Express Pharma February 1-15, 2013

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Pharma VOL 8. NO. 7 FEBRUARY 1-15, 2013

Chairman of the Board Viveck Goenka

CONTENTS MANAGEMENT

Editor Viveka Roychowdhury*

Caring Cadila

BUREAUS

PAGE 26

Fulfilling the promise of biotechnology

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

for India

PAGE 30

Compulsory licensing for anti-cancer drugs:

Bangalore Neelam M Kachhap

concerns and future ahead

Delhi Shalini Gupta

PAGE 31

RESEARCH

MARKETING

Lilly stomach cancer drug extends survival vs

Deputy General Manager Harit Mohanty

placebo

Senior Manager Rajesh Bhatkal

PAGE 32

Botox receives US FDA approval to treat overactive bladder

PRODUCTION

PAGE 33

New study could help earlier diagnosis of

General Manager B R Tipnis

Parkinson’s disease

Production Manager Bhadresh Valia

PAGE 34

PHARMA ALLY

Asst. Manager - Scheduling & Coordination Arvind Mane

‘HRS is a ‘one stop solution’ provider for all

Asst. Art Director Surajit Patro

heat exchange solutions’

Chief Designer Pravin Temble

TAKE Solutions implements mobile-based

Senior Graphic Designer Rushikesh Konka

Patient Diary System

PAGE 35

PAGE 36

PHARMA LIFE

Photo Editor Sandeep Patil

Hiring in pharma sector up by 8 per cent in

Layout Rakesh Sharma

Dec 12 over Nov 12

PAGE 59

C I R C U L AT I O N

Quintiles bags accreditation from College of

Circulation Team Mohan Varadkar

American Pathologists

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021.

(Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act.

PAGE 60

Wockhardt receives ‘Best Enterprise’ award

MARKET

from the Europe Business Assembly

'The next 3-5 years would see stem cell banking penetration rise

Shripad Desai joins AmeriCares

above 1 per cent'

India as MD

PAGE 18

Evolva in collaboration with Ajinomoto

PAGE 60

PAGE 60

PAGE 19

Venus launches US patent protected product ELORES in India SIRO Clinpharm unveils new brand identity

PAGE 20

PAGE 21

IPM sees lowest growth rate in December 2012

PAGE 22

Bangalore INDIA BIO 2013 to provide latest trends in biotech Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

February 1-15, 2013

business opportunities

PAGE 23

RDD Europe 2013 to see congregation of pulmonary and nasal drug delivery experts

PAGE 25

www.expresspharmaonline.com

EXPRESS PHARMA

9

EDITOR’S NOTE

The media on clinical trials: Watchdog or hound?

'The Fourth Estate: A Watchdog or A Hound?' That was the topic of the 17th Lalit Doshi Memorial Lecture, given by Shekhar Gupta, Editor-in-Chief of The Indian Express in August 2011. His view was that the problem is not with the normative question of whether the Fourth Estate should be a watchdog or a hound, but in the way in which it assumes the role of a watchdog or a hound. (See report at http://bit.ly/VbqREI) Of late, I found myself re-visiting the same query when some industry contacts commented that most media reports were "inaccurate" and "one-sided" when reporting on clinical trials. Pharmaceutical companies and CROs in India seemed to be feeling boxed in, not just by regulators (my editorial in the last issue referred to some of these issues: 'Clinical trials: Edicts and effects', http://bit.ly/XuU11Q) but also by the Fourth Estate.

Regulatory oversight is welcome, say industry insiders, but it should come with greater clarity and transparency. But are reporters given the same courtesy? Journalists who do want to feature both sides of the story are almost always stonewalled when they approach industry representatives for more information or clarifications.

Industry observers say that they understand that media has every right to be a watchdog, highlighting unethical practices and informing the public. The trouble starts, they say, when selective information is put out in the public domain, or when its given a slant that they feel is not logical. For instance, though India's share of the global clinical trial pie is minuscule (less than two per cent), media reports refer to the country as a 'clinical trials hub' which paints the industry as a profiteering Goliath.

Reports that clinical trials are cheaper to conduct in India often mask the fact that certain trials, especially those calling for regular diagnostic tests like MRIs and CT scans, are more expensive to conduct in India because in other geographies, these are covered by insurance or the government. Industry sources claim

10 EXPRESS PHARMA

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that these costs get billed to the industry in India.

Industry claims that reportage on deaths of subjects during clinical trials will result in patients refusing to sign up for clinical trials. A pharma company insider narrated how an oncologist's attempts to convince a relative of a cancer patient that a new investigational treatment had a good chance of working on his relative, only to hear him refuse permission, quoting some of these headlines. The doctor faced a moral and ethical dilemma. Who would take responsibility for the death of that cancer patient?

The relative, for withholding a potential treatment, that could have given the patient a few more months with his family? Or the doctor, for failing to convince the relative of the merits of the best possible treatment available at the time?

Clearly, the pharma and CRO industry's negative image has also rubbed off on the medical fraternity, thanks to shows like Aamir Khan's reality show where the doctor-pharma company nexus was once again raked up. (Express Healthcare, June 2012, ‘Whose truth is it anyway?’: http://bit.ly/UYteMU) But of late, there is a thaw, however slight, with some industry representatives coming forward to share information and clarifications. The dialogue has just started and it might take some time for both sides to develop a degree of mutual trust, but it is a step forward.

Maybe the thaw stems from the fact that it is completely in the industry's interest to turn the tide of public opinion and go back to business as usual. But a common foe (dreaded diseases like cancer, diabetes, etc) needs some commonality of purpose. If we want the benefits of the latest medications, we need them tested as well. Of course, as per the highest possible ethical standards. Therefore, we will need to be both watchdog and hound, striking a pragmatic balance.

Viveka Roychowdhury viveka.r@expressindia.com

February 1-15, 2013

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

'The next 3-5 years would see stem cell banking penetration rise above 1 per cent' PG18 Evolva in collaboration with Ajinomoto PG19 Venus launches US patent protected product Elores in India PG20 SIRO Clinpharm unveils new brand identity PG21 IPM sees lowest growth rate in December 2012 PG22 Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities PG23 Event brief PG24 RDD Europe 2013 to see congregation of pulmonary and nasal drug delivery experts PG25

MANAGEMENT 26 RESEARCH 32 PHARMA ALLY 35 PHARMA LIFE 59 February 1-15, 2013

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The pharmaceutical industry may have been a tad slower than other industries to sign up on social media platforms like Twitter and Facebook but seems to be making up for lost time. For instance, 2012 saw social media campaigns from major pharma companies like Roche, Pfizer and GlaxoSmithKline, and new blogs from AstraZeneca, Sanofi, Bayer, Lilly, Shire and Boehringer Ingelheim to name just a few of the bigger initiatives.

Manish Gupta, CEO, Indegene Lifesystems traces the pharma industry's engagement with social media to 2008 when top pharma companies joined social media communities (mainly physician communities) to initiate meaningful dialogues with its stakeholders.

However, it was only after the November 2009 US FDA public hearing on 'Promotion of FDARegulated Medical Products Using the Internet and Social Media Tools’, that pharma companies got some clarity on the regulations of using internet and social media tools. (See Express Pharma, Feb 16- 28, 2010, ‘The social media super market: Pharma still plays safe’, http://bit.ly/VZN63n) Gupta opines that pharma companies have come a long way since, exploring different avenues to leverage social media platforms.

One of the key drivers for use of social media by pharma companies, says B Sriram, Executive Director– Healthcare, Direxions Marketing Solutions, was to generate an opinion or standpoint on a topic and influence change. For example, blogs on the race to eradicate polio from the globe. The pharma industry also used social media to create awareness about a disease; a good example would be Merck’s work on cervical cancer awarenes. A third driver would be to connect with patients suffering from similar ailments, like

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the way Sanofi has taken to Facebook and Twitter in a big way where over the past two years they have created a community of 4000 patients suffering from diabetes on both these platforms.

Rise of the e-patient As Gupta says, “Social media has become a channel that the pharma/medical firms cannot afford to miss, given that many patients these days look up the internet to understand their symptoms and the disease they (or their family members) are suffering from before consulting a doctor.

Another interesting sign is that consumers are also using social media to validate costs associated with the treatment/procedure, information on reimbursement and the insurance associated with the treatment."

India has proven to be one of the fastest growing digital markets in the world, with an Internet population that has surged 38 per cent in the past year. Health is one of the 'Super Seven' projected areas of explosive growth, according to an August 2012 comScore webinar on the 'The Rise of India's Digital Consumer' As Dinesh Chindarkar, Co-founder and Vice President – Operations, M e d i a M e d i c Communications puts it, "With an increasing number of Internet and smart phone users in the country, and increased searches on health, the e-patient is on the rise."

Similarly, an increasing number of doctors in India are seen using smart phones to stay connected to the Internet to better understand the landscape of the healthcare industry, Gupta points out.

In fact, Indian healthcare providers' (HCP) are at the forefront when it comes to using social networks for getting information as comwww.expresspharmaonline.com

pared to their international peers, according to Chindarkar. There is a dayto-day increase in internetbased health searches and acceptance of new ways of reaching out. For instance, the Indian twitter healthcare hashtag, #hcsmin, which stands for 'healthcare social media in India' registered by

is an upward trend in terms of digital spend in tune with the changing habits of HCPs. Globally, it is predicted that emerging markets including India will have the maximum spend and adaptation on digital and social media platforms, according to Chindarkar.

Reviewing the pharma-

MANISH GUPTA

DINESH CHINDARKAR

CEO Indegene Lifesystems

Co-founder and Vice President – Operations, MediaMedic Communications

For pharma/medical firms, social media has become a channel that they cannot afford to miss, given that many patients these days look up the Internet to understand their symptoms and the disease they (or their family members) are suffering from before consulting a doctor

Globally, it is predicted that the emerging markets including India, will have the maximum spend and adaptation on digital and social media platforms

Chindarkar in August 2011, today clocks around 25 tweets a day.

Chindarkar also points out to the parallel trend of the medical representative (MR)-doctor relationship going through a revolution as communication media get more digitised. Hence, there

related social media scene in India, Gupta comments that some very successful social media campaigns currently being run are in pregnancy and child care, oncology, and geriatrics. Hospitals too are starting to provide access to authentic, trustworthy and comprehensive February 1-15, 2013

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health related information to patients.

An emerging influencer Pharma companies cannot promote or sell prescription products online because as Sriram cautions, they are supposed to follow guidelines set by the Medical Council of India and code of conduct set by The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The IFPMA code sets standards for the ethical promotion of pharma products to healthcare professionals, and for member companies’ interactions with them and pharma companies are very aware that they have to follow these standards in the virtual world as well.

But, even if the net cannot be a sales channel for prescription products, it serve another important purpose. Social media has emerged as a key influencer and medium, says Gupta and therefore pharma

February 1-15, 2013

majors are looking to understand stakeholder sentiments, and drive appropriate programmes to proactively engage with patients and HCPs. An active social media presence thus becomes crucial as a branding strategy in an increasingly competitive and over-crowded market. "With the advent of more locally available drugs/devices, companies are under tremendous pressure to reach out to maximum number of consumers with optimum information about their products. This has led to pharma companies latching onto the digital media space to promote brand awareness and mind share," says Gupta.

In fact, as ‘word of mouth’ marketing plays an important role in the healthcare delivery sector, stakeholders, particularly HCPs, have realised the potential of social media, concludes Gupta.

Chindarkar too refers to this trend when he says,

www.expresspharmaonline.com

B SRIRAM Executive Director– Healthcare Direxions Marketing Solutions

"Closed loop marketing (CLM) in the pharma industry is slowly gathering speed. Engaging the end user with customised information through blogs, live chat rooms, video streaming etc. has made the pharma industry think beyond plain vanilla websites."

Trends in digital spend

A pharma company cannot sell prescription drugs to patients on the net as they are supposed to follow guidelines set by MCI and the IFPMA code of conduct

The pharma industry’s share of spend on traditional versus new media seems to be still skewed in favour of the former but this is true across sectors. In an article titled, 'Demystifying social media' in the April 2012 edition of Mckinsey Quarterly, the authors make the point that social media still accounts for less than one per cent of an average marketing budget and while many chief marketing officers want to increase that share to five per cent, one problem is that a lot of senior executives know little about social media. But the main obstacle is the perception that the return on investment

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(ROI) from such initiatives is uncertain.

Its still early days in India. Chindarkar says that social media campaigns in the Indian pharma industry are still in the nascent stage because the industry still believes in and follows the traditional methods of promotions through the MR. This traditional marketing strategy accounts for almost 17-20 per cent of sales revenue while he estimates that social media campaigns would not be more than two to three per cent as of now, even including digital media like websites for both doctors and patients, healthcare mobile applications, online information tools etc.

Lifestyle brands, nutraceuticals and health foods are taking the lead here.

Convincing managements to increase digital spend would require a clear picture of the exact ROI from such

spend. Chindarkar concedes that though ROI is difficult to measure in the short term, some indicators like number of likes, number of page hits etc are generally taken into consideration.

Going from numbers to insights If the current trend keeps up, social media evangelists should have no problem convincing pharma managements to up their digital spend. Sharing some interesting statistics from Indegene's digital initiatives in India, Gupta reveals that the average time spent by doctors on digital activities has gone up by 40 per cent in the last two years while the average numbers of doctor registrations has doubled in the last two years. A majority of doctors enrolled in Indegene's programmes are from Tier-2 cities and this too shows up some

important insights.

But the numbers are just the tip of the iceberg. "The biggest challenge for pharma companies," feels Chindarkar, "is not just promoting their brands, but how to build goodwill among consumers and customers alike. How can they engage with doctors, how can they influence them?

The first movers within pharma will have a definite advantage."

Thus, Chindarkar stresses that laying out clear objectives while planning a social media campaign is very critical. Pharma companies looking at social media options should be very clear on these points: Why are they engaging?

Whom are they engaging?

And how are they going to track, analyse and optimise?

