly effective, but are being used very ineffectively – the biggest challenge is to get them to those individuals who need them the most. Achieving this is as, if not more, important than developing new drugs. This was the reason behind the UMPIRE trial

others to break their hegemony, there has also been noise on the side effects of statins, which is cited as one of the key reasons in the quest for non-statin options.These include CETP (Cholesteryl Ester Transfer Proteins) inhibitors and PCSK9 inhibitors, both lipid modulators just like statins, albeit with different action mecha-

nisms. While the former are plasma proteins that mediate the transfer of triglyceride and cholesteryl ester between lipoproteins by inhibiting this pathway and as a result elevating high-density lipoprotein cholesterol (HDL-C). In contrast, PCSK9 inhibitors aim to lower the low density lipoprotein cholesterol (LDLC) in plasma. Late-stage trial failures of Pfizer’s torcetrapib and Roche’s dalceptrapib have dampened enthusiasm on CETP inhibitors alongwith doubts on whether a rise in HDL-C could actually result in reduction of cardiovascular events. However, not all is lost. “Merck’s anacetrapib and Eli Lilly’s evacetrapib are currently in the pipleline with anacetrapib considered to be more promising for its impact on both HDL-C (increasing) and LDL-C (decreasing),” says Vijaya Vulapalli, Senior Analyst, GBI Research. Pam

Narang, analyst from Decision Resources expects them to gain blockbuster status in the next ten years. “CETP inhibitors will launch with long term outcomes data, and will likely be the most potent HDL-C raising agents available at this time. Furthermore, their ability to substantially reduce LDL-C levels somewhat offsets concerns about the therapeutic merits of raising HDL-C, on the back of dalcetrapib’s Phase III data,” she explains. PCSK9 antibodies work by inhibiting a protein by the same name, that reduces the ability of liver to remove LDLC from the blood. Regeneron’s alirocumab and Amgen’s AM145, posted promising results in Phase II and just entered into Phase III trials. Interviewed thought leaders by Decision resources as part of their report titled 'Dyslipidemia'are highly enthusiastic about this

LATE-STAGE TRIAL FAILURES OF PFIZER’S TORCETRAPIB AND ROCHE’S DALCEPTRAPIB HAVE DAMPENED ENTHUSIASM ON CETP INHIBITORS ALONGWITH DOUBTS ON WHETHER A RISE IN HDL-C COULD ACTUALLY RESULT IN REDUCTION OF CARDIOVASCULAR EVENTS. HOWEVER, NOT ALL IS LOST 14

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PROFESSOR VIVEKANAND JHA Executive Director, The George Institute for Global Health India

September 16-30, 2013

M|A|R|K|E|T

category with a convincing mechanism of action on the back of impressive Phase II results and the effect on LDLC levels. “We expect the drugs to launch initially for high risk cardiovascular patients, with a broader label contingent on long-term car-

diovascular outcomes data. Their injectable administration and high cost, however, may restrict their use to high risk patients, and prevent them from usurping the statin strong-hold,” opines Narang on a caustiously optimistic note. However, some suggest

And the others are ... ❖

❖

Niacin based drugs: With the failure of the HPS2 THRIVE study and AbbVie’s Niaspan (ER niacin) g physician confidence in the niacin drug class, and potentially the HDLC hypothesis, is likely to be irrevocably dented. Drug prescriptions expected to fall dramatically. Fibrates: Currently used in primarily patients with high triglycerides, in preference to the prescription omega-3 fatty acids, owing to their superior tolerability, and lower cost. However, lack of convincing clinical data on better long term cardiovas-

September 16-30, 2013

cular outcomes benefit on a statin background has led to . physician ambivalencet about the benefits of lowering triglycerides (beyond preventing pancreatitis). ❖

Fish oil : A number of recent metaanalyses have found no benefit for prescription omega-3 fatty acids in the prevention of cardiovascular events. However, a long term outcomes trial for Amarin’s Vascepa is underway, and due to report in 2016. A positive outcome here will provide a substantial boost to the franchise.

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to reserve any judgement, given that even CETP inhibitors looked promising early on, until results from bigger trials trickle in.

Statin plus drugs? Even as drugs with new mechanisms are under clinical trial, statins remain undisputable as first line agents for their use in primary and secondary cardiovascular risk prevention. The wealth of clinical data till now that further supports that the drug improve long term outcomes is the reason why some are betting on combination therapies which use a statin as opposed to simply using a statin. For example, the HPS2-THRIVE study investigated the efficacy of Merck’s Tredaptive (fixed dose combination of modified release niacin and laropiprant) on a statin background in more than 18,000 high cardiovascular risk patients but failed to show long term cardiovascular outcomes relative to placebo while increasing HDL-C modestly. It also led to

significantly higher rate of adverse effects relative to placebo, including skin reactions, gastro-intestinal side effects, new-onset diabetes, and myopathy. Earlier this year European Medical Agency(EMA) recommended the drug be suspended, after which Merck withdrew the drug from markets worldwide. Physicians are keeping a close eye on IMPROVE-IT, that received a go-ahead from an independent data safety monitoring board (DSMB) recently. The study is investigating the efficacy of Merck’s Vytorin, a combination of ezetimibe (Zetia) and simvastatin (Zocor) relative to simvastatin treatment in more than 18,000 high cardiovascular risk patients. It is one of the most awaited trials in the market as it acts on both HDL-C and LDL-C. “Given that ezetimibe primarily acts by raising LDL-C, a failure for the drug to show benefit here could be bad news for the LDL-C hypothesis, and so for drugs in development which

EXPRESS PHARMA

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also act in this way (the statins are known to have an anti-inflammatory effect, in addition to LDL-C lowering, which could contribute to their efficacy),” pontificates Narang. Vallupalli doesn't see Vytorin gain a major share in the market due to cost efficiencies of the genric versions , one already off patent and one to go off patent soon. “Simvastatin is already in the statins market as one of the key drugs and the Vytorin trial is to prove if combining both is going to yield better outcomes. Even if it gets approved, it may not gain in the market on the potential entry of new class of drugs that have different mechanism of action or pathways,” she postulates.

The polypill The UMPIRE trial published recently in the Journal of the American Medical Asociation has demonstrated increased adherence in patients with cardiovascular events who take the fixeddose combination pill or a polypill( statin, aspirin, and two anti-hypertensive drugs). In 2004 participants in the UK, Ireland, the Netherlands and India with an average age

of 62 years of which 80 percent were male, either the polypill, or their normal combination of medicines was randomly assigned. 90 percent of the patients had experienced a previous heart attack, stroke or serious blockages in arteries in the legs while the remaining had one or more risk factors (blood pressure, cholesterol, diabetes, smoking) that placed them at high shortterm risk of experiencing one of these cardiovascular events. While both versions of the polypill contained sim-

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vastatin, 70 percent of those in the usual care group were prescribed either atorvastatin or rosuvastatin. Corroborating the results, Professor Vivekanand Jha, Executive Director, The George Institute for Global Health India says, “Switching to a fixed dose combination can improve blood pressure and cholesterol control as seen in the polypill group, who reported 30 percent increased use of appropriate medicines. It is important to provide this type of evidence so that governments, doctors and patients

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can make the right decisions about medication use.” Professor Jha fiercely supports statins and even goes a step ahead , perhaps shedding a light on what could be the next frontier for statins when he says, “Statins themselves are highly effective, but are being used very ineffectively – the biggest challenge is to get them to those individuals who need them the most. Achieving this is as, if not more, important than developing new drugs. This was the reason behind the UMPIRE trial.” While the polypill does indicate that giving medicine at prescribed doses does make prescribing easier and even improve adherence, but critics might still say that better clinical outcomes are needed. So clearly, the cholestrol drug market is witnessing a plethora of activity, be it through new mechanisms of action, or fixed drug combinations. However, statins remain a formidable marker in terms of the outcomes even as the target is to move beyond. But till the time that does not happen, they will rule even after generisation. shalini.g@expressindia.com

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‘Patient adherence team spending more than doubled from 2009 to 2011’ Patient adherence and disease education programmes now account for a combined 20 per cent of pharmaceutical brands’ marketing budgets. M Neelam Kachhap speakes to Manish Gupta, Chief Executive Officer, Indegene Lifesystems Bangalore, to know more about the rising trend Patient adherence is a hot topic for the healthcare industry. Why? World Health Organisation defines adherence as the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. Reports state that the global pharmaceutical market lost about $564 billion, or 59 per cent of the $956 billion in total global pharma revenue in 2011 due to patient non-adherence.

Adherence is important especially in the case of brands serving chronic conditions. Evidence states that it costs fewer dollars to retain a patient as compared to acquire a new patient. The focus is no longer only on acquisition, retention is equally important. Quality patient support programmes are thus needed to address: ● Differentiation among other brands in a crowded marketplace ● Addressing the expectations of informed patients

INTERVIEW

Decrease disease burden and morbidity by ensuring compliance ● Promote a holistic approach which includes lifestyle changes ● Bridge the gap between patient and physicians leading to effective disease management. Adherence programmes are no longer just a valueadd service. They can be used to measure patient outcomes, thus driving the pharma industry shift towards an outcome-based model. ●

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What is the function of patient adherence teams at a pharma company and how many companies in India have these teams? Most of the large pharma companies today have resources that are either dedicated to the patient support programmes or work with in liaison with the brand teams to develop these programmes. A recent survey reported that a majority of the pharma and biotechnology companies - close 71 per cent of surveyed companies â&#x20AC;&#x201C; had dedicated patient adherence teams. At present most of these programmes are carried out through partnerships with third-party service providers and NGOs. Most of these programmes are aimed at providing patient counselling about disease and wellness, medication reminders, value added services and provide complementary medications to low income group patients. The function of the patient adherence teams is to design the scope and scale of the adherence programmes. They also work closely with the partner organisations to ensure efficiency of the programs. What are the patient adherence budget allocations at pharma companies? The business segment has been growing at a tremendous pace. According to a recent report, overall patient adherence team spending has more than doubled from 2009 to 2011 and nearly doubled again in 2012. In the US specifically, patient adherence budgets rose 281 per cent from 2009 to 2012. The report also states that the patient adherence and disease education programmes now account for a combined 20 per cent of pharmaceutical brandsâ&#x20AC;&#x2122; marketing budgets, more than any other single marketing activity. The budget also differs across geographical territories. The US patient adherence budgets are usually much higherâ&#x20AC;&#x201D; higher than the average Europe/Canada or Asia Pacific budgets.

References http://www.capgemini.com/resources/patient -adherence-the-next-frontier-in-patient-care http://www.indiaoppi.com/OPPI%20Membe r%20Companies%20Contributions%20in

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%20Improving%20Access%20to%20Heal thcare%20in%20India.pdf http://www.in.capgemini.com/estimatedannual-pharmaceutical-revenue-loss-due-tomedication-non-adherence http://www.micromass.com/downloads/docu-

Being a niche and growing segment, exact numbers for the Indian market are not known. But the trends followed worldwide seem to be followed here as well. Many pharma companies have turned to outside vendors for these services? Kindly comment. A recent survey reported that pharma companies spend an average 41 per cent of their overall disease management and patient adherence budgets on outsourcing activities. These percentages vary across the world. 50 per cent of the surveyed companies in Europe and Canada outsource patient adherence efforts, while 38 per cent of the US companies and 33 per cent of Asia Pacific organisations use outside vendors. Driving the decision for outsourcing are the laws over patient data confidentiality and storage, which have become more and more stringent across the world. Pharmacological companies look for capable partners who can store the data in a secure and compliant manner. Moreover, this also eliminates the possibility of misuse of patient data making both doctors and patients feel more comfortable. Also, outsourcing specific programme activities allows these companies to more effectively manage several key steps in programme development and focus on core activities. What kind of adherencesupport activities do vendors provide? Most of these vendors provide a patient-centric model which promotes medication adherence, predominantly for chronic diseases. While the programmes are designed in conjunction with the parent pharma company, the project, logistic and people management is carried out by the vendor. Once the patients are actively enrolled on the programme, there are various services offered to the patient during the course of his/her therapy. These services revolve around medication adher-

ments/MMC11_PatientSupport_SinglePg.p df http://www.businesswire.com/news/home/20 130312005045/en/PharmaceuticalIndustry-Sees-Sharp-Rise-PatientAdherence

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ADHERENCE PROGRAMMES ARE NO LONGER JUST A VALUE-ADD SERVICE. THEY CAN BE USED TO MEASURE PATIENT OUTCOMES,THUS DRIVING THE PHARMA INDUSTRY SHIFT TOWARDS AN OUTCOME-BASED MODEL ence, disease awareness, behavioural counselling, lifestyle modification, drug procurement, medication reminders and other valueadded services such as subsidised test coupons, disease literature and so on. The patient is given assistance and support on a regular basis on his doorstep by field counsellors and remotely through telephone calls, SMS, emails and mobile applications. How many vendors are there in India and what is the market size of this sector? The Indian market is in a growing stage. Some of the bigger pharma companies have rolled out large patient adherence programmes which are aimed primarily at providing support for patients suffering from chronic conditions such as diabetes mellitus, cardiovascular diseases, and oncological illnesses. While some of these are run as pilot projects, some of these programmes are rolled out pan India employing more than 100 counsellors and engaging thousands of patients. What are the pros and cons of in-house vs outsourced adherence-support activities? Outsourcing these activities gives pharma companies a lot of advantages. Outsourcing can eliminate costs of maintaining the infrastructure needed to support the programme specific activities. Moreover, these activities are not their core competency and it need not employ its resources to managing these programmes. The other bigger advantage that encourages compa-

http://www.prnewswire.com/newsreleases/disease-management-and-patientadherence-41-of-program-budgets-are-outsourced-53292062.html http://www.reuters.com/article/2013/04/18/nc-cutting-edge-info-

nies to outsource specific portions of a programme is patient data confidentiality. Not only doctors and patients are more comfortable with third-party vendors handling patient records, but also in most countries it is illegal for the pharma companies to store patient data. Moreover, the companies often develop long-term relationships with these vendors and can leverage the vendors' expertise to create effective programmes. What is the future of outsourced adherence-support activities? With tightening data security laws and the increasing focus on achieving cost effectiveness and operational efficiency, the future of the outsourced adherence-support activities appears to be extremely bright. As more and more companies realise the need to differentiate their products in an extremely-competitive and almost-commoditised market, value added services in the form of patient support programmes will soon influence the decision to purchase a drug. Moreover, as the business segment becomes mature, the pharma companies are looking beyond these programmes as mere value added services or corporate responsibility. The programmes are now increasingly being structured so as to measure patient outcomes. This drives the companies to an outcome-based model where increasing adherence can be linked to improved patient outcomes and revenue. mneelam.kachhap@expressindia.com

idUSnBw185011a+100+BSW20130418 http://www.cuttingedgeinfo.com/2011/patien t-adherence-disease-education-pharmaceutical-marketing-budgets/

September 16-30, 2013

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COMPANY WATCH Ranbaxy completes 20 years in Russia Has operations in 56 regions of Russia

Head of Russia, Ranbaxy, said, “Over the years, Ranbaxy has established itself as a preferred generic pharma company in

Russia. In the coming years, we look at further expanding our product portfolio to include value added and inno-

vator products from our parent company, Daiichi Sankyo. We are working closely in partnership with regional gov-

ernments in line with the Russia Pharma, 2020 Healthcare Plan.” EP News Bureau - Mumbai

anbaxy has completed 20 successful years in Russia. The company established its operations in the Russian market in 1993 with the launch of its key brand, Cifran. Since then, Ranbaxy has grown to become number one player with a market share of 15.4 per cent in the represented market segment in Russia (IMS, May 2013). Ranbaxy today has operations in 56 regions of Russia. The company has a portfolio of products covering antiinfective, cold, pain management, cardiovascular, diabetology, central nervous system, urology and dermatology segments. So far, the company has registered 51 drugs in the Russian Federation and commercialised 72 SKU’s. Ranbaxy’s leading brands in Russia include Ketanov, Coldact, Faringosept, Cifran, Pylobact and Fenules. Last year, Faringosept was selected as the People’s brand of choice. Another brand, Cifran OD was ranked by IMS as the best antibiotic launch in 2004. Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy said, “Ranbaxy was one of the first pharma companies from India to set up operations in Russia. We have been providing high quality, affordable

RANBAXY HAS GROWN TO BECOME NO. 1 PLAYER IN THE REPRESENTED MARKET OF RUSSIA generic medicines to the citizens of Russia for the last two decades, thereby supporting the Government to bring down healthcare costs. We remain committed to the Russian market and will continue to operate from the paradigm of Quality and Patients First”. Aman Khanna, Country September 16-30, 2013

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UKTI signs MoU with ABLE Will aim at combining UK's heritage and leadership in the area of healthcare and life sciences and India's emerging and thriving healthcare ecosystem K Trade & Investment (UKTI) and the Association of Biotech Led Enterprise (ABLE) recently signed a memorandum of understanding (MoU) in Bangalore to encourage and develop collaborative opportunities between Indian life sciences organisations and the UK. Ian Felton, British Deputy High Commissioner, said, "Oncology is a key area of concern in the UK and in India. This mission is here to firm up relations on some extremely innovative work in the area of oncology. UKIndia Joint Innovation in the discovery and delivery of oncology will help to make this element of healthcare accessible and affordable to patients in both countries." Dr PM Murali, President, ABLE said, "ABLE is pleased to be signing an MoU with UKTI for collaborating on a range of opportunities. Cancer represents one of the

most challenging disease areas that require researchers and clinicians to work together at a global level. We recognise the importance of this delegation and appreciate its purpose." The MoU, a milestone for the UK Oncology Mission will aim at combining UK's heritage and leadership in the area of healthcare and life sciences and India's emerging and thriving healthcare ecosystem to promote and develop the life sciences sector in both countries. ABLE and UKTI also run the core initiative groups in different sector strands in life sciences. The partnership will include the participation of UK and Indian experts in life sciences in the areas of industry, research and trade. It will further promote UK and India as each other's partner of choice in life sciences such as drug discovery, bioinformatics, regenerative medicine, clinical research, agri-bio, oncology and regulation. This will be done through on-going research and discussion, identifying areas of potential business

Dr PM Murali, President, ABLE and Ian Felton, British Deputy High Commissioner opportunity that can be addressed by Indian and UK firms. At Bangalore, the delegation visited Health Care Global (HCG) Hospital, Biocon, Mitra Biotech, Mazumdar Shaw Cancer centre etc. "Our main aim is to facilitate collaboration between like minded Indian organisations in lifesciences and healthcare having common interest in oncology with the Uk-based organisation to make oncology care more affordable and accesible," said John Lownds, Acting Head of UK Trade &

Investment’s Strategic Trade Life Sciences Team. “The MOU would cement relationship we are looking to build in India.” he added. Jon Mowles, Life Sciences Sector Specialist, UKTI said, “There are three fiscal incentives for investors. First, corporation tax in the UK will go down to 20 per cent by 2015; companies will get tax credits for research in the UK and the patent box initiative, whereby tax on profits from the UK patents will be reduced to 10 per cent.” EP News Bureau–Bangalore

Competition intensifies as pharma companies race to launch type II diabetes drugs New Frost & Sullivan report analysis which products will eventually succeed and why, in the race against time he global pre-diabetes population is three times the size of the current diabetes patient population. A tremendous increase in the pandemic’s prevalence is in store, and the industry is in dire need of better tools to prevent disease progression. Identifying the precursors to fully developed diabetes through prophylactic therapy is vital, as an unexplored market segment driven by an ever-growing customer base. Meeting patients’ needs through the inclusive therapeutics approach allows practitioners to prevent and manage disease progression. This is crucial in the shift to prevention over treatment in the healthcare market

