Express Pharma (Vol.10, No.18) July 16-31, 2015 by Indian Express

VOL. 10 NO. 18 PAGES 72

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Market Incubating right Pharma Ally 'EXCiPACT will certainly add value to the companyâ&#x20AC;&#x2122;s brands in the global space' 16-31 JULY 2015,` 40

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CONTENTS Vol.10 No.18 JULY 16-31, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

INCUBATING RIGHT Pune—based Venture Center is abuzz with new start-ups in the biotechnology space and is showing the way to other incubators on how to approach these early stage companies | P8

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble

P16: PRE EVENT

Senior Graphic Designer Rushikesh Konka

Pack&PrinTech Expo 2015 to be held in Indore from Oc 30, 31 to Nov 1, 2015

Senior Artist Rakesh Sharma, Vivek Chitrakar

P29: CLINICAL UPDATE

Photo Editor Sandeep Patil

FDA approves Novartis' heart failure drug Entresto

MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East

P30: RESEARCH UPDATES

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta

P35: INSIGHT

PRODUCTION General Manager B R Tipnis

Immunotherapy tablets for seasonal allergies offer small benefit Primary packaging material for parenteral drugs

RESEARCH

BI'S AFATINIB LUX-LUNG 8 TRIAL DATA RELEASED AT ASCO 2015

PACKAGING SPECIAL

WEST PHARMACEUTICALS: A SEAL OF QUALITY

PHARMA ALLY

MARKET

ANANTH KUMAR LAUNCHES PHARMA PRICE DATA BANK

DR REDDY’S UNVEILS NEW CORPORATE BRAND IDENTITY

SUVEN GETS 3 PRODUCT PATENTS IN ISRAEL, JAPAN AND SOUTH AFRICA

PHARMA PRO&PACK EXPO 2016 AND PHARMALAB EXPO 2016 TO BE HELD IN MUMBAI

MANAGEMENT

HOW PLACEBOMES COULD CHANGE CLINICAL TRIAL DESIGN

GLOBAL CRO DEALS VALUE ROCKETS TO ALMOST $10 BILLION BETWEEN JAN- APRIL 2015: GBI RESEARCH

GLOBAL GENE THERAPY DEALS SKYROCKETED TO NEARLY $5 BN IN 2014: GLOBALDATA

P38: CASE STUDY

Manager Bhadresh Valia

Keeping an eye on automation

Scheduling & Coordination Mitesh Manjrekar

P68: INITIATIVE

CIRCULATION Circulation Team Mohan Varadkar

Merck supports free diabetes screening in collaboration with MUHS and MoHFW

'EXCIPACT WILL CERTAINLY ADD VALUE TO THE COMPANY’S BRANDS IN THE GLOBAL SPACE'

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. 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 © 2015. The Indian Express (P) 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.

EDITOR’S NOTE

Lee Pharma revives the CL debate

ith little known Lee Pharma filing India's third compulsory licensing (CL), legal eagles and everyone interested or connected to pharmaceutical IP are gearing up for yet another discussion on this topic. In a battle that is going to look like a David versus Goliath, the Hyderabad-based API maker has chosen to go after an anti-diabetes molecule, saxagliptin, which is covered by Patent No. 206543. Originally granted to Bristol-Myers Squibb in 2007, it later passed on to AstraZeneca in 2014 when the latter acquired BMS' interests in the companies’ diabetes alliance. There are some similarities between Lee Pharma's CL and India's second CL, filed by another relatively unknown pharma company, BDR Pharma, against BMS' anti-cancer molecule Dasatinb. BDR Pharma's CL was rejected because the Controller General (CG) of the Indian Patent Office ruled that it had not fulfilled the basic condition for making a case for a CL, i.e. BDR Pharma had not made too much of an attempt to first get a voluntary license (VL) from the patentee. Though BDR Pharma had sent a VL request to BMS, it did not respond to the latter's response which was a list of queries, basically inquiring if BDR Pharma had the capacity to produce good quality APIs, etc. BDR Pharma went ahead and filed a CL application as soon as it was legally permitted; i.e. after a year had passed from its initial request to BMS. When questioned as to why they did not reply to BMS' queries, to take forward the process of negotiating for a VL, BDR Pharma indicated BMS was using a delaying tactic, referring to an article written by members of the patentee's legal team recommending that a series of questions to counter a VL request was the best delaying tactic. The CG refused to accept this defence as he contended that the defense attorneys' article cannot be taken as a reflection of BMS' stand as it represented many other companies as well and rejected BDR Pharma's application. IP analysts are already seeing similar weak links in Lee Pharma's CL application. As analysed by Balaji Subramanian’s blogpost on Spicy IP,

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It is heartening that smaller companies like Lee Pharma are showing the confidence to challenge the status quo, but do they have the wherewithal to fight these legal battles to the logical conclusion?

(Compulsory Licence Application filed over AstraZeneca’s Saxagliptin: http://bit.ly/1ftpwKi), in Lee Pharma's case, it claims it approached the original patentee, once again BMS, in May last year. BMS asked for clarifications, which Lee Pharma claims it provided in November. While Lee Pharma did not receive any further word from BMS, it received an email from the present patentees, AstraZeneca, which it claims it 'could not open'. If the CG this time decides to give the benefit of doubt to the CL applicant, then Lee Pharma's other arguments will be up for scrutiny. There are some grey areas here too, indicating that it will not be an open and shut case. These grey areas are natural when you consider that we are at the start of what is sure to be a long (and convoluted) journey for pharma IP, litigation on CL, etc. in India. India's record on CL has been mixed, with the first CL, Natco Pharma's application for Bayer’s Nexavar, being a success while the second one (BDR Pharma’s application for BMS’s Dasatinib) faced rejection. (Lee Pharma files India’s 3rd CL: http://bit.ly/1LVEOUk) It is heartening that smaller companies like BDR Pharma and Lee Pharma are showing the confidence to challenge the status quo. According to Lee Pharma's website, Promoter/Director, A Venkata Reddy seems a veteran in APIs. He started his career in Dr Reddy’s Laboratories, co-promoted Hetero Drugs in 1993, then promoted Genix Pharma three years later and finally started Lee Pharma in 1997. But do smaller companies have the wherewithal to fight these legal battles to the logical conclusion? AstraZeneca is reviewing all legal options and points out that the company "enables affordable access to their medicines in India and elsewhere." (Have complete confidence in our IP: AstraZeneca: http://bit.ly/1NTEzHO). The battle between two corporate unequals could be balanced out by support from patient/health groups and/or parliamentarians but none of that has happened so far. We’ll have to wait and see how India’s third CL fares at the IPO. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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INCUBATING RIGHT Pune—based Venture Center is abuzz with new start-ups in the biotechnology space and is showing the way to other incubators on how to approach these early stage companies BY SHALINI GUPTA

fter having worked in various capacities in drug discovery, with leading pharma companies for almost 15 years, Dr Vishwas Joshi understood that awareness of the risk involved in drug discovery becomes a handicap for companies venturing into this space. Rather than being a deterrent, he used this insight to break out from the league to chase his idea of developing a technology for production of protein in animal cells. Today, he is the founder of Seagull Biosolutions, a company, with a technology platform for vaccine production, which could be a gamechanger once it is introduced in the market. Joshi is just one of the several scientists who are

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developing innovative new technologies with an eye on the future, housed in the Venture Center, nestled within the NCL Innovation Park in Pune, near Mumbai.

Ground for innovation Set up by Council of Scientific and Industrial Research’s (CSIR) National Chemical Laboratory, the NCL Innovation Park began operations in 2006 with an aim to promote and support innovative technology development and advancement carried out in partnership/ collaborative mode. Venture Center is furthering its mission to create, shape and sustain a "Pune cluster" of innovative technology businesses with a significant economic impact region-

ally, nationally and globally within the next 20 years. It is one of India’s largest inventive enterprise incubator, a critical component of the innovation ecosystem in the NCL Innovation Park. The Center is a technology business incubator approved and supported by DST- National Science and Technology Entrepreneurship Development Board and has also operated schemes of the DSIR, TDB, TIFAC and DC/MSME. It is also home to a BIRAC (Department of Biotechnology, Government of India) BioIncubator, which Joshi is a part of. With around 30 inventive start-ups in-house, a large range of services, facilities and resources available and more

than 130 events a year, the Venture Center stands out amongst various incubators across the country, and is Pune’s startup hub now. While most incubators support start-ups after a founding team comes to them with a preliminary business plan, Venture Center goes one step further by identifying competencies in research institutions, helping put teams together around that and help arrange funding and then take it ahead as start-ups as a part of its Lab2Market programme. Says Dr V Premnath, Director, Venture Center, “We believe that this approach is critical for science –led start-ups to come up in India with more than 80 per cent of research spending in

publicly funded research institutions (unlike the US where less than 40 per cent happens in academic and research institutes). So, not tapping these centers of knowledge to build knowledge intensive start-ups will be unproductive. Furthermore, in India there is a chasm between knowledge workers (who often do not have family wealth behind them) and business communities (which often do not have knowledge assets with them). The Lab2Mkt programme helps bridge this gap.” Out of a total of 33 business ideas that were screened under the Lab2Mkt programme, eight start-ups have been advanced to the point where a company has been

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“We believe that this approach is critical for science led startups to come up in India with more than 80 percent of research spending in publicly funded research institutions (unlike the US where less than 40 per cent happens in academic and research institutes). So, not tapping these centers of knowledge to build knowledge intensive startups will be unproductive” Dr V Premnath Director, Venture Center

We got a grant to develop a virus for cancer therapeutics which causes no toxicity in humans unlike chemotherapy which has side effects Dr Vishwas Joshi Founder, Seagull Biosolutions

incorporated and initial funding arranged, he informs. What is even more interesting is that, seven of out these eight companies are in the biosector. This is only where is begins to get even more exciting, as further figures are revealed. Venture Center incubatees include beneficiaries of BIRAC’s BIG, SPARSH and SBIRI grant schemes. The BIG grant has so far had a major impact. Five Lab2Mkt companies received grant funding from BIRAC in the year 2013-14, two companies received funding in 2014-15. So far, six rounds of funding have been completed. As many as 29 companies from Venture Center’s network (including those not resident in Venture Center) have got BIRAC grants. Companies who got funding under the BIG programme of BIRAC have raised ` 430 lakhs so far. The numbers speak for themselves, even as the Centre is buzzing with activity. So when prodded for figures on how many companies have commercialised their research so far, Dr PremNath elaborates, “Venture Center is a young incubator for a life sciences incubator. Most of our companies are under four years old and work in domains which have long regulatory approval periods. So, the number of companies who have already sold products based on their research is relatively small. However, several of them have filed Intellectual Property (IP) or are in the process of filing IP. Several others have licensed IP and are advancing them. The proportion of companies who are either developing their own IP or leveraging licensed IP is larger at Venture Center than most other incubators.”

Breaking through Joshi’s company, Seagull Biosolutions, is a part of the bioincubator and a BIG awardee from BIRAC (2013).

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A small grant from DSIR after he achieved his proof of concept in June 2012 offered the much needed impetus to go forward. He has developed a technology platform called eSAME by using an enzyme present in measles vaccine that can allow not only protein but virus production, thus making it versatile. When he started toying with the idea in 2011, drugs like erythropoetin and GCMSF were commonly produced in India. However there was little or no expertise or technology platform to develop in the production of monoclonal antibodies. “We got a grant to develop a virus for cancer therapeutics which causes no toxicity in humans unlike

eight months time. He informs that using measles vaccine as a vector, all vaccines can be produced at a very low cost, less than $1-2, at par with measles vaccine, which is the cheapest so far. He is again looking for funding, with the product yet at least seven to eight years away from the product being in the market, and is afraid that it might be hard to come by. A second vaccine for dengue is also in development and has completed animal studies, just like the one above. Joshi is not alone. The entrepreneurship bug hit Dr Chaitanya Saxena when he was working for Eli Lilly at its Indianapolis based drug discovery unit as a key mem-

proteomics based technologies that offer multiple benefits to drug discovery efforts at different levels. At the same time, we are using these technologies internally and developing our own 'first-in-class' drug-discovery programmes. Our technologies are validated and we are already offering them as services,” he elaborates. He already has six global customers for these technologies which (1) allow identification of drug targets of phenotypically screened molecule at early stages of their development so that lead molecules can be rationally developed, (2) profile proteome-wide toxicity of the 'lead' molecule during lead to lead-optimisation

Five Lab2Mkt companies received grant funding from BIRAC in the year 2013-14, two companies received funding in 2014-15. So far, 6 rounds of funding have been completed. As many as 29 companies from Venture Center’s network (including those not resident in Venture Center) have got BIRAC grants chemotherapy which has side effects. Once the virus is injected in the patient, it knocks down the cancer and people who could have died in a months time, can survive for years. Such therapies are now being considered as the next paradigm for cancer therapy,” he adds. In April 2015, Amgen got an approval for the first such drug for cancer. “If we can have this therapy in the market, immediately after it gets approved, and that too at a lower cost, it will be a big boon for Indian patients. I’d be able to produce it at ` 10, 000-12,000. And subsidise it further, “ he says confidently. The excitement in his voice is palpable since the platform can form a vaccine from a new virus in less than

ber of a team that was developing technologies for identifying new drug targets. He had a plan to start a company that will develop chemical-proteomics based target identification technologies and offer it to multiple drugdiscovery efforts across the globe. In May 2010, he set up base in the Venture Center and there has been no looking back. A series of grants from DBT in the ensuing years made sure that the momentum continued. His company Shantani Proteome Analytics has received a total of four grants so far. While he is not keen to reveal the amount of funding received till now, he tells us more about the technology. “W e are focused on developing and commercialising

phase and (3) provide a basis of repurposing molecules that are at late stages of clinical development. The company’s internal drug discovery efforts have also come a long way, with its first programme at pre-IND stage. This is a 'first-in-class' programme in Type-2-diabetes therapeutic area and animal studies have established that therapy under development, if successful in clinical trials, will provide well-differentiated benefits to patients, he explains. The therapy will not only control higher glucose-levels in patients but additionally it will protect their pancreas to limit the progression of disease and control the weight gain that is often associated with diabetes.

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services, mentors, funding options, experts, events, networks etc which gives a certain degree of comfort and certainty to entrepreneurs to even begin venturing into biotech/biomed. These sec-

The biggest limiting factor is the limited understanding of drug discovery processes across stake holders. A few to none venturecapitalists, academic groups are doing great biological research, but it does not necessarily cut into developing a new drug. Big-pharmas of India, barring a few, do not have significant interest in new drug discovery for their own valid reasons. In an Indian set up, the right approach is most likely to work in developing new drugs Chaitanya Saxena Founder, Shantani Proteome Analytics

tors demand knowledge intensity, technology inputs and technology risk alongwith high investment due to expensive equipment and supplies. Given the larger journey to market due to need for reg-

ulatory clearances, entrepreneurs need experience, passion and interest in commercialisation of inventions or scientific ideas of which there is paucity in India, he concludes.

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The right ecosystem Both Joshi and Saxena are scientists turned-entrepreneurs and going by their progress so far, their future certainly looks promising. While one is working in the area of vaccines, the other is into drug discovery and both are challenging fields where new innovation is a dire need. Biotech incubators could be the nurturing grounds for such innovators. Premnath adds that an incubator needs to build a conducive ecosystem with the right facilities,

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And it is not just about creating the right incubator that will solve the problem. “The biggest limiting factor is the limited understanding of drug discovery processes across stake holders. A few to none

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MARKET venture capitalists, academic groups are doing great biological research but it does not necessarily cut into developing a new drug. Big pharmas of India, barring a few, do not have significant interest in new drug discovery for their own valid reasons. In an Indian set-up its the right approach that is most likely to work in developing new drugs,” reiterates Saxena. He feels that substantial earlystage funds and an inability to identify people driven for excellence in commercial application of science and science ingeneral is the key challenge. He is quick to add that they are evolving business models in drug discovery more suitable for Indian investors who seek to exit in three years. So, what would be critical to ensure that such scientific start-ups reach a critical mass? Premnath says that we need mechanisms to create a pipeline of such start-ups by grant funding as the US does via SBIR and POC funding as done by the Deshpande Center at MIT in the US. Incubators operating the scientific start-ups space need to find ways to make accessible various pockets of funding- including grants from the government and international/charitable organisations, soft loans, equity investments etc. Of this, grants and equity are preferred modes where the revenue foresight is weak or unpredictable and entrepreneurs are first

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Incubators operating the scientific start-ups space need to find ways to make accessible various pockets of funding- including grants from the government and international/charitable organisations, soft loans, equity investments etc. Of this, grants and equity are preferred modes where the revenue foresight is weak or unpredictable and entrepreneurs are first generation entrepreneurs generation entrepreneurs. Universities and research institutions are not geared to support start-ups directly, he

states. Their mandate, motivations, their structure, their institutional processes etc are not conducive for entrepre-

neurship. Also, academic and research organisations often have legal limitations in supporting start-ups. In this con-

text, incubators set up as independent entities are often better suited for nurturing start-ups and supporting entrepreneurship, he adds. Meanwhile Tania Paul, who has received the BIG grant late last year is working on multiple coagulation disorder to formulate a herbal drug to reduce excessive blood loss in trauma, thrombocytopenia and in genetic disease like hemophilia. Currently, there is infusion with costly recombinant factor eight injections. “ It is long journey where I have stepped a mile it seems, I am on the way to develop the prototype formulation and presently gathering scientific evidences to prove and promote the product by conducting various experiments. Soon we shall be done with preclinical safety and will be head towards clinical trials. All being well, the product shall reach the market after getting a FDA licence.” It is a long journey for sure, not only for these start-ups but also for India to create a thriving ecosystem for biopharma and biotech start-ups. While NCL has set a prime example of a buzzing incubator helping early stage start-ups, there is a need to create a wholesome ecosystem so that not only do such start-ups begin, flourish and break even but also go on to become iconic companies in their own right. shalini.g@expressindia.com

MARKET COMPANY WATCH

Ananth Kumar launches pharma price data bank Pharma price data bank is an integrated pharmaceutical database management system THE UNION Minister of Chemicals and Fertilisers, Ananth Kumar launched the Pharma Price Data Bank on June 25. It is an integrated pharmaceutical database management system, managed and operated by National Pharmaceutical Pricing Authority (NPPA). The Minister said that this is the first data bank of pharma industry that will help the manufacturers, regulator as well as the consumers. He said that now manufacturers can fill their mandatory forms online, the Government and NPPA can have comprehensive data, and consumers can benefit by having full information about the medicines. He said that 21st century is the era of information, and information is power. He called for ushering in next generation of reforms in the pharma industry so that the consumers are empowered to make right choice of medicines, based on complete information about the products, their composition and their rates. Kumar expressed the hope that the availability of real time data will help in better policy interventions. Minister of State for Chemicals and Fertilisers Hansraj Gangaram Ahir said that the Government is working for the welfare of the society. Appreciating the initiative of NPPA, he expressed the hope that the database will benefit the common man. The Secretary, Department of Pharmaceuticals, Dr VK Subburaj said that the databank will help in simplification of procedures. He expressed the hope that online system will become

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popular and companies will provide complete and timely information.