Taming the data demon Launching

a

social

media campaign is just the beginning of the company's engagement with its stakeholders. "The social media universe creates tremendous amount of data which can help decision sciences," says Gupta as "social media creates two unique platforms; the first creates a channel to engage stakeholders, most popularly through websites, and the second, via realtime market feedback."

Transforming this data into insights will be crucial, because mere monitoring of social media campaigns is not going to be reason enough to continue to pump resources into the campaign.

Chindarkar points out that while companies use various social media monitoring tools like Radian6, Sysomos, etc for measuring campaigns, one has to manage and filter (the data) carefully, as these tools generate only numbers. So it is

Metrics for analysing social media campaigns ndegene Lifesystems has metrics and key perfomance indicators (KPIs) defined at various stages of its clients’ campaigns, based on the objectives of the campaign and while these are confidential, these are some examples to indicate the scope of insights and learnings that can be gleaned from such social media campaigns

I

Example 1) Expert social networking webplatform enabled to capture analytics Indegene developed a social networking website as a virtual community involving patients with Chronic Myeloid Leukaemia (CML) and related stakeholders i.e. HCPs, patient groups, etc. using Indegene proprietary physician engagement tool. Pre-andpost analytics and reporting of outcomes was part of the campaign deliverables. The platform was programmed with all the necessarily regulatory restrictions and audit mechanisms to meet all regulatory requirements

breast cancer.

Social Analytics ● Impact map– Placement of prominent social media platforms into a grid of comment polarity and user interaction volume based on qualitative analysis ● Impact tracker- Reflection of real-world developments in social media ● Effectiveness analysis– Insights from social media events evaluated within timeframeand buzz generation- based analytical frameworks ● Case study preparation– Value-add; a casestudy on real world impact of social media centered petition initiative ● Effectiveness analysis– Insights from social media events evaluated within timeframeand buzz generation- based analytical frameworks ● Case study preparation– Value-add; a casestudy on real world impact of social media centered petition initiative.

Social analytics ● User Demographics– profession, HCP specialty, zip code ● Simple analytics: Number of visitors (new and returning), sections visited, time spent in each section, assets viewed, time for each asset, benchmarking data ● Polling– Polls, surveys and reports ● Complex analytics

Example 3) Social media based conference tracking

Example 2) Product X in breast cancer – social media sentiment analysis

● Discussion profile tracker– Segmentation of interaction by topic and complementation with sentiment analysis ● User analysis- Identification, profiling and analysis of opinion shapers across platforms ● Implication analysis– Insights into poten-

A global pharma company with key stakes in the oncology space requested public sentiment analysis pertaining to regulatory and payer decisions regarding product X in

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tial implications of the social media chatter about the studies

A global pharma with products in oncology requested a social media buzz analysis of two key studies presented at ASCO 2011. The objectives were two-fold: a comparative analysis as well as real world implications.

Example 4) Competitor activity analysis in social media A Top 10 pharma company requested identification and analysis of social media engagement of its competitors. The insights informed the development of the client’s social media engagement strategy.

Social analytics ●

Social media from strategic perspective– Insights into strategic employment of social media by competitors ● Level of success analysis– Analysis of success levels of competitors’ social media initiatives ● Case study preparation– Case studies on successes and failures of pharmaceutical companies in the social media space ● Social media strategy formulation– Identification of best practices and inputs into formulation of client’s social media engagement model

Example 5: Industry engagement with social media platform A leading pharma company requested an analysis of the level of engagement of premier pharma companies with Twitter and the relative effectiveness of such engagements.

Social analytics

www.expresspharmaonline.com

Social analytics ●

Twitter activity landscape– Overview of presence of the pharma industry on Twitter. ● Individual activity map– Research encompassing quantitative and qualitative analyses to map the Twitter presence of each company.

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important to further analyse the results manually.

Taking the analysis one step further, Chindarkar points out that while Radian6 or Sysomos give clarity in terms of campaign numbers, it is very important for companies to develop their own tools and measures. "With the above tools, companies can get the analytics of a campaign, but making the campaign more effective is by getting insights (useful data) which can be further used in product development and designing marketing strategies. All this will lead to the BIG Data that everyone is talking about," reasons Chindarkar.

Thus, it is equally important to monitor the right metrics and parameters and to tailor while measuring the impact of social media campaigns.

(See BOX: Metrics for analysing social media campaigns )

Future trends Currently, digital con-

sumers in India are predominantly accessing information oriented websites (content based). However, with the ever increasing Internet and mobile penetration and pharma companies’ focus on social media, Gupta expects this trend to change towards more interaction and interactive websites rather than information oriented ones.

But the promise of social media comes with its own problems, which highlight the shortcomings of the medium as well as the fact that the pharma industry is very different from other industries that use social media. As Gupta notes, the social universe provided by a Facebook or Twitter are not configured to provide the required regulated environment for social outreach in the pharma context.

For example, Gupta says, "The reliability of healthcare information is troublesome due to the easy access to ‘post’ content online, lead-

ing to patients finding incorrect and irrelevant information. The need for reliable and regulated information is paramount as this sector continues to grow. Content risks becoming anecdotal in nature." Gupta recalls a few cases in which some pharma companies were served notices to refrain from keeping certain web pages and blog posts as people had posted sensitive information.

Countries like the US which took to social media much earlier have evolved mechanisms to cope with these issues. The quality, authenticity, and outreach mechanisms are highly regulated in the US, observes Gupta, and this is an important area to consider as this sector continues to grow in India.

Another trend Gupta predicts is the development of localised content and country specific platforms in India, with the country's internet penetration reaching

35 per cent. This mirrors what is already the case with nations like China which has more localised platforms.

On the regulations front, the November 2009 US FDA guidelines are a start but much more clarity is required. Gupta opines, "The US FDA guidelines are more from a guidance perspective; they do not answer any specific dos or don’ts."

This draft guidance addresses some of the questions about the kind of communication pharma companies can adopt, suggests how drug makers could respond to any solicited or unsolicited requests for off-label information, but other specifics are not clear.

Social media is clearly here to stay, medico-legal /ethical issues et al. As the pharma industry cannot wish it away, each stakeholder will have to learn how best they can harness the medium to fit their own needs. viveka.r@expressindia.com

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'The next 3-5 years would see stem cell banking penetration rise above 1 per cent' LifeCell International has achieved quite a few milestones in the last few years and is today the most preferred stem cell bank in India as per a Nielsen survey, with 100 centres across India.

Mayur Abhaya, Managing Director and Chief Executive Officer, LifeCell International reveals more in an interview with Shalini Gupta How has the previous year been for Lifecell? What have been the major accomplishments?

The year 2012 has been another remarkable year of progress. Within this year we launched Express Shipment Service, by which we can offer industry's leading shipment time for transport of stem cells and that too in a highly secure manner. This was launched in collaboration with Sequel Logistics.

We made a foray in newborn screening with our BabyShield Newborn Screening Service. It is the world's most advanced newborn service whereby over 100 metabolic conditions can be screened at birth and that too in a completely non-invasive manner. It is to be noted that even the US mandatory panel is only for 54 conditions and is not painless.

December saw us introduce India’s first dual storage service launch of our new storage facility at Manesar, Gurgaon, that allows stem cells to be stored at two geographically distant locations.

How huge is the global market for stem cell banking?

What is the situation in India?

The global stem cell banking market is about $500 million. India is a nascent market at less than 10 per cent of this at ` 200 crores.

As compared to Singapore which ranks highest with a penetration rate at 250/1000 children, in India it remains at 2/1000. This also indicates there is a huge unmet clinical need in India that needs to be addressed. The next three to five years would see stem cell banking penetration rise above one per cent and that would be driven by increasing awareness, reach and affordability.

Japan, China and Korea

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lead the stem cell banking market in Asia. What are the lessons for India from these countries?

Enabling research environment along with supportive regulatory policy have made these countries leaders in stem cell technology. Last year's Nobel Prize winner in Medicine was from Japan; the world's first allogeneic stem cell product approval was from Korean FDA. Autologous cancer vaccine treatment is considered as practice of medicine in Japan and therefore out of regulatory approval purview. The lessons to be learnt are: Don't always be conservative. Being a follower can reduce failure risks but also delays availability and access to critical medical technologies. Also, regulatory bodies need be more enablement and funds to put a full-time team on this.

What is Lifecell's reach and share in the Indian market?

We have a market share of 45-50 per cent and take pride in being market leaders as far as distribution and reach is concerned. We are looking at expanding around the Indian geography in markets such as Nepal, Sri Lanka and Bangladesh in the next six months. We also have a presence in the Middle East but with Government restrictions around opening of private stem cell banks, the reach has not been that much. We have 60,000 clients in cord blood banking and an equal number in tissue banking. More than 80 per cent of our revenues come from cord blood banking. Menstrual blood banking is an emerging stream for us with 14,000 clients as of now.

What is being done to increase the awareness levels about stem cell banking?

So far for marketing, we have been looking at a medical approach wherein the concept is being managed through hospitals. Doctors today are aware of stem cell banking and 99 per cent recommend it to their patients.

There is also a growing awareness among parents www.expresspharmaonline.com

INTERVIEW

and in larger hospitals it is through word of mouth. We also run hospital awareness patient programmes. At the consumer level, we are conducting programmes at the college level in Delhi and Chennai, to educate young women about menstrual blood banking and engage them as change agents to take charge of their future.

This would include showcasing our labs in both the cities to them as a part of a tour so that they can have the trust to bank with us.

Recently the Competition Commision of India has been probing unfair practices in stem cell banking.

What are your views on it?

The matter relates to practices of hospitals at large.

While the case is specific to provision of stem cell services may be the CCI should take a larger view on the entire gamut of healthcare services distributed by hospitals such as diagnostics, medical devices, medicines, etc.

The consumer is medically more aware than ever before and will want to participate in choosing the best medical options available.

What are your plans to foray into the stem cell therapy space?

Stem cell therapy is mostly still limited to bone marrow and cord blood transplantation. Globally, while there is a lot in the pipeline,

it is still a few years away from marketplace. Due to lack of regulatory policy and policing, emerging stem cell therapies are at the moment being provided mostly by the unorganised sector. Dendritic vaccines form the basis of the newest modality of cancer treatment i.e, immunotherapy which won the 2011 Nobel Prize in Medicine. It was also the basis for a product launch in the US for treatment of prostrate cancer. Data from emerging clinical trials shows unmatched clinical benefits and therefore looks promising. LifeCell has initiated development of cancer vaccines but is still years away from launch as the clinical development phase is yet to be initiated.

India represents a huge market for newborn screening, which remains largely a public health initiative, often mandatory in other countries. Only two Indian states, however, have launched this initiative. How do you see the future?

India has the highest infant deaths worldwide with less than one in 1,000 newborn screened at birth, although its mandatory in over 60 countries for all newborns. Countries that have mandated newborn screening through public programmes have achieved first an infant mortality ratio of 10, so such a milestone is essential before countrywide adoption of newborn screening. In India, only Goa and Kerala have achieved this and therefore have embarked upon it. It is only natural that other states will look at this closely for their healthcare initiatives especially now that higher allocations are being committed for healthcare in next five year plans.

We see BabyShield as an innovative solution not just for India but the world. It helps us to secure future health of newborns through preventive approaches - a space where we have market leadership, and also an area with significant unmet needs. shalini.g@expressindia.com February 1-15, 2013

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COMPANY WATCH Evolva in collaboration with Ajinomoto Ajinomoto will be funding research and development activities at Evolva volva Holding entered into a collaboration agreement with Japanese company Ajinomoto for the joint development of novel fermentation production routes for a natural functional ingredient for application in personal care.

Ajinomoto is a world leader in the area of amino acids.

As per the agreement, for the 3½ year collaboration, the company will be funding research and development activities at Evolva, focused initially on building a novel, valuable pathway with Evolva’s fermentation technology and subsequently on improving production yield through the scale-up and manufacturing phases.

During the collaboration, seven full-time scientists at Evolva are expected to work on the programme. Evolva will

E

a percentage on product sold.

Panchapagesa Murali,

Chief Executive Officer of Evolva India said, “We value highly the confidence in our capabilities that Ajinomoto Co is showing by entering into

receive an upfront exclusivity and technology access fee as well as monthly research fees.

In addition, Evolva will receive milestone payments upon achieving certain goals in terms of yield, productivity and production costs. The total fees and milestone payments to Evolva during the collaboration will amount to more than CHF 10 million. In case of commercialisation, Evolva will receive a royalty as February 1-15, 2013

project has long-term benefits as it allows us to build a pathway which can be important for other products.”

EP News Bureau – Mumbai

33-year history of partnership with leading pharma companies

TELMISARTAN TELMISART AN GREEN Non-Infringing Process

active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular

THE TOTAL FEES AND MILESTONE PAYMENTS TO EVOLVA DURING THE COLLABORATION WILL AMOUNT TO MORE THAN CHF 10 MILLION. IN CASE OF COMMERCIALISATION, EVOLVA WILL RECEIVE A ROYALTY AS A PERCENTAGE ON PRODUCT SOLD

this collaboration. We look forward to providing Ajinomoto with efficient production routes for their important product. For Evolva, this

Pyrazinamide# * Isoniazid # *

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

#

Antifungal Flucytosine

#

Cetirizine dihydrochloride # Hydroxyzine diydrochlorid + Meclizine diydrochlorid

Antiosteoporotic

#

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

* WHO APIMF

CEP / COS

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.

Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India.

Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

www.expresspharmaonline.com

EXPRESS PHARMA

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Venus launches US patent protected product Elores in India It is a novel antibiotic adjuvant entity enus Remedies recently launched CSE1034 under the brand name “Elores”. It is a novel Antibiotic Adjuvant Entity (AAE) to combat antimicrobial resistance caused by MDR, ESBL producing strains.

The product was launched by Dr KN Parsad, Associate Professor, Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow at Manthan 2013, a seminarcum-workshop organised by 'Venus Medicine Research Centre' (VMRC).

At the unveiling ceremony of Elores, Dr Manu Chaudhary, Joint Managing Director and Director Research, Venus Remedies said, “Receiving a US patent for Elores was a landmark development to initiate the process of commercialisation and today we are launching it in India as Elores.” Designed specifically to target growing bacterial resistance mechanisms, Elores has a unique profile of action which gives it an edge over all the existing therapies.