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and aligns with the new paradigm of physician quality over quantity. According to Frost & Sullivan’s Competitive Intelligence research, Analysis of the Global Type II Diabetes Therapeutics Market, 15 new drugs for type II diabetes are in latestage development (Phase III and preregistration). The analysis outlines opportunities in the market and the industry’s future through an international evaluation of current drugs and those in the pipeline. “The type II diabetes market continually advances, primarily due to the dominance of obesity”, noted the analyst, Frost & Sullivan. “Among the many trends we see coming, the pharma industry will address the ubiquity of diabetes by a steady stream of new product launches over the next www.expresspharmaonline.com

six years.” New diabetes treatment options meet many unmet patient needs. Subsequently, payers and regulatory authorities raise the bar for approval and reimbursement even higher, and the risk of regulatory or commercial failure then increases. Therefore, in a crowded market, new participants must demonstrate a spotless safety profile, along with superior disease control to ensure a competitive position. This is particularly important in the US where the diabetes patient population continues to expand, as is the case in several other countries, such as the UK, Germany, Spain, China, South Korea and India. The total health expenditures globally allocated to diabetes are eventually more than these regions can afford, as we see inefficient healthcare budgets addressed by expan-

sive measures such as the Affordable Care Act in the US. “Physicians desperately need patient-friendly tools that enable aggressive yet safe management of the disease to prevent complications that are costly to both the patients’ quality of life and the healthcare system,” said the analyst, Frost & Sullivan. “Due to the evolutionary nature of diabetes, many patients must progress through continuously altered regimens to maintain control of their disease. Therefore, therapies that preserve or restore beta cell function, postpone or prevent disease progression, and allow patients to remain on a single therapy will be the game-changers in the years ahead, based on what the market demands and needs today,”he added. EP News Bureau - Mumbai September 16-30, 2013

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FIS and IMCD in distribution partnership I Forays into new territories together

September 16-30, 2013

MCD Group is in distribution partnership with Milan-based FIS (Fabbrica Italiana Sintetici) for their range of active pharmaceutical ingredients (APIs), in particular: anxiolytics, anticonvulsants, antidepressants, analgesics, anti- inflammatory agents, antibacterials, antifungals, cardiovascular drugs, diuretics, oncological products and hormones. The new deal covers the following territories: Hungary, Slovenia, Serbia, Croatia, Macedonia, Bosnia and Herzegovina, Albania, Australia and New Zealand. The successful partnership of the two companies already covers a large number of countries in Maghreb, Central and Eastern Europe, most CIS countries and Russia and Austria. Anne-Claire Bizet, European API Development

Manager, IMCD said, â&#x20AC;&#x153;We are delighted about this new partnership at IMCD Business Group Pharmaceuticals, as this is the first time IMCD has an agency for an API manufacturer in Australia and New Zealand. APIs are a great complement to our comprehensive excipient portfolio which makes our offer to the pharma market complete.â&#x20AC;? FIS has custom synthesis as their core business, thus having the exclusive production of intermediates, advanced intermediates and APIs for leading pharma companies. FIS provides a wide array of integrated services to the customer, including process research and development, optimisation, and scale-up facilities to support both validation and commercial launch. IMCD Pharmaceutical Business Group is the num-

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THE NEW DEAL COVERS HUNGARY, SLOVENIA, SERBIA, CROATIA, MACEDONIA, BOSNIA AND HERZEGOVINA, ALBANIA, AUSTRALIA AND NEW ZEALAND.THE SUCCESSFUL PARTNERSHIP OF THE TWO COMPANIES ALREADY COVERS A LARGE NUMBER OF COUNTRIES IN MAGHREB, CENTRAL AND EASTERN EUROPE, MOST CIS COUNTRIES AND RUSSIA AND AUSTRIA ber one distributor of pharma ingredients in Europe, supplying a comprehensive range of excipients, active ingredients, speciality solvents, process chemicals and intermediates. IMCD's team of high-calibre pharmacists across the Group work closely with principal partners to provide expert

formulation support and advice, focusing on key project development to deliver innovative solutions. Furthermore, IMCD's commitment to conduct regular seminars ensures that all customer requirements are met and target objectives can be agreed upon. EP News Bureau - Mumbai

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Avesthagen signs license agreement with AvestaDHATM Through the non-exclusive agreement, Avesthagen stands to earn $30 million over the next decade

vesthagen, an integrated systems biology platform company has announced a license agreement with AvestaDHATM for animal feed application. The agreement is non–exclusive and Avesthagen stands to earn $30 million over the next decade. Dr Villoo Morawala Patell, Founder and Chairperson, Avesthagen said, “This is one step towards our continuing commitment to discovery and commercialisation of science-based products that promote health and well-being throughout life. AvestaDHA will serve as an acceptable and safe source of DHA for the much neglected field of animal health.” DHA is naturally found in different types of fish oil and

marine plankton, but it is anticipated that the supply from this source will be insufficient to meet growing demands. As per industry analysts, just the algal DHA/EPA market for 2013 is expected to exceed $525 million while growing at an annual rate of 24 per cent. The total global market for products containing DHA exceeds $26 billion (Source: Frost and Sullivan, 2011) Avesthagen’s innovative patented and trademarked technology allows commercial production of superior quality, 100 per cent vegetarian AvestaDHA derived from microalgae found in the Indian Ocean. Adds Patell, “Avesthagen is open for global licensing, manufacturing and marketing alliances for human and med-

ical nutrition, animal feed and many other applications. AvestaDHA is targeted at improving the nutritional health of the bottom of the pyramid and Avesthagen invites like-minded government, private organisations and civil society to join in the mission.” Avesthagen developed AvestaDHATM with a grant from CSIR under the New Millennium Technology Leadership Initiative (NMITLI) scheme for production of cost effective and renewable sources of DHA and other long chain polyunsaturated fatty acids. The project also involved the National Institute of Oceanography, the Indian Institute of Integrative Medicine, Jammu, and the Indian Institute of Chemical

Technology, Hyderabad. DHA is a polyunsaturated Omega-3 fatty acid found throughout the human body. More specifically, DHA is a major structural component found in the brain grey matter, eye retina and the heart. DHA Omega-3 fatty acid is an essential nutrient for people of all ages and known to promote healthy brain, eye and heart and in treating certain cancers. It is also used as an additive in animal feeds as well as aquaculture. It can help overcome the nutrition deficit faced by a majority of the population in India and can be especially effective for overcoming physical and mental stunting prevalent among nutritionally deprived children. EP News Bureau - Mumbai

Novo Nordisk launches basal insulin for adult patients with type I and type II diabetes To be available in India soon

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resiba, a new basal insulin developed by Novo Nordisk for the treatment of type I and type II diabetes was recently launched in India. Tresiba is a once-daily basal insulin with a duration of action beyond 42 hours, allowing for flexibility in dayto-day dosing time when needed, without compromising efficacy or risk of hypoglycaemia1,2,3 , as mentioned in the company release. It happens to be the first insulin to offer people with diabetes the flexibility in the timing of insulin administration on occasions when administration at the same time of day is not possible. A particular problem people with diabetes face while taking insulin is a condition of low blood-sugar called hypoglycaemia.Hypoglycaemic episodes are unpleasant and experiencing them might lead to a lower compliance with insulin therapy, leading to increased risk of long-term complications4. Night-time hypoglycaemia is of particular concern for people living with diabetes, as these are often unpredictable and difficult to detect and react upon5. The lower rates of night-time hypoglycaemia with Tresiba will allay some of these concerns and encourage patients and physicians to aim for more

ambitious glucose targets. Tresiba reduces blood glucose levels with a lower risk of night-time hypoglycaemia compared to other molecules available in the market. The price and the availability date of the product has not been decided as yet. During the launch of Tresiba in Mumbai, Mads Bo Larsen, Vice President for Business Area Africa, Gulf and India, Novo Nordisk said, “Innovation has always been at the core of Novo Nordisk, aiming to deliver high-performing products and drugs that will help in meeting the demands of tomorrow's challenges. With the launch of Tresiba we are bringing in a world class innovative product to India that will give the person with diabetes a better way to take control of their condition.” “Novo Nordisk has a long heritage in changing the diabetes landscape with 90 years of leadership position in diabetes care. We have focused our efforts in developing treatments that address key challenges faced by patients and clinicians. We have been constantly innovating and discovering new molecules that bring in significant clinical benefits to patients that would enable them to lead a healthy and productive life. We have www.expresspharmaonline.com

always ensured we have a wide range of products to address the growing requirements of patients across genre. Tresiba is one such product that reiterates our commitment and passion for delivering better value to people with diabetes,” said Melvin Oscar D’souza, Managing Director, Novo Nordisk India. Dr Ib Jonassen, Senior Principal Scientist, Novo Nordisk and the inventor of the molecule said, “Degludec works in a different way compared to other insulin treatments. The insulin forms a long chain of hexamers, like a string of pearls. Individual Degludec molecules break away from the chain, like a pearl coming off the string, one at a time and they are slowly and continually absorbed into the bloodstream. This allows Degludec to be slowly and steadily absorbed, at a constant rate, into the bloodstream providing an opportunity for long duration of action which can be beyond 42 hours.” Dr Raman Shetty, Clinical Medical and Regulatory Director, Novo Nordisk India said, “In current insulin treatments, people with diabetes are required to take their longacting insulin at around the same time each day. However, the mode of action of insulin

degludec ensures that, on occasions when this is not possible, people with diabetes can alter the time they take their insulin without compromising their diabetes control or putting themselves at increased risk of hypoglycaemia. However it is important to note that patients must consult their doctor and strictly follow their advice about any change in their treatment.” EP News Bureau - Mumbai

References 1. Kurtzhals et al., Multi-hexamer formation is the underlying mechanism behind the ultra long glucose lowering effect of insulin degludec. Diabetes 2011;60(Suppl 1): LB12 (Abstract 42-LB). 2. Nosek L et al., Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect. IDF 2011 21th World Congress Abstract Book. Diabetes 2011;60(Suppl 1): LB14 (Abstract 49-LB). 3. Tresiba® [summary of product characteristics]. Bagsværd, Denmark, Novo Nordisk A/S; 2012. 4. Leiter LA et al., Assessment of the impact of fear of hypoglycemic episodes on glycemic and hypoglycemia management. Can J Diabetes 2005;29:186-92. 5. Allen KV et al., Nocturnal hypoglycemia: Clinical manifestations and therapeutic strategies toward prevention. Endocr Pract 2003;9:530-43. September 16-30, 2013

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US FDA accepts Boehringer Ingelheimâ&#x20AC;&#x2122;s supplemental new drug application To be used for use of dabigatran etexilate mesylate in deep vein thrombosis and pulmonary embolism oehringer Ingelheim Pharmaceuticals announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for its use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT and PE are collectively referred to as venous thromboembolism (VTE), which is the third most common cardiovascular disorder after coronary artery disease and stroke. A DVT occurs when a blood clot develops in a deep vein, usually in the leg or pelvis, and either partially or totally blocks the flow of blood through the vein. A PE occurs when a DVT, or part of it, breaks off, and travels through the bloodstream to the lungs, blocking a vessel. This is considered a life-threatening condition. There are an estimated 900,000 VTE events per year in the U.S., approximately onethird of which result in death from PE. Further, roughly onethird of people with VTE will have a recurrence within 10 years. The standard of care for patients with acute VTE is anticoagulation. Sabine Luik, Senior Vice President, Medicine & Regulatory Affairs, US Regional Medical Director, Boehringer Ingelheim Pharmaceuticals (BIPI) said, Boehringer Ingelheim is committed to addressing the complex medical need of patients with deep vein thrombosis and pulmonary embolism. We look forward to discussing with the FDA dabigatrans use in these two potentially lifethreatening conditions. The sNDA is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of this condition, specifically RECOVERTM I and II, REMEDYSM and RE-SONATE. Pradaxa is currently approved by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), and was the first oral anticoagulant approved by the FDA in more

September 16-30, 2013

than 50 years for this indication. Prescribing experience

with Pradaxa continues to grow with more than six million prescriptions for Pradaxa 150 mg and 75 mg filled for more than 800,000 NVAF patients in the US since

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its approval in October of 2010. Pradaxa is included on formularies that insure about 95 per cent of covered lives in the US, through commercial and Medicare Part D plans.

Pradaxa is also included in recommendations from three leading US cardiology guidelines for stroke prevention in Afib. EP News Bureau - Mumbai

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Bilcare starts field validation studies of its nonClonableID technology Developed in collaboration with CSIR, the system aims to secure the pharma supply chain as well as improve patient compliance eptember 1 marked the roll out of field validation studies of Bilcare's novel nonClonableID technology which got approval under the Council of Scientific and Industrial Research (CSIR) under its New Millennium Indian Technology Leadership Initiative (NMITLI) Scheme last May. The nonClonableID technology is based on novel aspects of material science and utilises the law of randomness to create unique non-duplicable fingerprints. These fingerprints when processed, digitised and activated can function as unique identification tags. Speaking to Express Pharma, Dr Praful Naik, Executive Director & Chief

Scientific Officer, Bilcare who is the principal investigator for the project, said that, "two leading brands of anti-diabetes and anti-TB medicines from leading MNCs have incorporated the nonClonableID technology into their packaging." A total of 50 patients, (25 patients on each disease arm) will be enrolled by the 10 participating doctors. The study is expected to continue over 5-6months and both arms will be monitored by a super specialist. The aim is to securitise the supply chain in the existing scenario, from the point of origin to the point of sale. The technology allows tracking of the medicines from the manufacturing facility to warehouses, then on to CNF agencies and stockists and finally to the retail level ie. the stockists and chemists. But what differentiates this technology is that it moves

into the patient's home as well. So the patient can scan the medicine strips, authenticating that the product is genuine. A second improvement over existing track & trace technologies is that it records consumption/non-consumption of doses and also alerts patients that their medicines are getting over allowing them to replenish their medicines in time so that no dose is missed. This attempt to monitor medicine usage and non-compliance was added based on feedback from medical practitioners who were consulted during the planning stages. For instance, if a patient delays consuming a dose at the prescribed time, he receives a reminder. If the medicine is still not consumed, the second reminder is sent to the patient as well as his doctor and caregiver (generally a family member). This signals a missed dose/non compliance to the doctor who can counsel the patient about the risk of developing drug resistance if the prescribed dosage regimen is not followed and ensure that better compliance is maintained via the caregiver as well. Thus, Bilcare's nonClonableID tags are useful not just to crack down on counterfeit medicines but also to reduce non-compliance leading to drug resistance. As Naik speaks of the problem of multi-drug resistant TB plaguing India, as well as the impor-

Zandu Ayurveda launches its first clinic at Nature Cure & Yoga Centre in Kolkata Plans to launch more Z clinics in other select cities

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andu Ayurveda has launched its first clinic in Kolkata. Located 30 minutes from the city of Kolkata the Nature Cure & Yoga Centre is at Konchowki on Diamond Harbour Road. The clinic has been set up under the guidance of RS Agarwal and RS Goenka of Emami with the active cooperation of Sunil V Khaitan, Managing Trustee, Nature Cure and Yoga Centre. The clinic has on its panel a number of ayurvedic experts and has also enlisted the

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tance of diabetes patients taking their medication at the prescribed times, it is evident why these two disease conditions were chosen for the field validation study. The scanning device (reader) currently costs around Rs 2000-Rs 2500 and Naik indicates that the price will reduce after commercial launch as more manufacturers start making the device. There is also a chance that the government might subsidise the cost in certain cases.The field validation study is expected to last five to six months, and will involve around 10 doctors (five in each arm) headed by a super specialist who will monitor both arms. The study size may be small (a total of 50 patients, 25 patients on each disease arm will be enrolled by doctors) but represents almost a year of extensive background work done by CSIR and Bilcare to create a completely scaled up system infrastructure for eventual nationwide implementation. Naik hopes the field validation it will go a long way towards demonstrating the utility of the nonClonableID tags in establishing product accountability through secured traceability from the point of origin to the point of dispensation, authenticity check and establishing epedigree as well as improving medication compliance by patients. EP News Bureau â&#x20AC;&#x201C; Mumbai

services of Dr P Debasis, a renowned ayurvedic expert. The clinic has been operational since early July. In coming months, Zandu Ayurveda has plans to launch more clinics in other select cities. The Clinic aims to support the traditional health heritage and promote ayurvedic principles. Along with naturopathy, the clinic also aims to use ayurveda for additional preventive and curative support. EP News Bureau - Mumbai September 16-30, 2013

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Lupin receives US FDA approval for generic rifadin capsules Is indicated for the treatment of all forms of tuberculosis upin's US subsidiary, Lupin Pharmaceuticals has received final approval for its Rifampin capsules USP, 150 mg and 300 mg strengths from the United

States Food and Drugs Administration (US FDA). Lupin’s Rifampin Capsules USP, 150 mg and 300 mg are the AB-rated generic equiva-

lent of Sanofi Aventis' Rifadin Capsules 150mg and 300mg strengths. Rifampin capsules is indicated for the treatment

of all forms of tuberculosis for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the

nasopharynx. Rifadin capsules had annual US sales of approximately $18.5 million. EP News Bureau - Mumbai

Your production process for tomorrow Integrated and tailored solutions for your process

DRL launches divalproex sodium extended - release tablets, USP

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Glatt Engineering Consulting Process Engineering

Receives US FDA approval

General Planning r Reddy’s Laboratories (DRL) has launched Divalproex sodium extended - release tablets, USP (250mg and 500mg), a therapeutic equivalent generic version of Depakote ER (divalproex sodium) Tablet, extended release in the US market. DRL’s ANDA for Divalproex sodium extended- release tablets, USP was approved by the United

THE DEPAKOTE ER BRAND AND GENERIC HAD COMBINED US SALES OF APPROXIMATELY $194 MILLION

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Indian Office: Glatt (India) Pharma Engineering Pvt. Ltd. 13 Ground Floor Palam Marg, Vasant Vihar New Delhi - 110057 / India phone: +91 -11 - 460 529 60 / 61 / 62 fax: +91 -11 - 460 529 64 eMail: info@glatt-india.com

States Food & Drug Administration (US FDA). The Depakote ER brand and generic had combined US sales of approximately $194 million MAT for the most recent twelve months ending in June 2013 according to IMS Health. DRL’s Divalproex sodium extended - release tablets, USP 250 mg are available in bottle count sizes of 100 and 500 mg are available in bottle count sizes of 100 and 500. EP News Bureau - Mumbai September 16-30, 2013

Headquarters: Glatt Ingenieurtechnik GmbH Nordstrasse 12, 99427 Weimar / Germany phone: +49 -3643 -47-0 fax: +49 -3643 -47-1271 eMail: info@glatt-weimar.de

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Expansion of product offerings with focus on cancer therapeutics drives M&A activity worldwide and the total number of cases is globally increasing. According to World Health Organization, the number of global cancer deaths is projected to increase 45 per cent from 2007 to 2030 (from 7.9 million to 11.5 million deaths), influenced, in part, by an

India market sees no deals in August â&#x20AC;&#x2DC;13 &A activity in the pharmaceutical sector was focused on strengthening product portfolios with a focus on cancer therapeutics, as cancer is a leading cause of death

Figure: M&A (including private equity) trend analysis

2 6 5

3 4

11 16

4 5

& '

# $ ! % !

Source:

Top M&A deals (Aug 2013) Rank 1 2

Date 08/25/13 08/27/13

08/26/13

08/16/13

08/28/13

08/30/13

Target Onyx Pharmaceuticals, Inc. (US) Hi-Tech Pharmacal Co., Inc. (US)

Acquirer Amgen, Inc. (US) Akorn, Inc. (US)

Deal value ($m) 10400 640

Amplimmune, Inc. (US)

MedImmune, LLC (US)

500

Thornton & Ross Limited (GB)

STADA Arzneimittel AG (DE)

344

Boca Pharmacal, Inc. (US)

Qualitest Pharmaceuticals, Inc. (US)

225

Acton Pharmaceuticals, Inc. (US)

Meda AB (SE)

145

42.5

42.08 16.04 15.92

08/26/13

Argos Therapeutics, Inc. (US)

Green Cross Corporation; Forbion Capital Partners; TVM Capital Group; Lumira Capital Corp; Intersouth Partners; Morningside Group (Holdings) Limited; The Aurora Funds, Inc.; Caisse de depot et placement du Quebec; Pharmstandard International S.A.