Pharma Price Data bank will be used by pharma manufacturers/marketing/ importer/ dis-

tributor companies to make online submission of mandatory information/data as prescribed

under the Drugs Price Control Order, 2013. EP News Bureau- Mumbai

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Dr Reddy’s unveils new corporate brand identity The new identity speaks of Dr Reddy’s constant endeavour to understand the unmet and under-met needs of patients, and the swift action to solve them DR REDDY’S Laboratories (DRL) announced the launch of its new visual identity and brand, that will guide its actions across the globe: Good Health Can’t Wait. According to a company release, the new logo is an expression of empathy and dynamism, which helps keep patients at the centre of everything thatDRL does. Empathy helps gain rich insights into patients’ needs, and dynamism enables DRL to address these needs— innovatively and with agility. The heart depicts empathy and caring while the circles connote dynamism and responsiveness. The company has also chosen a new corporate colour – purple, which is associated with creativity and wisdom. Overall, the new identity speaks of DRL’s constant endeavour to understand the unmet and under-met needs of patients, and the swift action to solve them. The objective of the rebranding exercise is to derive a unifying, patient–centric approach, to meet new and daunting challenges that patients are facing. With the healthcare scenario changing rapidly, it is im-

The objective of the re-branding exercise is to derive a unifying, patient–centric approach, to meet new and daunting challenges that patients are facing portant to be driven by a common goal that adds value to every touch-point for patients and partners alike. The re-branding will be executed in two stages. In the first phase, the corporate brand has transitioned to the new identity. Phase two will see the new identity transitioning on to the company’s product packaging. The existing logo and brand identity will remain in place and valid until changes that are pertinent to legal processes, documentation and other regulatory or statutory changes are complete. Commenting on the launch, Satish Reddy, Chairman, DRL said, “Over 31 years, DRL has grown from a manufacturer of

APIs into a multinational pharma brand of repute, with operations in over 25 countries. Throughout this journey, we have remained true to our core values, even as we continually transform to keep pace with the changing needs of our patients and partners. Our belief ‘Good Health Can’t Wait’ lends new meaning to our core purpose of accelerating access to affordable and innovative medicines.” GV Prasad, Co Chairman and Chief Executive Officer, DRL stated, “Our goal has always been singular: to ensure expensive medicines are within the reach of patients. Our focus has always been the patient. While we have expanded over the years, our purpose has re-

mained unchanged: to bring high quality medicines within the reach of all. Today, we wish to re-dedicate ourselves to that purpose because we believe that for every human being, good health is always the first priority. In simple terms: ‘Good Health Can’t Wait.’ DRL will deliver on its purpose and belief through five promises: ◗ To bring expensive medicines within reach of patients who need them ◗ To address unmet patient needs ◗ To help patients manage their disease better ◗ To enable and help partners ensure availability ◗ To work with partners to help them succeed. ◗ DRL’s new identity expresses its purpose and belief in a compelling way and reiterates its focus on keeping patients at the heart of everything it does. Together with its partners, DRL aims to ensure a better world for all, as Good Health Can’t Wait. EP News Bureau- Mumbai

Confident in our IP:AstraZeneca MNC reviewing options on Lee Pharma's CL IN A statement reacting to Lee Pharma's application for a compulsory license (CL) for saxagliptin, AstraZeneca has said that it was aware of the CL application filed with the Indian Patent Office and are reviewing their options. The statement goes on to say that the company enables affordable access to their medicines in India and else-

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where and has "complete confidence in its intellectual property that protects our inventions and does not believe that such intellectual property is a barrier to access to medicines in developing countries.” Lee Pharma's CL application is being closely watched as were the decisions on India's previous two CLs. The first went in favour

of the CL applicant (Natco Pharma) when it was found that all three conditions under section 84(1) of The Patents Act, 1970 had been satisfied, leading to grant of the CL for Bayer's Nexavar. On the other hand, the second CL, BDR Pharma's CL for BMS' dasatinib was rejected as BDR had not made a sufficient attempt to procure a volun-

tary license from the patentee, therefore not fulfilling this condition under section 84(1) of The Patents Act, 1970. Commenting on the developments, a spokesperson from Khaitan &Co said, "In view of these precedents, it would be interesting to see the outcome of this third CL application." EP News Bureau- Mumbai

Akaal Pharma extends collaboration with GVK BIO GVK BIO has announced that the extended collaboration with Melbourne, Australia based clinical stage biopharmaceutical company, Akaal Pharma for the scale-up of its novel topical AKP-11 ointment to support phase II clinical study in psoriasis. GVK BIO’s formulation development business unit in Bengaluru has developed robust and scalable process for novel topical AKP-11 ointment. GVK BIO plans to support clinical studies of Akaal Pharma’s topical psoriasis drug by providing clinical supplies, manufacturing and analytical support. Discussions are also on-going to work towards exploring appropriate commercialisation packaging and various formulations for the topical use in other inflammatory diseases. Seetharaju Gembali, Senior Vice President, Formulation R&D, GVK BIO said, “Strengthening of our partnership with Akaal Pharma is testimonial to our expertise in the formulation development and we look forward to working with other clients.” Dr Dale Dhanoa, Chief Executive Officer, Akaal Pharma said, “We have had a very efficient CRO relationship with GVK for our clinical trials supplies support due to GVK BIO’s experience, capabilities and facilities. We are excited to advance our first-in-class multimodal acting topical drug candidate AKP-11 into phase II stage of clinical development for the treatment of psoriasis. There are several other inflammatory diseases that we are targeting with our clinical compound and are currently exploring various formulations for its topical applications.” EP News Bureau- Mumbai

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Suven gets 3 product patents in Israel,Japan and South Africa Patents are for the treatment of disorders associated with neuro-degenerative diseases SUVEN LIFE Sciences announced that the grant of one product patent from Israel (218525), one from Japan (5714729) and one from South Africa (2013/09100) corresponding to their new chemical entities for the treatment of disorders associated with neuro-degenerative diseases. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention Deficient Hyperactivity Disorder, Huntington’s disease, Parkinson’s disease and schizophrenia. With these new patents, Suven has a total of six granted patents from Israel, 17 granted patents from Japan and 20 granted patents from South Africa. These granted patents

It has 11 internallydiscovered therapeutic drug candidates currently in pre-clinical stage of development are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase-I or phase-II. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,”

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says Venkat Jasti, Chief Executive Officer, Suven Life Sciences. It has 11 internally-discovered therapeutic drug candidates

currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington’s dis-

ease, Parkinson’s disease and obesity in addition to phase II ready developmental candidate SUVN-502 for and phase I can-

didate SUVN-G3031 for Alzheimer’s disease and schizophrenia. EP News Bureau- Mumbai

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Pack&PrinTech Expo 2015 to be held in Indore from Oc 30,31 to Nov 1,2015 KNS GROUP is also hosting Pack & PrinTech Expo 2015, a co-located and concurrent event PHARMATECHNOLOGYINDEX.COM, a KNS Group company is organising the 3rd Edition of Pharma Tech Expo 2015 which boasts of an exclusive pavilion for ayurveda, herbal and contract manufacturers. It is being jointly organised with Indian Pharmaceutical Association (IPA) – MP State Indore Branch and in association with Pharmexcil and fully supported by MPPMO, Pithampur Audhyogik Sangathan and MP Small Scale Drug Manufacturer’s Association, Association of Industries – Madhya Pradesh and MP Ayurvedic Medicine Manufacturing Association from October 30 to November 1, 2015 at Brilliant Convention Centre Indore, Madhya Pradesh. The trade show combines indigenous, innovative technological processing methods to accelerate the growth trends in packaging, printing, pharma, food and beverage industrial segments. The event is being jointly organised by IPA – MP State Indore Branch and KNS

MEDIA in association with Pharmexcil, and supported by IMPA. These two exhibitions – Pack & PrinTech Expo 2015 and PharmaTech Expo 2015 are expected to be ideal platforms for the complete spectrum of the pharma, laboratory, packaging and printing industries, and machinery manufacturers from india and across the globe. It will serve as a great opportunity for packaging, printing, machinery and equipment manufacturers to showcase their products.

Why exhibit in Pack & PrinTech Expo 2015? ◗ Technical know-how and industry inputs gained at Pack & PrinTech Expo 2015 and PharmaTech Expo 2015 ◗ Meet and interact with professionals from leading companies across the country at one place ◗ Commercial insights with regards to industrial packaging and printing products, ayurveda and herbal raw materials and services by displaying absorbing

It will serve as a great opportunity for packaging, printing, machinery and equipment manufacturers to showcase their products technical information on new and existing projects ◗ Get to know about new products, technology innovations and manufacturing solutions from across the continents ◗ Find out latest trends in packing and printing from experts sharing their valuable knowledge on the sector

◗ Opportunity to rub shoulders and network with decision makers, company heads, consultants, industry professionals ◗ The visitors are decision makers from advertising agencies, production houses, design companies, retailers, publishers and other consumers of packaging and printing services and products ◗ Opportunity to be in the midst of bustling business activity and experience and envision deals getting done, enquiries being generated and contacts being made ◗ Pack & PrinTech Expo 2015 gives an opportunity to interact with foreign manufacturers and innovators to form joint ventures, technology transfers and even distribution networks in India and across the globe ◗ Pack & PrinTech Expo 2015 will present many cutting edge packing and printing machines from indian and global manufacturers ◗ Pack & PrinTech Expo 2015 will act as a catalyst to 'Make in

India' movement and provide an impetus to Indian economy

Event highlights ◗ An international exhibition which which will see the presence of 5,000 trade professionals/decision makers ◗ More than 150 industry majors will exhibit their products/technologies / services ◗ Most affordable participation tariff ensures control on unexpected expenses Most affordable exhibition related services/utilities ◗ An equal opportunity to all the participants to exhibit their products/services to the Indianand global packaging and allied Industries ◗ A must attend event to share the knowledge, discuss the updates and evolve the new ideas towards the advancements in the packaging and allied industries ◗ Will cover an exhibition space of 75000 sq ft EP News Bureau- Mumbai

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industry-accepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 - 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

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July 16-31, 2015

❒ We welcome information on new products and services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

Email your contribution to: The Editor, Express Pharma, Business Publications Division, The Indian Express (P) Ltd, 1st Floor, Express Towers,

Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

MARKET

PHARMAPro&Pack Expo 2016 and PharmaLAB Expo 2016 to be held in Mumbai The last edition of the event, held in May this year, elicited a great response from the industry PHARMA PRO&PACK Expo 2016 and PharmaLAB Expo 2016 will held in Mumbai from April 27 - 29, 2016. A premier pharma event, the last edition of the event, held in May this year, elicited a great response from the industry. It witnessed participation from 471 exhibiting companies and was attended by over 18,000 trade visitors from India including 580 hosted international buyers from 124 countries.

Feedback from key exhibitors and participants on PHARMA Pro&Pack Expo 2015 and PharmaLAB Expo 2015 ◗ Mahendra Mehta, Chief Executive Officer, Parle Global Technologies and Treasurer, IPMMA. This third edition has been beneficial in terms of foreign delegates visiting our booth and considering the 'Make-inIndia' programme initiated by

Exhibitors and visitors at 2015 show

the current government, it was very interesting to have foreign buyers coming and inspecting our products. Seeing is believing and when you showcase and demonstrate the working of your products to buyers at the show, the product speaks for itself. ◗ Dr SP Rijhwani, Promed Laboratories, Indore and Vice President – Indian Pharmaceutical Association (IPA) I am really very happy to

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MARKET attend the shows here and it was very interesting to come across new technologies and developments in the field of pharma machineries. The best part is that along with iPHEX, the shows put together showcase the entire spectrum of the Indian pharma industry”. ◗ Ashutosh Gupta, Chairman, Pharmexcil With increasing R&D spends, Indian pharma sector has become a cost-effective centre for world class research as also for contract R&D. Indian companies in recent years have produced many cost-effective drugs that are affordable to the masses. We are making concerted efforts to promote India’s status as the manufacturing hub of the world. ◗ Bhavin Mehta, Committee Chief of iPHEX and CoA member, Pharmexcil

The unique model of exhibition format where each buyer from various countries meet each and every exhibitor is a model by itself. Due to this model, Pharmexcil has taken a lead to increase the reach of these buyers so that exhibitors can in turn maximise the potential of these buyers and explore new business opportunities ◗ David Keefer, President, Elizabeth Carbide Die Co, US We are exhibiting at this expo for the third time and the profile of buyers who visit our booth fits in perfectly with the products that we manufacture. Buyers are spending a lot of time reviewing our machinery and we successfully closed a few orders with the buyers who visited our booth. We are a joint venture partner with Parle Global Technologies and they too are happy with the results that we

generate from this show. ◗ Kedar Sathe, Director Arbess Tools We are a repeat exhibitor at the PHARMA Pro&Pack Expo and we are very happy with the way the show has been organised. And just like last year, we are really impressed with the quality of in-

ternational visitors who are here. Additionally, since this show is being held alongside iPHEX, the show generates extra exposure, since our machinery users are part of the iPHEX show. ◗ Shafiuzzaman, Secretary General, Bangladesh Association of Pharmaceutical Indus-

tries, Bangladesh The PHARMA Pro&Pack Expo 2015 is very well organised and at this just one trade show, I have been able to see all kinds of pharma machinery. One of the buyers from US, Hemant Joshi It was a wonderful experience for me as I have never visited such an expo in India. I have been to may exhibitions in the US; however the PHARMA Pro&Pack Expo 2015 is comparable to those held in the US. Talking about the technologies on display, I came across many latest types of machineries. I came across two to three producers of that equipment. I can say that Indian pharma manufacturers are at par with those in the US. Secondly, the prices of Indian machines are very affordable to those available in the US EP News Bureau- Mumbai

EVENT BRIEF JULY -AUGUST 2015 20

2nd Annual Advanced API Convention

2ND ANNUAL ADVANCED API CONVENTION

CONCLAVE 2015 (GIGANTIC 2015)

Date: July 20 - 23, 2015 Venue: Mumbai Summary: CPhI 2nd Annual Advanced API Convention will focus on the development of high quality API’s for the Indian pharma market. To counter India’s 90 per cent dependency on China for essential drugs, this conference will focus on quality, technology and cost efficiency in the processes for making the API drugs.

Date: August 6-7, 2015 Venue: Ahmedabad Summary: The conclave brings together technologists, scientists, academicians, policy makers and end-users of the nanotechnology platform for discussing the various aspects of development and characterisation, exploring the possibilities of Indian industry to take part in nanotechnology research, product development, growth and initiating new ventures through partnerships with foreign players who are leader in the field. Objectives of the conclave are to provide a platform for researchers and

Contact details Phone: +44 (0)20 7921 5000

GLOBAL GREEN NANOTECHNOLOGY

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July 16-31, 2015

Global Green Nanotechnology Conclave 2015

industrialists to interact with each other and share knowledge, create awareness among the end-users and consumers on nanotechnology, to facilitate the technology requirement and other related needs of the industry through national and international networking, to interact with the government to establish policy and standards for nanotechnology processes, to facilitate the training needs of the start-up companies in nanotechnology field, facilitate knowledge flow by working with international organisations through bilateral/multi-lateral cooperation mechanism and discuss scope, challenges and

future application of nanotechnology. Contact details Gaurang Patel Executive Centre of Excellence in Nanotechnology Confederation of Indian Industry, CII House, Gulbai Tekra Road, Near Panchwati Ahmedabad – 380 006 Contact No: 08460464349 Tel. (079) 40279994; Fax. (079) 40279999 Email. Gaurang.patel@cii.in

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai

CPHI INDIA

Summary: Key decision makers in the pharmaceutical industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors can meet all major suppliers of pharmaceutical ingredients, outsourcing, equipment and bio-solutions in one location. P-MEC, ICSE and BioPh will be co-located with CPhI event. Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol Andheri (East) Mumbai – 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

cover )

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THE MAIN FOCUS

SIBLING SHOW

Targeting a turnover of ` 1000 crore by FY2017, bothers Alok and Anuj are determined to take their father Jagdish Saxena's vision to the next level. Will the infusion of bold and complementary new strategies from both sons be strong enough to weather the competitive times ahead? Or will sibling rivalry play the spoiler? BY USHA SHARMA

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cover )

O “

pportunities don't happen. You create them,” is a common motivational quote which possibly best defines the journey of Mumbai-based company Elder Pharma. It was founded by Jagdish Saxena in 1987 and after his demise in 2013, is currently being managed by his sons: the elder Alok Saxena and the younger Dr Anuj Saxena.

From the archives Interestingly, company lore has it that the patriarch had no plans to set up his own pharma venture. He joined the Indian Air Force in 1960, and quit three years later to join Sarabhai Chemicals. Two years later, he joined Tata Fison Industries, where he put in a long stint, going from a liaison officer for their pharma products, agro chemicals and industrial chemicals division, to Sales Manager of their pharma division at Mumbai with added responsibility of Delhi. In 1973, he joined Martin & Harris as Marketing Manager and was promoted as Director in 1975. In 1978, he joined Walter Bushnell, as Managing Director. In 1987, the company shocked employees when it announced that it was shutting down its pharma division. Concerned about the future of the 300-odd employees of his division, Saxena senior took the bold step of investing his personal funds to launch his own pharma company. Even though this was his first venture, all the 300 employees, including key personnel from the pharma marketing division, who were about to lose their jobs decided to join him. The company was up and running by 1987.

Story behind the name While deliberating on many options, inspiration struck sen-

20 EXPRESS PHARMA July 16-31, 2015

ior Saxena when he was on holiday in Australia and saw a trailer truck for the first time, which had the world 'Elder' written out along its side. Struck by the sight, he decided to name his company, Elder Pharma. For the next two and a half decades, Elder Pharma came to be defined by his continuous efforts, be it making the company a successful brand or developing new products like Shelcal. After his demise on October 11, 2013, the responsibility passed smoothly onto the shoulders of his two sons, both of whom already had key responsibilities in the business. Recalling the lessons learnt from his father on business and life, as he joined him after leaving law studies, at the age of 22 years, Alok Saxena, Managing Director and Chief Executive Officer avers, “This has been a great journey for me. We started with a small operation and have built great brands. I think this journey for me still has a long way to go.” Till the demise of his father, younger son Dr Anuj Saxena's involvement in the company's activities was much lesser as he was pursuing a full time career in the TV and films industry. Today, he is working full time with Elder Pharma. Explaining the division of responsibilities, Alok says, “Anuj is the COO of the company and takes care of all domestic operations while I handle international business.” Recalling his successful stint on the small screen, spanning TV and ad films, Anuj points out that he waspart of some of the most successful television shows like Kkusum (Sony), Kumkum (Star Plus) Saara Akaash (Star Plus), and Prratima (Sahara) to name a few. Another passion he

in operational and decision making roles.”