This unique antibiotics adjuvant entity

V

creates a synergistic effect due to its activity on AMRINGER (Acquired Multiple Resistance in Gram Negative Enterococci and Rods) which stops development and spread of bacterial resistance. Chaudhary further added that the product is effective against Metallo betalactamases (MBL) producing pathogens which are not susceptible to most of the existing antibiotics. It is also unique in its way that it not only kills resistant pathogens (bacteria) but also prevents the spread of resistance.

Elores consists of a third generation cephalosporin, a beta lactamase inhibitor along with non antibiotic adjuvant disodium edetate for intravenous administration. It is effective against MDR pathogen producing ESBLs, MBLs like NDM-01, increases cell permeability while working on cell impermeability mechanism of MDRs, regulate efflux pump over expression, breaks bacterial biofilms, prevents transfer of resistant plasmid and hence the spread of resistance is controlled.

The company is positioning Elores as the need of the hour as it would be able to

reduce a minimum of 30 per cent of the hospitalisation cost and almost 50 per cent of the drug cost, thereby proving to be very beneficial for patients. As per a study conducted in Delhi, patients with hospital-acquired infections experienced a significantly longer hospital stay (mean: 22.9 days); significantly longer intensive care unit (ICU) stay (mean: 11.3 days); a significantly higher mortality (mean: 54 per cent) and cost significantly more (mean: $14, 818) than controls. So, Elores would be able to curtail these statistics.

It took Venus almost 10 years of constant hard work and dedication to develop this breakthrough technology. The company has conducted clinical trials phase I, II and III successfully on a large patient population of 654 patients to prove clinical efficacy and safety in ESBL/ MBL resistant pathogens.

On an average, the company has spent 10 per cent of its revenue on research and has been investing almost 20 per cent of its R&D expenditure for developing and establishing this technology itself.

Pawan Chaudhary,

Chairman and Managing Director, Venus Remedies said, “Elores is a novel product with a unique technology specifically addressing the compounding medical emergency of antimicrobial resistance, and thus there is no direct competition as such. However, products like meropenem and pipracillin+tazobactum are the closest in contested category though they are also getting huge resistance.”

Chaudhary further said, “We want to cater to this segment effectively and immediately and are expecting to capture 10 per cent share of the total AMR market in India in the next five years, making it an over `2.0 billion product. Apart from the domestic marketing plans, we are also in talks with leading pharma companies to launch the product in US as well.”

Furthermore, Elores has already secured patents from all over the world including countries like US, EU (37 European countries), Australia, and Russia. The company is awaiting registration grant for Elores with European regulatory bodies to commercialise it in the EU as well.

EP News Bureau – Mumbai

approvals including two from Aurolife Pharma and 25 tentative approvals) from US FDA. The company has also received to manufacture and market oxacillin for injection USP, packaged in 1g and 2g vials (ANDA 201539) and oxacillin for injection USP 10g/vial pharmacy bulk package (ANDA 201538).

The products are ready for launch.

Oxacillin for injection USP is a sterile semisynthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase

producing staphylococci which have demonstrated susceptibility to the drug.

These ANDAs have been approved out of unit XII formulation facility in Hyderabad, India and will be marketed and sold by Aurobindo's US subsidiary AuroMedics Pharma LLC. Aurobindo now has a total of 174 ANDA approvals out of total 149 is final approvals including two from Aurolife Pharma LLC and 25 tentative approvals from US FDA. EP News Bureau – Mumbai

Aurobindo Pharma receives two final approvals the approvals are for felodipine ER and oxacillin injection urobindo Pharma has received final approval from the US FDA to manufacture and market Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg. (ANDA 203417) and oxacillin for injection USP. Felodipine Extendedrelease tablets USP 2.5mg, 5mg, and 10mg is the generic equivalent of AstraZeneca’s Plendil Extended-release tablets, 2.5mg, 5mg and 10mg and

A

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EXPRESS PHARMA

indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 172 ANDA approvals (147 final www.expresspharmaonline.com

February 1-15, 2013

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SIRO Clinpharm unveils new brand identity Rebrands as a customer-centric organisation IRO Clinpharm, a leading full service clinical research organisation (CRO), unveiled its new brand identity recently. The new look affirms the recent transformation in the company's business strategy.

A few months ago the company had embarked on a very ambitious goal to revamp its business and integrate various functions to deliver better value to its customers.

"With the vast experience garnered over the past 16 years, SIRO was set to take a leap forward. With its customer centric leadership, we have built depth in various areas of competencies, leveraging our four pillars - people, processes, technologies and solutions," said Dr. Gautam Daftary, Founder and Chairman, SIRO Clinpharm.

"SIRO is one of the few CROs to offer end-to-end clini-

S

cal development solutions with a competitive advantage of high-end technology, inhouse domain expertise and evolving ecosystems. This new wave will take SIRO

beyond its services and bring in the much valued visionary approach, incessant customer focus and strong governance.

At SIRO, we aspire to provide solutions, not just services," said Gopakumar Menon, CEO, SIRO Clinpharm.

“With this transformation, the company aims to focus on customer experience, a differentiated customer experience which can happen only through the delivery of right solutions," added Gopakumar.

The launch saw SIRO

employees join in from offices across the globe. The launch was webcast live at all locations from Mumbai, where the new brand identity was unveiled by the company's leadership.

EP News Bureau – Mumbai

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

Glatt Engineering Consulting Process Engineering General Planning

Lupin bags US FDA nod for generic Lutera tabs

GMP-Compliance Services

Nod marks Lupin’s 7th OC product approval

Training

upin received final approval for its levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg from the US FDA to market a generic version of Watson Laboratories’ Lutera 28 tablets, which had annual US sales of approximately $103.6 million. The company's seventh OC product approval, Lupin’s levonorgestrel and ethinyl estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Lupin will be marketing its generic product shortly. The fifth largest generic player by prescription, Lupin is the most vertically integrated OC player for the US market and has a dedicated OC facility in Indore.

Lupin's current ANDA filings for OC's stand at 32 - which is the largest pipeline for the US OC market.

EP News Bureau – Mumbai

L

February 1-15, 2013

Implementation Validation/Qualification

From the idea to turnkey production in the pharmaceutical and biotech industries

Headquarters: Glatt Ingenieurtechnik GmbH Nordstrasse 12, 99427 Weimar / Germany phone: +49 -3643 -47-0 fax: +49 -3643 -47-1271 eMail: info@glatt-weimar.de Indian Office: Glatt (India) Pharma Engineering Pvt. Ltd. 13 Ground Floor Palam Marg, Vasant Vihar New Delhi - 110057 / India phone: +91 -11 - 460 529 60 / 61 / 62 fax: +91 -11 - 460 529 64 eMail: info@glatt-india.com

www.glatt.com www.expresspharmaonline.com

EXPRESS PHARMA

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GROWTH TRACKER IPM sees lowest growth rate in December 2012 For the first time ever, the diabetes market has grown lower than the cardiac market With bonus units at full value Val in Crores CORPORATE

Rank

MAT Dec -12

MAT

MTH

Abbott + Abbott Hc

1

1

Cipla

2

Sun Pharma Glaxo

Dec-12

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

69338

100.00

14.3

5776

100.00

5.1

4091

5.90

11.8

341

5.90

4.3

2

3496

5.04

10.6

302

5.23

0.4

3

3

3343

4.82

22.0

300

5.19

17.3

4

4

3239

4.67

16.9

267

4.62

2.1

Zydus + Biochem

5

5

4091

4.40

17.1

265

4.59

16.2

Ranbaxy

6

6

2899

4.18

8.8

252

4.37

7.0

IPM

Mankind

7

7

2495

3.60

26.1

198

3.43

14.5

Alkem + Cachet + Indchemie

8

8

2351

3.39

15.4

187

3.25

0.8

Pfizer + Wyeth

9

10

2213

3.19

17.0

181

3.13

6.6

Lupin

10

9

2098

3.03

14.4

182

3.15

8.7

Macleods

11

11

1771

2.55

27.8

152

2.62

16.0

Intas

12

12

1657

2.39

18.6

147

2.55

13.4

Aristo

13

14

1618

2.33

14.0

124

2.15

-1.5

Sanofi-Aventis + Universal

14

13

1556

2.24

14.0

133

2.31

6.4

Emcure + Zuventus

15

16

1467

2.12

14.3

121

2.09

10.0

Dr. Reddys

16

17

1362

1.96

9.8

119

2.06

3.6

Glenmark

17

15

1356

1.96

24.6

123

2.13

9.6

Micro + Bal

18

19

1309

1.89

17.4

106

1.83

-5.1

IPCA

19

21

1228

1.77

18.1

100

1.72

4.4

Reinhardt

20

23

1206

1.74

10.4

95

1.64

-5.0

Val in Crores

22

Super Group

MAT Dec 12

GR%

Mth Dec 11

Mth Dec 12

GR%

IPM

69338

14.3

5495

5776

5.1

ANTI-INFECTIVES

12404

11.7

995

998

0.3

CARDIAC

8476

17.4

665

742

11.5

GASTRO INTESTINAL

7942

15.5

591

614

4.0

VITAMINS / MINERALS / NUTRIENTS

6113

16.0

460

483

5.1

RESPIRATORY

5303

10.8

498

502

0.7

PAIN / ANALGESICS

5164

10.6

415

420

1.3

GYNAECOLOGICAL

4519

10.8

358

374

4.6

ANTI DIABETIC

4475

20.6

353

387

9.6

NEURO / CNS

4201

13.4

333

365

9.3

DERMA

3651

16.3

293

310

5.9

OPHTHAL / OTOLOGICALS

1235

14.8

94

100

5.9

HORMONES

1177

19.6

92

103

12.1

OTHERS

941

18.1

71

87

22.4

VACCINES

868

12.5

71

72

1.8

BLOOD RELATED

860

14.9

64

68

6.2

ANTI-NEOPLASTICS

671

11.2

45

56

24.5

ANTI MALARIALS

644

18.0

43

37

-15.5

SEX STIMULANTS / REJUVENATORS

388

20.4

31

34

10.7

STOMATOLOGICALS

307

14.0

24

25

6.8

EXPRESS PHARMA

www.expresspharmaonline.com

ecember 2012 has been the month with one of the lowest growth rates (GR) in the Indian pharmaceutical market (IPM) in a long period of time, if we ignore the low growth of November 2012 to Diwali effect. The year 2012 started with a bang (Jan-Mar 18.7 per cent GR) and ended on a whimper (Oct-Dec 9.1 per cent GR). The trend of Q1, Q2, Q3 and Q4 – 18.7 per cent, 16.9 per cent, 13.5 per cent and 9.1 per cent respectively – definitely points to a slow-down, although it does not seem as drastic as the last quarter suggests.

While the entire industry will analyse the data on what caused this slowdown, there are some trends which are being reported / discussed, including generics acquiring bigger share, slowdown in new patient detection in chronic therapies, as well as subdued seasonal anti-infective market due to lower respiratory infections compared to prior period.

Amongst the top 25 corporates for December 12 showing high GR are Sun – 17.3 per cent, ZydusBiochem – 16.2 per cent, Mankind – 14.5 per cent, Macleods – 16 per cent, Intas – 13.4 per cent and USV – 19.1 per cent. Among the top 10, Lupin has moved up one rank for the month.

While anti-infectives – the largest size and 17 per cent weightage – is flat, leading to lowering of growth rates, for the first time ever, the diabetes market is growing lower than the cardiac market, which is surprising as diabetes for most part of last several years has shown 510 GR percentage higher than cardiac GR. Another market that is virtually stagnant for the month is respiratory along with pain / analgesics. While anti-infectives, respiratory and pain/analgesics (including anti-pyretics) can have seasonal influence, the slowdown in cardiac and diabetes points to a definite lowering of mid-term growth forecasts for the Indian pharmaceutical market.

The first quarter of 2013 is a crucial period – wherein focus needs to be re-oriented into profitable rural penetration, higher detection and patient conversion into chronic therapies and improving compliance to drive the overall market growth by volumes. Despite one of the toughest quarters, nobody doubts the positive outlook of the IPM growth story.

D

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS in AIOCD AWACS stands for Advanced Working, Action & Correction System – reflecting the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Accurate and faster information flows from the market will help clients grow topline and bottom-line.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crs MS per cent - Market Share in Percentage GR per cent - Growth in percentage For more information, visit http://www.aiocd.net

February 1-15, 2013

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PRE EVENT Bangalore INDIA BIO 2013 to provide latest trends in biotech business opportunities Event to be held in Bangalore from February 6-8, 2013 angalore INDIA BIO, an annual event organised by Department of Science & Technology (DST) Government of Karnataka, under the guidance of Vision Group of Biotechnology, will give insights on latest trends and biotech business opportunities in India. Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strengths of the Indian biotech industry to the outside world .

Bangalore INDIA Bio 2013, to be held from February 6-8, will have multitrack conference, international trade show, biopartnering India, vision leadership

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February 1-15, 2013

series, CEO conclave, poster walkway of discovery, Bio Excellence awards, bioquiz and workshops. There will be deliberations on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-indus-

conference delegates and 5,000 business visitors from across India and abroad will take part in the event.

Discussions will be held on issues such as collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a

THERE WILL BE DELIBERATIONS ON ISSUES RELATED TO THE LATEST INNOVATIONS IN BIOTECHNOLOGY AND FOCUS ON BUSINESS OPPORTUNITIES trial, bio-services, bio- informatics and agri-biotechnology in the light of the emerging bio economy. Exhibitors,

www.expresspharmaonline.com

global bio economy and will provide networking and knowledge sharing platform for business leaders, policy

makers, research heads and academia. International conference will focus on areas such as Deal Making Trends—Partnerships that take Innovation to Realisation; India and the Shifting Global Regulatory Environment; Potential demand for Biosimilars— Pioneering the Future; Strengthening the Clinical Research Ecosystem; Bioinformatics and Computational Biology; Medical Biotechnology and Biomedical Devices and Equipment; Vaccines and Health Trends; Cell Science and Stem Cell Therapy; Diagnostics and Targeted Therapeutics and Protection of Intellectual Property.