8 9 10

08/13/13 08/01/13 08/01/13

Hwail Pharma Co., Ltd. (KR) Liaoning Baifeng (KR) Expansis (ES)

CrystalGenomics, Inc. (KR) Daewoong Pharmaceutical Co., Ltd. (CN) United Drug Plc (IE)

Source:

Figure: Venture financing trend analysis

increasing and aging global population. New cases of cancer in the same period are estimated to jump from 11.3 million in 2007 to 15.5 million in 2030. In line with the above trend, Amgen agreed to acquire Onyx Pharmaceuticals, a US-based biopharmaceutical company, for approximately $10.4 billion. This acquisition is fully consistent with Amgenâ&#x20AC;&#x2122;s strategy of advancing innovative medicines that address serious unmet medical needs and Amgen expects this acquisition will accelerate growth and enhance value for shareholders. With this acquisition, Amgen will benefit from the global rights to Onyx's innovative oncology portfolio and pipeline. Amgen will gain access to an important and growing multiple myeloma franchise, with Kyprolis (carfilzomib) for Injection, already approved in the US. Amgen intends to leverage its oncology capabilities and experience to support Onyx's clinical development programmes and maximise Kyprolis' potential in the US and the rest of the world. The acquisition of Onyx also adds to Amgen's robust latestage pipeline. This pipeline includes nine innovative products for which registration-enabling data are anticipated by 2016. Four of these are innovative, first-in class oncology products. Onyx's pipeline complements Amgen's growing oncology portfolio. In another key deal, MedImmune agreed to acquire Amplimmune, a US-based biologics company, for approximately $500 million. This acquisition significantly strengthens the AstraZeneca and MedImmune portfolio, enabling the pursuit of the most effective data-driven combinations of IMT-C molecules, as well as combinations with highly targeted small molecules. With this transaction, MedImmune will gain access to multiple early-stage assets for its immune-mediated cancer therapy (IMT-C) portfolio, including AMP-514, an antiprogrammed cell death 1 (PD-1) monoclonal antibody (mAb). AMP-514 is currently in late-stage pre-clinical development with an aim to file an investigational new drug (IND) before the end of 2013. Other Amplimmune assets include multiple preclinical molecules, targeting the B7 pathways. M&A activity in the pharma sector decreased in volume terms and increased in value terms, when compared to the average of the previous six months (February â&#x20AC;&#x201C; July 2013). According to Datamonitor's Medtrack database, the pharma sector recorded 30 M&A transactions in August 2013, against the previous six monthsâ&#x20AC;&#x2122; average of 32.8 transactions. In value terms, the sector recorded deals worth $12.4 billion, against the previous six monthsâ&#x20AC;&#x2122; average of $7.1 billion. The Indian pharma sector witnessed no deals during August 2013, against the average of 0.6 deals over the previous six months.

Venture funding Companies in the pharma sector raised $111.6 million during August 2013, against the previous six monthsâ&#x20AC;&#x2122; average of $211.6 million. In terms of volume, the sector recorded five venture funded deals, when compared to the previous six monthsâ&#x20AC;&#x2122; average of 21.1 transactions.

Notes and Definitions

Source:

Top venture financing deals (Aug 2013) Rank

Date

Target

Investors

Deal value ($m)

Aug 1, 2013

Dicerna Pharmaceuticals, Inc. (US)

RA Capital Management, LLC; Brookside Capital; Omega Funds; Domain Associates, L.L.C.; Oxford Bioscience Partners; Skyline Ventures; SR One; Deerfield Management Company; Abingworth Management Limited

60.00

Aug 27, 2013

Syndax Pharmaceuticals, Inc. (US)

Domain Associates, L.L.C.; MPM Capital; RusnanoMedInvest; Forward Ventures

26.60

Aug 22, 2013

MicuRx Pharmaceuticals, Inc. (US)

BioVeda China Fund; Morningside Group (Holdings) Limited; Devon Park Bioventures

25.00

Definitions

Source:

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Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrackâ&#x20AC;&#x2122;s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking. 1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals. 3.Value and volume analysis excludes private equity exits. For more information, visit us at www.medtrack.com

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September 16-30, 2013

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Piramal Healthcare to invest $11 million at its UK facility Work on the new suite, which will house formulation, packaging coating and tableting equipment, will commence at the end of 2013 iramal Healthcare will invest $11 million at its Morpeth, UK facility to triple the production capacity for hormonal products, including contraceptive pills and hormone replacement therapies. The expansion, which has been commissioned in response to customer demand and new business gains, will see the Morpeth site’s production capacity increase by around 2 billion tablets per annum. Work on the new suite, which will house formulation, packaging coating and tableting equipment, will commence at the end of 2013, with mechanical completion anticipated within 12 months and full operations expected to begin following a six month validation period. This latest investment follows Piramal Healthcare’s recent announcement that it is to invest $2.5 million at its FDA approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing suites, from clinical phase to commercial grade, in response to customer demand. The upgrade will give Piramal two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site. Vijay Shah, Executive Director and COO, Piramal Enterprises said, “The production of hormonal products is a highly specialised, niche area. The Morpeth facility is our Centre of Excellence for these products and this expansion will greatly enhance our offer and potential for growth in this space. The hormonal sector currently represents a $11 billion market globally and is growing at a pace of four to five per cent annually. With major competition limited to a small number of CMOs in Europe, Piramal sees major opportunities for growth in this area given our vast experience in this field, which spans more than 40 years.” With this expansion, Piramal aims to be one of the largest contract manufacturers in this niche segment which, as per the US FDA

September 16-30, 2013

and MHRA regulations, requires a dedicated manufacturing facility for the handling of high potent

molecules. The 13,000 sq ft Morpeth facility also houses Active Pharmaceutical Ingredient (API) production, general solid formulation production, and a range of clinical trial supply and research facilities, and was acquired by Piramal

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from Pfizer in 2006. Piramal Healthcare provides Late Phase API services on an integrated manufacturing model across North America, Europe and Asia. All its facilities manufacturing commercial phase APIs have been GMP certified and possess

API finishing facilities. Piramal has a successful performance record of over 40 years for the supply of APIs to the US and European markets from its facilities located in Canada, India and the UK. EP News Bureau-Mumbai

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EVENT BRIEF Master Class on Bio-entrepreneurship Date: September 20-23, 2013 Venue: National Institute of Immunology, New Delhi Summary: BIORx Venture Advisors (BIORx) has launched comprehensive Master Class Bio-entrepreneurship with the theme 'Accelerating Innovations to marketplace – A small step towards strengthening India’s Bio-economy.' Perceiving the acute need for enabling technologists to become successful business women/men in the life sciences sector, BIORx has designed this programme on bio-entrepreneurship. Contact details Uttam Singh NegiCompany Secretary BIORx Venture Advisors Tel: (0120) 6450521 Mob: 8130155022 Email: uttam.negi@biorxventures.com

Spectrum 360o Date: September 21, 2013 Venue: MGM Institute of Health Sciences Auditorium, Kamothe, Navi Mumbai Summary: MGM School of Health Management Studies (constituent college of MGM Institute of Health Sciences) will organise the second chapter of Spectrum 360o under the theme Supply Chain in Healthcare – 'Delivering Care in Real Time'.

Fax: (020) 6607 0061 Email: tikenderjit.singh@fleminggulf.com Website: www.fleminggulf.com URL: http://www.fleminggulf.com/ conferenceview/Clinical-Trials-AsiaSummit-/485

Lex Witness 2nd Annual Pharma Legal & Compliance Summit 2013 Date: September 27, 2013 Venue: Hotel The Leela, Mumbai Summary: With increasing management expectations from senior professionals on business strategy formulation, especially in a complex regulatory environment, the 2nd Edition of Pharma Legal and Compliance Summit is the best investment of time to analyse, interpret and strategise your current and future response to legal, regulatory and compliance challenges. Contact details Bhupinder Kaur Sr Executive- Special Initiatives Team Lex Witness - India's 1st Magazine on Legal & Corporate Affairs B 1/6, Hauz Khas New Delhi – 110016 Tel: (011) 43440013 Fax: (011) 43440099 Mob: 9654155065 Email: Bhupinder@witnesslive.in

Clinical Trials Asia Summit Date: September 26-27, 2013 Venue: Hyderabad Summary: Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for further growth towards establishing sustainable leadership of India in global Clinical Trials scenario. Contact details Tikenderjit Singh Makkar Dy. Mktg. Manager - India Fleming Gulf, 605, City Tower Boat Club Road, Pune - 411001 Maharashtra (India) Tel: (020) 67276403

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Contact details Prachi Sr Manager - Publications & PR IDMA 102-B, 'A' Wing, Poonam Chambers Dr. Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: ppr@idmaindia.com / prach17@gmail.com Website: www.idma-assn.org

Health Technology Assessment (HTA) at IIT Madras in collaboration with National Health System Resource Centre (NHSRC). The fellowship programme will feature international and national faculty giving lectures on various facets of HTA. Healthcare professionals like biomedical and clinical engineers; students pursuing public health management and health policy courses; patient safety officers and care providers; health economists; hospital and healthcare programme managers; and professionals and providers who deal with healthcare technologies, are likely to be benefitted from the programme. Contact details Mohammad AmeelConsultant Biomedical Engineer,Healthcare Technology Division (Medical Devices)National Health Systems Resource CentreMinistry of Health & Family Welfare, Govt. of IndiaNIHFW Campus, Munirka, New Delhi110067Tel: +91-1126108982,84,92,93 Fax: +91-11-26108994, 83, Cell: 9971234320Website: www.nhsrcindia.org Alternate mail: Mohammad.Ameel@nhsrcindia.org

PharmaTech Expo 2013 Date: October 6-8, 2013 Venue: Brilliant Convention Centre, Indore

6th Symposium on Nasal and Pulmonary Drug Delivery Date: October 24-25, 2013 Venue: Hotel Novotel, Juhu, Mumbai

16th PAC-2013 Date: September 27-28, 2013

Contact details Mob: 9892194282 / 9833774269 / 9987539191 Email: spectrum360@outlook.com Website: www.spectrum360.webs.com

Government laboratories; research institutions; academic institutions; business consulting companies; contract manufacturing organisations; contract research organisations; R&D equipment / machine manufacturers; supply chain management; API, excipients and intermediates manufacturers and CROs. Heads of strategy and business development, R&D, regulatory affairs; analytical development laboratory; quality control / assurance; production; packaging; purchase; exports; medical affairs; pharmacology and toxicology; outsourcing; supply chain; pharma product development; logistics and clinical research services are likely to attend the convention.

Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013. The main theme for this year's convention is 'Generics The Game Changer'. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest. Experts in analysis, research, academia and regulatory spheres from the Indian pharmaceutical industry, will converge and get-together to interact on various recent developments. The convention will be held in order to update and exceed the current regulatory requirement and science-based systems approach in pharma industry. The convention is designed to cater to all those involved in: pharma industry; biopharmaceutical industry; biotechnology industry; nutraceutical industry; microbiological industry;

Summary: PharmaTechnologyIndex.com and Indian Drug Manufacturers Association are jointly organising the second edition of PharmaTech Expo 2013 in association with Pharmexcil. Contact details Keena Shah PharmaTechnologyIndex.com 702, Corporate House Opp. Dinesh Hall, Income Tax Ashram Road Ahmedabad - 380009 Tel: (079) 27541142/ 27540493 Mob: 09825698756 Email: kns@pharmatechnologyindex.com Website: www.pharmatechexpo.com

3rd International Fellowship on Health Technology Assessment Date: October 21-26, 2013

Summary: The Indian Pharmaceutical Association announces the 6th Symposium on Nasal and Pulmonary Drug Delivery with a theme “Global Regulatory Trends”. The two-day scientific symposium is tailored specifically to nasal and pulmonary drug delivery and will welcome a panel of highly renowned scientists and technical experts for sharing knowledge about Orally Inhaled and Nasal Drug Products (OINDPs). Contact details S D Joag Indian Pharmaceutical Association Kalina, Santacruz (East) Mumbai - 400 098 Tel: (022) 26671072 Tlfx: (022) 26670744 Email: ipacentre@ipapharma.org Website: www.ipapharma.org

analytica Anacon India 2013

Venue: IIT Madras Summary: Healthcare Technology Innovation Centre (HTIC) will conduct the 3rd International Fellowship on

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Date: November 12-14, 2013 Venue: Bombay Exhibition Centre, September 16-30, 2013

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Mumbai Summary: The seventh international trade fair and conference for laboratory technology, analysis, biotechnology and diagnostics will have visitors from various domains like, pharmaceutical, chemical and petrochemical, health care, food, electrical engineering and electronics, medical laboratory, medicine, universities, research institutes and more. Contact details Anish Gangar Sr Manager - Marketing Communications MMI India 507/508, INIZIO Cardinal Gracias Road Chakala, Andheri (East) Mumbai - 400 099 Mobile: 98205 82197 Email: anish.gangar@mmi-india.in

API organisations, machinery and packaging, laboratory and analytical equipments, diagnostics, contract manufacturers and clinical research organisations will take part. The event will be colocated with IndiaLabExpo 2013. Contact details Atanu Bhattacharya Director Human Crayon Management Services C-28, Sector - 4 Noida - 201301, India Tel: (0120) 6528801 / (011) 65378800 Mob: 9810303916 (Delhi) / 9167280126 (Mumbai) Email: atanu@crayon4.com Website: www.pharmabiotika.com

Innovation in OTC Business: From Concepts to Action

Date: November 21-23, 2013 Venue: Hitex Exhibition Centre, Hyderabad Summary: Doctors, nursing homes and hospitals, formulation organisations,

September 16-30, 2013

Venue: The Westin Mumbai Garden City, Goregaon, Mumbai Summary: CubeX, in association with Nicholas Hall & Company isorganising a one-day conference, Innovation in OTC Business: FromConcepts to Action. Hear the expert views of Nicholas Hall himself oninnovation as a significant growth driver for OTC industry.

Mumbai - 400 059 Tel: (022) 61727162 Fax: (022) 61727273 Email: chaitali.patil@ubm.com

65th IPC, 2013 Date: December 20-22, 2013 Venue: Amity University, Noida

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai

Date: November 22, 2013

PHARMAbiotika 2013

Contact details CubeX (a Division of Sorento Healthcare Communications), Unit No. 12, Garodia Estate, 3/A Udyog Nagar, SV Road,Goregaon (West), Mumbai - 400 064 Maharashtra Tel: +91 022 4036 2008 Email: rshriyan@cubex.co.in

Summary: CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia's leading pharma industry event.

Summary: Indian Pharmacy Graduates' Association will host 65th IPC, 2013. Express Pharma has been chosen as the â&#x20AC;&#x2DC;Exclusive Official Media Partnerâ&#x20AC;&#x2122; for the 65th IPC, 2013. The event will be organised by Indian Pharmaceutical Congress Association. The academic partner for the event is Amity University, Noida. Contact details Dr Arun Garg General Secretary-IPGA Director-PDM College of Pharmacy Bahadurgarh, Haryana Mob: 09416056213

Contact details Chaitali Patil UBM India, Times Square Unit No 1 & 2, 'B' Wing, 5th Floor Andheri Kurla Road Marol, Andheri (East)

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POST EVENT PSM India organises workshops on pharmacovigilance Stakeholders across the spectrum deliberated on the current state of pharmacovigilance and ways to make the system stronger. Viveka Roychowdhury present key highlights ndia has good planning but faulty implementation.” This analysis by Dr Surinder Singh, Director in charge, National Institute of Biologicals summed up the uphill task before India can claim to have a robust pharmacovigilance (PV) system. Therefore two workshops, the first in Bengaluru followed by a second in Mumbai within a week, by the Partnership for Safe Medicines (PSM) India Initiative, are a welcome move to get together the different links of the PV system Both workshops served as platforms to discuss near-term solutions that help train health care professionals, patients, consumer groups and other stakeholders throughout India. The key points that were discussed ranged from the regulatory (role of the central government in developing policies on patient safety and quality health, the role of the state government on strengthening the drug regulatory mechanism at the ground level) to the clinical (practitioners deliberated on the impact of non-adherence to medication compliance). Integration of technology measures in monitoring of

“I

ACTIONABLE SUGGESTIONS ❑

❑

❑ ❑

Dr Urmila Thatte, Prof and Head Dept of Clinical Pharmacology, Seth G S Medical College & KEM Hospital: Outreach to clinicians should increase; improve reporting from centres, attitudinal change is vital Dr Ketan Parikh, paediatric surgery consultant, Indian Medical Association: Educate patients; sensitise clinicians to see the purpose of ADR reporting; ADR reporting should be un-biased Dr Pervez Ahmed, Vice Chairman, PSM India Initiative: Change training and curriculum of medical schools to influence prescribing habits of doctors; incorporate triggers and alerts Dr Surinder Singh, Director in charge, National Institute of Biologicals: Recognition of ADR reporting clinicians to encourage others clinicians Gauri Shyam Panda, President, RARE Consumer Organisation, Orissa: From the BPL consumer's point of view, there should be a mechanism to allow the patient/consumer to directly report that the doctor has not reported ADRs

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adverse drug reactions (ADRs)) was followed by representatives from NGOs like RARE Consumer Organisation from Orissa on community engagement and communication on PV and specifically India's PV programme, the Pharmacovigilance Programme of India (PvPI). Dr Surinder Singh's comment set the tone of the day in the inaugural session which had regulators like C P Singh, IAS, Chairman, NPPA, Dr V G Somani, Joint Drugs Controller India, and Mahesh Zagade, FDA Commissioner, Govt. of Maharashtra spelling out their initiatives on the PV front as well as admitting to gaps which need to to be filled. The workshop was hailed by all speakers as an opportunity to come up with workable action points which could be built into the system. Bejon Misra, trustee of the Consumer Online Foundation and founder of PSM India Initiative indicated that these points would be summarised and presented as a proposal for actions. For instance, the private healthcare provider's perspective came from Dr Pervez Ahmed, Vice Chairman, PSM India Initiative who opined, “We have to not reform but transform the system.” He is also lead director and vice chairman, Saket City Hospital, Delhi and his views possibly reflected that of many private healthcare providers when he recommended engaging medical schools to influence the prescribing habits of doctors. The system has to be made more patient centric by redesigning the training schedule and curriculum. He recalled his own experience of practice in the US where the system has in-built triggers, for instance, anyone over 65 years on more that nine medicines immediately sets off an alert that there is some problem of quality of care. He hopes that such triggers and alerts can be built into our county's PV system as well. Dr V Kalaiselvan, Senior Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad gave an update on the role of the National Coordination Committee in PvPl while Dr Urmila Thatte, Prof and Head Dept of Clinical www.expresspharmaonline.com