Difficult choices

WE STARTED WITH A SMALL OPERATION AND HAVE BUILT GREAT BRANDS. I THINK THIS JOURNEY FOR ME STILL HAS A LONG WAY TO GO ALOK SAXENA, MANAGING DIRECTOR AND CHIEF EXECUTIVE OFFICER, ELDER PHARMA

indulged is was to run a restaurant in Mumbai. Anuj managed to strike a balance between his responsibilities at Elder Pharma and his on-screen career. As he

explains,“I was always a part of the Elder team, even while acting and would manage my time in such a way that I could devote six to eight hours to Elder, involving myself

After showing a steady growth graph for several years, the company started facing a financial crisis. Dealing with the issue called for some hard choices, selling off Shelcal and 29 other brands to Torrent Pharma, for `2004 crores in 2014. Explaining the hard choices before the company Anuj says, “Over the last seven to eight years, Elder grew and spread its wings and invested in various acquisitions in India and abroad, which is expected to generate major revenues and profits - but in the long term. These investments resulted in certain short term fund issues, forcing us to take a practical and business decision of selling off our brands to Torrent; keeping in mind the longevity and future of the group.” When the announcement broke in the market, the obvious question was why does the company have to sell such an impressive and performing brand like Shelcal? Is it because the company is facing financial issues? Answering such hard hitting questions, Anuj says, “With competition increasing and market conditions getting tough, our company decided to take certain pragmatic decisions which involved selling-off of vour key brands.” But the company clearly believes in the Shelcal brand, and hence retains the international rights which will help the company in growing further. Expressing the possibilities of regaining momentum from Shelcal among the international markets, Anuj informs, “Elder sold only the rights for the brands in India and Nepal and we still have the international rights for the

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THE MAIN FOCUS

ELDER PHARMA PLANS TO DEVELOP OTHER PRODUCTS AS SUCCESSFULAS SHELCALAND EXPAND THE GEOGRAPHICAL REACH OF THE COMPANY brands. Currently, brands like Shelcal and Chymoral are under registration in a lot of African and South Asian countries and we expect it to increase in the next two to three years. These brands will grow and will contribute to the business turnover. We will register these brands in more countries in times to come. Our initial response to Shelcal internationally has been extremely positive and encouraging.” According to the company's press release issued in this June, Elder Pharma has commenced exports of Shelcal to more than 25 countries, and targets to receive `100 crores from global sales. For FY201516, the company is likely to notch up sales of over `25 crores with demand coming from countries like Cambodia, Myanmar, Sri Lanka, Mauritius, Maldives, Zambia, Uganda, Yemen, Guyana, Burkinafaso, Cameroon, Congo, Ivory Coast, Gabon, Papua New Guinea, Mali, Mauritania, Niger, Senegal, Burundi, Rwanda etc. Shelcal is currently exported in the form of 250/500 mg tablets and syrup but new line extensions are also being planned which will include Shelcal CT (Calcitrol), Shelcal OS (alpha Calcitrol) and Shelcal HD (high dosage of Vitamin D3). The company is also targeting the markets of Europe, CIS and LATAM. Shelcal’s European thrust will be spearheaded by Neutra Health, its wholly owned subsidiary in the UK which will market it across the EU. Sold through the ethical route, Shelcal has found support from health conscious persons as the source of calcium used in it is from ‘oyster shell’, which provides calcium in its purest form. With international markets under his wing, Alok

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cover ) projects that with the overwhelming response and acceptance of its product in all these markets, the company is looking at a strong prescription base in over 70 countries by March 2017.

Building a new superbrand A logical and major part of Elder Pharma's future growth strategy is to develop other products as successful as Shelcal and expand the geographical reach of the company. Spelling out some of this blueprint, Anuj reveals, “Going forward, our mother brand is going to be Eldervit. Eldervit falls in the category of multivitamins and minerals and Eldervit Injection enjoys very strong brand equity in the Indian market. In terms of opportunity and market size, Eldervit has much bigger and better opportunity as it is mass market and the size of the market is much bigger when we compare with a calcium supplement, especially for osteoporosis and other such diseases. The idea is to obviously capture all other markets as well. Currently, Elder Pharma is predominantly present in class I and II towns in metro cities. With products like Eldervit, we would eventually spread our base to the interiors, wherein we would explore the mass population to get maximum returns.” Building Eldervit into a super brand will obviously be no cakewalk, given the profusion of brands in the supplements category. Even more so when you consider the change in management. Perhaps unfairly, but Shelcal's success is largely attributed to the late Saxena senior's expertise with marketing and promotion strategies, even though both sons were very much part of the company. But there are already signs that both sons have learnt their lessons well. Predicting the future of Eldervit and other promising brands, Dr Saxena says, “I personally feel the brands like Eldervit and some of the anti-infectives like

22 EXPRESS PHARMA July 16-31, 2015

Formic have the potential to be a bigger brand than Shelcal. We are also working on new molecules and brands in the years to come to increase our market presence, both in size and value. “ An example of this is Anuj's role in helping the company diversify its business portfolio. According to him, “The Elder Health Care Division/Company took full form under my leadership after 2006, when our company foresaw the huge potential of the fast moving health goods (FMHG) sector. Before that, there were a few brands in Elder Health Care and its team. However, the team and the company came into force as an independent existence in 2006, when I took charge.” Under his leadership, the company launched several products in FMHG segment like mouth wash AMPM, which the company has since relaunched with an addition of a range for smokers/tobacco users. It has also expanded its Solo range of OTC products with the launch of the Solo range of inhalers for nasal congestion. The newly re-launched AMPM has the key ingredient ‘triclosan’, an antibacterial and antifungal agent. The new version of the product is available in three variants: AMPM PLUS, AMPM SPECIAL and the newly launched AMPM NICOFRESH which is specially formulated for smokers/ tobacco users. In addition to triclosan, AMPM NICOFRESH contains sodium perborate which helps remove smoke and tobacco tar. The oxygenating effect of NICOFRESH hits one of the most stubborn sources of sulphur-producing bacteria and stops it at its source. While justifying the relaunch of the AMPM product and the company's focus to strengthen its presence in FMHG, Anuj says, “The FMCG brands like AMPM and Solo have just been reintroduced in the market. It is too early to comment, but I am hopeful that in times to come we can see the success of the same. In the next

revamp its presence in both the markets, he mentions, “As we restructure, going forwards, we will obviously concentrate on the prescription market because that has been our strength. However, we will also slowly increase our FMCG/ OTC brands exposure. Till now Elder Health Care was responsible for the sale and marketing of the FMCG/OTCS brands. Going forward, the brands will now be marketed and distributed through the Elder Pharma distribution chain. The advantage that we have within the group is that a lot of our FMCG/OTC brands require chemists for placement of the products and this is where we have an edge over a lot of other companies. We will exploit our inherent strength in the years to come.”

Challenges galore

OVER THE LAST SEVEN TO EIGHT YEARS, ELDER GREW AND SPREAD ITS WINGS AND INVESTED IN VARIOUS ACQUISITIONS IN INDIA AND ABROAD DR ANUJ SAXENA, CHIEF OPERATING OFFICER, ELDER PHARMA

one to two years, we will focus on our existing brands port folio, but at the same time we will be doing the homework to keep new products ready and

at an appropriate time we will launch them, as and when needed.” While sharing the company's business strategies to

The company has received a considerable amount from Torrent but has it been enough to put an end to the question mark on its financial viability? Going by market buzz, the business environment of the company has not changed much and it is still in the process of settling its debts. Fending off these queries head on, Anuj informs, “The challenges the group faces today are the liabilities that still need to be cleared off, but which are more than sufficiently covered by our assets and brands. The support of employees at all levels has also been a major factor in turning around the cash flow situation of the company. The current products of the company are in great demand and are enabling the company to generate good cash flows. We expect a complete turnaround in our financial position by FY 2015-2016. Every organisation, big or small, goes through such challenges and we are no exception, but it has been a huge learning which we hope will stand by us in the long run. By FY 2017 Elder Group (domestic and international) is expecting a turnover of `1000 crores.”

( Bumpy road ahead? Unfortunately, business is not the only arena where the family is finding it difficult to sustain its identity. There seemed to be some turbulence on the personal front as well. A year after the death of Saxena senior, a legal case was filed for division of his assets. The legal battle pitted Anuj against the rest of the family members ie; Alok, mother Sneh and sister Shalini. Giving an update on the developments of the legal dispute, Anuj says, “Keeping the best interests of the business, employees and the shareholders, the family is working out a solution to settle the matter. Hopefully it will happen soon.”

journey, Alok unveils the ultimate goal of the founding family saying, “We are looking at making Elder Pharma one of the top companies in the healthcare arena. ”

Many companies start out as a dream, but it takes executors to weather the challenges and translate a dream into reality. Elder Pharma is facing

Nurturing their father’s vision Saxena senior has played a mentor’s role in his children’s life. Now it’s time for his children to nurture the father's vision for Elder Pharma to its fruition. Both Alok and Anuj have geared themselves up to take up their father's responsibilities and are trying their best to improve the company's present performance. Reminiscing about his father and his advice, Anuj says, “His guidance was crucial to us but we are working along the lines he used to take decisions. In the past two years, I have involved myself in - and successfully restructured - every aspect of the group, from finance, accounts, sales, marketing, HR, administration etc. I think that this is the right way to make the company grow because it was important for me to understand the real situation of the company before I embark on rebuilding the group.” Though the company is a family-run business entity, the promoters value professionals as well. As Anuj mentions, “We have a very professional team led by my brother Alok and by my late father and founder Jagdish Saxena. There is a substantial delegation of authority in our organisational set-up.” While mentioning his father's dream which he had set long before starting his final

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July 16-31, 2015

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THE MAIN FOCUS

several challenges but the founding family has already shown the courage and pragmatism to take difficult decisions as well. Navigating the road ahead

will need creativity and courage but above all, a speedy resolution of all tangles on the personal front. u.sharma@expressindia.com

MANAGEMENT INSIGHT

How placebomes could change clinical trial design

DR JOSEPH KAMALESH, Associate Vice President, Quest Life Sciences

Analysing recent preliminary research on the 'placebome' - a set of genes that trigger some placebo responders to respond to the placebo effect, Dr Joseph Kamalesh, Associate Vice President, Quest Life Sciences concludes that this could lead to a possible revolution in clinical trial design. This is because with the incorporation of genetic screening at the clinical trial design stage, placebo responders could be excluded, resulting in more accurate and precise clinical trials. However, there are certain ethical issues which will need to be first sorted out

A SMALL change made today can become history to be reckoned with someday. Just to prove the statement to be true, the study of Kathryn Hall a researcher at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, is on the cusp of unearthing data that can in future change the design of clinical trial studies as we see it today. Clinical trials have always been a basis for the approval of pharmaceutical products to be marketed on a commercial scale. It is an extremely sensitive field of study since it also carries an element of risk for the human volunteers participating in the trials. Before any drug can make its way into the market, safety and efficacy studies should be performed and have to be proved beyond debate. Human volunteers play a very crucial role by rendering their co-operation in the clinical trials conducted. As stated by a clinical trial researcher, "The first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it". Keeping this in mind, over time the field of

24 EXPRESS PHARMA July 16-31, 2015

clinical trials has faced many revolutionary changes, of which a major one was the formation of the placebo controlled clinical study.

Placebos in clinical trials Placebos can be considered as a therapeutically inert substance given to the human volunteers, thereby giving them the perception that they are being treated while in reality, there is no therapeutic treatment. On the other hand, studies now suggest that random patients do exhibit responses when administered with a placebo formulation, which in turn has spurred the debate amongst the scientific community, that the body has genes responsive to placebo molecules, and this reaction of the body has been termed as placebo eesponse. Common placebos include inert tablets, vehicle infusions, sham surgery etc.In technical terms, placebo-controlled studies are a way of testing a medical therapy whereby, in addition

to a group of volunteers subjected to the treatment to be evaluated, a separate control group receives a placebo treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. The aim of incorporating a placebo arm in the study is to determine the treatment effects in the study which are not related to the treatment itself. In different phases of clinical trials, placebos, either inactive drug or sugar pills, are used as controls for the comparison against the effectiveness of active substances. The placebo effect makes it difficult for the evaluation of clinical studies conducted. Placebo responders who are basically human volunteers with a genetic makeup that makes them susceptible to the effects of the placebo formulation, as they participate in the

trial and when administered with the placebo, will tend to have a misconception of it, where the person comes to a conclusion that the betterment of their health had occurred due to the uptake of it. This placebo effect might be the outcome of the genetic programming of the placebo responders which eventually makes them conclude that the placebo had really worked wonders by eliminating their physical abnormalities. Hall states, "Our findings strongly support the idea that genetic signatures for placebo responses exist, but our findings are preliminary." The findings stated by her indicate the finding of the 'placebome' a set of genes that trigger some placebo responders, to respond to the placebo effect. Previous studies prove that certain signaling pathways like the dopamine, opioid, endocannabinoid, and serotonin pathways in the brain can play a mediatory role in the variations seen in the placebo re-

Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment

sponses. Taking the dopamine pathway as an example, Hall and her team have gained more evidence from their work that some small variation in the dopamine pathway can extract favourable outcomes from patients subjected to placebos that might overcome the placebo effect, since the dopamine pathway seems to be responsible for all the pain and pleasure responses of a person. In her study the variations instilled in the COMT (catechol-Omethyltransferase) gene which influences the dopamine pathway eventually alters the placebo responses of a person since the placebo effect is mediated by the dopamine. This variation is believed to bring about a revolution in the clinical trial design by the incorporation of genetic screening where the placebo responders can be excluded and the trial can be conducted with placebo nonresponders and concluded accurately with more precision. The refined acceptance of the subjects for the trial would be made possible by the study of Hall and there are possibilities of great noticeable changes occurring in the trial design.

Impact of â&#x20AC;&#x2DC;placebomesâ&#x20AC;&#x2122; on clinical trials

MANAGEMENT A general hypothesis states that, the pathways that influence the placebo response, can also produce the same outcome, in the responses of the human volunteers to drugs that target these pathways. Again these responses are said to vary from person to person based on their genetic makeup. If this hypothesis is proven, then it can further help in cutting the costs of clinical trial studies, by the incorporation of a no treatment arm in addition to the placebo controlled arm. All the above mentioned findings, if and when proven, will take the researchers another step closer to making the concept of personalised medicine more accurate and viable.Personalised medicine in a nutshell, it is the mode of treatment, whereby a patient is subjected to their genetic

analysis as well as the molecular and cellular data are collected, and this data is used as a template to provide personalised singular treatment to the patient, and this includes prescription drugs, medical decisions and therapeutic procedures.

Ethical aspects There are also certain other ethical issues which need to be answered like, whether a person would be psychologically disturbed when becoming aware of their placebo response effects. Another point to be debated upon will relate to the labeling of drugs, as to whether a drug clinically tested only on placebo non-responders can be prescribed for use on patients who are genetically prone to show a placebo response. Another probing issue is

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The aim of incorporating a placebo arm in the study is to determine the treatment effects in the study which are not related to the treatment itself

on whether the physician during disease diagnosis, should be allowed to carry out patient profiling based on their response/non-response to placebos, and if allowed to do so, then are the patients to be given the right to accept or decline such a type of profiling. If the physicians are allowed access to this information, then what are the measures to be taken to ensure that this patient information will be used by the physicians without any compromise on the ethical norms. "If there is indeed a biological element and you can actually find a genetic basis for it, you would absolutely be causing a revolution in clinical trial design," says Arthur Caplan, an ethics researcher at New York University Langone Medical Center. On the same

note, if the studies of Hall managed to be scientifically proved with proper evidences, clarifying all the ethical issues, would become a great breakthrough in clinical trial designing. The acceptance of the new design of the clinical trial which can be more constructive and cost effective is a big question to be answered in the near future by the CROâ&#x20AC;&#x2122;s.

Reference: http://www.worldpharmanews.c om/research/3065-certaingenes-might-make-some-peoplemore-prone-to-experience-theplacebo-effect http://www.reuters.com/article/2015/04/15/us-placebo-effectgenesidUSKBN0N62L220150415 http://www.dispatch.com/content/stories/local/2015/04/26/he alth/placebo-effect-might-be-genetic.html

EXPRESS PHARMA

July 16-31, 2015

MANAGEMENT REPORTS

Global CRO deals value rockets to almost $10 billion between Jan- April 2015: GBI Research Struggling to balance R&D expenditure and profitability, pharma companies are outsourcing R&D and clinical trial activities to CROs to improve cost effectiveness THE TOTAL number of deals in the global Contract Research Organization (CRO) market reached 700 between January 2010 and April 2015, achieving an overall value of $33 billion, says business intelligence provider GBI Research. The company’s latest report states that 2015 has already contributed the most to the overall deals value during this period, with $9.86 billion achieved between January and April this year alone, representing an almost fourfold increase from the $2.5 billion reached in 2014. This impressive growth was significantly bolstered by

Laboratory Corporation of America’s (LabCorp) record $6.1 billion acquisition of Covance in February 2015, enabling LabCorp to strengthen its laboratory and CRO service offerings. In its bid to acquire Covance, the company also issued debt offerings of $2.9 billion. Priyatham Salimadugu, Associate Analyst, GBI Research says, “While acquisitions achieved the highest deal value globally between January 2010 and April 2015 as a result of this transaction, venture financing represented the highest number of deals during this period, with 134.