EP News Bureau-Mumbai

EXPRESS PHARMA

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EVENT BRIEF Green Chemistry & Engineering for pharmaceutical industry Date: February 5, 2013 Venue: Hotel Green Park, Hyderabad Summary: The event is organised in partnership with the Andhra Pradesh Pollution Control Board and the Bulk Drugs Manufacturing Association.The objective of the workshop is to bring together the API & API Intermediate manufacturers in and around Hyderabad and introduce them to the technology and solution providers to address their process relevant environmental challenges.

The first half of the day will cover case-study presentations on various initiatives by other pharma companies in this direction; whereas the second half will exclusively focus on connecting the green chemistry and engineering-based solutions provider companies to the audience through their technology presentations, interactions and exhibition through a customised ‘Technology Showcase’.

The event will see participation from 100 chief representatives.The exhibition is a very niche exhibition with not more than 10 booths showcasing their specific technology, solution, product and/or service that has the potential to positively impact the environmental footprint of their manufacturing processes.

Contact details: Krishna Dave Green ChemisTree Foundation C/o Newreka Green Synth Technologies Ph: +91-22-2879 1835, +91-22-2879 1275 Mob.: 9920333228 Fax: +91-22-2879 4790 www.IndustrialGreenChem.com www.Newreka.co.in

Bangalore INDIA BIO 2013

agri-biotechnology in the light of the emerging bio economy.

It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia.

Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052 Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 Website: enquiry@bangaloreindiabio.in

4th Annual Biosimilars Date: March 6-8, 2013 Venue: Mumbai, India Summary: With over 100 attendees in 2012, the 4th Annual Biosimilars is all set to be bigger and better with exclusive focus on process development and analytics to suggest best strategies for developing the first commercially successful molecule. Designed under the guidance of the strategic advisory members, this threeday strategic meet will be a platform to understand practical solutions to minimise the risks associated with the highest spend areas of the biosimilars development cycle.

Contact details: Tel: +91 (0)22 40461466 email: conferences-india@ubm.com Website: http://www.biosimilarsindia.com/?utm_campaign=MEDIAPARTNER&utm_medium=EVENTLISTING&utm_source=EXPRESSPHARMA

Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences.

Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bio-informatics and

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EXPRESS PHARMA

Global Pharma Regulatory Summit

Chohan - PEC, UK and many more.

Contact details: Tel: +91 (0)22 40461466 e-mail: conferences-india@ubm.com Website: http://www.pharmaregulationindia.com/?utm_campaign=MEDIAPARTNER&utm_medium=EVENTLISTING&utm_source=EXPRESSPHARMA

Workshop on USP standards for Microbiological

across the world to showcase their products.

Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack.com

Date: March 18-19, 2013 Venue: USP- Rockville Summary: USP (US Pharmacopeia) will be hosting a workshop on USP standards for Microbiological.The workshop will present information on current USP Microbiology Expert Committee chapters and potential and draft chapters in the areas of bio-burden control of non-sterile products, sterilization and sterility assurance, validation of alternate microbiological methods, and rapid/modern microbiological methods.The breakout sessions will solicit discussion and input from stakeholders.

The workshop will provide an overview of recent and current work of the USP General Chapters Microbiology Expert Committee vis-a-vis new and revised chapters and chapter proposals in order to solicit feedback on the committee’s current and future standards-setting activities. It will foster conversation that focuses on better understanding the needs of stakeholders.

Microbiology laboratory supervisors and microbiologists, contract microbiology laboratory staff responsible for testing pharmaceuticals, biologics, dietary supplements, food ingredients, and medical device products and regulatory QA, QC, and compliance personnel will participate in the workshop.

Contact details: Dr Radhakrishna Tirumalai Principal Scientific Liaison General Chapters Department Global Science and Standards Division Tel: (301) 816-8339- rst@usp.org

iPHEX 2013 Date: April 24-26, 2013 Venue: Bombay Exhibition Centre Summary: The Pharmaceuticals Export Promotion Council of India (Pharmexcil), has announced the launch of iPHEX 2013, India’s own pharmaceutical show under the support of Ministry of Commerce and Industry, Department of Commerce, and Government of India.

Over 400 leading Indian companies are expected to showcase the best of pharma products at the event.

The organisers claim that iPHEX 2013 will see the presence of 5,000 business visitors including overseas buyers and drug regulators. Huge business opportunities are expected to emerge during the event. Further, the presence of large number of drug regulators from overseas market is expected to help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in ‘Brand India’ pharma campaign.The campaign has been initiated

by Ministry of Commerce and executed

by Pharmexcil in association with IBEF. Contact details: Sanika Patil ProjectManager – IPHEX 2013 Tel: 91.11.23324288 M: 91.9582758812 E-mail: sanika@falcon-mail.com

Date: March 11-15, 2013 Venue: Mumbai

PHARMA Pro&Pack 2013

Summary: 2nd Annual Global Pharma Regulatory Summit will focus on the recent regulatory amendments for 2013.

The conference agenda includes a preconference summit on GDUFA, US focused day, EU focused day, ROW focused day and a workshop on eCTD Lifecycle management. Some of the confirmed speakers for this summit include Ashish Kohli - Pfizer UK, Naveen Kumar Jain - Dr Reddy’s, Dr Rajkiran Jain Zydus Cadila, Dr Hoss Dowlat PharmaBio Consulting, Germany, Jasbir

Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo.The event will offer a single platform for more than 200 exhibiting companies from India and

www.expresspharmaonline.com

February 1-15, 2013

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PRE EVENT RDD Europe 2013 to see congregation of pulmonary and nasal drug delivery experts Event to be held in Berlin from May 21-24, 2013 he Respiratory Drug Delivery (RDD) Europe 2013 scientific conference, to be held in Berlin on May 21-24, 2013, will see pulmonary and nasal drug delivery experts from all over the world.

The joint organisers of the event, RDD Online and Aptar Pharma, have announced the opening of registration at: www.rddonline.com/rddeurope2013.

More than 450 delegates are expected to attend the meeting to be held at the Intercontinental Hotel Berlin. The scientific symposium will welcome an audience of high level academic, industrial and regulatory experts involved in the research, development, investigation, and marketing of existing and new therapies for delivery through the nose or lungs.

The meeting will begin with a plenary lecture titled ‘Biomarkers and Targeted Treatments for Small Airways Diseases – The Past, Present and Future’ presented by Dr DS Postma, Professor at the Department of Pulmonary Medicine and Tuberculosis, University Medical Centre Groningen, Groningen, The Netherlands.

The symposium will also focus on: Drug Development -- New Drugs, Targets and Formulations; Weighing the Evidence in Support of Bioequivalence; Orphan drugs – Opportunities, Regulatory and Clinical Challenges; Harmonising the Clinical Requirements for LABA/ICS Combinations in the US and Europe; Designing Devices for the Marketplace; Optimising Formulation and Device Partnerships.

As part of the event, RDD Europe conferences highlight innovative research contributions through podium and scientific poster sessions. These are enhanced by 12 technical interactive workshops from vendors and service providers in the industry. In all sessions, the latest technological

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advances related to nasal and pulmonary drug development will be presented.

RDD Europe 2013 will feature an expanded highprofile exhibition showcas-

ing the latest technologies and equipment in this exciting field. RDD Europe 2013 offers numerous opportunities for networking, including a cocktail reception on

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the evening of May 21.

RDD conferences take place in both Europe and the US in alternate years and are widely regarded as the premier venue for presenting

the latest pulmonary and nasal drug delivery advances. Last year, RDD 2012 was held in Phoenix, Arizona.

EP News Bureau - Mumbai

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MANAGEMENT INSIGHT FOR MANAGING PHARMA

Fulfilling the promise of biotechnology for India PG 30 Compulsory licensing for anti-cancer drugs: concerns and future ahead PG 31

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While states like Maharashtra were enjoying the privilege of hosting key big domestic and international pharma companies, Cadila Pharmaceuticals, in the adjacent state of Gujarat, was growing steadily and made inroads into the league of big pharma companies in India.

Today, Cadila is one of the largest privately held pharma companies in India, headquartered in Ahmedabad. Over the last five decades, the company has been developing and manufacturing pharma products in India and selling and distributing these in over 90 countries around the world.

Medicine man of Gujarat

Gujarat's medicine man and Cadila Pharmaceuticals' late Founder and Chairman, Indravadan A Modi made the world notice India's ability of making affordable yet quality medicines. He redefined the way the world looks at India, as far as medicine production was concerned. For more than five decades Cadila met the healthcare needs of not just Indian citizens but also patients from across the globe.

Modi's journey from bicycle to Rolls Royce is an example of sheer self belief and hard work. The post independence era was not at all conducive for indigenous medicine manufacturers.

Medicine production was considered the monopoly of European countries.

However, 'When the going gets tough, the tough gets going,' goes an old saying.

Modi dared to foray into this February 1-15, 2013

J P PARSWANI Executive Director, Cadila Pharmaceuticals

The US FDA approval to Cadila Pharma has come without any 483 comments, which shows the competency of the group in its facilities, documentations etc industry with a small pharma unit, namely 'Cadila Laboratories,' way back in 1951. The idea to manufacture medicines germinated in Modi's mind while he was pursuing higher studies at Bombay University where his chosen area of study was pharmaceuticals and fine chemicals.

Modi inspired many young technocrats to follow the same path, which ultimately paved the way for self-reliance of the Indian pharma industry. His small but entrepreneurial venture and vision drastically transformed the scenario of the pharma industry.

Business is a thing, not everything Not just the growth of his organisation but also the well being of human beings remained focus areas for Modi as a business person and as a leader, throughout his life. “Indravadan Modi was a very simple and down-toearth man. He used to go on bicycle from doctor to doctor to sell medicines. He knew what it takes to become big and exceptional.

For him, business mattered but the patient and his sufferings mattered the most.

He built the company's overseas plant in a country like Ethiopia, as he felt that www.expresspharmaonline.com

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people from this region needed quality healthcare more than people from European countries,” reveals J P Parswani, Executive Director, Cadila Pharmaceuticals.

He adds, “Modi was a true patriot as well. We have facility in Jammu, in the Samba region. This region is unfortunately sometimes targeted by terrorists but such activities did not deter Modi from continuing our operations over there. In fact he decided to expand our operations. He was of the belief that if youngsters from terror affected regions get jobs, they would not turn to terrorism.”

Manufacturing facilities The business that once started with a small pharma unit has now flourished into many highly advanced manufacturing facilities in India and abroad. All the facilities have all the necessary regulatory certifications. The company has state-of-the-art manufacturing facilities conforming to the most stringent international cGMP norms vis-à-vis WHO-GMP, WHO, Geneva (GDF site for Anti- TB), TGA Australia Pharmaceutical Inspection Cooperation Scheme

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Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Dr Raghu Pillai The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/

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(PIC/S), US FDA, UKMHRA, MCC-South Africa, ISO 9001 and ISO 14001. No wonder, Cadila's products enjoy a good market all over the world. The company has manufacturing facilities at Dholka, Ankleshwar, Kadi, Samba (Jammu) and Addis Ababa (Ethiopia).

The company’s two Active Pharmaceutical Ingredients (API) units at Ankleshwar manufacture a wide-range of APIs and intermediates including US FDA certified products. UnitI is spread over 42,000 sq. mtrs. The API manufacturing facility of Cadila Pharma group at Ankleshwar encompasses one of the highest capacities in India to produce loratadine (anti-histaminic), glibenclamide (anti-diabetic) and chloro hexidine base (disinfectant).

The ethambutol and the fluoxetine plants at Cadila Pharma, Ankleshwar, are approved by US FDA. Fluoxetine is an anti-depressant and Cadila Pharma has a capacity to produce 5000 kgs/month at its Ankleshwar unit. “The US FDA approval to Cadila Pharma has come without any 483 comments, which shows the competency of the group in its facilities,

28543033/28543034 Fax: 28543035 E-mail: raghu.pillai@expressindia.com BANGALORE Khaja Ali Business Publications Division, The Indian Express Ltd. 5th Floor, Devatha Plaza 131, Residency RoadBangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com

documentations etc.,” says a proud Parswani. The manufacturing facility at Samba, near Jammu, started its commercial operations in August 2006. Cadila has also set up its first ever overseas formulation manufacturing facility in Ethiopia.

The company also has significant presence in plant tissue culture, bio-formulations and bio-fertilisers, with one of the largest production facilities in India for plant tissue culture. The division was started in 1992 with a plant tissue culture laboratory and commercial production of bio-fertilisers.

Today the agro division specialises in tissue cultured banana, potato, lily bulb, foliage, pointed gourd, teak, sugarcane and seed raised papaya plants as planting material for farmers. The Cadila agro-division today is one of Asia’s most reputed and preferred companies when it comes to production and supply of quality bioformulation based on Mycorrhiza and Aspergillus niger. The company also specialises in common liquid growth promoter based on gelatin derived amino acid, humic acid, multi activity growth promoter etc.

2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732

KOLKATA Prasenjit Basu / Ajanta Sengupta The Indian Express Limited Business Publications Division 5, Pannalal Banerjee Lane (Fancy Lane), 2nd Floor, Kolkata - 700 001 Tel No. (Direct) +91-33-2213 8567 / 8573 Board No. +91-33-2213 8587,

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In the quest of innovation Cadila believes in Public Private Partnerships (PPPs) for developing diagnostic, preventive and curative pharma and diagnostic products. Innovations that have resulted from such partnerships include 'Immuvac', a unique immuno-modulator that has various applications including reducing duration of therapy for treatment of multi drug resistant tuberculosis and multibacillary leprosy, 'NEVA'- a rapid HIV detection kit and more recently Risorine, worlds first boosted-Rifampicin containing fixed-dose combination for use as an antitubercular drug.

“Cadila emerged on the world map in 2009 with the development of Polycap, a novel and world's first drug combination for prevention of cardiovascular diseases,” says Parswani.