Pharmacology, Seth G S Medical College & KEM spoke on the role of ADR monitoring centres. She emphasised that outreach to clinicians is very important and highlighted that more work needs to be done to improve reporting from centres as its important to have Indian data. Her sense was that unless there was pressure from patients, reporting rates would not improve as practising doctors would then be forced to report ADRs. Dr Ketan Parikh, paediatric surgery consultant, Indian Medical Association, expressed his previous reservations about the PV system and the difficulties of clinicians like him incorporating ADR reporting into their daily practice. Patients need to be alerted that there could be ADRs to any medication so that they do not go on the offensive blaming either the doctor for faulty diagnosis or prescription, the drug company for faulty medicines. This attitude puts the doctor on the offensive who blames the patient for not following the dosage regimen. The drug company could go on the offensive but also highlighted the impact of non-adherence to medication compliance. He resolved to listen to clinical pharmacologists like Dr Thatte more often. Given the many challenges, hope came from the integration of technology into the PV system. Dr Praful R Naik, Executive Director & Chief Scientific Officer, Bilcare gave details of a collaborative project with the CSIR. Field validation studies rolled on from September and the hope is that Bilcare's non-clonable tags integrated into medicine strips would work as both

anti-counterfeiting devices as well as improving patient compliance and ADR reporting. (More details in Express Pharma report: 'Bilcare starts field validation studies of its nonClonableID technology'; http://bit.ly/1al0J6L) Some of the suggestions are already on the agenda. For instance, Dr Singh said that they will be taking the “battle into the clinicians' court” through CMEs (six planned for this year itself) and such PV workshops (two per month). And since the sensitisation has to start from the top, Dr Singh indicated that Dr Shakti Gupta, medical superintendent and HOD, hospital administration, AIIMS, has been approached to speak to this community of medical superintendents. There are plans that the Drug Controller General (India) will involve his army of lieutenants, i.e. the CDSCO's drug inspectors to visit ADR centers where there is zero reporting of ADRs but Dr Singh gave an assurance that ADR reporting will be non-punitive. For once, funds are not an issue. Dr Singh indicated that Rs 100 crores has been set aside for PvPI in the current Five Year Plan, with Rs 10 crores allocated for the current year. The finds are being deployed to set up the basic infrastructure like the ADR reporting cells, etc. With both the funding and the policy aspects in place, lets hope that the PvPI finds wider acceptance. Organisations like PSM India and other consumer activist groups need to keep up the pressure to ensure that these activities pick up momentum and do not fizzle out. viveka.r@expressindia.com September 16-30, 2013

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National Forum on Tuberculosis holds first meeting in New Delhi Discusses the rise and challenges of drug-resistant TB in India

September 16-30, 2013

he National Forum on Tuberculosis held its first meeting in New Delhi. The members of the Forum deliberated upon the increased need to introduce new and more accurate diagnostics for tuberculosis (TB) to ensure timely and appropriate diagnosis. The members also discussed the rise and challenges of drug-resistant TB in India. The Chief Guest at the meeting was Shashi Tharoor, Minister of State for Human Resource Development,

Minister of State for Health and Family Welfare (MoHFW). Soumya Swaminathan, Director, National Institute for Research in Tuberculosis (NIRT) made a presentation on the emergence of drug-resistant TB as well as the challenges of the Indian TB diagnostic landscape. The National Forum on Tuberculosis also released the first national Standards of TB Care (STCI). STCI has been developed by the Central TB Division (CTD). It is a way to engage with the Indian private sector for effective TB prevention and control. The standards take into account World Health Organization (WHO) and International Standards for TB Care (ISTC) endorsed regimens used across the globe. The standards will be updated with the latest evidence and practices for TB control in India and disseminated to all private providers. The forum was launched on May 8, 2013 with the vision to discuss and highlight criti-

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cal challenges in TB prevention and control. The launch also saw the release of a Handbook on TB in India. The National Forum on TB will work to raise awareness on the need for improved TB control. The members of the forum will meet several times in a year to discuss critical challenges in TB control. Based on these discussions, the members will formulate key recommendations to address these challenges which will then be presented to the MoHFW for further action. The forum consists of an advisory board comprising leading members of the Parliament. This meeting brought together parliamentarians, policymakers, technical experts, civil society representatives as well as government officials. Dalbir Singh, convener of the forum commented, â&#x20AC;&#x153;The forum is dedicated to fight TB and as a first vital step, this meeting has brought together

key stakeholders including parliamentarians, policymakers, civil society organisations and technical experts, who are committed to the cause. We are resolved to achieve enhanced TB prevention and control in India.â&#x20AC;? TB kills one Indian every two minutes. India bears the highest burden of TB in the world- 2.3 million annually. This accounts for one-fifth of the global disease burden. TB is the cause of extensive economic losses leading to individual, family and community suffering. TB is also associated with a deep-seated stigma that often leads to discrimination within the workplace and the community. As representatives of the worldâ&#x20AC;&#x2122;s largest democracy, policy makers, parliamentarians and the civil society play a pivotal role in influencing policy decisions. The forum will aim to leverage this power to make an impact on the TB landscape in India. EP News Bureau - Mumbai

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OPPI seminar debates healthcare access in India The event saw the presence of distinguished professionals, acclaimed experts and scientists from the Indian healthcare industry and allied sectors ith the participation of many policy makers and healthcare stakeholders, Organisation of Pharmaceutical Producers of India's (OPPI) seminar on ‘Access to HealthcareChallenges and Way Forward’, turned out to be a highly successful event. The event also saw the presence of distinguished professionals, acclaimed experts and scientists from the Indian healthcare industry and allied sectors. While addressing the gathering, Ranjit Shahani, President, OPPI and Vice Chairman and Managing Director, Novartis, said, “Every individual should be able to easily receive optimal preventive and curative care, without adverse financial impact to access to healthcare. The primary role of pharma companies is to

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develop and market high quality medicines for medical needs. Multiple stakeholders need to come together to improve access to healthcare and one of the key members would be the Government. Partners such as UN agencies, NGOs and others also play a meaningful role with their expertise and resources.” While providing insights into the Indian healthcare market to improve access, Amit Backliwal, Managing Director, IMS Health Information and Consulting Services, said that quality, human resource and healthcare infrastructure are some of the factors that decide the healthcare access. He also pointed out that the Indian healthcare environment is a complex one with significant variations across the country in terms of population and geography. The comprehensive IMS study, based on a survey of nearly 15,000 households across 12 states along with 1,000 doctors and experts, has revealed that

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while progress has been made in India over the past decade by both public and private sector initiatives, significant challenges persist in providing quality healthcare on an equitable, accessible and affordable basis across all regions and communities. Dr Sanjay Oak, Vice Chancellor, Padmashree Dr D Y Patil University, gave a very informative speech over the ways to make healthcare delivery more efficient. He spoke about innovative concepts like mobile clinics/ diagnostics/ dialysis units/ operation theaters/ ICUs and door to door delivery. Mobile care units would ensure the availability of healthcare to needy patients. He stressed that people's involvement is the most important thing in increasing healthcare access. “Accessibility is as important as affordability,” Oak argued. A lot has been said about PPP in the healthcare sector. Venkat Raman, Associate Professor, Faculty of Management Studies, Delhi University, discussed the

challenges and opportunities associated with this concept. Significance of private health sector in India and PPP models in service delivery were also the key points in his speech. He said, “Given the respective strengths and weaknesses neither the public sector nor the private sector alone is in the best interest of the health system.” Speakers at the event unanimously opined that industry should contribute parts of their profits for building the healthcare infrastructures in needy areas. Besides to make working in rural areas compulsory for doctors, increased expenditure through PPP model was also debated as important thing to increase healthcare access. In a country like India with more than a billion population, healthcare access is very challenging. Debates, as such will not immediately improve the situation but will definitely lay the foundation for the same. sachin.jagdale@expressindia.com

September 16-30, 2013

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UK seeks to create healthy business environment with India 13 British pharma, life sciences and research organisations on a business visit to India K and India's business ties within the pharmaceutical and healthcare sectors continue to grow, with 13 British pharma, life sciences and research organisations visiting India this September. The delegation's first engagement was in Mumbai on September 2. As part of their engagement in Mumbai, UK Trade & Investment (UKTI) Mumbai, hosted a panel discussion on ‘International collaboration in drug delivery science' aimed to create an opportunity for Indian and UK business delegates to meet and interact to explore trade links in Western and Southern India. The panel discussion brought together major pharma MNCs, CROs, oncologists, hospitals, scientists, intellectual property experts and other healthcare professionals to provide areas of opportunities for UK companies as well as to deliberate on issues related to drug delivery systems that need urgent attention. Express Pharma and Express Healthcare were the media partners for this discussion. Kumar Iyer, British Deputy High Commissioner, Western

Kumar Iyer

Mahesh Zagade

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India & Director General, UKTI inaugurated the event and explained the reason for their visit to India. It was followed with a small welcome note by Mahesh Zagade, Commissioner Food & Drugs Ad m i n i s t r a t i o n , Commissioner of Food Safety, Maharashtra state who spoke about increasing UK and India business ties within the healthcare sector. He stated, “I believe this kind of interaction will further developments within the Indian pharma and healthcare industry and will also help in research and development (R&D) which will ultimately be beneficial to the end consumer i.e. patients.” He also pointed out the need for an efficient drug delivery system in India, and issues such as over use of antibiotic drugs in India. Raising a valid point, he said that excess prescription of antibiotic drugs leads to drug resistance which is a bigger threat in India. He left it to the audience and the panelists to ponder on these important points. This was followed by the panel discussion. The panelists were Sangeeta Topiwala, Director-Market Access,

Dr Tselepi

Ranga Iyer

Nidhi Saxena

Sangeeta Topiwala

John Lownds

Inbaraj Baskara

Speakers at the event www.expresspharmaonline.com

September 16-30, 2013

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Sanofi, Nidhi Saxena, CEO, Karmic Life Sciences, Ranga Iyer, Promoter, Salus Lifecare, Dr Tselepi, Founder Director, Cavendish NanoTherapeutics and Inbaraj Baskara, Mirada Medical . The discussion was moderated by Viveka Roychowdhury, Editor, Express Healthcare and Express Pharma, The Indian Express Group. Topics discussed included opportunities and challenges in Indian pharma and healthcare sector, need for advance drug delivery systems,opportunities in NDDS in India, etc. The discussion started off with Topiwala speaking on the need for advanced drug delivery system for medicine in India. She stress upon topics such as chemotherapy and toxicity which is one of the biggest challenges in today’s time. Additionally, she spoke about the advancements in targeted therapy in the fields of oncology and diabetes. Introducing one of their latest products, AllStar insulin pen, she spoke about how the company as part of their CSR activity contributes Rs 10 from each pen towards creating better healthcare networks. Dr Tselepi spoke about her company which offers advanced medical systems aimed at increasing the efficacy of chemotherapy or radiotherapy by targeting solid can-

Delegates at the event cer tumours. She further drew notice towards the various business opportunities in this segment. Moving on, Iyer brought in a different perspective on drug delivery. “Any drug delivery system has to be patient centric rather than business,” he stated. Further on, he suggested that India pharma needs to focus on fixed dose combination systems. Pointing out another of India's biggest challenges, he said that the country lacks in logistic and compliance ratio. “Compliance to medicine in India is horrible,' he claimed. Citing an example of the 'goli ke humjoli campaign'- an initiative based on providing free oral contraceptives to women in the rural areas of India, he went on to say that inspite of distributing contraceptive pills free of cost, these women skipped their medicine doses.

"Drugs should be developed in such a way that the patients would not require to take them on a daily basis. This will make chances of skipping the dose less likely," On these lines, he urged the industry to look at the compliance factor while developing a drug delivery system.“ Drug delivery to patients must be done efficiently without worrying about the compliance factor,” he added. Further, Saxena highlighted the opportunities within the new drug delivery system (NDDS) market in India. “Today 17 per cent of the global NDDS market is present in India which is a $100 billion market”. She emphasised, “Indian companies should join hands with partners from the US, Europe and other developed countries and conduct clinical trials. Through such partnerships

they can bring products to market in less than or within 24 months. This kind of synergy will help in bringing new technologies at much affordable costs in India and will be beneficial to the patients.” Despite having one of the largest pharma industries in the world India hasn't yet managed to produced a single new chemical entity (NCE) and Saxena touched resons for this lapse like the lack of proactive support from the government and the huge investment required to develop NCEs, hampering the growth of this area of research. Moreover, there was a common consensus among the speakers over the fact that while developing new NCEs, efforts should be taken to reduce their side effects as well. Baskara also spoke on the role of IT in facilitating efficient drug

delivery system. While concluding the panel discussion, speakers also felt that the Government needs to play a bigger role in making healthcare affordable. The speakers pointed out that India's healthcare spend as a percentage of its GDP is very less. Also Indian pharma companies, namely Cipla, Piramal Enterprises, Ranbaxy Laboratories and Sun Pharma are currently working on various NDDS projects and results are likely to be seen in the near future. The Government of India has started a national immunisation programme but thanks to issues like nonmaintenance of cold chain etc, only 65 per cent of babies are benefited from the programme according to Iyer. “The Government of India has launched the food security bill in the Parliament, it also needs to look into the access of medicines at affordable costs,” he commented. The delegation proceeded to Bangalore where UKTI and the Association of Biotech Led Enterprise (ABLE) signed an MoU to encourage and develop collaborative opportunities between Indian life sciences organisations and the UK. Rounding off the tour, UKTI hosted a two- day Oncology Summit in Chennai. EP News Bureau - Mumbai

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September 16-30, 2013

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W H AT ’ S INSIDE

MANAGEMENT INSIGHT FOR MANAGING PHARMA

Boehringer Ingelheim India: Revving up PG42

MARKET 13 RESEARCH 44 PHARMA ALLY 50 PHARMA LIFE 71

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www.expresspharmaonline.com

September 16-30, 2013

M|A|N|A|G|E|M|E|N|T 'Companies need to proactively hedge their risks and minimise impact on their earnings' he Indian rupee has depreciated significantly against the dollar, raising anxieties amongst many stakeholders in the country. Year to Date (YTD), rupee has depreciated ~21 per cent against USD. At the same time, the Prime Minister of India, Dr Manmohan Singh recently made a public statement, â&#x20AC;&#x153;To some extent depreciation can be good for the Indian economyâ&#x20AC;? So, what is the true impact? We looked at this question from the perspective of the Indian pharma industry. Here are some of the key points; Rupee depreciation does not seem like an India-specific phenomenon even though it looks like India has been more seriously impacted. The below chart show the YTD currency performance of BRICs vs USD Also, this is not the first time that Indian rupee/emerging

NEERAJ VASHISHT Senior Principal, IMS Consulting Group

Source: www.oanda.com

Source: EXIM Bank India; IMSCG Analysis

September 16-30, 2013

www.expresspharmaonline.com

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markets currencies have depreciated significantly. In 2008, Brazil currency depreciated ~34 per cent against USD followed by Indian rupee which depreciated ~24 per cent. During these periods, the Indian pharma market (IPM) market growth saw a short term dip but bounced back significantly in the following year (INR terms). While the dip and the growth cannot be attributed to currency fluctuations alone, it is useful to keep the macro picture when reviewing the impact. The key point being that currency depreciation does not imply a gloom and doom scenario for the industry. ❑

In general, Indian pharma exporters have an opportunity to benefit from rupee depreciation. Indian companies get paid in dollars when they export. With a strengthened dollar, they make a better top line which gets directly translated to its bottom line in rupee terms at the same time it allows them to compete for more business on price. Ability to handle pricing pressures is especially valuable in relatively commoditised spaces like the Contract Research And Manufacturing Services / Active Pharmaceutical Ingredient (CRAMS/API) segment where the sector is facing stiff global competition from countries like China, Brazil. Of course this advantage will not equally apply across all sectors

because some of the BRIC countries have depreciated comparably. ❑ MNCs/private equities waiting to invest in India may find it cheaper to raise stakes in the country. Rupee depreciation might attract foreign direct investment (FDI) in pharma sector as cheaper currency makes it easier to invest in India for those planning to raise stakes in the country. Suddenly, valuations look attractive and spur investment action. However these factors might have a muted effect over the short term to the extent the buyers/ sellers have hedged themselves. e.g. Lupin has hedged 35 per cent of receivables for 18-20 months, Dr Reddy has outstanding cash flow hedges worth US$ 480 mn hedged between ` 56-59 for a period of 18 months. (Source: Company quarterly earnings call transcript) ❑

On the flip side Indian companies intending to expand globally having plans to do global transactions will find it more expensive. Rupee depreciation might put inorganic growth plans on hold (as currency depreciation makes it more difficult to do global transactions) ❑

MNCs that have already invested in the country may further hesitate to invest in India: As they see one more hindrance in their way after the

recent government price caps through new exploration licensing policy/ weak intellectual protection law (Novartis denied Glivec patent: Novartis said the decision "discourages future innovation in India”).

'Exports will encash the benefit'

❑

Companies saddled with external cost and debt commitments will get impacted: As their effective cost of borrowing has gone up significantly For e.g. Aurobindo Pharma has forex loans of $600 million which has resulted in increase in total liabilities. At the same time, companies that rely heavily on importing material will be impacted significantly, if not properly hedged. IMS view on the Indian market is focused around its fundamentals i.e. country demographic trends, public spend trends, disease burden trends etc.- all of these factors continue to point towards long term growth of the industry. Companies need to look beyond just the immediate term outlook and focus on these underlying growth drivers since currency fluctuations do not typically impact fundamentals. The bigger risk may be in hesitating and incurring opportunity costs, given the fast evolving nature of the Indian market. In the same breath, over the short term, companies need to proactively hedge their risks and minimise impact on their earnings, since these are factors beyond their control.

BHAVIN MUKUND MEHTA Director, Kilitch Drugs (India) epreciating rupee shall have mixed impact on the sector. Companies which are highly dependent on exports or more than 50 per cent of their turnover is from exports shall gain from the depreciation, where as companies who have hedged their positions might not be able to benefit of the depreciation. Top companies in India have good exposure for exports in west, they will be in a position to encash the benefit. Moreover, there are many companies who have substantial exposure to imports of intermediates in order to process the raw material and some companies import API's and they have already booked their orders at a particular dollar value, the depreciating rupee will be an issue for them since this will be in inverted position but if the company have entered into forward booking then they can take the advantage of the same.