Pharma companies have struggled to balance R&D expenditure and profitability over recent years

“The US was the top market for overall CRO deal activity with 337 deals, accounting for a 48 per cent share of the global total, largely due to the majority of leading CROs being head quartered in the country.” The report adds that pharma companies have struggled to balance research and development (R&D) expenditure and profitability over recent years, due to rising drug development and clinical trial costs, as well as rigorous regulatory and quality assurance requirements. As a result, these companies are outsourcing R&D and clinical trial activities to CROs

to improve cost effectiveness. CROs have developed operational strategies to maximise their business opportunities in response to this, by entering new geographies and adding new services. Salimadugu continues, “Among the CRO market leaders is Quintiles, which generated revenues of $5.4 billion in 2014. “Quintiles was able to drive ahead of its peers with its product development services, namely phase II–IV clinical trials, and integrated healthcare services segments, boosted by the company’s global presence,” the analyst concludes. EP News Bureau- Mumbai

Recent drug approvals to boost Parkinson’s disease therapeutics market: GlobalData Treatment market value across eight major countries to reach $4.7 billion by 2022 THE PARKINSON’S disease treatment market value across the eight major countries of the US, France, Germany, Italy, Spain, the UK, Japan, and Brazil will reach $4.7 billion by 2022, driven primarily by an aging population and increasing disease prevalence, according to research and consulting firm GlobalData. The latest report, titled ‘Parkinson’s Disease – Global Drug Forecast and Market Analysis to 2022’, states that most late-stage pipeline agents are set to meet the needs of advanced Parkinson’s disease patients, with three drugs ex-

26 EXPRESS PHARMA July 16-31, 2015

pected to launch by 2022, namely CVT-301, opicapone, and tozadenant. In a strong first quarter for Parkinson’s disease treatment, Impax’s Rytary was approved by the US FDA in January 2015, while Newron’s Xadago was approved in Europe in February and accepted for a new drug application by the FDA in March. Additionally, AbbVie’s Duopa, which has been available for over 10 years in Europe, also gained US approval in Q1 2015. Heather Leach, Senior Analyst GlobalData, Immunology and Neurology says that the most promising products are

Xadago and Rytary for early and advanced patients, and Acorda’s CVT-301 for advanced patients. Leach explains, “Xadago will be a strong market competitor for early and advanced-stage Parkinson’s disease patients, prescribed ahead of Teva/Lundbeck’s Azilect (rasagiline), due to its additional activity as a glutamate-release inhibitor. Also making an impact will be Rytary, a slow-release formulation of levodopa that has shown good efficacy and improvements in quality of life during clinical trials. GlobalData predicts that global sales for Xadago and Ry-

tary will reach $409.6 million and $202.2 million, respectively, by 2022.” The analyst adds that CVT301 is a novel reformulation of levodopa and the first inhaled drug for Parkinson’s disease. It is expected to be the first widely-used emergency therapy to fulfil a key unmet need in wearing-off, and is forecast to garner strong sales of $458.6 million in 2022. While GlobalData does not expect a disease-modifying agent to be introduced during the forecast period, the entry of any such product would be the most significant advancement

in Parkinson’s disease therapeutics since the development of levodopa in the 1960s. Leach continues, “Many early-stage clinical and preclinical programmes are in progress towards reaching this goal, such as AstraZeneca’s phase II drug, AZD-3241, a myeloperoxidase inhibitor that aims to reduce neuroinflammation. The Parkinson’s disease treatment market is very dynamic, with abundant opportunities for partnerships in both the early and late stages of clinical development,” the analyst concludes. EP News Bureau- Mumbai

MANAGEMENT

Global gene therapy deals sky-rocketed to nearly $5 bn in 2014: GlobalData M&A typically low in gene therapy field as technology remains highly experimental and majority of products are in early-stage clinical development; rise in financial investment may be indicative of renewed investor confidence THE TOTAL number of deals in the global gene therapy market more than doubled from 16 in 2013 to 36 in 2014, with their combined value rising spectacularly from $122.8 million to $4.9 billion over the same period, representing a forty-fold increase, says research and consulting firm GlobalData. The company’s latest report states that merger and acquisition activity is typically low in the gene therapy field, as the technology remains highly experimental and the majority of products are in early-stage clinical development. Despite this, the impressive growth in the overall deals value for 2014 was boosted primarily by Abbott Laboratories’ $2.9 billion acquisition of CFR Pharmaceuticals (CFR), a Chilean biotechnology company developing gene therapeutics for alcoholism and chronic pain. CFR has a product in its clinic that targets aldehyde dehydrogenase, an enzyme produced in the liver and kidneys aiding alcohol rejection. Adam Dion, MS, GlobalData’s Senior Industry Analyst says, “Licensing and partnerships, together with capital raisings, have represented the largest number of gene therapy deals struck since 2009. Licensing deals have so far outpaced historical levels, with over $1.8 billion signed in 2015. “These deals include Bristol-Myers Squibb’s $1 billion licensing agreement with UniQure to develop S100AI, UniQure’s phase I candidate for congestive heart failure, representing the deal with the greatest financial impact so far this year. Voyager Therapeutics also signed an

The total number of deals in the global gene therapy market more than doubled from 16 in 2013 to 36 in 2014 $845 million agreement with Genzyme to develop three phase I programs concerning the central nervous system.” The analyst adds that as well as licensing agreements, equity offerings are a common strategy for companies to raise funds, enabling them to advance clinical pipelines and bring gene therapies to market. Dion continues: “Nearly $1.5 billion was raised in the gene therapy arena from 2014 to 2015, of which almost $750 million resulted from Avalanche, bluebird bio and Spark Therapeutics going public. Furthermore, Parisbased Cellectis announced in March 2015 that it had raised $230 million in an initial public offering, which the company will use to advance its blood cancer pipeline from preclinical testing to phase I clinical trials. “This rise in financial investment may be indicative of renewed investor confidence, and could lead to higherthan-expected deal activity for gene therapies in the future,” the analyst concludes. EP News Bureau- Mumbai

EXPRESS PHARMA

July 16-31, 2015

RESEARCH

BI's afatinib LUX-Lung 8 trial data released at ASCO 2015 Patients from 23 countries, including India, participated in the trial, which is reportedly the first prospective trial to directly compare two different TKIs, afatinib and erlotinib BY VIVEKA ROYCHOWDHURY

ancer treatment is today based on greater understanding of both the histological as well as molecular classification of the disease. Hence research is aimed at discovering molecular targets and mutations which are linked to tumour growth. Among the mutations most studied in non-small cell lung cancer (NSCLC), a specific type of lung cancer, is the over expression of Epidermal Growth Factor Receptors (EGFR), specifically the ErbB Family of receptors consisting of four related tyrosine kinases: EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. Thus the right tyrosine kinase inhibitor (TKI) treatment could potentially be a life saver for patients with such lung cancers and therefore a blockbuster molecule. The battle for supremacy between TKIs went one step further at this year's American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US when Boehringer Ingelheim (BI) presented data from LUX-Lung 8, reportedly the first prospective trial to directly compare two different TKIs, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. According to results presented by the company, treatment with afatinib significantly reduced the risk of death by 19 per cent, extending the survival of patients to a median of 7.9

28 EXPRESS PHARMA July 16-31, 2015

months compared to 6.8 months on erlotinib. Afatinib also significantly improved control of cancer-related cough and shortness of breath compared to erlotinib, providing a better quality of life to patients. SCC represents approximately 30 per cent of NSCLC which is the most common form of lung cancer comprising over 85 per cent of lung cancer cases. Treatment options are reportedly limited and SCC of the lung is associated with a poor prognosis, with less than 5 per cent of patients with advanced SCC surviving for five years or longer. Thus even a small improvement in clinical outcomes, as shown in this trial, is big news for clinical oncologists and patients. According to the World Cancer Research Fund International, lung cancer is the most

common cancer in the world, with 1.8 million new cases diagnosed in 2012.

Mode of action BI's confidence that afatinib will be a breakthrough molecule is based on results from eight ongoing studies in the LUX-Lung clinical trial programme where it has been proved that unlike other TKIs, afatinib irreversibly blocks EGFR (ErbB1) as well as other members of the ErbB family that are known to play a critical role in the growth and spread of the most widespread cancers and cancers associated with high mortality (death). Thus, according to a BI backgrounder, unlike other compounds which are reversible, afatinib aims to provide a sustained, selective and complete ErbB family blockade. The company

believes that 'afatinibâ&#x20AC;&#x2122;s unique mechanism of action could potentially lead to a greater overall effect on the tumour, preventing tumour cell growth and spread across a broad range of cancers, compared to other treatments which offer single, reversible, receptor blocking.' Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and six trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.

Benefits for lung cancer patients in India Of the nine abstracts presented by BI at this year's ASCO meet, the LUX-Lung 8 trial holds special significance for lung cancer patients in India. The incidence of lung cancer in India is projected to increase, primarily due to smoking habits. According to India's National Cancer Registry Programme's Three Year Report of Population Based Cancer Registries spanning 2009-2011, lung cancer constitutes 6.9 per cent of all new cancer cases in the country and 9.3 per cent of all cancer related

deaths in both sexes. Moreover, it is the commonest cancer and cause of cancer related mortality in men. Afatinib is approved in more than 50 countries for the firstline treatment of distinct types of EGFR mutation-positive NSCLC (as GIOTRIF in the European Union, Japan, Taiwan and Canada and as GILOTRIF in the US.) Afatinib's approval in India, as XOVOLTIB, last November was an important milestone in BI India's journey as it marked BI India's entry into oncology. The LUX-Lung 8 trial included 795 patients from 23 countries, including India, with advanced SCC of the lung, previously treated with first-line platinum-based chemotherapy who were randomised 1:1 to receive either afatinib or erlotinib treatment. According to company sources, in India, afatinib/ Xovoltib is priced at 13.8 per cent to the US price. This makes Xovoltib's maximum retail price similar to the price to patient of other innovator TKIs in lung cancer. Afatinib has a different brand name in India (Xovoltib) as compared to Giotrif/Gilotrif in other countries due the Indiafriendly pricing strategy adopted by the company. The company is reportedly working on other options to improve access for patients. (The author attended ASCO 2015 as a BI invitee) viveka.r@expressindia.com

CLINICAL UPDATE

FDAapproves Novartis' heart failure drug Entresto First in the world approval brings hope of longer life and fewer hospitalisations for millions of Americans with heart failure with reduced ejection fraction US FOOD and Drug Administration (FDA) has approved Novartis' drug Entresto, usually known as LCZ696, for the treatment of heart failure with reduced ejection fraction. Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalisation. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker. "Despite the uncertainty and high financial risk we designed the world's largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital," said David Epstein, Division Head, Novartis Pharmaceuticals. "We recognise our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week." The FDA's decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACEinhibitor enalapril. At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed

Nearly 6 million people in the US suffer from heart failure and about half have the reduced ejection fraction form. About 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit their physical activity

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that Entresto had a similar tolerability profile to enalapril. "The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers," said Dr Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, US. "Entresto is expected to change the management of patients with HFrEF for years to come." Nearly 6 million people in the US suffer from heart failure and about half have the reduced ejection fraction form. About 2.2 million of these patients have heart failure classified as NYHA II-IV, based on how much their symptoms limit their physical activity. Heart failure is a debilitating, lifethreatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalisations and symptoms such as breathlessness, fatigue and fluid retention significantly impact quality of life. Entresto is currently undergoing review by health authorities around the world, including in Canada, Switzerland and the EU. Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion for the reduced ejection fraction indication. Reuters

EXPRESS PHARMA

July 16-31, 2015

RESEARCH RESEARCH UPDATES

Immunotherapy tablets for seasonal allergies offer small benefit In total, the trials included more than 4,000 patients with seasonal allergies ORAL TABLETS for grass pollen allergies, which are available in Europe and the US, offer only a small benefit for people with seasonal allergies, and more than half will have side effects from the medication, according to a new review of existing research. “The reported benefit is very small on average,” said lead author Dr Danilo Di Bona of the Azienda Ospedaliera Universitaria Policlinico di Palermo in Italy. “This means that some patients will respond, but the majority will not, and it is not possible to predict who will respond to the treatment.” An injectable version of the same therapy, which is also available, is preferable, since more patients will respond to it, he said. The researchers considered 13 randomised controlled trials comparing under-the-tongue “meltaway” immunotherapy tablets with placebo pills, and measuring changes in reported allergy symptoms and the use of other allergy medications. In total, the trials included more than 4,000 patients with seasonal allergies. All of the studies found some symptom alleviation with the immunotherapy tablets, but six of the 13 did not demonstrate more improvement than was seen in the placebo group. In seven studies, the group taking the immunotherapy tablets decreased their use of other medications like antihistamines and corticosteroids, but not in the others. About 60 per cent of people taking the immunotherapy tablets suffered a side effect due to the medication, usually a moderate one like mouth itching or burning and gastrointestinal tract

30 EXPRESS PHARMA July 16-31, 2015

symptoms, compared to 21 percent of those in the placebo group, as reported in JAMA Internal Medicine. Of the 4,659 people included in the trials, seven people all in the immunotherapy group reported a serious allergic side effect requiring epinephrine, a rescue treatment for potentially life-threatening allergic reaction. The benefit of the tablets originally reported from these randomised controlled trials was overestimated, Di Bona said. “With the metric we used, that is the one suggested by the World Allergy Organization, the real difference between (under-the-tongue tablets) and placebo was correctly estimated, and the benefit was comparable to placebo,” and below the 15 per cent difference required by the US Food and Drug Administration (FDA), Di Bona said. Last year, the FDA approved two types of immunotherapy tablets for pollen allergies, including Merck’s product,

Grastek and Oralair from French manufacturer Stallergenes S.A. Under-the-tongue Grastek tablets can be prescribed to anyone age five to 65 who has grass pollen allergies and suffers from sneezing, runny nose and itchy or watery eyes. As directed, it can be taken daily for 12 weeks before springtime, the grass pollen season, and throughout the season. In an editor’s note accompanying the new study, Dr Patrick G O’Malley of the Uniformed Services University in Bethesda, Maryland, called the immunotherapy’s benefit an “unimpressive small effect.” Doctors should be aware of these data, in addition to the cost of these medications, which is approximately $90 for a three-month supply, plus the requirement to co-prescribe an epinephrine autoinjector, writes O’Malley, who was not involved in the study. “Sublingual immunotherapy may seem more convenient

than nasal corticosteroids or subcutaneous immunotherapy and therefore tempting to prescribe, but the evidence shows minimal benefit and moderate adverse effects for patients with seasonal grass pollen allergies,” he says. Untreated or inadequately treated seasonal allergies can cause sleep and mood disorders and impair school or work performance, Di Bona said. About 20 per cent of Americans suffer from these allergies, largely due to grass pollen, he said. Other available treatments, like antihistamines and nasal or oral corticosteroids, are effective in controlling most symptoms, Di Bona said. Immunotherapy tablets, though their mechanism is poorly understood, modify the immune system to induce a kind of tolerance for the allergen, he said. “The treatment would be worth the expense if the response rate was higher,” he said. Reuters Health

J&J vaccine completely prevented HIVin half of monkeys in trial An experimental Johnson & Johnson vaccine completely prevented HIV infection in half of monkeys that got the shot and then were exposed to high doses of an aggressive virus, results that spurred the company to test the vaccine in people, academic and company researchers said. The international trial is underway in 400 healthy volunteers in the US, East Africa, South Africa and Thailand. It is the first time since Merck's failed 2007 trial that a major pharmaceutical company has sponsored clinical development of an HIV vaccine, said Dr Dan Barouch, a vaccine researcher at Beth Israel Deaconess Medical Center and the Ragon Institute of Massachusetts General Hosptial, MIT and Harvard. Some 35 million people are infected with HIV, the virus that causes AIDS. In a pair of studies, published online in the journal Science, Barouch and colleagues at J&J and elsewhere tested a two-step vaccine, which involves priming the immune system using a weakened version of the cold virus to sneak HIV genes into the body. The second, boost phase involves injecting individuals with a purified HIV surface protein designed to provoke a strong immune response. The company is using the same prime-boost strategy in its Ebola vaccine, now in early-stage human trials, Dr Paul Stoffels, J&J's chief scientific officer and worldwide chairman, pharmaceuticals, said. Reuters

RESEARCH

Insulin pump may cut risk of heart disease deaths with diabetes Insulin pumps provide better control of blood sugar than multiple daily injections PEOPLE WITH Type I diabetes must control their blood sugar with insulin, but getting it automatically from an implanted pump may also help to stave off death from heart disease, according to a large Scandinavian study. Among more than 18,000 Type I diabetics in Sweden followed over time, those with an insulin pump were about half as likely to die of heart-related causes, and 25 per cent less likely to die of any cause, compared to those who injected themselves with insulin many times a day. “Our study shows that treatment with an insulin pump almost halves the risk of cardiovascular mortality,” said lead study author Dr Isabelle Steineck from Aarhus University Hospital in Denmark. “Personally I think that more persons with type 1 diabetes could benefit from using an insulin pump as long as they get all the right education about the pump and are able to understand how to use it,” she said. Insulin pumps deliver insulin 24 hours a day through a catheter that is placed under the skin. The insulin is delivered in either a steady measured and continuous dose, or if more is needed, such as at mealtime, the dose can be increased. This system is designed to more closely mimic the body's normal release of insulin. Previous studies, the authors point out in the journal BMJ, have shown that insulin pumps provide better control of blood sugar than multiple daily injections. And past research has shown that even with fairly well-controlled blood sugar, people with diabetes have a risk of death from cardiovascular causes, and any cause, about double that of the general population. When blood sugar is poorly controlled, the risk is several times higher, the study team notes. For the new analysis, Steineck and her team looked at 18,168 patients with Type I diabetes in the Swedish National Diabetes Register. Of these, 15,727 controlled their diabetes with multiple daily injections of insulin, while the other 2,441 patients used implanted insulin pumps. The group was followed for almost seven years, until

December 2012. The study team analysed the rates of fatal coronary heart disease, fatal cardiovascular disease (coronary heart disease or stroke) and death from all causes. Using an insulin pump was associated with a 45 per cent reduction in risk of fatal coronary heart disease compared to using injected insulin, a 42 per cent risk reduction for fatal cardiovascular disease and a 27 per cent lower risk of dying from any cause. There were some differences between the two groups, the researchers note. Patients who used insulin pumps tended to be somewhat younger, had lower blood pressure and less heart disease, were more active, smoked less and were better educated. But when the authors did a second analysis that only included the 16,427 patients without any history of cardiovascular disease, heart failure or a type of abnormal heart rhythm called atrial fibrillation, the results were similar to those of the whole group. Steineck and her team point out, however, that they don’t know what other factors could have influenced their results. For example, better education and more frequent monitoring of blood sugar among insulin pump users could have helped lower their risk of heart disease. “We evaluated the patients who used insulin pump therapy and do not know if the observed effect is attributable to continuous infusion of insulin or that some, if not all, of the effect is attributable to intensified glucose monitoring, increased motivation to control blood glucose, or a better knowledge about having diabetes Type I,” they said. Reuters Health

EXPRESS PHARMA

July 16-31, 2015

PACKAGING SPECIAL Chennai facility

WEST PHARMACEUTICALS

ASEAL OF QUALITY West Pharmaceuticals' growth in the Asia Pacific (AP) region got further impetus with the launch of its Chennai plant at the Sri City Special Economic Zone (SEZ), which manufactures flip off seals BY SACHIN JAGDALE

he Indian market has always lured pharmaceutical and allied players from across the globe. How can a major packaging company like West Pharmaceutical Services be an exception? West opened its first manufacturing facility in India in July 2014 to meet the demand for pharma packaging components in the Asia Pacific (AP) region. The initial

32 EXPRESS PHARMA July 16-31, 2015

investment in the plant was $15 million. The facility further established West’s presence in this growing market. The plant is a 15,300 sq. m. facility that produces seals used in primary packaging of injectable medicines for biopharma customers in India and the wider AP region. In the future, West plans to expand production at the site to include elastomer components.