Looking at the future for biotech based products, Cadila has also prepared a plan to add two biotech products every year.

Parswani informs, “In terms of biotech products commercialised by any company in Gujarat, Cadila has the highest numbers to its credit.”

As far as R&D is con-

E-mail: bpdcbe@vsnl.in JAIPUR The Indian Express Limited, C-7, Dwarika Puri, Jamna Lal Bajaj Marg, C-Scheme, Jaipur - 302001 Tel: 0141-370002/371272 Telefax: 91-141-376606 BHOPAL The Indian Express Limited, 6, Vidya Vihar, Professors Colony, Bhopal - 462002, Madhya Pradesh Tel: 0755-2661988 AHMEDABAD Rajesh Bhatkal The Indian Express Limited, 3rd Floor, Sambhav House, Nr. Judges Bunglow Bodakdev, Ahmedabad - 380 015.

Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications.

We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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cerned the company has a multi-disciplinary workforce with skill sets from biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry and different disciplines of engineering. Cadila has the unique of distinction of becoming the first company to get an Investigational New Drug (IND) approval

by US FDA for clinical trials to be conducted in India.

Manufacturing facility, Dholka

Joint ventures Cadila has also entered into some key strategic alliances. CPL Biologicals is a joint venture (JV) with Novavax-US, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. CPL Biologicals has established manufacturing facilities in India to develop, produce and sell products such as seasonal influenza vaccine and potentially other novel vaccines against dengue fever and chikungunya fever based on Novavax's Virus Like Particle (VLP) vaccine technology. “With VLP vaccine technology vaccine production can be increased many times. We are the only company in India that uses VLP,�

Parswani points out.

StemCyte India, which is into umblical cord blood stem cells banking and research is a JV of Cadila with StemCyte, US and Apollo Hospital Group.

Cadila also has a JV with Apollo Hospital Group to manage Apollo Hospital, Ahmedabad. More recently, Cadila entered into a strategic alliance with the Swedish Bactiguard which provides world leading solutions preventing hospital acquired infections.

Cadila's current turnover is more than ` 1000 crore. Within the next five years the company intends to cross the ` 3000 crore milestone.

Cadila

API unit, Ankleshwar

would focus on taking its products to every possible part of India. As the Cadila management believes in ethically backed business, while providing quality medicines, efforts will also be put to keep them affordable. Modi's great work has put on a lot of responsibility on the shoulders of his son, Dr Rajiv Modi. However, company employees who are already familiar with Rajiv's leadership skills, strongly feel that company would rise to even greater heights under his leadership.

Manufacturing facility, Ethiopia

Birdseye view of manufacturing facility, Dholka

sachin.jagdale@expressindia.com

Manufacturing facility, Jammu

February 1-15, 2013

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INSIGHT Fulfilling the promise of biotechnology for India Despite the immense potential, a lot still needs to be put in place to turn India into a biotechnology hub says James C Greenwood, President and CEO, Biotechnology Industry Organization or most people, biotechnology is a mysterious word that is known in the abstract, but is ambiguous in regard to real world applications. Yet, many recent advances enjoyed by the average person have been made possible by biotech. For example, all vaccines and many modern medicines are products of biotech. 95 per cent of all the cotton grown in this country is the product of biotech cottonseeds. Our food, fuels, and even our waste water treatment have benefitted from the work of biotech scientists in India and around the world.

The latest industry reports too project India as a potential biotech hub growing at an impressive rate of 18.7 per cent per annum with over Rs 20,000 crore in revenues in the year 201112. The government has invested significant funds into helping this nascent sector grow even faster.

These investments have the potential to turn India into a truly innovative country and a global leader in biotech.

Biotech holds great hope for enhancing the income of rural farmers by increasing crop yields, preserving and improving soils, providing drought resistance, improving control of pests, weeds and harmful diseases, and producing more healthful food with enhanced vitamin and nutrient levels. By using biotech tools to enhance crop yields, India will see immediate benefit for the largest and the most-vulnerable section of Indian society.

For example, Nuziveedu Seeds, India’s top seed company, based in Hyderabad, uses modern biotechnology techniques such as DNA fingerprinting to optimise hybrid cotton, rice and maize seeds.

The demand for better food, especially for milk and meat products are growing

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even while the food inflation is escalating; productivity gains in major crops will result in much needed rural transformation and stimulus to Indian economy which is largely based on domestic consumption.

Agricultural biotech has helped produce dramatic increases in yields of cotton, soybeans and maize. The numbers of cotton farmers who have adopted Bt cotton in India increased from 50,000 in 2002-2003 to 7,000,000 in 2011-2012, a 140X increase representing about 88 per cent of the cotton growing farmers and 95 per cent of all cotton grown in India. Unfortunately this amazing growth story has cooled considerably in India since the government instituted a moratorium earlier this year on all new GM crops, bringing new investment and research by Indian research institutes and companies to a screeching halt.

Governments around the world, faced with the prospect of out-of-control healthcare costs are looking for ways to save expenses and vaccines are an efficient and cost-effective way of doing so. Globally, sales of human vaccines are forecast to grow by 10–13 per cent per year over the next five years and as the world’s largest manufacturer of vacwww.expresspharmaonline.com

cines, India is in a good position to benefit from this growing trend.

The growth of India vaccine manufacturers arises from their ability to develop and produce highquality vaccines with low manufacturing costs.

Biotech innovation is improving the odds for millions of patients around the world with serious, lifethreatening conditions. Today, six of the top 10 homegrown biotech companies specialise in biopharma, including several that focus on vaccines such as Serum Institute of India and Bharat Biotech.

Finally, India is in need of greater, cleaner sources of energy to keep the economy growing. A move to biobased, renewable, low-carbon or carbon-neutral fuels is of central importance to the future health of the planet. Industrial and environmental biotech helps make manufacturing processes cleaner and more efficient; creates new materials, food ingredients and other products; unlocks cleaner sources of energy; and reduces industrial waste. Biotech helps to unlock the potential of biofuels like bio-ethanol and global companies like Praj Industries based in Pune are bringing these advances to the market.

India is not the only country that recognises the growth potential of biotech.

Others, in particular other emerging markets like Brazil, China and Russia, have devoted additional resources to assisting its biotech companies to succeed in this difficult space.

Therefore, India’s success in this space is not guaranteed.

Despite the advantages of a large potential market and a seemingly inexhaustible supply of scientists and engineers, not all the ingredients are in place for long-

term, sustainable growth in this sector.

What is missing includes access to capital, entrepreneurial skills, and government policies to encourage innovation and investment in the biotech space. In these areas, India falls short.

The Government can help fill these gaps by establishing science-based regulations, strong and predictable intellectual property protections, and an overall stable legal framework that can help provide clarity and predictability for businesses. In short, by making India a business friendly environment. This in turn will attract investors, especially foreign investors who understand the risks and rewards of biotech and are looking for a safe, secure environment in which to make their investments.

Foreign investors bring an additional benefit that is not well acknowledged: because their money is on the line, they ensure their companies and their CEOs get the training and support they need in order to be successful entrepreneurs.

During this period of tremendous growth in both the Indian economy and its healthcare sector, it is a critical time to capitalise on the biotech opportunities available within India. The Biotechnology Industry Organization (BIO) organises the annual BIO India International Conference and the BIO International Convention is an ideal opportunity to connect with potential businesses with partners from around the world.

We are committed to helping to support and grow the biotech sector in India, working with partners such as the Association of Biotechnology-Led Enterprises (ABLE) and many of our member companies that are actively engaged in research and development in India.

Working alongside ABLE, we aim to help the industry flourish within India's borders and help Indians benefit from the promise of biotech.

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LEGAL EAGLE Compulsory licensing for anti-cancer drugs: concerns and future ahead Rai S Mittal, Partner, Titus & Co, Advocates, opines that the recent recommendation for compulsory licensing by the Government would enable generic drug manufacturers to bypass patents allowing cheap copies to hit the market ndia’s Health Ministry’s recent recommendation for compulsory licensing (CL) of three anti-cancer drugs belonging to Roche and Bristol-Myers Squibb — trastuzumab (used for breast cancer), ixabepilone (used for chemotherapy) and dasatinib (used to treat leukaemia) — is being hotly debated by the pharma industry, patient advocacy groups and intellectual property law experts alike. If the said recommendation is accepted, it would enable generic drug manufacturers to bypass patents in respect of these drugs and their cheap copies (a month’s dose of each of which currently costs more than ` one lakh) could soon hit the Indian market. Incidentally, India issued its first CL in March last year when Natco Pharma won the rights to manufacture Bayer AG’s anti-cancer drug Nexavar. Since then, Natco Pharma has been marketing its version at a small fraction of the original product’s price.

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Current legal scenario Under the Indian Patents Act, a CL can usually be issued in cases where the medicine is deemed unaffordable or is not sufficiently available. The licensee can then manufacture and sell the patented drug on payment of a royalty to the patentee and subject to other terms and conditions imposed by the government. This CL process cannot be a random process but a decision taken judiciously.

WTO/TRIPS requirements During the earlier golden days of Indian generics, India did not recognise patents in areas considered vital to human life, being food and health, as long as the process used for manufacturing was different from that used by the inventor. This allowed February 1-15, 2013

Indian generics to compete in the world market by providing medicines at an affordable price in poor/underdeveloped countries. In 1994, India became a part of the World Trade Organization (WTO) and signed the agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS) and as part of that, it was required to recognise internationally patentable inventions, including those for food and health.

Are the fears of the industry imaginary?

Based on some studies, doubts have been raised as to any substantial impact of CL on the profits made by giant pharma companies. It is hence an arguable point whether by licensing to generic producing companies, the pharma companies can increase the reach of their drug by tapping into a market that is not catered to by these giants, i.e., middle and low income group, and make sufficient profits through royalties. Some studies also seek to suggest that grant of CL does not hurt innovation and in any case the hurt is only a small fraction of what is feared.

To the contrary, the common perception of pharma giants is that these are just studies, most of which are based on imaginary data, and there should be little doubt that inability of the patent holder to deal with the drug in an unrestricted manner does have substantial effect on their profits and their willingness and ability to invest time, efforts and money in other research activities. The view, that CL can possibly be justified in the given facts and circumstances only on humanitarian grounds, thus has large acceptability. A section of researchers also argue that years of research results in trade secrets and undisclosed information that the patent does not cover but which is necessary to produce the effective product, though this argument may have little application to drugs. www.expresspharmaonline.com

Is Governemnt’s move right?

Certainly, reasonably priced healthcare is important for patients in any humanitarian society, however, CL is not the only way to deliver it. The GoI should have looked and can still look at other commercial measures to bring down the prices for these drugs, rather than CL which arguably is the option of last resort, for example, in national emergencies. The other ways of ensuring drug price affordability include, for instance, discounted bulk procurement by the government and price control.

In many countries, treatment for cancer is also managed effectively by government agencies through suitable reimbursement mechanisms thereby making expensive therapies very much affordable. The GoI could also look at a suitable public-private partnership model.

Similarly, the drug-makers, on their part, could look at slashing prices for Indian market on certain products, by signing deals with India's drug makers or otherwise, so as to avoid any government action by way of CL. These products may be sold under new brand names to protect pricing in the developed world. It is learnt that some companies are already working on this model.

The right approach There cannot be any doubt that there needs to be a right balance between commercialising intellectual property and delivery of healthcare at an affordable cost, especially in an emerging market like India.

This would ensure that the country breeds a culture of investing time, efforts and money in research and development and at the same time ensure that innovation benefits all those who need it. The industry and the various chambers of commerce and industry need to work closely with the government to strike this perfect balance. There should be little doubt that in case steps are not taken judiciously and CL is allowed in a large number of cases, without adequate justification or

on biased terms, India may be perceived to be taking major swipes at big pharma companies. In addition, while imposing conditions on which CL is to be granted, the authorities should also consider the large costs incurred in developing the patented product. It should also be uderstood that CL is a provision provided under TRIPS, though it is hardly implemented in western countries especially for pharma products.

What lies ahead?

The concerns are already expressed that the intellectual property protections India adopted to invite foreign investment and to honour international commitments are not real with the GoI moving into protective mode.

Clearly, we do not see a sooner end to the wrangling over patent protections and drug prices by Indian government and major drug makers. The disputes over aspects such as revocation of patents and whether a generic version steps on the patent would also continue to engage IP lawyers and Indian courts. The debate whether CLs are the only effective and practical way in the present Indian society to get lifesaving treatments to the Indian masses and what could be a better alternative in the given facts and circumstances would also continue.

Other costly therapies such as HIV drugs may be next to get the CL treatment.

But even worse for big pharma companies is the prospect of other developing nations following India's path. China recently amended its patent laws, permitting CL to local firms in cases of state emergencies, unusual circumstances and in the interests of public and is already considering CL in specific cases as a way to keep drugs affordable for its people. We could also see that the availability of CL is sufficient to encourage patentees to grant voluntary licenses on mutually agreed terms.

The author can be reached at rsmittal@titusindia.com EXPRESS PHARMA

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Botox receives US FDA approval to treat overactive bladder PG 33 New study could help earlier diagnosis of Parkinson’s diseaser PG 34

RESEARCH UPDATE Lilly stomach cancer drug extends survival vs placebo The drug also improved survival without the cancer worsening in patients who had failed to respond to earlier drug therapy li Lilly and Co's stomach cancer drug ramucirumab met its primary goal of improving overall survival in a late stage-study, extending the lives of patients for more than a month longer than those who received a placebo. This information was provided by the American Society of Clinical Oncology.

The overall survival among patients treated with the Lilly drug in the study was 5.2 months, compared with 3.8 months for those who received a placebo.

However, some analysts were looking for a survival benefit greater than two months from the monoclonal antibody.

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The Indianapolis-based drugmaker previously said ramucirumab met its main goal of improving overall survival, but the extent of the benefit was not revealed

earlier.

The injectable drug, which Lilly acquired in its purchase of ImClone Systems four years ago, is also undergoing late-stage

trials for cancers of the breast, colon, lung and liver.