'The rupee depreciation has happened at the wrong time for the pharma industry' he Indian rupee is under great stress as overseas investors are paring their exposure to Asia’s third largest economy amid international uncertainty and mounting worries over the domestic economy. The rupee has depreciated to over 19 per cent just a matter of three months, and is further expected to depreciate. This depreciation has caused much concern in overall industrial growth and pharma is no exception to the same. While it may seem that majority of the pharma exporting companies will benefit by this by their forex earnings, their forex gain would become negligible if they are importing their API/s or even intermedi-

TS JAISHANKAR Managing Director, Quest Life Sciences

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www.expresspharmaonline.com

ates. The biggest beneficiaries are those who are making shipments in the current month and probably in the next month wherein the raw materials are already in place. Besides, companies manufacturing their own API could also be the biggest beneficiaries. The majority of the small medium enterprises (SMEs) will find it extremely difficult to honour their loan commitments, especially because their costing is based entirely on imported raw materials without duty. The companies supplying to domestic market would also be affected because of higher cost of inputs and there is no export earnings. The rupee depreciation has happened at the

wrong time for the pharma industry considering that the drug price control order (DPCO) has come down heavily in price reduction exercise for nearly 350 essential drugs. The impact of this depreciation would be known very clearly by October 2013. However, it is very evident that the pharma industry would be affected by higher input cost on account of depreciating rupee. Besides, pharma is the only industry heavily controlled by price control. It does not give any flexibility to increase the retail price. The overall production and consequently employment opportunities will take a very severe beating. September 16-30, 2013

M|A|N|A|G|E|M|E|N|T 'Rupee depreciation is expected to increase manufacturing costs'

DR E SANEESH Research Analyst, Business & Financial Services, Healthcare, Frost & Sullivan

he rupee’s weakness unfolded when it depreciated over 16 per cent against the US dollar between January 2013 and July 2013. With the rupee expected to fall further, its impact on the pharma industry is cut both ways. The Indian pharma industry is majorly an export oriented business with exports contributing nearly 50 per cent of the revenues. Since the US is the major export market, depreciation of rupee against the dollar will result in cash inflows for pharma companies that have a majority of their sales in US. However, the extent to which US sales can positively impact the profitability of these companies is questionable, because the leading participants ‘hedge’ their revenues or cash flows, by locking into a fixed exchange rate for a portion of their revenues. Companies like Sun Pharma, Cipla and Divi’s Labs realised quick gains compared to other companies because of their favourable hedging policy. Another key factor influenced by rupee depreciation is the debt held in foreign currency by pharma companies; interest and loan repayments in

US dollars will negatively impact the earnings of these companies. Aurobindo Pharma, Jubilant Life Sciences, Glenmark, Shasun and Ranbaxy have a significant portion of their debt in foreign currency, so export gains will be partially hindered by debt and interest payments. If these companies have not hedged their loans at fixed dollar rates they will have to pay back at a higher dollar conversion rate than those at which they acquired the loan. Rupee depreciation is expected to increase manufacturing costs, primarily for companies, which are dependent on imports for raw materials. However, the impact is very mild for major companies because imports are mainly from China. A depreciating rupee coupled with increasing price of raw materials will raise input costs for small pharma companies that primarily cater to the domestic market. Amidst strong earnings in the export market, the revenue and profit growth of the companies in domestic market will slow because of the new drug pricing policy. Therefore, the slump in domestic sales is expected to slightly offset the gains from export business. Moreover, currencies of other emerging economies like Russia, Brazil, and some African countries have also depreciated over the past few months. Indian pharma companies have made their presence felt in other emerging economies like Brazil, Russia, etc. Dr Reddy’s in Russia, Lupin in Japan and Torrent in Brazil are a few examples. So the net effect of export gains from depreciating rupee are expected to be partially neutralised by reduced returns from sales in other emerging economies. Impact of rupee depreciation on the pharma industry is not an openand-shut case, the impact can only be assessed by the end of second half of 2013 because it is also expected that the buyers in exporting countries will have higher negotiation power and they might pitch for more discounts, which can reduce the margins of these export-oriented pharma companies.

IMPACT OF RUPEE DEPRECIATION ON THE PHARMA INDUSTRY IS NOT AN OPEN-ANDSHUT CASE,THE IMPACT CAN ONLY BE ASSESSED BY THE END OF SECOND HALF OF 2013 BECAUSE IT IS ALSO EXPECTED THAT THE BUYERS IN EXPORTING COUNTRIES WILL HAVE HIGHER NEGOTIATION POWER AND THEY MIGHT PITCH FOR MORE DISCOUNTS September 16-30, 2013

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'The depreciation of the rupee is a pointer to the imbalance in the countries'

SUSHEEL KOUL Director, Enaltec Labs

he rupee has depreciated against the US$ by almost 20 per cent in the past one year, about 11 per cent in the past 30 days and about four per cent in the past one week. That in essence sums up the ‘unsteady’ decline of the rupee in the recent past. The $ Index (which measures the performance of the $ against a basket of currencies) has appreciated by about 2 per cent in the past one year, reflecting movement of trade/capital to the $. The depreciation of the rupee is a pointer to the imbalance in the countries. Balance of

Payments (BOP) and market sentiments being in favour of the $ for various reasons. As per the 2011-12 annual report of the Department of Pharmaceuticals, Ministry of Chemical & Fertilizers, Government of India, the Indian pharma sector generates about 40 per cent of its sales from exports. Therefore, a sharp depreciation of the rupee positively impacts the sector. However, as per the same report, imports account for 38 per cent of the cost of raw materials of the pharma sector. This, to an extent, checks the higher margins on account of rupee depreciation. Therefore, a 20 per cent rupee depreciation will have a net positive impact of about 8 per cent on the gross margins of the sector, assuming raw material accounts for about 63 per cent of sales. However, the impact of the movement in the rupee will vary across companies depending on their individual hedging policies, net exports and foreign currency

borrowings. Given the one way slide of the rupee, it is tempting for a net exporter to leave currency positions open. However, companies, (especially large listed companies) look at managing their forex positions by borrowing in foreign currency at lower interest costs, selling or buying currencies in the forward or the futures market or perhaps buying put or call options so as to provide a stable earnings visibility to investors. Small and medium sized companies generally lack the expertise to dabble in the forex markets and given their smaller transaction sizes, options too are limited. These companies can perhaps look at covering a part of their net positions over a period of time with forward covers or adding cheaper foreign currency loans with the objective of reducing fluctuations in their earnings. A related concern in the near term may be a general slowdown in overall business as currencies across the globe grapple with falling growth rates and a rising dollar.

THE IMPACT OF THE MOVEMENT IN THE RUPEE WILL VARY ACROSS COMPANIES DEPENDING ON THEIR INDIVIDUAL HEDGING POLICIES

‘Government should look to effectively promoting alternative ancient Indian medical therapies’ he rupee is in a vicious circle of low investment, high risk, negative sentiment, investor sentiment dipping and exiting all this putting more pressure for withdrawal of investment from India. This vicious circle needs to be broken. Some tough measures to address these negative aspects need to be taken and boldly implemented although these may be of a high risk nature, politically. This will send a strong message of a 'no nonsense approach' on the part of Indian establishments to global and domestic investors, who will then start to re-evaluate coming back and slowly the circle will get broken. The near future seems to be very choppy, with currency fluctuation and inflation remain-

KH VISWANATHAN Executive Director, RSM Astute Consulting Group

EXPRESS PHARMA

ing the bad boys. Indian healthcare industry should look to go for more effective import substitution and use of local resources in providing services. Government should look to effectively promoting alternative ancient Indian medical therapies to enable people to have options for a low cost but reasonable effective treatments for ailments. Most Indian pharma companies need to spend quite an amount on overseas markets for marketing costs, R&D costs, trial costs, US FDA payments and approvals etc., all of which being in $, the effective costs in India go up. This results in an increased cost loading on the Indian production leading to substantial squeeze in profitability. www.expresspharmaonline.com

'Exact impact can be understood in times to come'

DHEERAJ AGGARWAL Chief Financial Officer, Venus Remedies he rupee stands at an alltime low against the US dollar. This depreciation should make Indian commodities/products relatively cheaper for importers and as a result, the volume of exports will rise. However, its exact impact can be understood in times to come. At the same time, the cost of imports will rise. It can lead to an adverse balance of trade initially. But with the passage of time, the volume of sales will only improve the balance of trade. The companies heavily relying on imports will have to bear the brunt of the devaluation and may opt for bulk purchasing if they have to import from their foreign client, or else they will have to make-do with a new Indian client within Indian liaisons. In the domestic market, the cost of the products distributed by a company will increase due to higher import costs, thus causing a rise in the prices of products offered for domestic sale. Impact of the depreciating rupee on the Indian pharma industry

Pros: 1) Benefit of currency conversion on inward payments 2) In order to remain better placed in international markets, exporters have an option of passing on the value addition benefits to the customers. 3) It will allow domestic

API manufacturers to have a competitive advantage. 4) The growth of pharma exports will help the Indian economy arrest the fall of the rupee through reduction in CAD. Cons: 1) It will negatively impact the Indian currency rates as some pharma products will have to be imported. 2) The volatility in currency rates can result in losses for exporters who import API and re-export after value addition. 3) The transportation charges for goods from factory to port and vice versa will increase as a volatile currency will result in rise in petroleum prices in India. 4) The cost incurred on paying salaries of overseas employees will escalate. 5) The import of APIs, intermediates and special packaging materials will further aid in the volatility of the Indian currency.

Steps to cope with the depreciation of rupee A pharma company heavily relying on exports or operating in the domestic market should take the following steps to minimise the impact of the depreciation: 1) Manufacturing companies which import raw materials must consider Indian API manufacturers because they will not be affected by the currency devaluation. 2) A company can resort to bulk purchasing of raw materials to guard against process costs, reorder costs, import duties and freights. 3)Companies which are into exports must have a rich inflow of the currency against which the rupee is devalued (in this case the US dollar and euro). Since L/C negotiations take time, immediate telegraphic transfer or advance payments should be resorted to. 4)Companies should avoid making payments in dollar during the depreciation period or wait till the situation improves. 5)It is highly imperative for companies operating in the domestic market to work on economies of scale and devise new methods for cost cutting so that the increased API cost can be well balanced. September 16-30, 2013

M|A|N|A|G|E|M|E|N|T

'Company should try to free themselves from forex debt and should not hedged future revenues'

D K AGGARWAL Chairman and Managing Director, SMC Investments and Advisors he Indian rupee has again pushed the domestic economy back by falling below 66.09 vis-a-vis the US dollar, and increased inflation is on the cards. At present, the Indian economy is reeling under pressure on the back of fears of flight of capital ahead of the Fed’s expected move of tapering off quantitative easing and negative domestic economic fundamentals; these

altogether have been dragging the rupee lower. To sum up, when the rupee depreciates as against the dollar, it simply means that value of the Indian currency has gone down relatively against the greenback. There is a high level of pessimism about rupee and the government, along with the policy makers, should address the rising current account deficit (CAD) and slow growth with concrete measures until optimism finally settles in. The steep fall in rupee as against the dollar presents both risk and an opportunity to the India pharma sector, depending on their business model, foreign debt vis-a-vis earnings and hedging strategies. With a depreciating rupee, the value of exports naturally increases. Hence export-oriented companies post gains in forex earnings. Yes, the worst affected are the net importers, with high forex loans. No doubt, most of the Indian pharma are net exporters and stand to gain through higher export realisations enhanced by a depreciating rupee. However, losses on external commercial borrowings (ECBs) and limited possibility of adaptation on foreign currency convertible bonds

(FCCBs) pose a concern to these companies, but the tread may not be huge. To note, Indian pharma companies are mostly into manufacturing of generic drugs and offers drugs at a price much lower than the patent holder company. Moreover, rupee’s decline increases price competitiveness of Indian products in overseas markets, which may aid the volume led growth. On the contrary, many think that rupee's weakness is a silver lining to the pharma sector as on the ground that it improves competitiveness and thereby exports, but one should not forget that price sensitivity of India’s export basket is very low and thus, rupee’s depreciation does very little in increasing exports. However, the free fall in rupee is expected to severely impact those companies, who import raw material, have large foreign currency debt on their books and only partial hedging in place to upset the currency fluctuation. Also the companies with large forex hedges or foreign liabilities will see substantial immediate negative hit due to translation loss or mark-to-market (MTM) loss. Furthermore, the fallen

THE STEEP FALL IN RUPEE AS AGAINST THE DOLLAR PRESENTS BOTH RISK AND AN OPPORTUNITY TO THE INDIA PHARMA SECTOR, DEPENDING ON THEIR BUSINESS MODEL, FOREIGN DEBT VIS-A-VIS EARNINGS AND HEDGING STRATEGIES rupee imposed a higher burden on interest charges and repayment obligations. Companies such as Ranbaxy, Cadilla, Wockhardt and Aurobindo import substantial inputs and have to sacrifice their margins. Ranbaxy is expected to take a substantial hit this year due to MTM loss on large outstanding forex hedge of $ 962 million. To note, the Indian pharma industry has slowed from over 17 per cent just two years ago to 10 per cent this year and trending even lower because of the price control regime. At present, the domestic currency has been sliding continuously and this fall is likely to impact those companies which are largely dependent on import. The impact of rupee depreciation will vary for companies, depending on their presence

in markets outside India, product mix and currency hedging position. In order to deal with the rupee depreciation, the pharma companies should choose the appropriate hedging instrument. Moreover, the pharma company should try to free themselves from foreign exchange debt and should not hedged future revenues. For example: Sun Pharma, being a major exporter, is a big gainer on rupee depreciation as falling rupee adds to sales and margins. However, if rupee remains at current level, the loans to be repaid in next fiscal would cost higher and the companies such as Aurobindo, Glenmark and Dishman that have huge loan books, and are likely to get impacted most as they have to pay more.

'Indian pharma companies are likely to halt their expansion plans and may wait to execute overseas plans'

UTKARSH PALNITKAR Partner, Head - Transactions and Restructuring, National Head - Life sciences ppactice, KPMG

he depreciation of the Indian rupee comes with a mixed bag of implications on the Indian pharmaceutical

September 16-30, 2013

industry. While the consequences are inclined marginally toward the positive, some companies are likely to bear the brunt of this devaluation. The rupee has depreciated ~11 per cent against the US dollar during the past quarter. This event is likely to benefit Indian pharma companies which are in nature primarily export driven. Exports comprise 50-80 per cent of revenues of Indian pharma companies and the majority of the revenues are US dollar denominated. On an average, one per cent depreciation in rupee results in ~1.3 per cent increase in operating earnings (assuming exports comprise 50 per cent of the overall revenues).

Considerations However, there are a few key factors that should be considered before drawing any inference: ◆ 70 per cent of raw material and 20 per cent of labour cost are linked to the dollar. ◆ The price competition

◆

among tier-II pharma companies. The depreciation in other emerging market currencies against the dollar.

Consequences While the impact could be positive for companies with significant international revenues, many pharma companies have substantial foreign currency loans as well. Many firms hedge their net exposure over varying time frames, thus the positive impact could be affected by hedges and mark-to-market losses on forex liabilities. Interest costs may rise due to depreciating Indian currency, which could eventually lead to restatement of loans and hedges for companies. Short-term loans and increased working capital requirements are also likely to contribute to higher interest costs. On the domestic front, there may not be a substantial change, but companies need to be vigilant about inflationary concerns impacting the input costs and expensive imports, if any. These should www.expresspharmaonline.com

be streamlined and monitored. Historically, the depreciation of the rupee has worked in favour of Indian generic companies, when rupee depreciated ~11 per cent q-o-q in 3QFY12, the margin performance of Indian pharma companies improved significantly. On the transactions front, Indian pharma companies are likely to halt their expansion plans and may wait to execute overseas plans. Also, the Indian companies may find fund raising to be a challenge as investors are likely to exercise extra caution over decreasing bond yields, which in certain cases are below the currency conversion

rates. However, it should be kept in mind that the reverse is also true as a strong dollar will encourage MNCs to scout for potential targets in the Indian pharma market; domestic companies with strong portfolios and offering unique propositions are likely to attract acquirers and investors. Recent FIPB clearances on FDI should initiate M&A activity presenting a win-win situation to the acquirers and the targets. To conclude, the current currency depreciation may be positive at an operational level, but it has mixed implications for transaction considerations for the Indian pharma companies.

Conclusion The depreciating rupee is like to have many repercussions however, the pharma industry feels that there are definitely some silver linings in the hovering dark cloud. Quite a few Indian pharma players believe that the adversity can be turned around into an opportunity if a suitable strategy is put into place. u.sharma@expressindia.com

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M|A|N|A|G|E|M|E|N|T

SPOTLIGHT Boehringer Ingelheim India: Revving up While other MNC pharma companies have long histories in India, Boehringer Ingelheim's India story has just begun. As BI India completes a decade of operations in India, Sharad Tyagi, chairman and managing director, BI India gives details of the company's high-growth strategy to Viveka Roychowdhury

lobally Boehringer Ingelheim (BI) is a 128-year-old company but is only a decade old in India. Since its registration in 2003, the company spent the first few years laying the ground work in the country and studying the market, as well as developing channel partners and building a base for clinical operations. Inspite of not having a direct base in the geography, the company has had a presence in the India market for the past 30 years, thanks to two brands: Dulcolax and Buscopan, two of what the company designates as its flagship international core brands (ICBs). Seven years after its late entry, the pace of growth at BI India picked up with the launch of Pradaxa (dabigatran) and Trajenta (linagliptin) in 2012. In fact, chairman and managing director Sharad Tyagi indicates that the company is planning to launch at least one new molecule/indication every year for the next several years. Thus he feels that from a perspective of strategy, BI entered India at the right time. In retrospect, 2012 was a landmark year for BI in India as it marked a transition from building the base to launching into a growth phase. Tyagi, who joined BI less than three years ago, has been tasked with executing BI's high-growth strategy for the country. He says that

the previous year. Thus for BI India, the launch of its CHC brands will be closely watched as emerging markets like India will be a major growth driver for BI's CHC portfolio.