Why India? “The pharma and biopharma market in India is experiencing an impressive period of growth, with many local pharma and biopharma manufacturers expanding operations and several global pharma companies creating a presence in the country in recent years. Establishing manufacturing operations for West in India was a natural progression of West’s overall business strategy in the Asia-Pacific market,”

says, Warwick Bedwell, President, Asia-Pacific, West Pharma Services. West’s investment in India is important to its strategy of working by the side of its customers to help them provide medicines to patients efficiently, reliably and safely. By opening its first facility in India, West is able to meet the growing market demand for the company’s primary packaging for injectable medicines in a very dynamic, emerging region.

WARWICK BEDWELL , President, Asia-Pacific, West Pharma Services

Key highlights of the Chennai plant Centre of Excellence (CoE) in Asia Pacific for flip-off seals: Equipped with world-class manufacturing facilities and the latest stamping and assembly machinery. Reliable, high-quality products: Equivalent raw material, process and products specifications across the region help to ensure that consistent, high-quality seals are supplied to customers in a timely fashion. Wide range of seal configurations: Flip off seals and mattetop seals in various colour options and sizes, including 13 mm, 20 mm and 32 mm. Shorter lead time: A reduction in lead time to customers in India and across the AP region. Seal production capacity: Up to one billion units in the near future. AP sourcing: Complements other West plants in China and Singapore to better serve regional customers. Experienced workforce: Managed and run by experienced personnel in project management, supply chain and production under the leadership of an expert team base out of Singapore.

Global footprint West is a well-respected and trusted name. The world’s top 35 injectable biologics (2012 sales of $108.5 billion) are packaged and delivered with components manufactured by West and its partner, Daikyo Seiko. Furthermore, every day 110 million West components reach patients around the world. To date, West has sold over 1.4 billion products in Europe for low molecular weight heparin. West is also the largest manufacturer of insulin pens and auto injectors. The company serves its customers from more than 50 locations around the world. West’s pharma packaging systems revenue in 2014 was $1 billion, whereas in the same year the company’s pharma delivery systems segment had revenue of $402 million.

With more than 20 customers qualified and placing production orders from the Chennai plant, the company finds itself well ahead of its plan Innovating its way to leadership The company always strives to bring new and benchmarked products to the market. In this pursuit, West recently hosted half-day seminars on Daikyo Crystal Zenith (CZ) a proprietary cyclic olefin polymerin at Ahmedabad, Bengaluru and Hyderabad. West is focusing on niche segments within the region where it can provide alternative solutions to glass. The company believes that there are opportunities for CZ in India across the product portfolio including vials, syringes and cartridges. With more than 20 customers qualified and placing production orders from the Chennai plant, the company finds itself well ahead of its plan, and expects this plant to be profitable by early 2016. Every day, injectable drugs are administered to improve the lives of millions of patients around the world. West has cutting edge production technologies, expertise in global regulatory compliance, and an ever growing knowledge base of pharma drug product testing, development, packaging and delivery. These are some of the qualities that have kept the company ahead of its competitors and will drive growth in future as well. sachin.jagdale@expressindia.com

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EXPRESS PHARMA

July 16-31, 2015

PACKAGING SPECIAL

Innovation in ß-lactam antibiotics packaging Unique eco-friendly sustainable packaging from DSP, a laminate bag comprising four-layers of polyester, aluminum, nylon and polyethylene, ensures better protection of material compare to conventional packaging PENICILLIN REPRESENTS one of the most important groups of ß-lactam antibiotics, specifially amoxicillin is. Its discovery is still a landmark in the treatment of bacterial infections and is first line of therapy and remains the most prescribed antibiotic. Conventionally ß-lactam antibiotics are produced by complexed chemical synthesis. Challenges associated with conventional processes are, these involve use of toxic solvents and chemicals as well as generate considerable amounts of non-biodegradable wastes. Conventionally beta lactam antibiotic bulk drugs are shipped in High Density Poly Ethylene Drums (HDPE)/ Corrugated boxes. A concern associated with such packaging is that these consumes significant amount of plastic and paper which have adverse impact on the environment. Specifically the plastic pollution is adversely affecting environment and also the life of people, animals and birds in some way or other. More than a million sea birds and mammals dies every year due to plastic ingestion of entanglement. Moreover, with increased consumption of plastic it’s becoming difficult to dispose off non-biodegradable waste¹. Another important concern of plastic, it consumes an incredible amount of fossil fuels. Most estimates put the figure at around eight per cent of world’s oil production. While significant amount of oil is consumed to produce plastic and then it is viewed as 'too valuable to throw away' as waste¹. Demand of situation is to find innovative ways and means to reduce bio burden on planet.

Solution from DSM Sinochem Pharmaceuticals (DSP) To combat the above challenges, in 1997 DSM Sinochem Pharma-

34 EXPRESS PHARMA July 16-31, 2015

ceuticals (DSP) has started systematic phase out of conventional processes with ecofriendly synthesis across the globe. DSP introduced Purimox (an enzymatically produced amoxicillin) in 2001 to counter above environmental concerns by eliminating toxic solvents and chemicals in the process and still delivers world’s highest stable and purer amoxicillin (close to 100 per cent). Green innovative processes inherently offset carbon footprints of earlier processes. The next step is to address the plastic bio burden, DSP has innovated the way of packaging its Active Pharmaceuticals Substances. Purimox now comes in an eco-friendly packaging, first ever initiative taken by any API manufacturing company in the world for the packaging of beta lactam antibiotics. The paradigm shift from conventional packaging to innovative packaging further offset carbon footprints (through conservation of natural resources like non-renewable fossil oils/energy) and at the same time providing an option of better and greener packaging and thus improving well-being of people and planet. Unique eco-friendly sustainable packaging, a laminate bag comprising four-layers of polyester, aluminum, nylon and polyethylene, ensures better protec-

tion of material compare to conventional packaging. Transformation of innovation is demonstrated as below:

Benefits of innovative packaging a.Reduction in non-biodegradable waste going to landfill Worldwide we have concerns of handling waste generated through various channels. With increased waste, available landfill areas are getting exhausted very fast, if we continue the same way, the question is, where will be the place to live? To secure land for generations to come, demand of situation is to control and minimise wastes going to landfill area. Innovation like Purimox with unique packaging curtail 4,23,000kg of waste (by 90 per cent reduction compare to conventional HDPE Packaging) and therefore ease out problem of limited landfill area up to large extent. b.Reduction in carbon dioxide emissions Reduction in 90 per cent consumption of non-biodegradable substance will cut down 1,69,2000 kg of CO2 emissions per annum and thus improve health of people and plant². c.Energy saving due to 80 per cent space reduction in warehousing As per regulatory requirement, pharma active ingredients are to be stored at cool conditions. Cooling process involve significant amount of energy.

Eco-friendly packaging significantly reduces the storage area. Purimox in innovative packaging can now be stored in 80 per cent lesser area compare to conventional HDPE drums and therefore it reduces energy conservation significantly. d.Conservation of non-renewable fossil fuels Reduction in non-biodegradable substance count for 7,40,000 liters savings of oil, equivalent to 35,955GJ energy³. e.Reduction in hydrocarbons A reduction of 90 per cent non-biodegradable substance will contribute in eliminating 4,23,000 liter of hydrocarbons. In addition, this will also save energy which is consumed during recycling/ disposal process. f.Material safety Industries have been facing concerns of pilferage in conventional packaging. Unique design makes Purimox packaging not only pilferage evident but also gives better protection to material from environment compare to conventional packaging. Eco friendly packaging also address the issue of denting and damage which is quite common with conventional HDPE drums. g.Operator-friendly packaging Wider opening of new packaging makes it operator friendly and also reduces the occupational health hazard which are associated with drums. Further in HDPE drums, metal ring and lock are the integral part of it, sharp rings have

potential risk of injury to operator while handling. h.Better GMP Compliant New packaging is better cGMP compliant than before due to improved hygienic conditions during its manufacturing and transportation compare to conventional drums and boxes. i.Customer satisfaction Benefits as explained above are been appreciated by the customers in Asia Pacific, Middle East, Africa and Europe. Space efficient packaging support their warehousing expansion plans as they can store up to 80 per cent more material in existing warehouse. Shipping more material in container makes customers better sustainable as this reduces overheads cost for them in terms of transportation.

Regulatory compliance European Directorate for the Quality of Medicines (EDQM) has granted the Certificate of European Pharmacopoeia (CEP) for eco friendly packaging. Expending scope of eco friendly packaging to global networking sites After successful introduction of eco friendly packaging at India site, a dedicated team is closely working with global networking sites to switch from conventional to packaging to eco friendly packaging across the globe. DSM Sinochem Pharmaceuticals stay committed for Sustainable Planet!!!

References: ¹http://www.plasticoceans.net/th e-facts/a-global-issue/ ²http://www.unep.org/ietc/Portals/136/Conventional per cent20vs per cent20biodegradable per cent20plastics.pdf ³Ref: http://www.photius.com/rankings/energy/electricity_consumption_per_capita_2013_0.html http://en.wikipedia.org/wiki/Elec tricity_sector_in_India

PACKAGING SPECIAL INSIGHT

Primary packaging material for parenteral drugs Dr Bettine Boltres, Product Manager Pharmaceutical Tubing, SCHOTT AG gives an introduction on the different packaging options and their requirements IT IS not easy being a primary packaging material for parenteral drugs these days. And not less complicated is the job of the pharma company. How to find your way through the jungle of regulatory requirements and ever increasing demands of the lately developed drugs? This article gives an overview of the different packaging options and their requirements. From all packaging materials, primary packaging for parenteral drugs has the highest quality standards. According to the European and the US regulations, â&#x20AC;&#x153;equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirementsâ&#x20AC;? 1, 2. This regulation applies to all materials that are in direct contact with the drug product including metals, glass, and polymer. The European (Ph. Eur.) and United States Pharmacopeia (USP) define a pharma container as being in direct contact with the drug product. The container shall be designed in a way as to protect the drug product from environmental influences and minimise the loss of the product. 3, 4 Except for when ampoules are used, the packaging consists of several components, like the container, a stopper, a plunger, a needle, etc. The FDA Guideline on Container Closure Systems for Packaging of Human Drugs and Biologics defines the whole Container Closure System (CCS) as a combination of all these individual components that contribute to the stability and quality of the drug product 5, p. 2.

From all packaging materials, primary packaging for parenteral drugs has the highest quality standards Primary packaging for parenterals can be either made of glass or polymer. Using glass there are two different possibilities depending on the specific requirements: Molded vials or bottles are made by filling a gob of glass into a mold and blowing or pressing it into its final shape. Tubing containers are produced in a two-step process where first the tubing is drawn and secondly the container is formed from the tubing by using heat and forming tools. The development of various different types of glass based on scientific principals was started over a hundred years ago, when the basic recipe for the borosilicate glass was developed. From these the borosilicate glasses have developed as the standard packaging material for pharmaceutical purposes. According to the current USP and Ph. Eur., borosilicate glass contains significant amounts of boric acid, aluminum oxide, alkali metal oxides and alkaline earth metal oxides. With a high hydrolytic resistance, this glass is classified as a Type I glass and is recommended to be used for

EXPRESS PHARMA

July 16-31, 2015

PACKAGING SPECIAL packaging parenteral drugs. On the other side, by increasing the amount of alkali and alkaline earth metal oxides in the glass composition a soda-lime glass is created. With an only moderate hydrolytic resistance this glass is classified as Type III and recommended to be used rather for preparations, not for parenteral administration 4, 3. Within the past years the pharma market was driven by an increased development of biopharmaceuticals, such as monoclonal antibodies, recombinant proteins, vaccines, blood- and plasma-derived products, etc. These drugs usually pose higher requirements on the container in terms of extractables and leachables, hydrolytic resistance, pH stability, etc. than the traditional drugs. As a consequence, regulatory agencies brought stricter and more individual quality controls into focus which can be seen from the increasing number of publications. This is why, now a known material like glass with a long history, is looked at in a new light. While choosing a primary packaging for their drug product the pharma company has to evaluate several quality criteria. Helpful guidelines are found in the Ph. Eur., USP and Japanese Pharmacopeia (JP). An overview of some important chapters is given in Table 1 In the meanwhile, for parenteral products there are in general five possible packaging options, as shown in Table 2. Which container shape and which packaging material to choose exclusively depends on the requirements of the drug product. The different quality aspects that have to be considered along the development process are discussed as follows:

Chemical resistance Within the chemical stability, an important measure for the suitability of glass for pharma containers is its resistance against water attack (hydrolytic resistance). There are two test methods to assess this, which are the glass grains test and the inner surface test. They are described in the international standards ISO 719, ISO 720, ISO 4802-1, ISO 4802-2 and the

36 EXPRESS PHARMA July 16-31, 2015

Ph. Eur., USP as well as 6, 7, 8, 9, 4, 3, 10 . Hereby, the Ph. Eur. JP and the USP are aligned whereas the JP testing method is different. A very important difference is that in the Ph. Eur. and USP, the classification is done into Type I and III according to their hydrolytic resistance, whereas in the JP the result of the test is ‘pass’ or ‘fail’. Glass tubing manufacturers in various regions of the world supply three different sub-types of borosilicate glasses for use in the pharma industry. Although all three are Type I glass, the hydrolytic resistance drops slightly from one type to another. At the same time, the coefficient of thermal expansion (CTE), a measure of the volume and length expansion of glass when subjected to a temperature change, increases. Based on the value of this coefficient, borosilicate glasses are classified as 3.3·10-6 K-1, 5.0·10-6 K-1 and 7.0·10-6 K-1, whereby the hydrolytic resistance decreases from 3.3·10-6 K-1 to 7.0·10-6 K-1. Borosilicate glass of 3.3·10-6 K1 poses some challenges on the converting process whereas borosilicate glass with a CTE of around 7.0·10-6 K-1 offers lower hydrolytic resistance. Given these aspects, borosilicate glass 5.0·10-6 K-1 is the ideal compromise of a high chemical resistance and convenient to convert. Thus it is used as a standard all over the world.

TABLE 1 Current Pharmacopeia

Content

3.2.1.

Glass Containers for Pharmaceutical Use

<660>

Containers – Glass

7.01

Testing for Glass Containers for Injections

Ph. Eur.

USP

FOR PARENTERAL PRODUCTS THERE ARE IN GENERAL 5 POSSIBLE PACKAGING OPTIONS, SHOWN IN TABLE 2: Container

Tubing glass

Ampoules

Pre-fillable syringes

Vials

Molded glass

Bottles

Cartridges

Borosilicate 3.3

Borosilicate 5.0

Borosilicate 7.0

SiO2

80 - 82

72 - 75

70 - 74

B2O3

12 - 13

9 - 11

5-8

Al2O3

5-7

4 - 6,5

Na2O/K2O

6-9

9 - 12

MgO/CaO/BaO

1-3

5-7

Working Point

~ 1260°C

1145 - 1170°C

1030 - 1100°C

525°C

560 - 575°C

550 - 580°C

CTE [10-6·K-1] (20-300°C)

3.3

4.9 - 5.5

6.3 - 7.5

Composition

Extractables and leachables Over the past years the biologically developed drug formulations growing in the areas of therapeutic proteins, vaccines and monoclonal antibodies exhibit much higher sensitivities towards any foreign substances and changes in environment than the chemical drugs do. Additionally the liquid formulations containing surfactants, salts and chelating agents coupled with ever lower drug levels placed a global focus on the interactions between the formulation and the packaging material and thus the whole CCS. Determination of potential extractables and leachables became part of the process validation when filing new drug applications. The composition of glass has always been widely

Chapter

Physical Data

known and official. So in the interaction of the drug with glass packaging, the amount of extractables and leachables has to be determined rather than their nature.

tion in a fast and cost-effective manner. Equally, the filling volume and the level of contamination can be checked. After storage, a discoloration or the occurrence of glass particles can be detected.

Transparency The transparent nature of glass permits a proper visual inspec-

Light protection Within the growing field of

biologics but also among the known drugs there are substances that are very sensitive to light and which decompose when subjected, especially, to UV-light. For these cases, coloured glass can be used, which is supplemented with either iron and titanium or iron and manganese. Still, this type

PACKAGING SPECIAL of glass remains transparent enough to allow for visual inspection. In order to ensure the safety of the drug the allowed amount of light passing through the glass is specified. Here the requirements are different when comparing Ph. Eur., USP and JP. The JP is the only one specifying the transmittance through the glass wall in the visible range (590-610 nm).

Permeability Apart from being light-sensitive, there are also drugs that are sensitive towards oxygen and water vapour. For ensuring the quality and efficacy of these drugs a tight CCS (Container Closure Integrity, CCI) is crucial. The structure of glass does not allow for any gases or pyrogens to travel through it and into the drug product. The helium permeation rate is somewhere around 10-10 mbar·l/s which is insignificantly low especially because helium is a third of the size of oxygen. But, not only are harmful substances prevented from contaminating the product but, in addition, it is impossible for the contents of the intact container to leak out.

Sterilisation Glass has a very stable structure which is kept even when confronted with high temperatures as e.g. 330°C in the depyrogenation tunnel. Exceeding this temperature glass generally stays stable up to 500°C. Only then a very slow deformation starts. Hence, temperature applications are in general not critical for glass.

Freezing On the other side glass also keeps its structure when exposed to very low temperatures. This makes it suitable for lyophilization and freeze/thawing. In these applications attention has to be paid not to exceed the temperature shock resistance of the glass. This value is given by a combination of composition, CTE and wall thickness of the container wall. Generally it can be said that the lower the CTE the higher is the temperature shock resistance. Due to the low thermal conductivity of the glass temperature needs some time to pass through the glass wall. If a hot glass container is in direct contact with a cold metal it might happen that at this particular contact spot the temperature shock resistance is exceeded which then leads to a thermal shock crack. For the CTE 5.0·10-6 K-1 tubing container e.g. a container with a wall thickness of one mm takes a temperature shock of 200°C. With this variety of requirements

Glass has a very stable structure which is kept even when confronted with high temperatures in the depyrogenation tunnel and container options it is not always easy for a pharma company to find the right solution for their new drugs. Here it is always recommended to be in close contact with the container suppliers, carefully evaluate the options on the market and by using the many regulatory advisories to choose on a case-by-case basis.