A study of the drug in combination with chemotherapy for treating stomach cancer is also under way.

The drug also improved survival without the cancer worsening in patients who had failed to respond to earlier drug therapy.

Progression-free survival was 2.1 months for ramucirumab, compared with 1.3 months for patients who got the placebo.

Lilly is in need of new products to offset plunging sales of its Zyprexa schizophrenia medicine and other drugs facing generic competition.

Reuters

Biolog’s PM technology by UK AHVLA makes discovery on TB bacterium Research team headed by Dr Paul Wheeler research team headed by Dr Paul Wheeler from the Animal Health and Veterinary Laboratories Agency (AHVLA, Weybridge, UK) reported breakthrough progress in understanding the metabolic and phenotypic properties of the bacterium Mycobacterium tuberculosis and its close relative, Mycobacterium bovis. This was reported at a paper published in the journal PLOS ONE. The publication from the AHVLA is important in several respects. Firstly, it shows that Biolog’s Phenotype MicroArray (PM) technology allows these bacteria to be studied much more quickly and easily, which will accelerate the pace of mycobacterial research. Results can be obtained in seven to 10 days.

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Secondly, it demonstrates diagnostic potential by phenotypically differentiating strains of these mycobacteria with different host ranges and levels of pathogenicity.

Thirdly, the paper expands, as well as confirms, the knowledge of the metabolic properties of these mycobacteria. As a consequence, genome annotation can be improved, the biology of these bacteria can be better understood, and hopefully these insights will facilitate discovery of antibiotics more effective in their eradication.

Wheeler said, “The genome sequence of Mycobacterium tuberculosis was published in 1998 and high-throughput phenotype analysis of pathogenic mycobacterial strains is needed and long overdue. www.expresspharmaonline.com

Molecular typing of Mycobacterium strains has limitations. Though key in surveillance and helpful in identifying emerging strains, it does not provide information on biological properties or phenotypes. This is a substantial gap in our knowledge since it is the phenotype which is selectable and must relate to the evolutionary advantage of one strain over another.”

Mycobacterum tuberculosis is the causative agent of the respiratory disease tuberculosis which infects an estimated eight million people worldwide and is responsible for two million fatalities each year. Mycobacterium bovis afflicts cattle with losses to agriculture of approximately $3 billion per year. These mycobacteria have been very difficult for scientists to study, because they grow

very slowly, so experiments can take weeks or months to perform. Other mycobacterial species have also been successfully studied with PM technology. In June last year, researchers in the laboratory of Prof Yung-Fu Chang at Cornell University College of Veterinary Medicine published also in PLOS ONE on their use of PM technology to analyse the metabolic phenotypes of Mycobacterium avium. In 2009, a team of researchers in the laboratory of Prof Lacy Daniels at Texas A&M, Kingsville used gene knockouts combined with PM technology to show that the Mycobacterium smegmatis gene homologue of the Mycobacterium tuberculosis gene Rv1238 codes for a transporter of the sugar trehalose and plays a critical role in pathogenicity.

EP News Bureau - Mumbai February 1-15, 2013

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Botox receives US FDA approval to treat overactive bladder Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity he popular Botox wrinkle treatment made by Allergan has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the US Food and Drug Administration (FDA) said.

Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity and reducing episodes of urinary incontinence, or leakage.

“Clinical studies have demonstrated Botox's ability

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to significantly reduce the frequency of urinary incontinence. The approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the US,” said Hylton Joffe, Director, FDA's Division of Reproductive and Urologic Products.

Botox had previously been approved for other noncosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage.

Allergan, which has yet to report full year financial results, said it expects 2012

Botox sales of $1.76 billion to $1.8 billion.

The treatment can be repeated when the effect wears off, but with a gap of at least 12 weeks between treatments, the FDA said.

About 3.2 million Americans suffering from overactive bladder take oral medications from a class of drugs called anticholinergics, such as Pfizer's Detrol. The Botox approval is for those who are not helped by, or cannot take, those drugs, the FDA said.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning.

Symptoms include leaking

GSK announces submission of albiglutide BLA to the US FDA To help in treatment of Type II diabetes laxoSmithKline (GSK) announced a regulatory submission to the US FDA for albiglutide, an investigational once-weekly treatment for adult patients with type II diabetes. Albiglutide is not yet approved as a treatment for Type II diabetes or any other indication anywhere in the world. GSK intends to submit

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a regulatory application in the EU in early 2013.

As per company release, Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of Type II diabetes designed for once-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which in turn helps release insulin to

control blood sugar elevations after eating. In people with Type II diabetes, GLP-1 secretion in response to a meal is reduced or absent. GLP-1 is rapidly degraded while albiglutide has been developed to have a longer duration of action by being comprised of two copies of modified human GLP-1 fused in series to human albumin.

Reuters

ArQule, Daiichi’s colorectal cancer drug fails trial It also failed to meet the secondary goal n experimental colorectal cancer drug being developed by ArQule and Japan's Daiichi Sankyo Co failed to improve patient survival without the cancer worsening, in a mid-stage trial. The trial, which enrolled 122 patients with refractory or relapsed colorectal cancer, also failed to meet the secondary goal of showing improved response to the drug tivantinib.

The drug tivantinib, ArQule's lead candidate, is also being developed as a potential treatment for hepatocellular carcinoma or liver cancer. ArQule and Daiichi in October said they reached an

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February 1-15, 2013

agreement with the US regulator on the design of a latestage trial of tivantinib in liver cancer.

The trial failure is the latest in a series of drug-related bad news for the company in the past few months. It discontinued a lung cancer trial in October and its Asian partner Kyowa Hakko Kirin Co halted another trial in August due to safety issues.

Both the trials were related to tivantinib. For the latest mid-stage trial, patients were either given the drug, tivantinib, twice daily, in combination with older cancer drugs irinotecan and cetuximab, or placebo plus irinotecan and cetuximab. www.expresspharmaonline.com

The drug improved patients' progression-free survival (PFS), or survival without the cancer growing, but the improvement was not statistically significant. PFS was 8.3 months for patients treated with the drug, compared with 7.3 months for those receiving a placebo.

ArQule tied up with Daiichi Sankyo in December 2008 to co-develop tivantinib in the US, Europe, South America and other regions.

The companies plan to continue discussions with colorectal cancer experts to determine how to proceed with further development of the drug for this cancer, Daiichi said.

Reuters

urine, feeling a sudden and urgent need to urinate, and frequent urination.

Common side effects for Botox injected into the bladder reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder, or urinary retention.

People being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure, the FDA said.

Reuters

EU agency confirms suspension of Merck cholesterol drug The medicine had been on the market in 40 countries worldwide, but is not approved in the US urope’s drug regulator has confirmed it is suspending marketing authorisations for Merck & Co's cholesterol drug Tredaptive in Europe after its failure in a major study raised safety concerns.

Merck began recalling the drug, which is also sold under the brand names Pelzont and Trevaclyn, recently and recommended that doctors stop prescribing it.

The medicine had been on the market in 40 countries worldwide, but is not approved in the US. The European Medicines Agency said patients currently taking the drug should see their doctor to discuss their treatment.

Reuters

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New study could help earlier diagnosis of Parkinson’s disease Study shows non-motor symptoms begin sooner than previously thought new study could help earlier diagnosis of Parkinson’s disease, after Newcastle University researchers identified that people experience symptoms even early in the disease .

While movement - motor - problems are the main symptom of Parkinson’s disease, non-motor problems such as drooling, anxiety and bowel problems affect a large number of patients and begin sooner than previously thought. Earlier diagnosis could lead to earlier treatment and therefore allow patients to have a better quality of life.

In the study, published in the journal Neurology, the

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medical journal of the American Academy of Neurology, researchers from Newcastle University compared 159 people with newly-diagnosed Parkinson's disease to 99 people of similar ages who did not have the disease. Participants were asked whether they experienced any of the 30 nonmotor symptoms screened for, including sexual problems, sleep problems and gastrointestinal problems.

Study author Dr Tien K Khoo said, “Often people don't even mention these symptoms to their doctors, and doctors don't ask about them, yet many times they can be treated effectively."

The people with Parkinson’s disease had an average of eight of the nonmotor problems, compared

to three non-motor symptoms for the people who did not have the disease. Among the most common symptoms for those with Parkinson's disease included drooling, urinary urgency, constipation, anxiety and a reduced sense of smell. These were all significantly more common in people with Parkinson's disease than in those without the disease.

For example, 56 per cent of the people with Parkinson have had problems with excess saliva or drooling, compared to 6 per cent of those without the disease. A total of 42 per cent of those had constipation, compared to 7 per cent of the control group. For anxiety, it was 43 per cent compared to 10 per cent.

Khoo said, "These results

show that Parkinson affects many systems in the body, even in its earliest stages.

Both doctors and patients need to bring these symptoms up and consider available treatments."

Newcastle University's Professor David Burn, Chief Investigator of the ICICLE-PD project, which this study is part of, said, “Hopefully clinicians can use these findings to improve the treatment of the thousands of people worldwide who suffer with Parkinson's disease. The earlier we can get a diagnosis the quicker treatment can start and patient’s quality of life will improve. This is one part of a much bigger study, which we are hoping will lead to better treatments for this devastating disease.”

EP News Bureau - Mumbai

FDA warns on insomnia drugs, suggests lower doses Levels of the drug zolpidem may be high enough to impair alertness in some patients the morning after using it he US health regulator warned that taking a widely prescribed insomnia drug at night may impair driving and alertness the next morning, and recommended the bedtime dose be lowered.

New data showed that lev-

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els of the drug zolpidem may be high enough to impair alertness in some patients the morning after using it, the U.S. Food and Drug Administration (FDA) said.

Women appear to be more susceptible to the risk as they eliminate zolpidem from their bodies slower than men do, the regulator added.

Zolpidem is marketed as a generic under several brand

names such as Ambien, Ambien CR, Edluar and Zolpimist.

Ambien is a Sanofi drug that is marketed by SciClone Pharmaceuticals in China.

Zolpimist is made by NovaDel Pharma Inc and Edluar belongs to Meda AB. The regulator has asked manufacturers to lower the recommended doses of the drugs. However, the FDA did

not recommend any change for another insomnia drug, Transcept Pharmaceuticals' Intermezzo, saying that the drug's label already recommended a lower dosage for women than for men.

The FDA also said that all drugs taken for insomnia can impair driving and other activities that require alertness the morning after use.

Reuters

Novartis wins EU backing for first meningitis B vaccine November.

Bexsero’s commercial success still depends on whether individual governments decide to add it to routine vaccination programmes.

MenB is caused by bacteria, leading to inflammation of the lining around the brain and spinal cord. It can kill within 24 hours and infants are at highest risk.

Around 10 per cent of those who contract the disease die, despite appropriate treatment, and up to 20 per cent of survivors suffer from serious disabilities such as brain damage and hearing impairment.

Reuters

MenB is caused by bacteria, leading to inflammation of the lining around the brain and spinal cord ovartis clinched European approval for the first vaccine against meningitis B, and will seek to sell the drug as soon as possible.

According to the Swiss drugmaker, Novartis is working with health authorities to provide access to Bexsero as soon as possible.There is currently no approved vaccine offering broad protection against ‘MenB,’ this particular type of meningitis.

Novartis won a European panel backing for Bexsero in

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February 1-15, 2013

PHARMA ALLY

W H AT ’ S INSIDE

‘HRS is a ‘one stop solution’ provider for all heat exchange solutions’

TAKE Solutions implements mobile-based Patient Diary System PG 36

The heating equipment industry is anticipated to show an upward graph, considering its prime role and application in most of the process industries. HRS Process Systems is a one of the companies in this segment who have registered good growth in the recent years. V Gokul Das, Managing Director, HRS Process Systems talks about his company, its role in the industry, future plans and more, in a discussion with Usha Sharma

Waters launches quality parts, chromatography columns and supplies catalogue PG 37

Tell us about the journey of HRS PSL from its inception.

HRS Process Systems is a part of HRS Group, which operates at the forefront of thermal processing technology. The company established its base in Pune in 2003, beginning with a modest turnover of Rs 24 million, today HRS PSL is a Rs 300 million company. Pioneers in the revolutionary corrugated tube technology for the process industry, we offer innovative technology of international standard for thermal processing like corrugated tube heat exchangers, plate heat exchangers, hot water systems, evaporators, systems for food/fruit/beverage processing with modern pumping and filling technologies.

Truly a one stop shop for all heat exchange requirements!

Which industries are you offering your services to and which sectors do you consider more profitable. Why? HRS caters to a spectrum of industry verticals like organic and inorganic chemicals, petrochemical, pharmaceuticals, agrochemicals, pesticides, fertiliser, steel and allied, power, oil and gas, paper and pulp, effluent treatment, automotive, cement, edible oil, etc. Our range of products for this industry includes ECOFLUX corrugated tube heat exchangers (CTHE), ECOFLUX smooth tube heat exchangers, Plate heat exchangers (PHE), heat exchanger based hot water systems, ASME ‘U’ stamp heat exchangers, condensers, etc. HRS also caters to food/fruit pulp and fruitbased beverages market and offers the innovative UNICUS scraped surface heat exchangers, hygienic piston pump, aseptic fillers February 1-15, 2013

INTERVIEW

and sterilisers, pre-heaters, pasteurisers, evaporators and integrated process lines for food/fruit/beverage processing.

Heating equipment industry is definitely anticipated to grow, considering its prime role and application in most process industries.

Many new companies are being set up to address the growing demands of various intermediates that make up for a host of consumer durables. With buoyant growth in pharma and allied sectors, demand is going to build up all kind of process equipment. Other sectors growing at a steady pace are chemicals/petrochemicals, edible oil, cement, steel, power etc.

Changing lifestyles and standard of living, have enhanced the demand for packaged and processed . Increasing populations and concurrent need for more will boost growth of processing machinery.

What is the importance of

heat exchanger in the pharma industry?

In pharma sector, heat exchanger is an important equipment used for recovering organic solvents coming out of reactors in various process. Applications like condensation, cooling, heating etc., is carried out in the heat exchanger. Apart from this, heat exchangers are also used to minimise the solvent losses through storage tanks.