EXPRESS PHARMA

Challenges

â&#x20AC;&#x153;

FROM A PERSPECTIVE OF STRATEGY, BI ENTERED INDIA AT THE RIGHT TIME ...THE COMPANY IS PLANNING TO LAUNCH AT LEAST ONE NEW MOLECULE / INDICATION EVERY YEAR FOR THE NEXT SEVERAL YEARS ... A REAL CAUSE FOR CONCERN IS THE UNCERTAINTY AND LACK OF TRANSPARENCY CONCERNING REGULATORY CHANGES SHARAD TYAGI CHAIRMAN AND MANAGING DIRECTOR, BOEHRINGER-INGELHEIM INDIA BI's strategy is to focus on their core research molecules. The two major product launches of 2012 typify BI's research-driven product portfolio and their tagline: Value through Innovation. Pradaxa, an oral anti-coagulant which came 54 years after the last breakthrough in this class of products, is touted to provide superior stroke reduction for atrial fibrillation patients. Similarly Trajenta, is a unique 'one-dose-fits-all' solution: an oral anti-diabetic that effectively brings about glycaemic control

with enhanced safety and less complexity in Type 2 diabetes patients. Globally, BI's four key therapeutic focus areas are diabetes, respiratory, neurology and oncology. In India, the first three are the present focus areas while 2014 will see BI's first step into the oncology segment in India. BI India has four business areas: prescription medicine, consumer health care, animal health and clinical operations. Under Rx medicine, the product portfolio spans cardiovascular and hypertension, diabetes, www.expresspharmaonline.com

oncology, CNS conditions like Parkinson's Disease. Tyagi indicates that BI India plans to grow its consumer healthcare (CHC) division by launching some of its global brands in India. He indicated that the gastrointestinal and pain segments could see CHC/over the counter ( OTC) launches from BI India in the near future. BI's global annual report states that CHC expanded in 2012 as well, mainly in emerging markets and achieved worldwide sales of EUR 1,505 million, corresponding to growth of + 7.8 per cent compared to

So how does the global BI management see the Indian market? Tyagi feels that India is unique as almost 80 per cent of medical expenses is out of pocket whereas most countries have some healthcare reimbursement systems in place. Therefore product pricing becomes very important. He says BI believes in pricing considering the local market conditions, pointing out that major BI India brands are priced at close to 1/3rd to 1/5th of US prices. For example, Trajenta in India is priced at six per cent of its US price and Tyagi believes this is an affordable price point for India. Tyagi indicates that the CHC/OTC range will be much more wide spread and mass market. The strategy is to tap India's smaller villages and towns through the CHC/OTC range which need such products even more as they donâ&#x20AC;&#x2122;t have access to the healthcare facilities in urban areas. But the push for affordable medicines is not unique to India alone. Tyagi says that different countries have different ways of dealing with these priorities. What he flags off as a real cause September 16-30, 2013

M|A|N|A|G|E|M|E|N|T for concern is the uncertainty and lack of transparency concerning regulatory changes. Having worked with Indian pharma for the past few years (his last stint was with Dr Reddyâ&#x20AC;&#x2122;s Laboratories), Tyagi feels that the fact that BI has been family-controlled for the past century and will continue to be so for this century as well, is a good sign because it conveys the message that there will be no change in its commitment to research. Twentythree per cent of BIâ&#x20AC;&#x2122;s turnover is invested in R&D and this makes for a very high focus on its research pipeline. This abiding long-term vision and strategy adds stability to the company. There is also an emphasis on building consensus during the decision making process. For the mother company, India still classifies as a new operative unit and as such at a growth stage

so it does make sense to look at it from a perspective of share in global BI revenues. According to the 2012 annual report, Europe sales made up 29 per cent in 2012, down from 31 per cent in the past year while the Americas contributed 47 per cent (up one per cent from 2011) and while the third region, (Asia, Australasia, Africa) clocked 24 per cent, up one per cent over the last year. Tyagi indicates that the company is in an investment phase in India and BI is certainly excited about the prospects in the medium and long term. BI India's share in the global BI revenues may not be great at this point of time but the company does seem to view the India operations as a vital part of its overall strategy. As BI India enters its second decade in India, we can only wait and watch. viveka.r@expressindia.com

Fact sheet I was founded in 1885 by Albert Boehringer in Ingelheim am Rheinm with a staff of 28 people. Today, as per the company's annual report for business year 2012, the company has more than 46,000 employees in 140 affiliated companies worldwide, R&D facilities at six sites worldwide and 20 production plants in 13 countries. R&D expenditure in prescription medicines corresponded to 23.5 per cent of its net sales. The company had an operating profit of EUR 1,853 million, corresponding to an operating margin of 12.6 per cent. The outlook for 2013 is positive as the management expects to maintain growth and anticipates a mid-single digit increase in sales compared to FY2012. Europe sales made up 29 per cent in 2012, down from 31 per cent in the past year while the Americas contributed 47 per cent (up one per cent from 2011) and while the third region, (Asia, Australasia, Africa) clocked 24 per cent, up one per cent over the last year. As part of R&D activities for innovative drugs, the company focuses primarily on the therapeutic areas of cardiovascular disease, respiratory diseases, diseases of the central nervous system, metabolic diseases, hepatitis C and oncology. The company has 94 products in its research pipeline,

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Albert Boehringer under its six disease focus areas. It has 31 molecules under research in the cardiometabolic area, followed by 24 in oncology, 17 in respiratory, 10 in CNS, nine in immunology and the remaining three in infectious diseases. The company entered the diabetes market in 2011 and expects to enter the oncology market in 2013 as well as extending their respiratory portfolio. The substances from the advanced pipeline, foremost afatinib in lung cancer and tiotropium or olodaterol in respiratory diseases, have the potential to be ready for the market as early as in 2013 as well as in the next few years, according to the 2012 annual report.

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W H AT ’ S INSIDE

RESEARCH

Scientists from University of Strathclyde invents technology to treat major illnesses PG 47 Almac Discovery and Queen’s launch £13 million cancer drug discovery partnership PG 48

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I In a quest to make treatment more target specific, time and again, scientists have come up with new ways and means to tackle certain diseases in a more effective manner than the conventional method of treatment. Nuclear medicine is one such branch that promises to revolutionise the way diseases are being treated. Use of radioactive material, that too in a controlled and risk free manner, has been touted as one of the most promising weapons to treat diseases such as cancer.

Research at its best For quite sometime, nuclear medicine has been an area of great interest for Indian researchers. Though the western world has remained a major player in this field traditionally, in India too, nuclear medicine research has started growing by leaps and bounds. “Major effort is directed towards early diagnosis of debilitating diseases, cancer, heart and neurological diseases such as Alzheimer’s, Parkinson's and depression. Nuclear medicine techniques are frequently used in development of new pharmaceuticals,” says Padmakar Kulkarni, Professor in Radiology, UT Southwestern Medical Center and Treasurer, Indo-American Society of Nuclear Medicine. Patients suffering from cancer have benefitted the most with the use of nuclear medicines. As it can highlight the abnormal metabolic activity, spread of cancer in different parts of the body can be discovered with this innovative form of treatment. KN Sudhir, Business Head, Molecular Imaging, Siemens Healthcare says, “Nuclear medicine has long been a cornerstone of diagnostic imaging due to its ability to illustrate metabolic activity and provide physicians with the answers they need, sooner than is possible with traditional anatomical modalities. However, globally as well as in India, today’s challenging healthcare environment, where the growing demand for higher-quality, patient-centred care is matched only by the need for definitive and timely answers, the limitations of conventional Positron Emission Tomography (PET)/CT and Single Photon September 16-30, 2013

Emission Tomography (SPECT)/CT scanners are becoming more evident.” He further explains, “Nuclear medicine programme is capital intensive, as it requires specialised imaging equipment, needs steady supply of short lived radioisotopes, trained physicians and technologists. Radiation safety is another issue.” Dr. Rao Papineni, Scientist and Adjunct Faculty Member at School of Medicine, Kansas University, explains that body emits light and glows in response to the radiation treatment. This phenomenon of light emitted as packets of photons is biologically called as bioluminescence. Sensitive camera can capture the light that is released by the body. Apart from the natural light produced as bioluminescence, Dr Papineni’s group injected chemical probes in animal models to capture additional form of light called chemiluminescence as a response to the radiation treatment. Papineni says, “This is quite unique from cherenkov light that the tissue produces when the external beam radiation dose is deposited. The illuminating work has been accepted for presentation at 59th Radiation Research Society Meeting at New Orleans, USA in September 2013. Such biological processes and the methodologies developed in my laboratory, will not only be useful clinically, but will be very valuable in assessing radiation damage in humans during nuclear terrorism or mass radiation accidents for response planning.” Papineni indicates that the chemiluminescent light described here is in response to initial inflammatory response, and further evaluation will pave way to understand and design adoptive cell therapies to aid in improved cancer treatment

Indian market is growing In the Asia Pacific region, India is seen as the potential market for nuclear medicine. Though countries like Japan have shown the largest use of diagnostic radioisotopes and PET diagnosis, with its rising healthcare budget and growing use of various radiopharmaceuticals in different clinical indications, India is also expected to see an increase in these areas. India's rising number of cancer patients and talented pool of doctors have further supported analysts' assumptions that like generic medicines, nuclear medicines will soon become a buzz word in the Indian medicine market. Dr Prasanta K Pradhan, President, Society of Nuclear Medicine, India, informs, “Nuclear medicine procedures have increased exponentially in India with the availability of positron emission tomography as well as globally. Nuclear medicine www.expresspharmaonline.com

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research is also growing, which is reflected in the Indian Journal of Nuclear Medicine, an indexed journal in Pubmed. Secondly, the number of abstracts presented in Society of Nuclear Medicine and Molecular Imaging (SNMMI), annual meetings in US and European Association of Nuclear Medicine (EANM) Annual Congress have increased significantly.” He adds, “These procedures require isotopes, chemical ligands and imaging equipment like gamma camera, PET/CT. Most of the equipment are imported. Many of the radioisotopes are imported while some are produced indigenously and are supplied by Board of Radioisotopes Technology, Mumbai (BRIT) which is a Department of Atomic Energy (DAE) unit, Government of India.”

Need for collective support Nuclear medicine scientists are doing their job of generating new ideas and converting them into reality. However, developing these medicines, working for their practical applications and public awareness are some of the things that require collective efforts. Organisations like Society of Nuclear Medicine, India and Indo-American Society of Nuclear Medicine (IASNM) are working with scientists, industries and governments to achieve this goal. “IASNM participates in the activities of Indian Society of Nuclear Medicine, particularly, annual meetings and special symposia. It recruits distinguished researchers and educators based in US to travel to India, present invited talks at the annual meetings and at hospitals/universities. Travel fellowships are awarded to young investigators from India to participate in annual meetings of Society of Nuclear Medicine, US. The society selects the best abstracts presentations at the annual SNM meetings (in US) from young clinicians and basic scientists from India. A special programme is offered by IASNM, in which two young physician scientists from India will be sponsored to visit Dr Sanjiv Sam Gambhir’s molecular imaging laboratory at the Department of Radiology, Stanford University,” informs Kulkarni.

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KN SUDHIR

RAO PAPINENI

Business Head, Molecular Imaging, Siemens Healthcare

Scientist and Adjunct Faculty Member at School of Medicine, Kansas University

Nuclear medicine has long been a cornerstone of diagnostic imaging due to its ability to illustrate metabolic activity and provide physicians with the answers they need, sooner than is possible with traditional anatomical modalities

Biological processes and the methodologies developed in my laboratory, will not only be useful clinically, but will be very valuable in assessing radiation damage in humans during nuclear terrorism or mass radiation accidents for response planning

Society of Nuclear Medicine, India, is also equally pro-active. Pradhan says, “Society of Nuclear Medicine, India encourages each member to do their research and present it at the annual conference as well as the local chapter meetings. We have earmarked a corpus for facilitating their presentation. The members comprises nuclear physicians, physicists, radiopharmacists, scientists and technologists. It also nominates three orations to senior members from India and abroad each year during the annual meeting. It also provides international travel grant to four students each year to present their research at SNMMI, US or EANM Annual Congress each year.”

evolving process. Advances in individual components propel the field. Further advances in development of imaging agents and imaging devices (hardware, software, image processing, and quantification) will influence the field. Development of new imaging systems (particularly, PET-MRI, SPECT-MRI) is on the horizon. These approaches is likely to reduce the radiation dose to the patients and also help the physicians to better interpret the scans. Development of new radioactive tracers would help in assessing the complicated neurophysiology, neurochemistry and efficacy of new therapeutic regimens. Nuclear medicine will likely play a major role in drug development.” According to Sudhir, diagnostic imaging is expected to deliver definitive and timely answers to clinical questions and, in today’s increasingly competitive and rapidly changing healthcare environment, these answers must be provided in the safest and most efficient way possible. “While every hospital and physician strives to deliver best care, patient expectations for a comfortable, stress-free imaging experience continue to increase.

Future perfect Nuclear medicine is a very challenging field and is still in its nascent stage in India. It will take some time before it would be accessible to larger populations. However, defying the odds and through trial and errors, scientists are coming up with more sophisticated and easy to apply forms of nuclear medicine. Kulkarni says, “Advances in any field would be an www.expresspharmaonline.com

PADMAKAR KULKARNI Professor in Radiology, UT Southwestern Medical Center and Treasurer, Indo-American Society of Nuclear Medicine

Development of new radioactive tracers would help in assessing the complicated neurophysiology, neurochemistry and efficacy of new therapeutic regimens. Nuclear medicine will likely play a major role in drug development

To meet these growing demands for higher-quality and more patient-centred care, nuclear medicine must overcome the limitations defined by conventional technology,” he opines. Pradhan says, “New clinical PET-MR equipment is also started offering its value in clinics globally. Small animal imaging with micro PET and micro SPECT also furthers nuclear medicine research which will pave the way for many new drug developments.” India, home to more than a billion people is also home to different disease types. This population has shown its rising vulnerability to diseases like diabetes, neurological disorders and cancer. Lack of target specific treatment is adding to the death toll caused by cancer, which in turn increases the importance of nuclear medicine. Doctors have understood the potential of this field of medicine. Meanwhile, to nullify the cost factor associated with this treatment, producing nuclear medicines indigenously through the collaboration of manufacturers and government will further help the patients. sachin.jagdale@expressindia.com September 16-30, 2013

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UPDATE Scientists from University of Strathclyde invents technology to treat major illnesses ‘Shapeshifting’ computer programme will open up drug discovery for tricky disease targets unique computer technology that opens up the discovery of smarter drugs to treat major illnesses including heart disease has been invented by University of Strathclyde scientists. The Shapeshifting Inspired Discovery (SID) programme decodes the structures of proteins in human cells that scientists suspect may hold the key to new treatments. The programme can rapidly analyse the complicated shapes and identify how the proteins might be 'shapeshifted' by drugs. Shapeshifting involves an altogether different and more subtle mechanism than conventional drugs, which stop the proteins working completely. The team behind SID, developed entirely at Strathclyde over the last decade, and now being deployed exclusively in collaboration with US firm Serometrix, will apply it to drug discovery for a wide range of diseases and conditions. Dr Mark Dufton, Department of Pure and Applied Chemistry, University of Strathclyde said, “Conventional drug discovery is extremely expensive, time consuming and often heavily reliant on ‘lottery techniques’ to identify useful drugs by chance. While this has certainly reaped benefits before, these traditional methods are becoming less fruitful and many new drug candidates found in this way are being abandoned because of toxicity problems and side effects. Drugs that act by shapeshifting work in a much smarter way that is a closer mimic of natural mechanisms for control. The ability of SID to predict the scope for ‘shapeshifting’ enables us to probe large, complex biological molecules, which have evolved their intricate shapes over hundreds of millions of years, so that we

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can analyse where and whether they can be targeted to provide treatments. When targeting is more selective, and the mechanism is smarter, a new generation of better medicines beckons.” Dufton added, “There are thousands of different types of protein in the human system that cooperate and regulate each other so that we can function properly. Nature has evolved a beautifully intricate set of mechanisms that regulate many of our critical functions by simply changing protein shape. In simple terms, these ‘shapeshifter’ mechanisms allow the proteins to modulate their biological activity by changing their surface character, rather like tectonic plates moving around the surface of the earth. The more we understand these mechanisms, the more we can emulate what nature has already developed so elegantly. Diseases are often caused by certain molecules in the body being either too active or not active enough – or by them operating in the wrong place at the wrong time. The new technology helps discovery of ‘shapeshifting’ drugs that can carefully adjust these biological molecules, bringing them under control and thus less likely to cause problems. We can use this knowledge, in the case of a specific disease, www.expresspharmaonline.com

to help a key protein be more or less active when the system is not working optimally on its own.” Simon Mackay, Professor of Medicinal Chemistry & Drug Discovery Portal Director, University of Strathclyde said, “This is an exciting step towards rapidly and efficiently designing the next wave of innovative pharmaceuticals.” Dr John Wilson, Department of Computer and Information Sciences, University of Strathclyde said, “We have been able to understand how to optimise the SID algorithm such that it now provides a near real-time, three-dimensional, graphical output that makes it extremely easy for clients to quickly understand where to focus their efforts.” Mike Muehlemann, Chief Executive Officer, Serometrix said, “SID was already yielding promising early leads in the search for potential treatments for hypercholesterolemia – high cholesterol – and cardiovascular disease. Drug discovery and development represents one of the toughest technical challenges of our times. We have partnered with Strathclyde because their SID technology is best-in-class and fits exceedingly well with our own technology. The promise of better

pharmaceuticals at lower cost is a lofty goal but it is one we believe we can achieve. With this combination of technologies we expect to reduce the number of early trial compounds from millions to hundreds, potentially shaving years off the discovery-development programme. Even though regulatory costs may remain high or escalate, an increased yield has the potential for significant cost reduction in the resulting pharmaceuticals.” Kyle Monroe, Chief Financial Officer, Serometrix said, “This collaboration would not have been possible without the forward thinking of Strathclyde’s technology transfer office. Their ability to think and execute in an entrepreneurial fashion is one that is critical to commercial success, and could certainly provide a model for other academic institutions.” Catherine Breslin, Research & Knowledge Exchange Services, University of Strathclyde, said, “We are all excited about this partnership with Serometrix, as well as about demonstrating to the pharmaceutical community how a computational method combined with our drug discovery expertise can generate new candidate medicines for a wide range of diseases.” EP News Bureau-Mumbai EXPRESS PHARMA

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Almac Discovery and Queen’s launch £13 million cancer drug discovery partnership Involving up to 60 ovarian cancer patients, the drug being trialled has been created as a result of an earlier collaboration between Almac Discovery and Tracy Robson from the School of Pharmacy at Queen’s new £13 million partnership to accelerate cancer-focused drug discovery in Northern Ireland has been launched by Arlene Foster, Enterprise Minister. As part of the project, Queen’s and Almac Discovery have announced the scheduling of a phase one clinical trial for ovarian cancer, involving the first novel cancer drug fully developed in Northern Ireland. Involving up to 60 ovarian cancer patients, the drug being trialled has been created as a result of an earlier collaboration between Almac Discovery and Tracy Robson from the School of Pharmacy at Queen’s. Explaining about the trial, Robson said, “This latest trial involves a new treatment for cancer known as ALM201, which rather than attacking tumours directly, prevents the growth of new blood vessels in tumours, starving them of oxygen and nutrients and thereby preventing their growth. It targets tumours by an entirely different pathway to those treatments currently approved.” Alan Armstrong, Chief Executive Officer, Almac added, “Bringing new treatments to patients is a complex process. The announcement of a new clinical trial, which is the result of a previous partnership between Almac and Queen’s School of Pharmacy, is a timely

illustration of how collaboration between the University and industry is already creating novel approaches to cancer therapy which have a very real chance of helping patients.” Foster, said, “This significant investment in research and development will enhance collaboration between academia and industry. This will ensure the investment is maximised, that research is effectively commercialised and that ultimately, enhanced treatment solutions are made available to cancer patients. The fact that Almac and Queen’s are

A NEW CCRCB/ALMAC DISCOVERY JOINT PROGRAMME IN CANCER DRUG DISCOVERY WILL BRING RESEARCHERS FROM QUEEN’S UNIVERSITY BELFAST’S CENTRE FOR CANCER RESEARCH AND CELL BIOLOGY (CCRCB) AND SCIENTISTS FROM ALMAC DISCOVERY TOGETHER TO TRANSLATE RESEARCH DISCOVERIES INTO TREATMENTS FOR PATIENTS 48

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engaged in such groundbreaking research here in Northern Ireland is something that we should be extremely proud of. It will reinforce our position as a leader in research and development for the health and life sciences sector.” A new CCRCB/Almac Discovery joint programme in Cancer Drug Discovery will bring researchers from Queen’s University Belfast’s Centre for Cancer Research and Cell Biology (CCRCB) and scientists from Almac Discovery together to translate research discoveries into treatments for patients. The two projects represent a total investment of £13 million, with £7 million of support offered by Invest Northern Ireland, which includes part funding from the European Regional Development Fund. As a result of the joint programme, 17 scientists from Almac Discovery have been seconded to Queen’s CCRCB in an industry led venture. The discovery team will work to identify parts of tumours which are susceptible to treatment by cancer drugs and to then develop

the new drugs to target them. The partnership will also enable new approaches to selecting those patients who will be most likely to respond to the new drugs, and to create the technologies needed to deliver the drugs directly to the tumour site in the patient. The new discovery programme is being led by Tim Harrison, Vice President of Discovery Chemistry with Almac Discovery. As part of this partnership, Harrison has been appointed McClay Chair of Medicinal Chemistry at Queen’s for the next three years. Commenting on the new partnership, he said: “While Almac Discovery and Queen’s have already been successfully collaborating for a number of years, the new programme is bringing together for the first time, under one roof, some of our most talented scientists. As a result we expect to see an increase in both the breadth of drug targets we are able to identify and a subsequent increase in the development of potential therapeutics for patients.” EP News Bureau-Mumbai September 16-30, 2013