FDA APPROVED TESTING LABORATORY

SPECIALISED IN STABILITY STORAGE & ANALYTICAL TESTING. Our Services: w Testing Drug and Pharmaceuticals

w Sterility Test.

as per IP/BP/USP/EP/Specified.

w Storage of samples as per ICH guidelines including Photostability.

w Analysis of Stability Samples.

w LAL Test. w Method Transfers. w Microbial Assay.

w Analytical Method Development

References 1. European Comission of Glass, "Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use,," 2010. 2. US Government Printing Office, "Equipment construction," CFR, Code of Federal Regulations, Food and Drugs, Title 21, p. Part 211.65, 2010. 3. USP 36 NF 31, Chapter <660> Containers - Glass, United States Pharmacopeia, 2013. 4. Ph. Eur. 8.4, Chapter 3.2. Containers, European Pharmacopeia, 2014. 5. FDA, „Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics,“ 1999. 6. ISO719, Glass - Hydrolytic resistance of glass grains at 98°C - Method of test and classification, International Organization of Standardization, 1985. 7. ISO720, Glass - Hydrolytic resistance of glass grains at 121°C - Method of test and classification, International Organization of Standardization, 1985. 8. ISO4802-1, Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification, International Organization of Standardization, 2010. 9. ISO4802-2, Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification, International Organization of Standardization , 2010. 10. JP XVI, Testing for Glass Containers for injections, Japanese Pharmacopeia, 2011.

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and Validation.

w Microbial Limit Test. w Preservative Efficacy/Challenging Test.

LABORATORY DESIGNED AS PER GLP AND ENSURES DATA INTEGRITY AND SECURITY.

Thermolab House, Plot No. 19, Vasai Municipal Ind. Area, Umela Road, Vasai (West) - 401 207, Maharashtra, India | (T) +91-250-2323156, 2324866/7 | (F) +91-250-2321656 | (E) info@thermolabanalyticals.com | (W) www.thermolabanalyticals.com, www.thermolabgroup.com |

PACKAGING SPECIAL CASE STUDY

Keeping an eye on automation A case study demonstrating how Excelvision, a French eye drop vial manufacturer, accelerated production with help from Bosch SPECIALISING IN sterile manufacturing, Excelvision, based in Annonay, France, provides contract manufacturing services for liquid eye drop plastic vials to numerous companies. However, to increase production and capitalise on additional contract manufacturing opportunities, Excelvision enlisted Bosch Packaging Systems AG, based in Beringen, Switzerland, to install a fully automated packaging line. With significantly higher output capabilities, Excelvision expects to increase production by nearly five-fold. The new line also gives the company greater flexibility to meet the diverse requirements of its customers.

At the crossroads for an upgrade Excelvision manufactures vial cards in bulk, each hold five blow-fill-sealed single-use vials. Because the company produces different product shapes and configurations for its customers, it faced a logistical challenge in rapidly packaging the diverse products. Prior to working with Bosch, Excelvision relied on individual vertical form, fill and seal (VFFS) machines to package each vial card. However, this approach required vial cards to be manually fed into the system. At peak capacity, production only reached approximately 60 cards per minute, not fast enough to keep up with current demand, let alone plan for new market expansion. “We found ourselves at a crossroads,” says Philippe Pensuet, Head of Engineering and EHS at Excelvision. “Our operations were not flexible enough to react to our customers’ demands, and it was taking too much time and effort to win new contracts.” Purchasing multiple storage

38 EXPRESS PHARMA July 16-31, 2015

trays dedicated to each product format size would have been too costly. However, Bosch’s complete line solution allowed the company to use one storage tray type for all product formats. The line provided the necessary flexibility to separate the vial cards and then package them appropriately for each customer. “Also, as demand increases for single-dosage packaging, the new line gives us the flexibility to adapt production in the future,” adds Pensuet.

A trusted relationship Having visited an automated Bosch line in operation in the US, Excelvision was well aware of Bosch’s expertise in the plastic vial market. Impressed with what they saw, Excelvision reached out to Bosch about automating operations for its eye drop line. “This was a challenging project for us because we’ve always used stand-alone machines,” Pierre Laissy, Project Manager, Excelvision explains. “Bosch provided the consultation we needed for a successful upgrade to our first highly automated, complete line solution,” he further informs. The project also involved a lengthy approval process with Excelvision’s customers as they needed to verify that the new packaging solution would meet market needs and regulations. During this vetting process, Bosch regularly consulted with Excelvision about different packaging styles and materials. Because of the many parties involved, the project took two years to come to fruition, during which time the company developed a close partnership with Bosch. Pierre Laissy notes that two advantages offered by Bosch were flexibility and modularity.

Well aware of Bosch’s expertise in the plastic vial market, Excelvision reached out to Bosch about automating operations for its eye drop line To meet different customer needs, Excelvision required equipment that could be easily adapted to meet specific demands. This modular approach, allowing for quick and tool-less changeovers, was critical for Excelvision. In addition, the new line requires only three operators, letting Excelvision redirect labour to higher-skilled positions.

Flexibility from primary to secondary The bulk vial cards are first manually loaded into an intelligent feeding unit, which unscrambles and separates them equidistantly. It then aligns the individual vial cards before transferring them onto a conveyor. The intelligent feeding unit operates at adjustable speeds, with an output of up to 300 pieces per minute. The vial cards then travel to the Sigpack LDF feed placer, which features delta robots

that pick and place individual cards into an infeed wrapper chain. The Sigpack LDF is equipped with a vision detection system that ensures quality control of the products. It also communicates with the robot to ensure correct product orientation. Products then move along to the Bosch Sigpack HSL horizontal flow wrapper, which features a long dwell sealing unit for extended sealing time. This ensures that the aluminum-laminated film is hermetically sealed, which is critical to protecting the blow-fill-sealed products against water evaporation and light effects. In addition to automatic film splicing, the flow wrapper features printing and vision inspection of various data. “We decided to overwrap each vial card with PE plasticaluminum laminated film. This material significantly extends product shelf life by providing the highest protection from oxygen and humidity,” remarks Philippe Pensuet. The longer shelf life benefits Excelvision’s customers, as well as retailers and consumers. Bosch also subjected the wrapped cards to various tests, such as vacuum pressure and under water submersion, to verify that packs have an air-tight seal. For cartoning, Excelvision installed Bosch’s Sigpack TTM topload cartoner. The Sigpack TTM picks flowwrapped products out of a grouping chain and places them into cartons via a robotic top loader arm with gripper unit. The unit operates at speeds up to 70 cartons per minute, and the topload carton former has up to four lanes available for production. A key advantage of the Sigpack TTM is the ability to

make quick and tool-less changeovers for up to four different carton formats, giving Excelvision the flexibility to accommodate diverse customer needs. “Depending on the market sector we are serving, the system allows us to produce different configurations, including four-, five-, and six-counts,” Philippe Laissey explains. The Sigpack TTM is equipped with a leaflet carousel feeder to place information booklets into the cartons before they are closed. The pre-folded booklets, which include code verification, are manually placed in the magazine sections of the carousel, which necessitates reloading only once every 30 to 40 minutes. In addition, the cartons have a tamper-evident feature, with a glue closure and perforated lines, making it easy for retailers and consumers to spot packages that have been opened. Excelvision also installed a third-party carton printing verification unit to confirm variable data and weight. The module can be programmed for different formats and provides production statistics, trend curves, serialisation and current weights on its display.

Quality consultancy Pensuet reports that the strong relationship developed over the two-year period has been highly beneficial to Excelvision. Bosch performed performance and film tests to demonstrate the feasibility of the solution, every quality-relevant step of the way during the process. Prior to installation in early 2014, Bosch supplied Excelvision with flow wrapping equipment as an intermediate solution. For more information, please visit www.boschpackaging.com

PACKAGING SPECIAL PRODUCT

Anti-counterfeit blister packs from Romaco Noack The new packs is based on a banknote authentication system THE NEW system was developed exclusively with its partner company NANO 4 U and integrated into the Romaco Noack blister line 960. Anti-counterfeiting technology is an extremely important issue for global pharmaceutical producers and packaging contractors. In an exclusive partnership with NANO 4 U, Romaco has developed an anti-counterfeit solution for blister packaging that is suitable for pharma products and meets the EU falsified medicine directive 2011/62/EU. At the ACHEMA, Romaco introduced the Romaco Noack 960 blister line with the new technology for unique primary packag-

ing identification.

An anti-counterfeit packaging solution for pharma The new solution from Romaco for anti-counterfeit blister packs is based on a banknote authentication system. Romaco and its partner NANO 4 U took this technology further. The new system to protect the primary packaging of pharma solids can be integrated into all blister machines equipped with coding stations. An individual hologram stamp gives a unique indication of originality – in-line and without the use of additional materials. The individual blister packs are coded with overt and/or covert

Serious deterrent to counterfeiters

maco Noack blister machine is very simple. The security features are applied using a heated coding tool without affecting production speed. At the ACHEMA, the Romaco Group showcased how the Noack 960 blister line can produce anti-counterfeit blister packs with hologram stamps. The new solution also integrates future track and trace standards for the full traceability of pharma products.

The use of anti-counterfeit and high-precision stamps makes this technology a serious deterrent to counterfeiters. Whereas integrating the hologram stamp into the coding station of a Ro-

Company contact Susanne Silva Market Communications Romaco Group Am Heegwald 11

security features. Visible holograms with company logos, combinations of letters and digits, instantly identify the blister packs as originals. Invisible codes that can be verified quickly and easily can also be incorporated into the hologram. All you need for verification of a hidden logo or data matrix code, is a simple laser pointer.

76227 Karlsruhe Germany P:+49 (0)721 4804 0 F:+49 (0)721 4804 225 E:susanne.silva@romaco.com

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PHARMA ALLY I N T E R V I E W

'EXCiPACT will certainly add value to the companyâ&#x20AC;&#x2122;s brands in the global space' Recently, Ideal Cures obtained EXCiPACT certification for its Vasai manufacturing facility. It is the first Indian company to receive this certification and all its three facilities are now EXCiPACT certified. Suresh Pareek, Managing Director, Ideal Cures speaks about the recognition and its benefits, in an interaction with Usha Sharma

Ideal Cures has received EXCiPACT certification for its third manufacturing site located at Vasai, near Mumbai. Now all the manufacturing plants of Ideal Cures in India, based at Vasai, Jammu and Khambhat, are EXCiPACT certified. How will these certifications enhance the company's brand presence in the global space? A certificate adds credibility, good will and increases reliability factors which the customer associates with good quality. Being the first to receive the EXCiPACT certificate in India will not only create brand awareness but also enhance brand recall. I believe that EXCiPACT certificate will surely add value to our brands globally. Brand awareness is the extent to which the brand is recognised by potential customers. Certification makes customers aware of our brand and this recognition helps in the brand presence. This awareness is achieved through advertisements, participation in exhibitions, technical seminars and customer visits. EXCiPACT has the highest standards specified for

40 EXPRESS PHARMA July 16-31, 2015

excipient manufacturers and their audits are conducted by auditors who have to undergo a rigorous assessment process in order to be EXCiPACT registered. Since, Ideal Cures is the first Indian company to receive this certification for all its manufacturing sites in India, it will definitely inculcate additional trust and confidence amongst our existing customers and also invite attention of new customers. Ideal Cures has always been a company that values quality and innovation, and this additional accreditation through EXCiPACT will certainly add value to the companyâ&#x20AC;&#x2122;s brands in the global space. Your company is the first recipient of EXCiPACT certification from India. What does this recognition mean to you and your staff? Will this recognition expedite the company's business further? Recognition to be the first Indian company to receive the EXCiPACT certification adds great sense of achievement to me as well as to all my colleagues in the company. It has built a sense of pride amongst us to be

trendsetters in India and has inculcated a firm belief that with dedication, commitment and hard work, nothing is impossible. It will give confidence to the customers for doing business with the company as receiving a certificate is a stamp that the company follows GMP standards and about the standing of the company. This confidence will open opportunities from the customers who never tried our products or have been reluctant to give us opportunities.

EXCiPACT has the highest standards specified for excipient manufacturers

How did your company staff prepare for the certification process? What technical aspects need to be adhered to while applying for the EXCiPACT certification? How long does the process take? We followed the EXCiPACT standards for GMP and GDP, this works in accordance to the guideline of IPEC Europe, IPEC Americas, Pharmaceutical Quality Group (PQG), European Fine Chemicals Group (EFCG) and Federation of European Chemical Distributors (FECC). The EXCiPACT audit process is a two-stage audit.

The scope of both the audits is to confirm that the company conforms to all the requirements of the appropriate GMP/GDP legislations and guidelines for the manufacture of the desired products for use as excipients in pharma site as laid down in the EXCiPACT standard. The complete process of certification, right from contact with EXCiPACT, application, agreement, first and second stage audits, audit reports and CAPA, up to complete certification process takes around 10-12 months for a company. Does the EXCiPACT certification mean that the cost of normal operations, post-certification will rise as the level of compliance within the manufacturing plant has risen? No, the overall cost of operations will not increase much while complying with the standards. Initially, getting ready for compliance with the EXCiPACT certification might have extra cost for upgrading infrastructure, recruiting manpower, pay fees to certifying agencies and training cost wherever

required to formulate proper guidelines and procedure and system as set by EXCiPACT certifying authorities. MSME has the credit linked capital subsidy scheme to provide 15 per cent upfront capital subsidy to SSI units, to help them with the costs of installing the new equipment and technology upgradation. (http://msme.gov.in/WriteRead Data/Whatsnew/Sch-vol1151214.pdf-sri.pdf). Will the projected increase in business justify smaller companies opting for this extra cost? For companies that are starting fresh or smaller companies, investment in manpower may increase the cost. By following the system, procedures and guidelines, ultimately the company may end up saving and providing quality products to customers, thereby increasing business. India has the largest number of US FDA certified manufacturing plants outside the US which means that products for exports already meet compliance standards. What then is the rationale for EXCiPACT certification for excipient manufacturers, at the other end of the pharma manufacturing process cycle? True, India has the largest number of US FDA certified manufacturing plants outside US; however these certifications are for formulators. There were no GMP and GDP guidelines to evaluate the quality of the excipients. For this reason pharma formulation manufacturers had to personally carry out audits at each of their excipient manufacturers and suppliers. EXCiPACT uses IPEC guidelines to define GMP in its standards for excipients. The GMP guidelines formulated by the IPEC were in consultation with US FDA and European regulatory authority. Thus, certified manufacturers who comply

with EXCiPACT standards in turn also comply with USP guidelines. Usually the brand of excipients used by the originator are mostly used by the generic manufacturers for their new US FDA filings. Like US FDA certification builds trust and confidence in the regulators and consumers about the standards of medicines manufacturers, in a similar manner, EXCiPACT certificate will builds similar trust and confidence with the formulation manufacturers. This is the rationale. Since, this certification follows the procedures and standards of the GMP guidelines set by IPEC and it is also recognised worldwide, it will be a boon for the pharma excipient

When someone starts a trend others follow it, if it has benefits. Earlier, I remember ISO certification was done by only a few companies. Companies who didn’t have ISO felt left out initially, but eventually when they understood the importance of implementing ISO standards they joined in. Take another example of US FDA certification, you yourself mentioned that India has largest number of US FDA certified manufacturing plants outside of US. If I remember correctly, Ranbaxy was the first Indian company to receive FDA certification for its manufacturing facility and now there are 28 facilities in Maharashtra itself that are US FDA certified. Why did they do it? The answer is that

audits of EXCiPACT. Since three of your manufacturing facilities have already obtained EXCiPACT certifications, will you consider mentoring/guiding other excipient manufacturers aiming for EXCiPACT certification? We would be very happy to mentor and guide other excipient manufacturers who wish to acquire EXCiPACT certification and I would also be happy to help in my personal capacity to the excipient manufacturers. Our team has spent more than around 10 months in the process of obtaining the certificate and we will be glad to share our experience, guide the prospective

I certainly foresee that EXCiPACT certification will also become the highest standard for excipient manufacturers and eventually they will follow this trend set by Ideal Cures in India and get their excipients manufacturing sites certified by EXCiPACT

manufacturers as they would not have to face separate audits from its customers. The wide acceptance of this certificate will definitely save much time and energy. Can you tell us, globally how many companies have obtained this certificate and do you foresee that many Indian companies will also opt for it? As on July 7, 2015, 22 manufacturing sites spreading across three continents and nine countries have received EXCiPACT certification globally. These sites are located in countries like Canada, Belgium, Germany, France, India, The Netherlands, Saudi Arabia, Spain and the UK.

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they realised the benefits of following and implementing systems and getting certified, and I am sure having US FDA certification has given them a status and recognition of being reliable on a global scale. With this in mind, I certainly foresee that EXCiPACT certification will also become the highest standard for excipient manufacturers and eventually they will follow this trend set by Ideal Cures in India and get their excipients manufacturing sites certified by EXCiPACT. As per information gathered, four to five companies in India have already started compliance levels and have scheduled the pre-check

applicants with the infrastructure that needs to be developed to meet the requirements and documentation that needs to be done for audits of EXCiPACT. For general information, I lay down some of the steps that I would like to share for getting the certification: First stage: The company should be ISO9001:2008 certified from approved agencies, comply with the current GMP/GDP practices, before applying for EXCiPACT standards. Having the ISO certificate also means that the basic GMP standards are already followed by the company irrespective of the business. If this is not the case

then the company must first get the ISO certification and the first step towards that is appointment of a consultant who will guide, help and mentor the company in getting such ISO certification. The MSME also has schemes like ISO 9000 certification reimbursement scheme to provide incentive to small scale units for expenditure subject to a maximum of ` 75,000/incurred for obtaining ISO certificate. Second stage: After having the ISO certification, the EXCiPACT GMP and GDP guidelines as laid down by the IPEC federation should be followed. How will this recognition drive investment to our country and boost the 'Make in India' initiative launched by PM Narendra Modi? To me, the ‘Make in India’ initiative of Prime Minister Narendra Modi does not only mean that it has to drive investment to our country. As I see, the ‘Make in India’ campaign has many aspects, first where Indian companies in different sectors and areas produce and make goods and products which are of good quality with competitive costs for our own consumption. thus substituting imports and saving foreign exchange. Secondly, it also means, to my understanding that whatever is made in India, the Indian companies are able to export outside the country, thus earning foreign exchange as well as increasing brand value of Indian products in India and abroad. Both these aspects would also mean investment is made and employment is generated. Coming to the question of driving investment to our country; once the investors have trust, confidence and assurance of quality they will certainly invest in India. u.sharma@expressindia.com

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July 16-31, 2015

PHARMA ALLY PROFILE

Sakar Healthcare Ltd: On the path to progress Sakar Healthcare Ltd is evolving as a major contract manufacturing company catering to the specific requirements of pharma giants operating in India and abroad ESTABLISHED IN the year 2004-05, Sakar Healthcare Ltd is an emerging pharmaceutical company engaged in manufacturing pharma formulations. Sakar Healthcare is an ISO 9001:2008 certified company and its merits reflect in the long list of other certifications that it holds. Drug control authorities of various countries in South East Asia, Latin America, Africa and Middle East have acknowledged and certified the products. The company has evolved as contract manufacturing company catering to the specific requirements of pharma giants operating in India and abroad. Over the past decade, Sakar has matured into a reliable manufacturing organisation, that not only caters to the requirements of the giants in the Indian and overseas pharma industry, but also manufactures products under its brand name as well as markets them through its sales and distribution network. Sakar manufactures and markets pharma formulations related to analgesic, anthelmintic, anti-coagulants, anti-malarial, anti-spasmodic, anti-anaemic, antibiotics, anti-emetic, anti-histamines, bronchodilators, corticosteroids, cough and cold preparation, multi-vitamin etc. Sakar focusses on quality, delivery schedule, adherence to standards guidelines and these efforts have resulted in number of brand registration internationally. Sakar has a vision to become a global healthcare organisation based on three pillars- people, partnership and performance; making lives healthy happy and more meaningful by providing world-class healthcare solutions. It looks forward to strengthening the core competencies to become the preferred choice in existing partnerships and explore new market opportunities to expand its range of products and

42 EXPRESS PHARMA July 16-31, 2015

tems. Since the products are sold in global markets, it will be important for contract manufacturers to have quality system that meets the regulation of the various markets and of the pharma companies. Documentation compliance will be important as the process is evolved and confirmed during trials. Contract manufacturers will have to invest in project management skills as project scope would be exposed to scope changes owing to manufacturing complexity and various trial manufacturing runs and subsequent revisions during lab to plant scale-up phases. services- respecting laws, protecting environment and benefitting mankind. This would ensure the company's presence in the arena of contract manufacturing as well as self branding and marketing of brands, for both international and domestic markets. This transformation of Sakar Healthcare Pvt Ltd to Sakar Healthcare Ltd has set up a new milestone. It is now confident of having its plants EU-GMP approved in few months. On time service, quality assured products and most important, flexibility to meet the emerging market requirements are some of the salient advantages of Sakar over its competitors. To add on to the current facilities, Sakar Healthcare is coming up with a lyophillizer with auto loading/ unloading and orabs, to meet the increasing demand and ensure world standard formulations. Thereby Sakar Healthcare has transformed itself as a contract manufacturer with class. With 126 brands registered across the globe, Sakar Healthcare is emerging as a pharma company involved in functions like marketing and sales apart from contract manufacturing. For Sakar, selective partnerships with local players is the key to drive the

overseas markets. This approach has firmed up a number of JVs which have started giving returns. Thus, Sakar Healthcare has actually got transformed to an overall pharma house involved in manufacturing and marketing operations in both domestic and international markets.