Accurately designed heat exchanger will help in reducing solvent losses, improving the overall production and help in smooth operation.

Our ECOFLUX CTHE has prime application as primary/secondary condensers, vent condensers, reboilers, sub- coolers and heating and cooling applications. HRS Funke PHE offer versatile heat transfer solutions for various instant hot water applications required for the pharma industry. We also offer CTHE and PHE based hot water systems for AHU, HVAC, FFE, VTD, AFD, reacwww.expresspharmaonline.com

tor heating and such other applications. Our expertise at manufacturing heat exchangers in stainless steel grade and exotic materials like C276, C22, titanium and various other materials, give us an edge in this industry.

How large is the heat exchanger business market in India and how fast is it growing?

Heat exchangers are basically the heart of all processing applications and hence in demand due to growth in the process industry. Energy savings is a key requirement worldwide, and this global trend towards reducing heat energy costs, will lead to a boom in heat exchanger business. HRS has sold more than 8000 heat exchangers in a decade and has worked with top companies, engineering consultants, EPC contractors and process licensors. We estimates the market potential of Rs 300400 crore for our specific innovative products like ECOFLUX corrugated tube heat exchangers, shell and tube heat exchangers and plate heat exchangers.

What cost effective solutions do you offer to your existing customers and why it is called as cost effective?

Our major USP has been our innovative technology, timely service support and quality as per international standards, which is of utmost importance to our customers. We have designed our product/process lines to be fail proof and such that processing can start at full capacity immediately on installation. Our customers have appreciated our design capability and service backup and we have many success stories to second that.

Thermo Fisher Scientific introduces benchtop robot for automated workflows PG 37 TTP Labtech launches acumen hci for rapid multiplexed imaging PG 38

PHARMA LIFE 59

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Our innovative ECOFLUX corrugated tube technology minimises fouling and reduces production downtime and maintenance costs thus making the process cost effective.

Whom do you consider as a competitor and why?

We face competition from both international and domestic players and our primary competition is with the top players in this segment.

However, we are our own competitors since we supply the two major heat exchangers required in process industry (STHE and PHE) and the third technology edge product ECOFLUX CTHE. This helps the customer to make a better evaluation for the process requirement and in turn we get business. We have been able to make a dent in this market based on our innovative technology and service backup. Our innovative products backed by strong management, design and service team and sales network give us a winning combination. Our products and their applications are customised to not only give price advantage to the customer but also a technological edge over competition.

What challenges have you faced so far and how do you overcome these?

The heating equipment industry segment needs to address two key areas. One, energy efficiency vis-à-vis cost of the equipment and second-

ly reducing or eliminating down time for maintenance which can be due to fouling or wrong selection of equipment. This is possible by good interaction between the user and the equipment manufacturer. HRS is a “one stop solution” provider for all heat exchange solutions for the process industry. Another issue that also needs focus is educating the industry on advancements in the existing technology and availability of new technology. At HRS, we offer a clinical approach in evaluating study report on plant/process for energy efficiency and optimum production through our heat transfer solutions.

Which are the new technologies in the pipeline and when is it expected to reach the market?

We have recently introduced the HRS Hot Water System, a versatile and compact hot water generation system which provides a solution for instantaneous hot water generation using energy efficient heat exchangers (Funke Brazed or Gasketed PHE or Ecoflux CTHE). They find applications in industries like pharma, food, HVAC, hotels, hospitals, brewery etc. We have received an overwhelming response and hope to generate good business through the same. Evaporation, environment and energy recovery are some of our other focus areas that we wish to invest in near future.

How strong is your international presence and which are the new countries that you are eyeing?

Our group companies are located in UK, Spain, US, Peru, UAE and Malaysia. We operate with a network of agents in different countries.

We anticipate growth in other South East Asian countries, Africa and South America. We are strategising to target these future growth markets.

Who are your customers from the life sciences sector and in the coming financial year, do you think your existing client numbers will increase?

We can boast of major blue chip pharma companies of India being on our client list namely Cipla, Dr Reddy’s Laboratories., Hetero, Mylan, Lupin, Jubilant LifeSciences, Apotex Pharma, Eisai Pharmaceuticals, Hikal, Wockhardt, Biocon, Ranbaxy, Cadila Pharmaceuticals, IndSwift Laboratories, Sun Pharmaceuticals, Unimarck pharmaceuticals, Unichem Laboratories, NecLife Sciences, Suven Life Sciences, Sartorius. We have built a solid premise of trust and technical competence with our clients through our association. Our excellent customer track record has enabled us to establish a footprint in this industry, and with a vibrant growth in pharma sector we definitely foresee a significant increase in our client numbers.

How many manufacturing plants do you have and where?

We have our group manufacturing facility in Koregaon-Bhima near Pune.

Our manufacturing facility is spread over four acres having a covered area of 40,000 sq ft. Our other global facilities are in UK and Spain.

Do you plan to upgrade and expand or set up new plants in the near future?

We have recently undertaken the expansion of our factory premises and completed the first stage. The expansion plan is projected to increase the production capacity of the new plant and will also increase HRS PSL’s contribution to the global turnover up to 35 per cent.

How many people are associated with the company?

HRS Process Systems started with seven people in 2003 and today we are a strong team of 90. With growth in business opportunities we anticipate the number to increase.

What was your turnover during the last fiscal and what are your expectations from the current fiscal?

During the financial year 2011-12, our turnover touched Rs 295 million and the projected turnover for 2012-13 is Rs 350 million. u.sharma@expressindia.com

VENDOR NEWS TAKE Solutions implements mobile-based Patient Diary System The solution helps sponsors to improve patients’ treatment adherence and compliance towards the protocol and patient reported outcomes

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AKE Solutions has implemented its mobile patient reported outcomes tool ‘PaDiSys’ for a biopharmaceutical company focused on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders. TAKE is the exclusive reseller worldwide of PaDiSys through a strategic partnership with NowPos, a company that specialises in developing mobile-based solutions for life sciences.

The PaDiSys solution helps sponsors to improve patients’ treatment adherence and compliance towards

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the protocol and patient reported outcomes. PaDiSys allows sponsors to walk away from a paper-based approach to filling out questionnaires and assessments during clinical trials, thereby enabling the clinical staff to closely monitor patient compliance and safety. Clinicians and site staff are equipped with easyto-use analytical dashboards that monitor patient data in real time, and can intervene when necessary to ensure compliance.

With quick deployment, implementation and simple use for both subjects and clinicians, there is a much higher adherence to a study regimen, thus improvwww.expresspharmaonline.com

ing trial compliance.

Ram Yeleswarapu, President and Chief Executive Officer, said, “TAKE has been providing solutions and services to life sciences customers for 12 years, and safety is one of our core areas of expertise. In partnership with NowPos, we can provide bio-pharma companies with cutting edge mobile technology and quality, while reducing costs and accelerating trial execution.”

Vikram Marla, Chief Executive Officer, NowPos MSolutions, said, “The PaDiSys platform caters to clinical research studies across therapeutic areas. Flexible configu-

ration allows the product to be used in different types of research, ranging from drug efficacy, behavioural, observational, adherence, quality of life, or lifestyle based studies in various therapeutic areas.PaDiSys was developed from the ground up by embracing key aspects of mobile technology and the need for a low cost turnkey solution. Our strategic partnership with TAKE, along with their vast network of clients, is helping us reach out to the core pharma community needing to improve their PRO and study compliance by many folds.”

EP News Bureau-Mumbai February 1-15, 2013

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Waters launches quality parts, chromatography columns and supplies catalogue Free catalogue has information on Waters complete line of standards and reagents aters Corporation has published its new 2013 Waters Quality Parts, Chromatography Columns and Supplies catalogue. This 440-page, colour catalogue features part numbers and ordering information for thousands of individual parts including Waters Quality Parts, branded analytical and preparative-scale columns, vials, filters, sample preparation products, analytical standards and reagents and miscellaneous supplies.

The catalogue includes information on Waters latest offerings including: UltraPerformance Convergence chromatography (UPC2); Waters Analytical Standards and Reagents; DisQuE sample preparation products for QuEChERS; ACQUITY UPLC BEH 450 SEC columns for biomolecule separations; Waters eXtended

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Performance [XP] 2.5 µm, 150 mm columns that are fully compatible with all HPLC, UHPLC, and UPLC systems.

Fera,Waters open food safety traning facility Waters and Food and Environment Research Agency (Fera) recently opened an international food safety training facility in New York, aimed at im proving compliance with EU food import s t a n d a rd s.

The Fera International Food Safety Training Laboratory (Fera IFSTL) will primarily train scientists concerned with exporting foods to Europe.

Experts from Fera will lead training programmes that teach best practice methods to analysts from overseas, using

state-of-the art technology and equipment for determining chemical contaminants and residues in food. This will enable food producing countries around the world to implement their own solutions and gain access to the opportunities offered by trade with Europe.

As part of the collaboration with Fera, Waters helped establish the laboratory’s construction, provided analytical systems a n d assisted Fera in designing training programmes. The facility is equipped with Waters’ stateof-the-art ACQUITY UPLCMS/MS systems, sample preparation components, and mycotoxin analysis tools.

The Fera IFSTL dedicated training facility has the capac-

ity to teach 200 professionals per year. In the first year of operation courses will cover pesticide residues, veterinary drug residues and mycotoxins.

In subsequent years the range of courses will be expanded, including running bespoke courses for specific customers if required, and the number and length of courses offered per year will be increased.

The Fera IFSTL has been launched as part of an international network of food safety training laboratories aimed at raising standards of food safety testing globally. The first IFSTL was opened in the US in September 2011 by the US FDA, University of Maryland and Waters.

Art Caputo, Executive Vice President, Waters Corp, “We are pleased to partner with Fera in establishing this lab near New York. We believe that this collaboration will lead to better science and technology, and this in turn will help us raise the bar on food safety.

EP News Bureau-Mumbai

PRODUCTS Thermo Fisher Scientific introduces benchtop robot for automated workflows hermo Fisher Scientific board re-grip station, the high announced the launch capacity microplate storage can T of Thermo Scientific VALet, be placed on the left, right or at a benchtop robot enabling simple, configurable laboratory automation. Adaptable to user demands, VALetTM has been designed to allow multiple hotel positioning for customisable, high density microplate movement and storage, which can increase productivity in a limited work space. With four-axis plus servo-gripper, and the capacity to access both single and multiple arrayed nests, VALet is designed to be the ideal robot for instrument loading functions.

Built for the dynamic laboratory environment, the Thermo Scientific VALet caters to a broad range of applications, from simple instrument loading to more complex, integrated workflows.

With its flexible design and onFebruary 1-15, 2013

the front to optimise its fit in the laboratory. User-defined choices also include random or sequential storage access, giving a capacity of up to 45 or 120 microplates, respectively. VALet has been designed to enable the quick addition of connecting carousels, which can be mixed and matched to provide enhanced storage and workflow capacity tailored to specific requirements. This ability to accept multiple storage expansion options makes VALet an adaptable robot in the microplate mover sector, with considerable upgrade capability.

Thermo Scientific VALet users will also benefit from the integration of Thermotor technology that allows the VALet to

www.expresspharmaonline.com

be controlled directly from a computer without the need for additional controllers. This feature is designed to save valuable laboratory space, to permit a quieter working environment and to negate the need for dedicated automation engineers. In combination with the Thermo Scientific Momentum scheduling software, including the newly launched Momentum 3.2, the VALet bench-top robot is well positioned to provide users with a platform for creating, operating and fulfilling automated workflow needs, accurately and efficiently.

Contact details: Jeanette Minshall, Thermo Fisher Scientific +1 905-332-2000 ext. 319 email: jeanette.minshall@thermofisher.com EXPRESS PHARMA

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TTP Labtech launches acumen hci for rapid multiplexed imaging put whole well imaging of a TP Labtech has launched greater range of hard-to-autoacumen hci (high content T mate assays, including angioimaging) system, developed for researchers who are looking to increase the productivity of their high throughput imaging. Replacing the acumen eX3, the new acumen hci is the fastest imager on the market for multiplex assays in up to 1536-well plates, and the new open-source image format means users have complete flexibility to analyse images on their existing analysis software if required.

Together with whole-well imaging, these features make the acumen hci ideal for identifying 'hit' wells in cell-based screens.

Achieving unparalleled speeds during high throughput screening, acumen hci can image and analyse the whole wells of a 96- to 1536-

well plates in just eight minutes, at a resolution of 0.5 µm/pixel. This enables the effective screening of high density plates and facilitates assay miniaturisation, with associated increase in throughput and reduced costs. Data is robust and insightful even during rapid screening, and up to three lasers allow for easy multiplexing using a wide range of

fluorescent dyes. The new 561nm laser option offers compatibility with even more dyes, like mCherry.

Furthermore, with intuitive operation, multiple members of staff can be easily trained on the acumen hci for efficient use of the screening programme. The acumen hci incorporates TTP Labtech’s proprietary cellista software which enables high through-

genesis, neurite outgrowth, nuclear localisation, translocation and cytotoxicity. The novel open-source, OME-compliant TIFF images can be exported without reducing scan times and are easily imported into a range of open source and commercial image analysis packages, so they can easily fit into existing workflows. The acumen hci is also compatible with microscope slides using the widefield objective, for imaging of whole tissue sections in minutes.

Contact details: TTP Labtech Limited Barbara Bengyel Tel:+44 (0)1763 262626 Email: sales@ttplabtech.com

Thermo Fisher Scientific launches designed pipetting system hermo Fisher Scientific ClipTip pipette using a rest: For both right- and left- drift during operation. has launched Thermo patented three-interlocking handed operator comfort – T Scientific F1-ClipTip pipet- clip design. The pipette and allows the hand to relax dur- Contact details: ting system, enabling users to deliver consistent, reproducible pipetting with higher-quality results. Its revolutionary ClipTip interlocking technology locks tips securely into place to deliver an airtight seal on every channel.