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BioReliance opens US Clearance Services Laboratories Completes global facility upgrade plan

igma-Aldrich Corporation’s BioReliance, the biologics and earlydevelopment services business under SAFC, has opened a new Clearance Services facility in Rockville, MD. The facility, commissioned on August 1, 2013, allows BioReliance to offer increased capacity and flexible scheduling while maintaining its core focus on providing industryleading quality, expertise and value. The new US facility more than doubles the amount of space available to clients to conduct their critical downstream bioprocessing studies. Designed with input from clients and built to complement BioReliance’s global viral clearance services capabilities, the Rockville

facility features four large clearance suites with modular layouts that allow for customised laboratory setups. All studies performed at the facility are completely secure and supported by dedicated scientists and state-of-the-art chromatography equipment, such as GE Healthcare’s ÄKTA avant. Every project is fully compliant with applicable global guidelines and regulations, including those from the US Food and Drug Administration and European Medicines Agency. Completed studies receive a consolidated report that includes comprehensive titration and/or process data. BioReliance has already successfully conducted several client studies

and quality audits in the new facility. “Combining our deep knowledge and proven experience with a global investment in modern facilities and equipment enables BioReliance to offer robust validation packages and proprietary CompleteClearance services to our clients. It’s all about simplifying the viral clearance process through an unrivaled combination of scientific expertise, clientfocused service and decades of experience,” said Archie Cullen, President, BioReliance. “Any time a client comes to work with us, they are assured that their study is expertly designed and performed by personnel that have participated in thousands of successful stud-

ies in support of clinical and commercial biopharmaceutical products.” Clients using BioReliance’s US facility will have access to a wide range of resources, including personalised modular laboratory suites with spacious, technology-enabled lounges, unique 'suite-to-lounge' monitoring, and support from industryleading personnel. The Rockville Clearance Services facility investment completes BioReliance’s upgrade to its global offering designed to deliver a total client solution and experience. The Stirling, Scotland (UK), Clearance Services laboratories were completely renovated and expanded in 2011. EP News Bureau-Mumbai

Heart disease patients benefit from polypill in major international trial The polypill group also had lower blood pressure and cholesterol measurements

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ndian patients were much more likely to take preventive medicines if they are combined in one pill, according to the first trial of the polypill in patients with cardiovascular disease. The trial involved a thousand patients from India and a thousand from Europe, and was published in the Journal of the American Medical Association. Taking aspirin, cholesterollowering and blood pressurelowering drugs long-term more than halves heart attack and stroke recurrence. However, most patients in India and elsewhere do not take all recommended preventive medications long-term. This leaves tens of millions of people undertreated. In the first study to test the impact of a fixed-dose combination pill – called a polypill – in people with cardiovascular disease, 2,004 participants in the UK, Ireland, the Netherlands and India were randomly assigned either the polypill, or their normal combination of medicines. After an average of 15 months follow-up, the proportion of participants in the polypill group who were taking medications regularly was a third higher than in the group receiving usual care. The polypill group also had lower blood pressure and cholesterol

measurements. Professor Vivekanand Jha, Executive Director, The George Institute for Global Health India said: “The reality is that a large number of people who have already suffered heart attacks or strokes either don't receive these medications or get out of the habit of taking them. The findings of this study suggest that providing them in a single pill is a helpful preventative step.” D Prabhakaran, Executive Director, Centre for Chronic Disease Control India said: “These results show that the polypill is a viable strategy for heart attack and stroke survivors, especially those who currently do not receive all recommended preventive www.expresspharmaonline.com

treatments. Professor Prabhakaran said the new findings dispelled several myths about the polypill, “Despite the use of older medications and fixed doses, the polypill group had improved blood pressure and cholesterol levels simply because they took recommended medications more regularly. Also there were no differences whatsoever in diet or exercise patterns.” He also noted that the trial participants were almost universally eager to adopt the polypill if it were made available. “While the World Health Organisation and many others have noted the potential benefits and cost savings of such an approach for over a decade,

this is the first trial to show these benefits directly. This study is an example of Indian innovation and international collaboration and is the first study of its kind to show the potential benefits and cost savings of such an approach to prevention to stroke and heart disease. The polypills used in the study were developed by DRL, Hyderabad. The late Dr Anji Reddy gave the green light to the development, seeing an opportunity to provide an affordable, convenient treatment package to patients in India and elsewhere.” Most of the patients in the study had already had a heart attack or stroke; the rest were at high risk on the basis of risk factors such as blood pressure, cholesterol and smoking. Heart disease is a leading cause of premature death and disability in India, in both urban and rural populations, and is growing at epidemic proportions. The largest-ever study of deaths in India recently showed that heart disease caused one in four deaths among adults aged 25-69 years. Heart disease rates are now higher in India than in the West. The study was funded by the EU’s Seventh Framework Programme for Research. EP News Bureau-Mumbai EXPRESS PHARMA

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Easing the instrument calibration load PG 53 Aesica appoints Bhavesh Kotecha to newly created position of Corporate Services Director PG 54 Quintiles to acquire Novella Clinical PG 55

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The future of DPIs: Aligning design with market demands Dr Gerallt Williams, Director, Scientific Affairs, Aptar Pharma, takes a look at the market forces driving DPI innovation and focuses on a novel solution that has simplicity at the heart of its design n 1948, the first commercial dry powder inhalation device, the Aerohaler was launched by Abbot Laboratories. The technology seems archaic by today’s standards: a deep breath in would cause a ball to strike a cartridge containing penicillin powder and shake the powder out into the airstream. However, the same device was later used to treat asthma, which set a precedent for future treatment of the disease. Today, throughout Europe, dry powder inhalers (DPIs) are used by an estimated 40 per cent of patients to treat asthma and chronic obstructive pulmonary disease (COPD)1. The Aerohaler was followed by the ‘Spinhaler’ of the 1960s. The inhaler was developed for asthma treatment by Fisons Pharmaceuticals (later taken over by Rhone-Poulenc Rorer, acquired by what is now known as Sanofi) and represented a breakthrough in powdered drug delivery to the lungs. By using a capsule containing the active drug, sodium cromoglycate, which was released on inhalation, the device was very easy to use and

of new markets, arising from emerging economies in South America, India and China.

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The anatomy of a DPI

meant that patients did not have to coordinate the inhalation of the drug with the actuation of the device. Since this time, changes in the drug delivery market and regulatory pressures have driven innovation of DPIs forward: to-date, there are dozens of different DPI devices are commercially available and the DPI market itself is worth approximately $18 billion2. This article takes a look at the market forces driving DPI innovation and focuses on a novel solution that has simplicity at the heart of its design, and which hopes to address the growing pressure to reduce healthcare costs, as well as the needs

The basic components of a DPIs remain the same for most types: a powder formulation, a dose mechanism containing (or measuring) a single drug dose, a powder de-agglomeration principle, which disperses the powder into the inhaled airstream and the mouthpiece of the inhaler. Secondary parts of the inhaler have been developed to fulfill functions such as safety, ease of handling, patient feedback and moisture protection of the drug formulation. However, over the past few decades, much research has focused on the design of the inhaler with respect to the most important technical aspects that ensure the right amount of drug reaches the lungs i.e. powder de-agglomeration and air flow that is generated by the patient through the inhaler (and the resultant drug particle dynamics in the respiratory tract).

The needs of DPI market The most successful DPI

solutions will be those that match the changing needs of the drug delivery market as well as those of different patient groups, countries and cultures, diseases etc, as detailed below:

Reusability and cost: Single-dose vs multi-dose As a DPI is used repeatedly by the same user, reusability is a key factor driving down the cost per dose. Single-dose inhalers, which rely on capsules to be loaded into the device, can cause difficulties for patients having to load up a capsule; there is a need, therefore, for more patient-friendly devices. Multi-dose DPIs have also been developed to overcome some of the inherent limitations of single dose inhalers. The AB Draco company (now a division of Astra Zeneca) pioneered the design of multi-dose DPIs with their Turbuhaler. In this device, the drug formulation is contained in a reservoir and can be dispensed into the dosing chamber by a twisting back and forth action at the lower end of the device. One of the criticisms of reservoir designed DPIs, however, is

Figure 1 – Simple steps for operating the Twister DPI device www.expresspharmaonline.com

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the delivery of the drug at variable flow rates. The issues of multiple dosing and consistent doseto-dose delivery have been addressed with the development of individual aluminium blisters to contain the doses (as initially developed in the Diskhaler of the 1980s by Glaxo, now GlaxoSmithKline). Multiple pre-metred dose DPIs have seen strong market growth in recent years, aided in part by the introduction of combination drugs in this category of device.

Complexity and compliance The way the patient uses the inhaler can play a major role in ensuring a consistent dose to the patient’s lungs: therefore, capsule loading and inhalation technique are critical elements that can affect the efficacy of a DPI. It is important that patients are correctly trained to use the inhaler by the healthcare provider. Easy to use devices and those that can be easily taught to patients are ultimately ones that ensure high patient compliance and an accurate and acceptable dosage regime: a device requiring only a few basic steps will therefore be easy for the patient to master.

Filling technology The introduction of cap-

sules has meant standardised filling technologies can be incorporated into the manufacturing process, thus meeting the needs of large scale industrial filling of such devices, with millions of doses being manufactured yearly. Modern and accurate large-scale filling processes are also available to meet the needs of premetered devices (blisterstrips). With the availability of the above filling technologies it is realistic to manufacture and fill DPIs on a large scale to meet worldwide volume needs at acceptable costs.

Regulatory pressures The 1987 Montreal Protocol3, which called for the phase-out of chlorofluorocarbons (CFCs), diverted market interest away from CFC-propelled metered dose inhalers (MDIs) to DPIs; as a result, resources were channeled into creating new models of DPIs that could meet specific patient needs. In the past 25 years, there have been an increasing range of regulations affecting the design, testing and use of inhalation devices; namely for user safety4, optimising design for usability5 and for re-use of individual units. Specific guidance documents have been issued by various regulatory bodies on the subject of DPI

THE MOST SUCCESSFUL DPI SOLUTIONS WILL BE THOSE THAT MATCH THE CHANGING NEEDS OF THE DRUG DELIVERY MARKET AS WELL AS THOSE OF DIFFERENT PATIENT GROUPS, COUNTRIES AND CULTURES, DISEASES ETC performance and documents necessary for chemistry, manufacturing and controls for such products6,7. The US market and the corresponding FDA regulatory standards in the inhalation field are probably the most challenging, e.g. for issues such as moisture protection, dose content uniformity etc and this can lead to some products being absent from the US although present in Europe or the rest of the world.

patients so it is anticipated that the DPI growth trend will spread to these areas. The availability of lost-cost, patient friendly DPI options would encourage their use in emerging economies.

Efficacy through simplicity: Twister sets the record straight Twister is a new costeffective way to improve drug delivery, as well as patient compliance. The design of the patient-friendly device fulfills many of the market needs described previously: the versatile and affordable, capsulebased dry powder inhaler works well with most inhaled powders on the market and is simple to use; a simple twist of the device opens the internal capsule containing the drug. Only three simple steps

Emerging economies In Asia and Latin America, asthma has been treated predominantly with pMDIs which are considered to be a more cost-effective proposition than DPIs. However, healthcare reforms in these regions are making asthma diagnosis and medication more available to

Emitted Dose Performance Varying at Flow Rates (Asthalin capsules, 200 μg Sabutamol per dose) 120

100

6 Dose n

+/-25% of mean

+/-35% of mean

2 kPa (40 lpm)

4 kPa (60 lpm)

6 kPa (80 lpm)

Figure 2 – Dose delivery performance at varying flow rates September 16-30, 2013

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FPF Performance at Varying Flow rates FPF < 5 μm μg Salbutamol per dose) (Asthalin capsules, 200μ 50 45 40 35 30 25 20 15 10 5 0 2 kPa (40 lpm)

4 kPa (60 lpm)

6 kPa (80 lpm)

Figure 3 – Fine particle fraction content at varying flow rates

References 1. Atkins PJ. Dry Powder Inhalers: an overview. Resp. Care. 2005;50:1306 1312. 2. Market figures reference (Datamonitor) 3. United Nations Environment Programme. Handbook for the Montreal Protocol on Substances that Deplete the Ozone Layer - 7th Edition

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Promoting better healthcare worldwide

are needed to operate the inhaler – Insert, Twist and Inhale (see Figure 1) – and the patient is guided by various audible and visual feedbacks confirming that the full dose has been properly delivered. The capsule is easy to insert and a healthcare provider can easily teach a patient how to use the device. Patient safety has been optimised in the design of Twister: unlike other DPI designs, the capsule is not pierced, which reduces the risk of contamination and the patient inhaling particles of the container closure system, improving safety. The design avoids repeated dosage as inhalation is from a single capsule only that is inserted into the device at each inhalation. The transparent dispersion chamber makes it easy for the patient to see that there is powder in the device and, after inhalation; the patient can see that they have taken the full dose providing a clear visual feedback and helping to improve compliance. The transparent chamber also

allows the patient to see if cleaning is necessary. Twister, developed by the Aptar Pharma product development team in France, has been developed for fast growing markets but also has its place in developed markets as a low-cost alternative to pressurised metered-dose inhalers (pMDIs). Aptar Pharma’s aim is to bring cost effective drug delivery devices to pharma companies, helping them market affordable healthcare treatment to patients worldwide. Cost for the patient is reduced, allowing a wider range of asthma sufferers to gain better access to medication: capsules can be bought in small batches (30 or 60 capsules) by the patient to spread out the cost. The inhaler can also be used for COPD treatment, and during the development process, Aptar Pharma’s dedicated inhalation drug formulation research team tested and collected data on various drug formulations, validating Twister as an off-the-shelf device,

suitable for a variety of different drug compounds and formulations. Twister is designed for 'size 3' capsules; a format suitable for high speed filling technology, and functions with HPMC and gelatin capsule material, with a wide filling range from 530mg. Air inlets can be tuned to adjust the device resistance and the rotating and rattling of the capsule during inhalation helps with the de-agglomeration process. (Figure 1)

Some of the performance characteristics essential to DPIs are related to dose delivery (See Figure 2 ) , fine particle fraction (FPF) content (See Figure 3) and performance at varying airflows. These characteristics can vary from one powder formulation to another and some amount of fine tuning of either device or formulation or a combination of both, may be necessary to achieve optimal performance.

DPIs have shown great promise in their ability to deliver drugs reliably and effectively and novel designs can ensure that future cost, c o m p l i a n c e and safety challenges are overcome. Twister provides an easy to use solution that aims to meet the needs of fast growing markets generated from emerging economies, where resources may be an issue. A key factor helping to tap into new markets are the presence of local manufacturing sites, for example, Aptar Pharma’s state-of-the-art manufacturing facilities in China (Suzhou), India (Mumbai) and South America (Varela). The site in China facilitates logistical and regulatory support and allows changes in the needs of the local market to be quickly met. With the development of Twister, Aptar Pharma aims to provide a novel solution to fulfill the demands of the DPI market, whilst maintaining its goal of promoting better global healthcare access worldwide.

http://ozone.unep.org/Publications/MP_Ha ndbook/Section_1.1_The_Montreal_Protoc ol/ Published 2006 by the Secretariat of The Vienna Convention for the Protection of the Ozone Layer & The Montreal Protocol on Substances that Deplete the Ozone Layer. Accessed August 28, 2012. 4. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

(CDER). Guidance for Industry Bioequivalence Recommendations for Specific Products. Maryland, USA: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration; 2010. 5. U.S. Food and Drug Administration. Draft Guidance for Industry and Food and Drug Administration Staff. Applying

Human Factors and Usability Engineering to Optimize Medical Device Design. Maryland, USA: U.S. Food and Drug Administration; 2011. 6. U.S. Food and Drug Administration. Guidance for Industry Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. Chemistry, Manufacturing, and Controls Documentation, draft guidance. Maryland,

USA: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research; 1998. 7. European Medicines Agency. Committee for Medicinal Products for Human use (CHMP) guideline on the pharmaceutical quality of inhalation and nasal products EMEA/CHMP/QWP/49313/2005 Corr. London: European Medicines Agency; 2006.

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Key performance characteristics

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VALUE ADD Easing the instrument calibration load Mike Shelton, Product Manager, 4Sight, explains why it is important to be confident in the measurements taken by instruments and looks into the role of calibration oday’s instrumentation in the process and industrial sectors indicates, and often determines, the way in which a process or activity operates. Processes must operate within specified parameters, such as temperature, pressure, air quality etc. For example, it may be necessary to heat a product at a specific temperature and pressure to effect sterilisation, to cook it or to achieve a chemical reaction. If the temperature deviates by a few degrees or the pressure by a few millibars, then the process objective will not be achieved. Consequently, it is vital that we measure and indicate these specified parameters. However, it is equally important that we can be confident in the measurements taken by the instruments and this involves regular calibration of a plant or factory’s instrumentation. Such calibration is normally carried out as a part of maintenance procedures, although both activities can also be carried out in isolation. However, for maximum effect, they should be integrated to ensure that the

results of calibration are incorporated into maintenance procedures. Software has long been available for managing calibrations. Software packages are now available to combine calibration and overall maintenance management.

Calibration software Calibration management software has been with us for a few years. Laboratory pressure calibration equipment such as the PACE platform from GE, has been designed to communicate with such software, specifically developed to provide support for both laboratory and field calibrations. This provides easy control in a fully integrated pressure loop, giving 100 per cent automated calibration of pressure transducers and transmitters. The software has full documenting facilities to prepare reports and provide calibration certificates from its database, utilising readout data from connected calibration equipment and test devices. Portable calibration instruments for on-site application have now advanced considerably. Formerly, these relied on PC-based software, where the instrument database and history was held on a PC and the instrument technician downloaded the information relevant to his workload, carried out the required

calibrations and then uploaded his results and data so that reports could be produced and records maintained. Recent developments have created portable calibrators, allowing comprehensive management of a plant’s instrumentation inventory from a portable device in the field. This allows the field engineer, without reference to a remote PC, ready access to information such as device details, calibration history, trend analysis and calibration procedures, as well as all supporting documentation, including datasheets, drawings, loop diagrams, photographs, safety notes and written procedures. It also allows new device records and procedures to be created in the field while giving access to all historical data. Calibration and documentation are automated, saving time, costs and reducing human error. Regulatory compliance is improved by scheduling work procedures and documenting calibrations and actions. Calibration certificates and custom reports can be created, reviewed and electronically signed-off on the instrument, ensuring that plant is always audit-ready. If required, data can be transferred to a PC for printing and archiving.

Software integration The latest software development combines calibration and maintenance management and provides a comprehensive solution for streamlining maintenance workflow by improving data integrity, scheduling work activity, automating calibration and maintenance and correcting deviations. It offers a paperless system with e-signatures for regulatory compliance. At the same time 4Sight Calibration and Maintenance Software from GE, which can interface with existing enterprise business platforms, provides audit ready data in compliance with the most stringent quality systems including FDA and GAMP with full, 360° management reporting tools. It is also a web-based solution, which offers further signifi-

September 16-30, 2013

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cant benefits. Currently, most software has to be installed on a PC, even when it is a server-based installation. From a maintenance point of view, this means that the server database and the PC applications have to be installed and then periodically updated by the IT teams, while ensuring that everybody has the same version. The latest web-based technology allows the software to be installed on the company’s server and accessed through a PC and web browser. Alternatively, the software can be hosted by a third party as a service on an external server, so that there is no need for software installation and IT support at the company itself. In either case, the software, database, upgrades, etc are all handled externally and the company has no IT overheads. Resource management and efficiency improvement tools are also features of the new software. Interval Analysis allows calibration managers tasked with reducing costs by extending calibration intervals, to come to a researched and informed decision, providing reporting and analysis in minutes, without the risk of miscalculation or transcription errors. Key performance indicators (KPIs) update in real time to allow performance of the installed base and resources to be analysed and compared across the whole business or at different levels, such as by site, plant, process, team, etc. 4Sight deviation management ensures that calibration failure notifications are sent in a timely and controlled way e.g., by email, so that users can record the cause of deviations, investigate the reason and work to a resolution.