Contract manufacturing Majority of the leading pharma companies are trying to outsource more and more manufacturing activities to contract manufacturers so that they can focus on core activities of drug discovery and marketing. There is a rapid rise in the pharma contract manufacturing organisations in India and China in recent years and this will further aid to the growth of the contract manufacturing industry. Though there is lot of potential for growth for the pharma contract manufacturers, this prospect comes hand in hand with the challenges, which contract manufacturers have to face to capitalise on the opportunity. Contract manufacturers need to reinvent themselves for the challenges that lie ahead, from the traditional role of providing cost efficiencies, capacity, labour and machinery. They

have to get ready to the face more complex process technology that would be required to manufacture new drugs. The challenges of stringent process control and increased automation will require further skills and new ways of working. Also, it is foreseen that speciality drug administration will have an element of information technology in it as controlled dosage would be required to be released at a targeted spot in patient's body. Though the technical know-how will be supplied by the pharma, the contract manufacturers have to invest both in technology and people to meet this challenge. To achieve efficiencies and to beat the competition, contract manufacturers would have to invest in IT application in areas of ERP, MES and industrial automation. Next big challenge will be adoption and implementation of Good Automated Manufacturing Practice (GAMP) that will help contract manufacturers to build in quality in every process step apart from having it in a batch of a pharma product. GAMP coupled with current Good Manufacturing Practices (cGMP) will yield better compliance of manufacturing installations, processes and related sys-

Procurement Procurement is the acquisition of goods and/or services, preferably at the best possible cost and / or value, and ensuring those goods are purchased in the right quantity and quality, at the right time, in the right place, and from the right source. The procurements in our organisation ranges from automated repeat purchasing of office supplies through a vendor punch-out to the complex procurement of custom manufactured goods which involves sourcing raw materials and components from dozens of domestic and global suppliers and ensuring that they all arrive at the manufacturing plant at the right time for finished goods production and distribution. Over the years, Sakar has been able to identify and develop a database of vendors ranging from manufacturers to retailers for various goods and services being utilised at its facility. It has also developed an automated system of procurement and vendor management wherein the vendors are mapped to the products being offered by them, so that whenever a product is to be requisitioned Sakar has a ready list of suppliers who can supply

PHARMA ALLY the same at very competitive prices. This process helps in ensuring quality of material being delivered, timely delivery of material at the facility and competitive prices. The list of vendors is regularly reviewed and updated so that new suppliers are incorporated in the list and the suppliers who do not meet the quality requirements can be highlighted/blocked. Sakar also has an automated system for ordering wherein as soon as the material reaches the marked minimum quantity, respective store incharge is intimated about the same and he can initiate the requisition process as per the production requirements or minimum order quantity so that materials are procured just in time to avoid inventory holding cost. Material procured is subject to quality tests before including the same in the stores. Only those materials that satisfy the quality standards are included in the stocks and utilised for pro-

duction of various pharmaceutical formulations. The processing of documents is taken care by respective departments through an integrated online system. Site audits for vendor approval are critical for zeroing down on vendors for domestic market procurements. Site audits provides with an insight into the manufacturing facility of the vendors and also helps in understanding the quality standards implemented by the vendors in their manufacturing process and the quality of products manufactured and services offered. Pharma industry, being one of the highly regulated industries, has to comply with various regulatory requirements from the initial stages of manufacturing/procurements of API to taking approval from respective regulatory boards to sell the finished products i.e. the pharma formulations. In order to meet the various regulatory requirements for the quality of finished

product, Sakar have ensure the implementation of similar quality standards from the very stage of acquisition of material for production and site audit provides the assurance that the company is on the right path from the very beginning. Pharma is a highly regulated industry since it caters to the health of the human beings. The procurement of active pharmaceutical ingredient (API) is guided by the regulatory requirements of the country of manufacture and the market being targeted. API has to satisfy the regulations stipulated in the country of manufacture and also by the additional requirements of the sourcing country regulations e.g. an API manufactured in India to sell a final formulator, in say, US needs. The API will to be subjected to the regulatory authorities in India and the API manufacturer will have to produce it, at a minimum, with the

quality standards enforced by the Indian authorities. However, the US can require that for importation, it meets US FDA standards as well. Irrespective of the markets, whether it is regulated, rest of the world (ROW) or domestic, API, which is being procured to cater these markets, have to comply with regulatory requirements of the respective markets. The only difference could be with respect to the number of compliances to be met in these markets. Though every market has to adopt and implement the minimum requirements prescribed by WHO, to approve an API for utilisation in manufacture of pharma formulation. Therefore, care has to be taken of the additional regulatory requirements of the target market in addition to the minimum regulatory requirements while procuring API for pharma formulations.

Trade shows Today, trade shows provide a platform where manufacturers and customers get a chance to interact with other directly and understand each others requirements. It is a medium where manufacturers get a chance to display all their offerings at comparatively lower cost to the prospective customers. Manufacturers also get a chance to understand the requirements of the customers which helps the manufacturers to develop new formulations to cater the prospective demands. In the year 2015, there are 124 pharma trade shows planned in 64 cities and 39 countries including 10 in India. Sakar plans to participate in as many trade fairs as possible so that it is able to interact with prospective customers of as many countries as possible and help penetrate regulated, ROW and domestic markets.

INSIGHT

Microemulsions- Satisfy regulators using an orthogonal charactersation strategy A rundown on the benefits of opting for an orthogonal characterisation strategy for micro-emulsions and the offerings from Malvern to make it possible THE INCREASING use of use of microemulsions, such as cyclosporines, as the API in ophthalmic emulsions is a result of specific material properties, such as stability, low surface tension, and small droplet size. These features are responsible for ocular absorption and the retention of the drug in the eye, parameters on which the duration of action of the drug depends. The formulation of ophthalmic emulsions (eye drops) with long shelf lives is complicated by the tendency to aggregate, particularly in the presence of the polymers that are used to increase formula-

tion stability. Such complex formulation conditions also impart unique rheological characteristics to ophthalmic emulsions, characteristics that have a major effect on the applicability of the drug. This is also the case for generic versions of microemulsions, due to the regulatory requirement that they conform to the same standards of quality, efficacy and safety as the innovator. This article describes a comprehensive multi-parameter strategy for the characterisation of microemulsion stability, flow characteristics and particle size, used to im-

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prove the efficiency of the approval process for both innovative and generic ophthalmic emulsions.

The solution

Figure 1: Malvern Mastersizer 3000

The Malvern Zetasizer ZSP was used to characterise the zeta potential, using electrophoretic light scattering (ELS), of samples diluted 1/4 as per FDA guidance. Zeta potential measurements give assessment of microstructural stability, intermolecular repulsion meaning that formulations with larger zeta potential values are more electrostatically stable. Size and polydispersity

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July 16-31, 2015

PHARMA ALLY index (PDI) were also measured on the Zetasizer, using dynamic light scattering (DLS). Though such measurements are quick, simple, information rich and require very little sample, microemulsions often contain larger particles that are difficult to characterise using DLS. For this reason, use of laser diffraction as a complementary technique to calculate SPAN or D50 is advised. Laser diffraction measurements (Figure 1) were carried out using a Malvern Mastersizer 3000 with the newly released Hydro SV small volume wet sample dispersion unit. The Hydro SV accessory reduces the sample requirements of laser diffraction dramatically, with only 5 ml of dispersant and 0.45 ml of sample was required for the cyclosporine measurements presented here. Finally, in order to fully account for the dilution involved in the laser diffraction and zeta potential measurements described above, and to provide rheological analysis as per FDA guidance, analysis was performed using Malvern’s Kinexus rheometer (Figure 2). Viscosity profiling gives understanding of stability in terms of bulk flow (for instance, the likelihood of larger particles sedimenting), and allows quality and comparability assessments of samples under formulation conditions (without dilution).

Orthogonal assessment of stability, applicability, and efficacy Table 1 shows that the both formulations have highly negative zeta potential values, suggesting that both samples are electrostatically stable (though the innovator Zeta Potential is twice as great as that of the generic). The innovator also gave a much larger Z-average size and polydispersity index (PDI) than the generic. DLS data suggested the presence of large particles which would be better characterised using laser diffraction analysis. Figure 3 shows analysis of innovator (sample A) and generic (sample B) cy-

44 EXPRESS PHARMA July 16-31, 2015

closporine products using the Mastersizer 3000. Repeatability of D50 (and also D10 and D90) for each sample is excellent, so we can be sure that the differences in particle size distribution between the innovator and generic are real, with the innovator containing a greater quantity of > 200 nm particles. Table 1: Particle Size Distribution analysis of innovator and generic Cyclosporines using Mastersizer 3000. Figure 4 shows flow curves for the innovator and generic sample, measured using the Malvern Kinexus. Both materials demonstrate a similar shear-thinning trend, with viscosity decreasing with increasing shear rate. Such a quality is important for an ophthalmic emulsion, with high viscosity in the absence of force giving the sample stability during storage and a relatively long shelf-life, and lower viscosity upon application of force (such as squeezing of the container) making application of the drug to the eye much easier. Despite the similarity of the flow curve trends, at any given sheer rate the innovator is more viscous than the generic, suggesting that the likelihood of larger particles sedimenting in the generic is greater than in the innovator (all other things being equal).

Confidence in Your Product By acquiring data using 4 different methods, we were able to perform a complete comparability study of stability, polydispersity, particle size and applicability of the drug, as per regulatory guidance. The innovator cyclosporine was more stable than the generic in terms of both electrostatic (probed with zeta potential) and sedimentation (assessed with Kinexus) stability. Despite this, the generic showed greater uniformity (lower PDI), the innovator containing more > 200 nm particles and a significant quantity of particles > 5 microns (as measured using the Mastersizer 3000). As always, the decision of regulatory authorities to give approval to a generic is dependent on how clinically relevant these

TABLE 1: ZETASIZER ZSP ANALYSIS OF INNOVATOR AND GENERIC CYCLOSPORINES Parameter

Innovator

Generic

Zeta Potential (mV)

-60.4 ± 0.8

-30.1 ± 0.2

Z-average size (nm)

247.6 ± 0.7

167.0 ± 2.6

PDI

0.549 ± 0.006

0.249 ± 0.011

Figure 2: Malvern Kinexus dual action rheometer Orthogonal assessment of stability, applicability, and efficacy

Responsible for ocular absorption and the retention of the drug in the eye, parameters on which the duration of action of the drug depends

Figure 3: Particle size distribution analysis of innovator and generic cyclosporines using Mastersizer 3000

Table 1: Particle Size Distribution analysis of innovator and generic Cyclosporines using Mastersizer 3000

differences are deemed to be. In addition to providing an assessment of innovator-generic comparability without prior dilution, Malvern’s Kinexus system offers many other ways to characterise microemulsions. For instance, the effect of the blinking of a patient’s eye during application on the flow characteristics of the drug can be simulated by measuring using an appropriate shear rate range. Such data would give information on the applicability of the drug, a quality that is of concern to developers due to the difficulties of creating microemulsion formulations that fully permeate the eye. In summary, this article demonstrates the reason behind regulatory emphasis on an orthogonal approach to mi-

Figure 4: Flow curve analysis of innovator and generic Cyclosporines using Kinexus rheometer

cro emulsion characterisation, and the means that Malvern Instruments have developed to provide for such an approach. Contact Malvern Aimil Instruments

Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road, New Delhi – 110044 Tel : 011-30810244 Fax : 011-26950011 Email : delhi@aimil.com

PHARMA ALLY NEWS

Lonza announces additional long-term agreement with Alexion This agreement will supplement existing production of Alexion products at multiple Lonza facilities LONZA GROUP announced the signing of a new longterm product supply agreement with Alexion. Under the agreement Lonza will construct and launch a new suite dedicated to Alexion manufacturing. Lonza will own and operate the suite as part of its Portsmouth, NH (US) site. This contract is an expansion of an existing manufacturing agreement. This agreement will supplement existing production of Alexion products at multiple Lonza facilities. The expansion of the existing site in Portsmouth, near Boston, MA (US), will provide valued customers in-

This agreement will supplement existing production of Alexion products at multiple Lonza facilities

creased access to Lonza’s proven biological manufacturing and regulatory expertise, experienced global workforce and high level of focused customer service. Lonza has more than two decades of worldwide manufacturing experience with

mammalian biotherapeutics. “I’m pleased to be reinforcing our long-standing strategic relationship with Alexion,” said Marc Funk, Chief Operating Officer, Lonza. “Our new offering of suites with dedicated manufacturing capacity will give

customers greater flexibility in determining production quantities and timings. At the same time, we’ll continue to offer our services in our multi-purpose plants to meet our customers’ needs.” “Alexion is pleased to further enhance our manufacturing network with Lonza,” said Julie O’Neill, Executive Vice President, Global Operations at Alexion. “Developing a robust supply chain for our pipeline and commercial products is essential as we aim to serve more patients with our growing portfolio of life-transforming therapies.” EP News Bureau- Mumbai

Bosch unveils latest version of rotary pen assembly machine MRA AT ACHEMA, Bosch Packaging Technology showcased its latest version of the rotary pen assembly machine MRA. Developed by the Bosch subsidiary Moeller & Devicon, the machine is designed to assemble medical devices such as standard four-piece disposable pens or single-shot autoinjectors. These are used, for instance, for diabetes care, the treatment of autoimmune diseases, hormone replacement therapies or emergency medicine. “We introduced the MRA to the market at last year’s Interpack in Germany. Since then, we have refined the technology by cooperating with several manufacturers of pens and

auto-injectors, and have adapted the assembly processes for different models,” Michael Andersen, sales director at Moeller & Devicon, explained. “This way we can offer customers the appropriate machine with the required features according to the pens or autoinjectors in use.” Together with primary and secondary packaging solutions, the new MRA can be combined to complete lines.

Four pens at the same time The MRA assembles the four components of each pen one step at a time: infeed systems load the pen caps, cartridge holders, cartridges and dosing

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mechanisms into the machine from four different in-feed stations, and fit them together to ready-to-use pens. The fully-automated machine handles four pens at the same time and achieves an output of up to 70 pens per minute. Incorrectly assembled products are automatically detected and rejected. A Human Machine Interface (HMI) enables operators to monitor all process functions precisely. The compact design and small footprint fully comply with GMP and Good Automated Manufacturing Practice).

Standard upstream and downstream options As an option, the MRA plat-

form can be combined with additional upstream and downstream equipment. For instance, the liquid pharma can be filled into cartridges and inspected for particles and cosmetic container defects on other Bosch equipment. “The flexible and modular design of the MRA platform enables an upgrade with further process steps, such as laser engraving of the pens or serialization,” Andersen underlined. The entire range of rotary pen assembly machines by Moeller & Devicon is complemented by manual, semiautomated and fully automated linear solutions for all customer requirements.

GMP certification for SCHOTT’s pharma tubing sites SCHOTT’S FIOLAX glass tubing plant in Gujarat has achieved official Good Manufacturing Practice (GMP) compliance. The certificate, presented to SCHOTT by TÜV Rheinland, underlines the company’s global commitment to those standards. More and more countries are specifying GMP as a statutory requirement that pharma companies and suppliers of quality related components to the industry must meet. “SCHOTT considers quality assurance central to the production of pharmaceutical glass,” explained Dr-Ing. Karsten Hennig, Director, Quality Management, SCHOTT Tubing. Hennig continued, “It is therefore established practice for SCHOTT to work as per GMP standards at all our facilities.” SCHOTT manufactures glass tubing in Europe, South America and Asia, with a total production capacity of more than 140,000 tonne. Tubes made of FIOLAX speciality glass are the basis of many pharma packaging solutions, being converted into syringes, vials, ampoules, and cartridges. These containers need to safely store medication, sometimes for years, without compromising the efficacy of the drug, implying that the quality of glass is the key. “In order to provide patients with safe pharmaceutical products of the highest standard, quality is top priority throughout the production value chain, “said Georg Sparschuh - President SCHOTT Pharmaceutical Tubing, India. He further stated, “By earning GMP certification at our production site in India, we are helping our customers eliminate all potential risks from the very beginning. This helps establish confidence amongst our pharmaceutical manufacturing partners.” Sparschuh added. EP News Bureau- Mumbai

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July 16-31, 2015

PHARMA ALLY APPOINTMENT

Waters Corporation appoints Christopher J O'Connell as CEO Chris joins Waters from Medtronic plc WATERS CORPORATION announced that Christopher J O'Connell has been appointed as its new President, Chief Executive Officer (CEO) and member of its Board of Directors, effective in September 2015. Chris joins Waters from Medtronic plc. "From the outset, Waters' Board of Directors focused on identifying a new CEO whose experience best supports the continuation of Waters' culture, business strategies and performance drivers," explained Thomas P Salice, Lead Director, Waters Corporation. "Chris O'Connell's wide range of experi-

ences across all aspects of a technology focused global organisation prepares him well for the Waters CEO position. Through the process of getting to know him, we found a leader who reflects Waters' core values in addition to being an extremely motivated, thoughtful and engaging person. We are confident Chris is the right person to continue to drive Waters’ leadership performance and chart its future direction." "I am thrilled to join Waters Corporation. "Not only am I excited to enter an industry that enables its customers to advance and push the limits of sci-

ence, but I’m very proud to join the industry's technology and customer support leader, and to

be given the opportunity to lead a remarkable group of people, ”said O'Connell. Over his 21 years at Medtronic, Chris O'Connell held a variety of leadership positions, most recently as president of the Restorative Therapies Group responsible for $7 billion in revenue and more than 16,000 employees worldwide. He provided overall strategic direction and operational management of the Group’s five divisions, as well as led the integration of the Group’s activities within the overall strategy of the corporation. Retiring Chief Executive Officer, Douglas A Berthiaume will

continue in his role as chairman of Waters' board of directors. With this leadership transition, it is important to recognise Doug Berthiaume for all that he accomplished as Waters' President, CEO and Chairman of the Board," said Salice. "As the leading architect of the company's focused business strategy, Doug oversaw Waters’ drive to expand applications of our core technologies and commitment to customer relationships. We offer our heartfelt gratitude to Doug and look forward to his continued role as Chairman." EP News Bureau- Mumbai

PRODUCT

New super-hydrophilic cartridge for sterile filtration PORVAIR FILTRATION Group recently added an enhanced range of microbial rated disposable cartridge filters to its range of liquid filters. Biofil R cartridges are an addition to the successful Biofil polyethersulphone Food Safety and USP Class IV approved range of filters, and feature a novel technology which renders the product super-hydrophilic. Integrity testing of sterilising filter cartridges requires the membrane to be fully wetted; a cartridge that is insufficiently wetted will result in a false failure and require a retest or rejection of an intact filter. This development extends the availability of Biofil cartridges to users that are currently unable to easily wet and integrity test filter cartridges due to low feed pressure and flow. The extensive features and benefits of Biofil R cartridges exceed any competitor’s range

46 EXPRESS PHARMA July 16-31, 2015

of PDVF, nylon, mixed cellulose ester or polysulphone membranes. Using the latest developments in membrane technology, the cartridges can provide sterile filtration, bioburden reduction and the clarification of a wide range of process liquids and end products. Manufactured based on a polyethersulphone membrane

with an asymmetric pore structure, the cartridges also have optimal filtration pack construction to maximise the available filtration area and to ensure an efficient flow. The filter membrane, combined with the quality allpolypropylene cartridge components and high integrity manufacturing techniques, common to all Porvair cartridge

filters, results in high-strength, high-efficiency and long life disposable cartridges; thus ensuring consistent microbial retention, lower costs and high performance. The low non-specific protein binding characteristics of the membranes result in less product loss and a longer life. These disposable filters are highly resistant to integrity failure caused by steam sterilisation and have excellent chemical compatibility characteristics; to allow repeated Steam in Place and Clean in Place cycles. Mike Hughes, General Manager, said, “Many of our existing clients tell us that the new Biofil R cartridges are a welcome addition to our range of cartridges.” “Conventional PES membrane filters offer significant process advantages with respect to flow and fouling resistance compared to others, but

difficulties with wetting has hindered their easy adoption. The BiofilTM R overcomes this barrier” “Because of our strong understanding of industry standards, Porvair Filtration Group is seen as a good partner for developing new and existing products; manufactured with fully traceable materials in cleanroom conditions, which complies with the highest regulatory requirements.” “The launch of this range represents another step forward in our commitment to serve the scientific, medical, pharmaceutical, and R&D sectors.” Porvair has supplied the submicronic filtration sector with performance-driven filtration and separation equipment for over 25 years. Manufacturing in both the UK and US, it has an extensive network of sales offices and distribution channels throughout the world.

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MB-150 Multi Track

Sachet Packer with Servo Auger Filler All operation controls are located on the front of machine. l Stainless Steel finish as standard. l Automatic web tracking., Quick size change over. l Sensor controlled Motorized Auto Web alignment system. l Possibility of shaped pouches., User-friendly. l Customised to meet stringent Pharma and other International Standards. l High accuracy even at very low grammages (0.25 g). Filling Range: For powder From 0.5 g to 30 g; For Liquid & paste from 1g to 100g

Wraptech Machines Pvt. Ltd.

www.wrapmachines.com

Pack Size: W - 40 to 60 mm & L - 50 to 150 mm

Plot No. D-273 & D-274, T.T.C. Industrial Area, M.I.D.C., Turbhe, Dist. Thane, Navi Mumbai - 400 705, INDIA. Tel.: +91 22 2761 1648 to 53 l E-mail: abm@wrapmachines.com

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Associates

Rotary & Fixed Spray Balls

Diaphragm Valves

Aseptic Sampling Valves

Drain Trap

Product Range : Associates

Sight Glass :

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Elliptical Manhole

Sanitary Pumps Sanitary Auto / Manual Valves

Steam Water Sanitary Mixing Battery Pneumatic Valve Manually Controlled

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Safety Valve

Manholes Sight Glass

S. No. 28/27, Near Pari Company, Dhayari - Narhe Road, Pune - 411 041. Ph. : + 91 - 020 - 6500 1482 / 2469 0268 Fax : + 91 - 020 - 2469 0268 Mob. : + 91 90287 16622, + 91 99231 24949 Email : swastikpune@gmail.com / sales1swastik@gmail.com

Call for the best quote Exclusive Package : Ex- Delhi/Mumbai

Lobe Pump

Centrifugal Pump

CPhI worldwide

13-15 October 2015 Feria De Madrid, Spain PACKAGE INCLUSION

For more details call @

Return economy airfare Airport taxes for both India and Spain Accommoda on as per package opted for Daily breakfast at the hotel Dinners at the comfort of your hotel Return airport ‐ hotel ‐ airport transfers Daily fairground transfers as per i nerary City tour of Madrid Schengen visa charges for Spain Overseas medical insurance Service of professional tour manager Red Carpet a rac ve complimentary travel kit

+91 9560055905, +91 9560055904

Exhibitor Packages also available!

Date

I nerary

11th Oct 2015

Depart India, Arrive Madrid

12th Oct 2015

Visit CPHI WORLDWIDE 2015

13th Oct 2015

Visit CPHI WORLDWIDE 2015

14th Oct 2015

Visit CPHI WORLDWIDE 2015

15th Oct 2015

Visit CPHI WORLDWIDE 2015

16th Oct 2015

Depart Madrid, Arrive India

CORPORATE OFFICE:

REGIONAL OFFICE:

23/1, First Floor, East Patel Nagar, New Delhi - 110008, Tel: 011 - 46 275 275, Email: redcarpettours@redcarpettours.net

G 29, Fantasia Business Park, Nano Wing, Sec - 30/A, Vashi, Navi Mumbai - 400705, Tel: 022 - 66 737 435/36/37/38

July 16-31, 2015

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Innovation is our culture… Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

SERVICES Formulation Development. Microbiological Studies. Biological Studies. Pre Clinical Studies. Analytical Research. Bio-equivalence Studies. Clinical Trials. Dossier Preparation. Preclinical Pharmacopoeial Services.

Quality in our genes… Pharmacopoeial Services: (Accredited by NABL for ISO/IEC 17025:2005)

• • • • • • • •

Pyrogen Testing Abnormal Toxicity Undue Toxicity Bioassays Systemic Injection Test Intracutaneous Test Implantation Test Eye Irritation Test

Facility Infrastructure: • Individually Ventilated Cages • Designed as per GLP/ AAALAC • Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations

ACCREDITATIONS USFDA registered cGMP control testing laboratory. DSIR approved R & D Centre. Drugs Controller General of India (DCGI). NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical. Recognized by Bureau of Indian Standards. Drugs Control Administration (A.P). Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC). NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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PHARMA MARKETING CONSULTANCY A seasoned professional (B.Pharm & MBA ) with over 35 years of experience in top 20 Pharma companies, wishes to offer Consultancy to Pharma companies in the areas of : Sales - He has risen from a Medical Representative to Senior Vice President Sales and Marketing, Marketing - has successfully conceptualized and implemented innovative Marketing plans, Brand Management - has effectively managed large brands with focus on improvement of profitability, Launching of new products - has launched many mega brands Recruitment ecruitment - He has interviewed and recruited over 10000 field personnel. Training raining - has trained over 3000 Field Personnel. New Divisions - has successfully launched 5 divisions. Turnaround urnaround - has turned around two loss-making companies. He has now started his consultancy. Interested companies may contact

AVIV VIVA A PHARMATE PHARMATECH CH C CONSULT ONSULTANTS ANTS 09769817508 54

July 16-31, 2015

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Reduce energy cost and raw material rejection with 100% fresh air cooling solutions

HMX-PCU-F

Reduce energy costs Indirect evaporative cooling Most energy efficient way of pre-cooling air for air-conditioned areas Works as a standalone unit or in conjunction with an existing system

HMX-FAAC

Reduce raw material rejections Combination of indirect evaporative cooling and DX/CW coils Maintains desired RH and temperature inside a raw material warehouse in all weather conditions Suitable for both 100% fresh air application as well as return air application

Reduction in TR load on existing air-conditioning system

(Business Unit: HMX) T: +91-20-3088 1100 E: ambiator@hmx.co.in W: www.hmx.co.in, www.ategroup.com

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June 2015

A.T.E. ENTERPRISES PRIVATE LIMITED

CIN: U51503MH2001PTC132921

An installed base of over 20 million CFM cooling more than 400,000 square feet.....and still counting!

July 16-31, 2015 55

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

July 16-31, 2015

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

July 16-31, 2015

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MACHINERY FOR SALE CONDITION

CHAMBER SIZE (H x W x D in cm)

VOLUME OF THE CHAMBER

125 x 60 x 60 125 x 60 x 60 70 x 50 x 50

40°C/75%RH 30°C/75%RH 25°C/60%RH

450 liters 450 liters 175 liters

EIE INSTUMENTS PVT.LTD

< Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol

CLASS 100 TYPE DHS 1120 (W) x 1400 (D) x 1280 (H)

Heater:

Working Temp.:

275°c

Motor:

7.5 HP

Electric supply :

415V-3PH-50HZ AC

Make:

Triton Engg. P. Ltd.

Make

Name of Machine

3 Multicolumn with part 4 Ampoule Inspection 5 DHS

7 8 9 10

MANUFACTURER AT HIGHLY COMPETITIVE PRICES

COMPANY NAME

Chamber size:

AVAILABLE DIRECTLY FROM THE

STABILITY CHAMBERS

Nos.

Machine Febric

6 Head

Capacity - 1250 Ltrs.

Auto cleave

Machine Fabrics

Steam Ketal Half Lift Incubator Small Blower

Gopinath

Techno

York Scientic Industries

Not available

< 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid

Connected load – 1.5HP , 415V

Envee Pharma

< 3 / 4 / 5 – Methyl Salicylic Acid & Ester

Capacity/Technical Specification

Machine Fabrics

inspection m/c

< 1 / 6 – Hydroxy – 2 – Napthoic Acid

Capacity - 150 Ltr/ Hrs.

Envee Pharma

11 Automatic visual

< 2 – Ethoxy Benzoic Acid

39 KW

< 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

Size - 450(W) x 450(H) x 600(D) connected load – 3 HP, 415 volt Working Pressure – 2.2Kg/cm2 50 Ltr. Kg 1500 Kg (Aprox)

AN ISO 9001 : 2008 & 14001: 2004 COMPANY OUR PRODUCTS ARE STAR K-KOSHER & HALAL CERTIFIED

90 Ltr. (Aprox) 300 CFM (Aprox) 1) No. of head: 6 head with loading & unloading hopper facility. 2) Capacity: 2600 Amps./hr 3) Magnifying glass for better viewing of rejection. 4) Six nos. of rejection switch for the auto removal of individual rejection. 5) Suitable for 1 to 5 ml Amps. with different change part for each size of amps. 6) Three phase supply

3A, Barodawala Mansion, 81, Dr. A.B. Road, Worli, Mumbai-400018. Tel : +91-22- 43625500 Fax : +91-22-24974886 E-Mail : gujorg@gujaratorganics.com Web : www.gujaratorganics.com

Troikaa Pharmaceuticals Ltd. Please contact: Mr. Bhavin Upadhyay-09879615621, 079-26856242-45. Email.: bhavin@troikaapharma.com

False-positive identification becomes easy in Microbial Sampling • False-Positive Identification : Reduces investigation costs through the use of the BioCapt’s radial slit design. The inlets of the Impactor Head are precision cut to ensure laminar flow, thus maximizing collection and biologicalefficienciesinaccordancewithISO14698-1. • Makes the Job Easier : The MiniCapt Mobile Microbial Air Sampler simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data. The sampler incorporates a capacitive touchscreen, allowing easy use with gloves without the need for a stylus.

Compressed Gas Sampling Kit

• Does Not Contaminate : Cleanroom does not get contaminated through the use of a unique HEPAfiltered exhaust. The autoclavable BioCapt® Microbial Impactor and sanitizable enclosure are ideally suited for aseptic environments. • Flexibility : One sampler for multiple sampling applications including monitoring Compressed Gas, Remote Isolator sampling and the ability to connect to the BioCapt and BioCapt Single-Use Microbial Impactor.

Isolator Monitoring Kit

Mobile Microbial Air Sampler

Remote ISP Sampling Kit

Remote Connection to ® BioCapt Single-Use

Without measurement there is no control. For further information, please contact us:

E-mail: delhi@aimil.com

Tel: 91-11-3081 0244

www.aimil.com

Offices at : • Delhi (H.O.) • Mumbai • Bengaluru • Kolkata • Chennai • Vadodara • Hyderabad • Chandigarh • Guwahati • Bhubaneswar • Indore • Nagpur • Lucknow • Kochi

July 16-31, 2015

Aimil/Ad/A&I/15-16/06/23

MiniCapt®

• Reduced Errors : Intuitive user interface that is icondriven with multiple levels of security and allow the use of pre-configured recipes to avoid possible sampling errors.

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July 16-31, 2015

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July 16-31, 2015 67

PHARMA LIFE INITIATIVE

Merck supports free diabetes screening in collaboration with MUHS and MoHFW The initiative celebrated the success of the first year of Merck Capacity Advancement Program in India MERCK ROLLED out Merck Diabetes Day- MDD in collaboration with Maharashtra University of Health Sciences (MUHS) and Ministry of Public Health and Family Welfare of Maharashtra Government in order to provide diabetes free screening and education for more than 20,000 community members at the 18 medical colleges of MUHS as part of Merck Capacity Advancement Program. The Maharashtra Merck Diabetes Day— MDD rolled out across India and Africa to raise public awareness about diabetes early detection and prevention aiming to reverse this worrying trend by preventing or delaying the development of diabetes in the African and Indian population as part of Merck Corporate Social Responsibility (CSR) agenda. Merck will also celebrate the success of the first year of Merck Capacity Advancement Program in India. Reportedly, more than 5000 medical undergraduates and healthcare providers have benefited from the European-accredited Clinical Diabetes Management course in 2015. The programme aims to target more than 25000 students in India in the next five years. Dr Deepak R Sawant, Minister of Public Health and Family Welfare, Maharashtra Government during the inauguration event of the Maharashtra Merck Diabetes Day – MMDD emphasised, “The cost of managing diabetes is enormous and places a huge burden on already strained healthcare system. The lack of awareness on disease symptoms makes many diabetes patients to

68 EXPRESS PHARMA July 16-31, 2015

More than 5000 medical undergraduates and healthcare providers have benefited from the European-accredited Clinical Diabetes Management course in 2015. The programme aims to target more than 25000 students in India in the next five years be diagnosed late when they have already developed complications such as blindness, foot ulcers or gangrene, heart diseases among others. There is a strong, new argument that by combining screening to find prediabetes and early diabetes, along with management aimed to keep glucose levels as close to normal as possible, we can change the natural history of the disease and improve the lives of our patients. Hence, I urge all Indians to get screened and be active in order to get healthier.” During Maharashtra Merck Diabetes Day, Dr Frank Stan-

genberg Haverkamp, The Chairman of Executive Board and Family Board of E Merck KG stated, “We are pleased to engage with the Ministry of Public Health and Family Welfare, Directorate of Medical Education and Research (DMER) and Maharashtra University of Health Sciences to improve access to better Diabetes Care as part of our commitment to the social and economic development of India. Supporting the Diabetes education and community outreach programmes of the University will contribute significantly to improving awareness,

early diagnosis and prevention of the disease across India”. The rising numbers of diabetics all over the world calls for prioritising diabetes care and awareness to prevent the disease from turning into an epidemic. The Merck Capacity Advancement Program seeks to improve the healthcare sector in India with special focus on rural areas through educating and empowering those affected by diabetes on how to manage and prevent it. Rasha Kelej, Vice President and Head of Global Business Responsibility and Market Devel-

opment at Merck Serono, biopharmaceutical business of Merck emphasised at the event “In India, there is a significant increase in the burden of noncommunicable diseases, including diabetes. There is clear evidence to show that diabetes prevalence is rapidly increasing, especially in urban India. The conventional risk factors of urbanisation, unhealthy eating habits and physical inactivity, coupled with inherent genetic attributes and differences in body composition are propelling the increase in cases of diabetes. Accordingly, diabetes related complications are also on the rise and contribute significantly to overall morbidity and mortality. It was clear for us from the start that improvement of the levels of education and awareness of the disease will reduce its impact on health of the Indian population.” Prof Arun Jamkar, Vice Chancellor of Maharashtra University of Health Sciences, MUHS emphasised, ”Today we are happy to celebrate the success of the first year of the programme. We have successfully engaged the stakeholders in the field of medicine and diabetes in Maharashtra in joint collaboration with DMER and Merck to implement their Capacity Advancement Program, this diabetes education and awareness programme aim to provide awareness, guidelines and clinical practice for prevention, diagnosis and management of diabetes and its complications for Maharashtra community members and medical undergraduates of the 18 medical colleges in Maharashtra University.” EP News Bureau- Mumbai

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IDEAL CURES

BECOMES FIRST INDIAN COMPANY TO RECEIVE EXCIPACT

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Ideal Cures has received Excipact certification for two of its manufacturing plants.

CORPORATE OFFICE & R & D CENTRE - II Ideal Cures Pvt. Ltd. Unit No. A/223 to A/229, 2nd Floor, Virwani Industrial Estate, Western Express Highway, Goregaon (E), Mumbai - 400 063. Tel.: +91-22-42688741 Fax : +91-22-42688713 Visit us at : www.idealcures.com / www.idealcures.co.in