Conclusion Lord Kelvin was once famously reported as saying that there is nothing new to be discovered in physics; all that remains is more and more precise measurement. I doubt whether the people working on the Large Hadron Collider would agree with those sentiments but the EXPRESS PHARMA

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New instrument calibration and maintenance software from GE

omprehensive, Scalable Solution Facilitating Regulatory Compliance, Improved Safety and Operational Efficiency The new, easy-to-use, 4Sight calibration and maintenance software from the Sensing business of GE Energy’s Measurement & Control Solutions is a scalable solution for single user or multi-site businesses. It can streamline maintenance workflow by improving data integrity, optimizing work schedules, automating calibration and maintenance and correcting instrument deviations. Using web-based technology, the new software will help to achieve regulatory compliance and safety and can provide 25 to 40 per cent reductions in maintenance costs in the industrial, petrochemical, chemical, process, oil and gas and pharmaceutical sectors. As Mike Shelton, Product Manager, 4Sight, explains, “Most software has to be installed on a user PC, even for server-based installations. This means that the server database and PC applications have to be installed and periodically up-graded and synchronised by IT teams at significant expense and inconvenience. With this new, web-based technology, an end user can browse the internet to access the

statement is very relevant to the instrumentation sector. Just as more and more precise measurement should be

software and all maintenance and support is provided by GE. Even with a single user installation, maintenance and upgrading is greatly simplified.” 4Sight software can help companies meet regulatory compliance by providing continuous availability of records and data for audit to recognised quality systems. It can also interface with high-end computerised maintenance management systems (CMMS) to provide a seamless, automated workflow from the initial issue of a work order to the final notification on completion of the job, providing all the data for audit review and the tools for resource management and efficiency improvement. These tools include: Interval Analysis, which enables users to report quickly on device performance by scientifically analyzing historical data and drift to allow informed and qualified calibration interval recommendations to be made; Performance Management, providing key performance indicators (KPIs) in real time; and Visual Deviation Management to ensure that calibration failure notifications are sent in a timely and controlled manner so that deviations are investigated and resolved as quickly as possible. The new software complements

our aim, so it becomes even more important that calibration technology and techniques keep pace with

GE’s mobile and laboratory calibration and maintenance solutions. When operated with GE’s DPI620 multi-functional, portable calibrator/communicator, 4Sight offers mobile, paperless maintenance with a calibrator of class-leading accuracy and advanced features such as integral HART communication, a full plant database and Windows CE providing PDA capability. The DPI620 gives total independence to field engineers and WiFi connectivity allows global mobility without compromising data exchange. The software’s comprehensive filtering and assigned user rights allow a single system to be used over multiple sites, where supervisors and technicians see only information relating to their site. Senior managers can view and compare performance over all sites from a centralised database. 4Sight calibration and maintenance software is available as a single user basic package and a multi-site, serverbased platform, with add-on modules such as E-signatures and audit trail to comply with specific FDA regulations. GE can also provide services for installation, training and support, database migration and integration with higher level CMMS.

sensor and instrumentation advances. In this digital age, this also means ensuring that we have the software as well

as the hardware to meet new calibration and maintenance challenges.

VENDOR NEWS Aesica appoints Bhavesh Kotecha to newly created position of Corporate Services Director Role to oversee a group-wide services across IT, M&A process planning, health and safety, and internal audit system esica, the global contract development and manufacturing organisation (CDMO), has appointed Bhavesh Kotecha to the new position of Corporate Services Director (CSD). Reporting directly to Dr Robert Hardy, Chief Executive Officer, Aesica, Bhavesh will take functional responsibility for delivering operational efficiency and high standards across IT, health and safety, internal

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audit and M&A processes. One of the CSD’s key responsibilities is the use of IT for further efficiency in the running of M&A processes. The CSD, with the new team structure, will serve as an important asset to the Aesica acquisition strategy, with business integration teams being guided by Bhavesh. The corporate service discipline is a critically important function to meet the transitional challenges that stem from the acquisition process, thereby ensuring the full integration of all functions including finance, HR, sales and marwww.expresspharmaonline.com

keting, quality control, health and safety regimes, structures and regulatory compliance. Bhavesh’s combined functions in the management of strategy, cost in line with pre-set budgets, new technologies and ERP systems. Aesica has established an integrated team structure to assist the CSD with his multiple responsibilities and the effective implementation of best practice programmes and quality control across his functional competencies within the company. He is supported in his role by three IT country managers, a

global health and safety manager and specialist technical architect. Commenting on the CSD’s role, Hardy said, “The CSD position and responsibilities are crucial to the Aesica strategy and will be central to maximising efficiency and operational performance, ensuring compliance with the highest standards of health and safety, whilst achieving the optimum integration of personnel, corporate infrastructure, technology and processes as we continue to make strategic acquisitions.” EP News Bureau – Mumbai September 16-30, 2013

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Quintiles to acquire Novella Clinical Acquisition bolsters Quintiles’ small biopharma, oncology and medical device capabilities uintiles has signed an agreement to acquire Research Triangle Park, NC-headquarted Novella Clinical (Novella), a full-service clinical research organisation (CRO) focused primarily on emerging oncology customers as well as those in the medical device and diagnostics sectors. Novella’s infrastructure and approach to clinical research were created with the operational needs of its customer base in mind, and constructed to best support

these specific customer groups. By joining Quintiles, Novella will be able to continue this specialised focus while at the same time leveraging Quintiles’ scale and resources to provide new global capabilities to its existing and future customers. “The expertise and insight the Novella team brings will be a strong addition to our existing capabilities and help further differentiate Quintiles in an increasingly competitive marketplace,” said Paula Brown Stafford, President, Clinical Development at

Quintiles. “Novella’s understanding of emerging companies, as well as our shared commitment to quality, customer service, and above all, the patients we ultimately serve, makes this acquisition a good fit for both organisations. We look forward to working collaboratively with Novella to leverage the synergies that exist between our companies to help drive business growth while continuing to meet the needs of our customers.” “We are excited about the opportunity to join Quintiles – the global leader in our industry,” said

Waters unveil Oasis method development tools The Oasis tools W recommend optimised protocols customised to customer's samples

aters Corporation has unveiled its new web-based Oasis Method Development Tools designed to help customers reduce their sample preparation method development time as part of Waters Simple Prep campaign. Based on the customers’ sample requirements, the Oasis Method Development Tools will reportedly recommend the optimised solidphase extraction (SPE) protocol to develop robust methods with high recovery for liquid chromatography and mass spectrometry applications. “Oasis is the most widely used SPE sample prepara-

tion brand, used for a wide range of applications, including bioanalysis, clinical, food, and environmental,” said Michael Yelle, Vice President, Consumable Business Unit, for the Waters Division. Developed in collaboration with Oasis customers, the New Oasis Method Development Tools simplify the process of developing robust SPE methods. The tools help scientists to understand the chemistry behind the SPE products so that they can reduce sample preparation method development time to minutes, compared to the traditional hours and days. The

new Oasis tool features basic and advanced capabilities. The micro sample volume tool can optimise the right sorbent and protocol for sample volumes from 25 to 300 µL, eliminating the evaporation and reconstitution steps and concentrating your compound of interest by 15x. The maximum selectivity tool recommends ion-exchange and reversedphase methods for aggressive sample cleanup in complex matrices. The general purpose tool is ideal for screening across a broad range of compounds and molecules. EP News Bureau – Mumbai

VICAM launches mobile app for instant access to global mycotoxin regulations ICAM, a Waters Business, tomers can search products Radlo, General Manager, Product now available has introduced a mobile using commodity and finished Director of Operations, for V for download on Google application that provides product images, simplifying VICAM. Play, iTunes Store or www.commodityregs. com

September 16-30, 2013

instant access to global mycotoxin regulations. The app, available for download on Google Play, iTunes Store or www.commodityregs.com, reportedly enables instant searchable results for mycotoxin limits by geography and commodity or food type in seconds. A press release states that with the global mycotoxin regulations tool mobile app, food manufacturers and exporters can obtain critical regulatory data without general web searches, saving both time and resources. In addition, cus-

the search process and ensuring that clear and actionable results are available to stakeholders in food and agriculture markets worldwide. "The mobile app for the global mycotoxin regulations tool expands the functionality of the tool so that farmer, processor and exporter will all have access to the data they need. Users will be able to meet the complex demands of the global marketplace, while knowing they are minimising the impact of mycotoxins on human and animal health," comments Marjorie www.expresspharmaonline.com

Mycotoxins are naturally occurring chemical byproducts of ubiquitous mold species which are natural inhabitants of crop soils. Severe rain or drought can encourage mycotoxin production and, once released, mycotoxins are difficult to manage and virtually impossible to destroy. The USDA, FDA, EU, and other international government agencies impose specific regulations and guidelines for acceptable levels of mycotoxins. EP News Bureau – Mumbai

Richard Staub, President and Chief Executive Officer, Novella. “Since our founding fifteen years ago, Novella has been committed to serving emerging companies by offering personal attention and flexibility in addition to our extensive therapeutic experience. By joining Quintiles, we will be able to extend the geographic reach of our services exponentially while remaining committed to the values and business approach that makes us a great partner to our customers.” EP News Bureau – Mumbai

Ion Exchange (India) unveils new corporate identity The new logo celebrates the greenery and water around and more cogently reaffirms the constant effort to make the earth a better place

on Exchange (India) has launched their new corporate identity. The new Ion Exchange logo, with its hues of green and blue, celebrates the greenery and water around and more cogently reaffirms the constant effort to make the earth a better place. The grey underlining signifies the strong foundation and base the organisation has built over five decades. Rajesh Sharma, Chairman and Managing Director, Ion Exchange said, “In sync with the environmental transformation we strive to bring about, we have changed our logo and incorporated a positioning line 'Refreshing the planet', a move that accentuates our commitment to assume an ever greater responsibility to the cause of ecology and everything we stand for.”. EP News Bureau – Mumbai

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From Amsterdam to India

Pharmaceutical Consultancy Services (PCS) presents

GMP Actual Good Manufacturing Practices

For Mid-Level Management

An intensive Two-Day Course on cGMP with a focus on actual compliance practices and international regulatory expectations, will be held on the following dates: • November • December • February

28 & 29 2&3 (dates to be announced)

2013 2013 2014

Chandigarh Mumbai Delhi & Hyderabad

For More Information about the course and registration, please go to: http://www.pcs-nl.com/india PCS - Pharmaceutical Consultancy Services Pvt. Ltd. 997/4 NAVI PETH HIRA SATSANG SOCIETY PUNE - 411030 09 850 894 074 info@pcs-nl.com

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Pharmaceutical Grade Resins I Adsorbent Grade Resins I Polymeric Adsorbent Resins I Speciality Activated Carbon

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All India 24x7 Comprehensive Service Backup

E-mail: pharma1@ionexchange.co.in • Website : www.ionindia.com Ion House, Dr. E. Moses Road, Mahalaxmi, Mumbai - 400 011. Call 3989 0909 in Mumbai, Delhi, Kolkata & Chennai; prefix 022 from other cities.

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Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

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Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

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Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. Over dustr In to e ic of serv ing Stronger Grow t & Integrity us with Tr

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MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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Express Pharma Business Avenues CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

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Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

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8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

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Product Range Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

Parksan Filters Pvt. Ltd.

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39/2A, Purna Das Road, Kolkata - 700 029. Gram : Techpharma. Tel : 91 33 2464 4568 / 0457 7253 Fax : 91 33 2464 7254. Email : mails2neomachine@gmail.com, neocota@sify.com Website : www.neocota.com, www.neomachine.in Mumbai : 91 22 2261 4088, Chennai : 91 44 2432 2243 / 2432 8128, Delhi : 91 11 2546 0255

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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September 16-30, 2013

AWARDS Dr (Prof) Ranjit Roy Chaudhury awarded FICCI’s Lifetime Achievement Award 2013 The award is a token of his long service to the healthcare industry in his many roles as an academician, pharmacologist and researcher he Federation of Indian Chambers of Commerce and Industry, Healthcare Excellence Awards, 2013 conferred the 'Lifetime Achievement Award' to Dr (Prof) Ranjit Roy Chaudhury, Chairman, Clinical Trials & Ethics SubCommittee, Ministry of Health & Family Welfare, GOI and Chairman – Task Force for Research, Apollo Hospitals Educational and Research Foundation (AHERF) at New Delhi. The award applauds and felicitates individuals who moved the needle and raised the bar in their respective genus. Roy Chaudhury was instrumental on transforming nation's health and in institutionalising a culture of excel-

lence and this award is a token to his never-ending and relentless journey of service to the healthcare industry. Roy Chaudhury embarked his professional journey 40 years back, where over the years he spearheaded many projects as an academician, pharmacologist and researcher and establishing the Delhi Society for Promotion of Rational Use of Drugs and prestigious Department of Pharmacology in Chandigarh. He was also a part of WHO HeadquartersGeneva, Regional Office at Alexandria Egypt and Rangoon, Burma as Head of Mission and at Chulalongkorn University, Bangkok. He was presented with the Padma Shri in 1998 for his perpetual

contributions to the healthcare sector. Speaking on the occasion, Roy Chaudhary said, “I am immensely overwhelmed and honoured to receive this prestigious award by FICCI. It is an acknowledgement of the efforts of a large group of colleagues who have worked with me for the last many years. I foresee India as a healthier nation, emulating global healthcare standards. Health has to be interpreted as a total quality of life and by setting up the best practices in the field of ethics in medical practice and rational use of drugs. My endeavour has always been to set new yardsticks in the healthcare segment especially in medical teaching and health planning for the country.” Roy Chaudhury was a Member of the Committee which drafted the first Ethical Guidelines on Research in

Human Subjects of the Indian Council of Medical Research (ICMR) in 1980. He has written 25 books and has over 225 papers to his credit. He has been bestowed the Honorary Doctor of Science of Chulalongkorn University, Bangkok, the Honorary Fellowship of the Royal College of Physicians of Edinburgh. He has also served as President of the Delhi Society for Promotion of Rational Use of Drugs, Founder President of the Delhi Medical Council, chaired the

Committee for Postgraduate Medical Education. He was also nominated as a Member of the Central Council for Health and Family Welfare in 2009. He has been recently been appointed as Advisor to the Department of Health and Family Welfare, Govt of National Capital Territory of Delhi and more recently as Chairman of the Expert Committee for Reforms in Drug Regulation and Clinical Trials set up by the MoHFW, Govt of India. EP News Bureau-Mumbai

Delhi doctoral student Nehul Saxena bags top honours at Novartis International BioCamp in Switzerland 60 students from 40 leading universities in 21 countries got the opportunity to explore science and innovation at the Novartis headquarters ehul Saxena, currently pursuing her doctoral studies at the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi was selected among the top three students at the Novartis International Biotechnology Leadership Camp (BioCamp) that recently concluded in Basel, Switzerland. Other two individual toppers were from England and Switzerland. Students were evaluated by a jury on their contribution, performance, leadership and teamwork.

September 16-30, 2013

Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, said, “Novartis BioCamp offers young talent the opportunity to interact with leading scientists and to look at entrepreneurship as an option. India has some very bright talent and it's truly heartening to see a young woman from India win accolades at such a high level. I do believe innovation is the way forward for our country and I hope that Novartis through BioCamp will draw more young people to research, thereby generating new ideas around scientif-

ic innovation and improving patient outcomes.” Workshops and presentations were led by leading scientists and members of top management at Novartis including, among others, Rolf M Zinkernagel, a Nobel laureate and member of the Novartis AG Board of Directors, and Prof Susan Gasser, Director, Friedrich Miescher Institute of Biomedical Research. BioCamp students interacted with Novartis scientists and executives who lead the company's approach to drug development and learnt about new breakthrough medicines to address patients' unmet medical needs. The programme is designed to help students understand trends and challenges in the biotechwww.expresspharmaonline.com

nology and life science sectors as well as gain first-hand experience about starting and running a biotech company. BioCamp is an international forum for science and business students from around the world to learn, exchange ideas and work together in a highly competitive business environment. Previously hosted in Tokyo, Hong Kong and Cambridge, Massachusetts,

this year's seminar marked the fourth time the International BioCamp was hosted at the state-of-the-art Novartis global headquarters in Basel, Switzerland. Since launching BioCamp in 2004, Novartis has introduced more than 500 top graduate students to the research-oriented life sciences industry and entrepreneurship. EP News Bureau-Mumbai EXPRESS PHARMA

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Lloyd School of Pharmacy felicitates Atul Nasa He has been nominated as the President of the 65th Indian Pharmacy Congress loyd School of Pharmacy recently organised Orientation Day for the 10th batch of B Pharm students. On the occasion were present eminent personalities in the flied of pharmacy like SL Nasa (Registrar, Delhi Pharmacy Council), PP Sharma (Consultant, Pharmacy Council of India) and Atul Kr Nasa (President, IPGA). At the event, Atul Nasa was felicitated by Manohar Thairani, President, Lloyd Group, for being nominated as the President of the 65th Indian Pharmacy Congress to be held in Delhi-NCR in December this year. The event will witness the presence of more than 10,000 pharmacy delegates.

Atul Nasa briefed the students about importance of joining professional associations and participation in mega event like Indian Pharmaceutical Congress. SL

Nasa also congratulated the institute for maintaining such high standards of teaching in the Department of Pharmacy. He told the audience about the various initia-

tives that he, as the registrar of the Delhi Pharmacy Council had undertaken for the upliftment of the pharmacy profession. EP News Bureau-Mumbai

APPOINTMENT Eli Lilly appoints Edgard Olaizola as MD India operations Has over 13 years of diversified experience in Lilly

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li Lilly and Company India (Lilly), have announced the appointment of Edgard Olaizola as its new Managing Director, overseeing Lilly’s operations in India and Sri Lanka with effect from September 1, 2013. Olaizola will succeed Melt Van Der Spuy, the current Managing Director, Lilly India, who has been promoted to the position of Vice President,

Emerging Markets (Latin America and Asia Pacific) for Elanco Animal Health (fully owned subsidiary of Eli Lilly and company). Olaizola brings with him over 13 years of diversified experience in Lilly, with a host of senior level positions to his credit across different markets, including US, Canada, Peru, Ecuador and Bolivia. His last role was as General Manager,

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Lilly Taiwan, where Olaizola played a crucial role in making Lilly Taiwan as one of the best performing countries for Lilly in Asia region. Commenting on his appointment, Edgard Olaizola said, “I am delighted to be a part of Lilly India team. India is one of the key markets for Lilly in Asia, with an immense opportunity to positively impact the lives of patients

with our quality products and services. I am excited to continue Lilly’s journey to success in one of the most dynamic markets in the world.” Olaizola holds a degree in Economics from Universidad Catolica Andres Bello and has completed his Post Graduation in Business Management from Washington University in St Louis. EP News Bureau-Mumbai

September 16-30, 2013

VISIT Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop! As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

CPhI - Halls 1, 2 & 3 P-MEC - Halls 6, 7, 8, 5 & Open Bay Area of Hall 5

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process. Hitesh Doshi, Indeus Life Sciences Pvt. Ltd.

This event is an excellent opportunity to keep abreast with new developments in the pharma industry. Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

www.pmec-india.com

Co-located with:

Organised By:

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.