Available for both single and multichannel pipettes, the Thermo Scientific F1ClipTip pipetting system is simple but powerful. With minimal force, each tip is clipped securely on the F1-

tip form a complete seal to secure the sample volume in each tip for enhanced accuracy and precision.

Additional features include: ergonomic design: Low tip attachment, ejection and plunger forces for safe and comfortable; use, reducing the risk of repetitive strain injuries (RSI); exceptionally lightweight: Reduced fatigue during extended periods of pipetting; adjustable 120° finger

ing pipetting cycles; patented super blow-out: 150 per cent increase in air boost to ensure efficient delivery of micro volumes; and prevent capillary action for low volume pipetting; Patented softtouch tip ejection: Innovative gearing mechanism produces more downward; force with less effort, releasing tips with a gentle push; Volume lock adjustment: Secure volume setting prevents undesirable volume

Meenal Shinde Sr Executive - MarCom Laboratory Products - India Thermo Fisher Scientific 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai Mumbai - 400 076, India.

Tel: +91 22 6716 2200 Direct No: +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No.: 1800 22 8374 www.thermofisher.com or www.thermo.com

Thermo Fisher Scientific introduces advanced incubation solution for cell-based research hermo Fisher Scientific has onds. Additionally, multiple disinfection method practical- opening.

The Thermo Scientific introduced Thermo transfer positions and an ly eliminates germs and spore T Scientific Cytomat 10, a fully under-bench version allow suspensions, even in areas Cytomat 10 incorporates an automated incubator and storage module for high-capacity cell growth and assay incubation. Designed to fit into the busiest of cell biology or screening laboratories, the Cytomat 10 offers superior environmental control and can be seamlessly integrated with existing automated assay hardware.

The Cytomat 10 provides a fast plate access time of less than 10 sec-

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flexible incubator placement within the laboratory. As the first generation of automated incubator with a fully validated thermal decontamination system, the Thermo Scientific Cytomat 10 is designed to significantly decrease the risk of contamination and reduce assay variability.

Utilisng more than 40 years of experience in CO2 incubator technology, the Thermo Scientific Cytomat 10 provides scientists with a reliable and robust incubation unit for precious primary cell or cell-line cultures and assays. An efficient thermal www.expresspharmaonline.com

that are difficult to reach via manual cleaning. Based on the trusted ContraCon Routine of the renowned Thermo Scientific HERAcell incubators, the Cytomat 10’s decontamination is carried out in wet conditions at 90°C, leaving incubators virtually residuefree. The Cytomat 10 incorporates humidity control via an external water reservoir, reducing the risk of contamination from an internal source and the need for repetitive incubator access. Additionally, recovery times are virtually eliminated with a heated automatic access door, with small

LCD monitor for incubation parameters and full text readout messaging to inform the user of temperature, humidity and gaseous atmosphere level changes. As a flexible incubation unit, the Cytomat 10 incorporates the Thermo Scientific internally automated Plate Shuttle System (PSS) to serve multiple access and loading positions.

Contact details: Carsten Mang, Thermo Fisher Scientific Tel:+49 618-490-6693 Email: carsten.mang@thermofisher.com February 1-15, 2013

Express Pharma Business Avenues

February 1-15, 2013

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Bio Catalysts Immobilized Cal B

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Papain Pepsin Pancreatin Protease ( acid / alkali)

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G Rubber Expansion Joint/Bellows G Viton O-Rings, Cords & Strips G O-Rings (Viton & Silicone)

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Express Pharma Business Avenues 159, AshokaShopping Shopping Centre, Floor 159, Ashoka Centre, 2nd 2nd Floor, L.T.Marg, Mumbai 400 001.

L.T.Marg, Mumbai 400 001.

Tel.: 91-22-22642642 Tel.: 91-22-22642642 Fax: 91-22-22642640 Fax: 91-22-22642640 Email: sales@sparchem.com Email: response@sparchem.com Website: www.sparchem.com Website: www.sparchem.com

D&B and CRISIL CERTIFIED

Available from our ready stocks: l

1,2-Dimethoxy Ethane (MONOGLYME)

l

Hydroxylammonium Sulphate (BASF)

l

2,2-Dimethoxy Propane

l

Iso Amyl Alcohol

l

2,3-Dichloro-5,6-Di Cyano, Benzoquinone (DDQ)

l

Isoprene

l

Isopropenyl Acetate

l

Itaconic Acid

l

Imidazole

l

L(+) Tartaric Acid

l

Maltose

l

Methane sulphonic acid

l

Methane sulphonyl chloride

l

Methyl Cyclohexane

l

2-Methyl THF

l

Morpholine

l

Nitromethane

l

Pyrrolidine

l

Potassium Hydroxide Pellets

l

Sodium Hydroxide Pellets

l

Sodium Methoxide (Powder)

l

Sodium Sulphite (Food Gr. - Aditya Birla Make)

l

Acetyl Acetone

l

Amino Guanidine Bicarbonate Min 99%

l

Butyl Benzoate

l

Calcium Carbonate - Ppt

l

Cinnamic Acid

l

Cyclohexane

l

Di-t-Butyl Dicarbonate (DIBOC)

l

Dicyclohexyl Carbodiimide (DCC)

l

Diethyl Ketone 99%(3-PENTANONE)

l

Diethyl Carbonate

l

Dimethyl Sulphoxide (China/Gaylord)

l

Ethyl Cyclohexane

l

Ethoxy Methylene Malonic Ester Min 99%

l

Formamide

l

Formic acid

l

Fructose-N (Food/Pharma/Grade)

l

Guaiacol 99.5%

l

Triethylamine

l

Glutaric Acid 99% Min

l

Tri Ethyl Ortho Formate

Authorised dealers of RCF Products:

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l Ammonium Bicarbonate

l

Methanol

l Dimethyl Formamide

l

Sodium Nitrite

l Dimethyl Acetamide

l

Sodium Nitrate

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February 1-15, 2013

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February 1-15, 2013

Express Pharma Business Avenues E-mail: alokunipal@alokind.com

Alok Industries Limited (Alok) is the largest diversified and integrated textile manufacturer in India.

Alok's state-of-the art Packaging Division, amongst the largest in the country, has purchased the licence to produce UNIPAL corrugated pallets in India under the brand name, "Alok Unipal". “Alok Unipal" is a modular system to manufacture corrugated pallets. UNIPAL currently operates in more than 10 countries across the world and is known to outperform all other corrugated pallets in the market today.

An "Alok Unipal" Corrugated pallet is a patented, innovative system with flexible construction, high strength characteristics made of water resistant Kraft paper which does not require any fumigation for Export Purposes .By choosing "Alok Unipal" you will be choosing an environmentally friendly way of doing business.

Versatile: Size from 400 mm to

Hygienic: a totally clean solution

1900 mm

Customisable: tailor-made to your

Superior: dynamic loads up to 1 MT

requirements

static loads up to 4.5 MT

Efficient: Save money by assembling on

Light weight: between 6 to 10 Kgs

location

Compliant: in line with international shipping

Flexible: 2- or 4 -way entry

requirements ISPM 15

Safe: Secure handling

Can be assembled at point of use

Recyclable: 100% No fumigation required

Contact Details Plant Address: Survey No. 87/1 & 96/1, Falandi, Umarkui Road, Silvassa -396230 (U.T. of D.N. & H.) Corporate Office: Peninsula Towers, Peninsula Corporate Park, G.K Marg Lower Parel, Mumbai-400013 M.: 898 000 3486, 834 777 0005, 9099012209 | E.: alokunipal@alokind.com | W.: www.alokind.com February 1-15, 2013

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Express Pharma Business Avenues

For Assured Air Quality ( Sterile Room) & Flexible Cooling Solutions Cutting edge technology in air handling systems HEPA Filters

CONTEC AIR FLOW PROJECTS PVT . LTD. Building No-6 , Gala No - 138, Mittal Industrial Estate, Andheri Kurla Road, Andheri East, Mumbai- 400 059.

Tel - 022- 2859 8231/39 Mob - +91 9320 255 124 Fax- 022 - 2859 8229 Email : mks1_contec@yahoo.co.in. info@contecair.com. Website - www.contecair.com

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February 1-15, 2013

JOB TRENDS Hiring in pharma sector up by 8 per cent in Dec 12 over Nov 12 Year ends on a positive note eversing the usual trend of yearend holiday season hiring dip, the Naukri Job Speak index for the pharmaceutical sector in December 2012 grew by eight per cent when compared to November 2012 and 14 per cent higher than the same time a year ago. Traditionally, December has always been a month where recruitment slows down across sectors, however, this year there has been no impact. The index value at 1333 is the highest in the last six months.

Hitesh Oberoi, Chief Executive Officer and Managing Director, Info Edge India said, “It is definitely a positive sign that hiring activity perked up in the final month of 2012. Job creation in this quarter will take place in the new emerging growth sectors rather than the traditional ones.”

Similarly, mirroring the trends of the pharma sector, professionals in the sector also witnessed about eight per cent increase in demand in December

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2012 when compared to November 2012. The overall sentiment is positive and much better than all the other top industry sectors.

About Naukri.com Naukri.com, India’s No 1 job site and the flagship brand of Info Edge rev-

while outperforming its competitors in every sphere. Info Edge was the first internet Company to list in India. The site enjoys a traffic share of around 61 per cent as per the Sept Comscore data.

Naukri.com is a recruitment platform that provides hiring-related services to corporates/recruiters, place-

Access, and Response Management tools and its services include Job Postings, and recruiter branding solutions on the site. The site has a database of over 29 million resumes and has serviced over 46000 clients in FY2012. The company has over 2000 people operating through 48 offices in

The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas olutionised the concept of recruitment in India. Since its inception in 1997, Naukri.com has seen continued growth

ment agencies and to job seekers in India and overseas. It offers multiple products like Resume Database

31 cities in India and overseas offices in Dubai, Abu Dhabi, Riyadh and Bahrain.

Jobs from Naukri.com Manager- Research Information Company: Exp: Location: Job Id:

Ranbaxy Laboratories 5-8 Gurgaon 140113000199

Assistant Manager- Pharma Projects Company: Exp: Location: Job Id:

Pilot Plant Company:

Dishman Pharmaceuticals & Chemicals 1-6 Ahmedabad 251212000484

Exp: Location: Job Id:

Unichem Laboratories 2-4 Mumbai 100113000170

Officer Company: Exp: Location: Job Id:

Famy Care 2-5 Navi Mumbai 070113003162

Territory Sales Manager

Business Manager Company: Exp: Location: Job Id:

Sundyota Numandis 5-8 Jalandhar 191212000701

General Manager Operations Company: Exp: Location: Job Id:

Hemmo Pharmaceuticals 8-10 Navi Mumbai 130113000166

Assistant Manager- Pharma Warehouse

Dy. Manager - QA ( API ) Company: Exp: Location: Job Id:

Cadila Healthcare 8-13 Vadodara/Baroda 311212000399

Company: Exp: Location: Job Id:

Sava Healthcare 0-5 Bhubaneshwar 130113000517

Company: Exp: Location: Job Id:

Aanjaneya Lifecare 4-7 Pune 011212001647

Executive- Bio-pharma Production Officer - Accounts & Finance Company: Exp: Location: Job Id:

February 1-15, 2013

ACG Inspection Systems 3-5 Mumbai 251212000484

Company: Exp: Location: Job Id:

Richcore Lifesciences 2-5 Bengaluru/Bangalore 130113000441

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P|H|A|R|M|A| L|I|F|E

Quintiles bags accreditation from College of American Pathologists Meets global requirements for quality, competence ACCREDITATION

uintiles’ central laboratory in Mumbai has received accreditation from the College of American SM Pathologists 15189 Accreditation Programme, becoming the first laboratory in Asia to receive this accreditation and meet the programme’s rigorous requirements for medical laboratory quality and competence established by the International Organization for Standardization (ISO).

Thomas Wollman, Senior Vice President, Quintiles Global Laboratories said, “This accreditation is further evidence of Quintiles’ commitment to deliver high quality, harmonised test results to our biopharma

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customers globally.

Quintiles has the world’s largest CAP-accredited central laboratory network."

gramme optimises processes to improve patient care, strengthens quality standards while reducing institu-

IT HAS BECOME THE FIRST LABORATORY IN ASIA TO RECEIVE THIS ACCREDITATION AND MEET THE PROGRAMME’S RIGOROUS REQUIREMENTS FOR MEDICAL LABORATORY QUALITY AND COMPETENCE ESTABLISHED BY THE ISO CAP 15189SM is a voluntary, non-regulatory accreditation to the ISO 15189:2007 Standard and complements CAP accreditation and other quality systems. The pro-

tional errors and risks and controls costs.

CAP Council on Accreditation Chairman Richard Gomez, said, “Our goal with the CAP15189

Accreditation Programme is to improve patient care, mitigate risk, optimise performance, and advance quality for medical laboratory testing. The CAP, as it did more than 50 years ago with laboratory accreditation, is breaking new ground with our programme devoted to ISO 15189.”

Anil Raghavan, Managing Director, Quintiles India, said, “The accreditation focuses on the continuum of care directly connected with improved patient safety and risk reduction. We are proud to be the first Asia Pacific lab to receive this accreditation, which reflects our commitment to establishing best-in-class practices in the industry.”

EP News Bureau - Mumbai

Wockhardt receives ‘Best Enterprise’ award from the Europe Business Assembly Receives award for its achievements in the global pharmaceutical industry AWARD

harmaceutical and biotechnology major Wockhardt was bestowed with the ‘Best Enterprise’ award by the Europe Business Assembly in Vienna, Austria for its achievements in the

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global pharma industry.

The award was given in the field of pharmacy and is an acknowledgement of Wockhardt’s success within the industry and around the world.

Dr Murtaza Khorakiwala, Managing Director, Wockhardt, received the award at a glittering

ceremony at the Austrian Emperor’s palace in Vienna, Austria.

Speaking about the award, Murtaza said, “We are happy to be recognised by the Europe Business Assembly and be awarded the Best Enterprise Award. This is indeed a testament to our suc-

cess in being able to establish a truly global pharma business.”

The award is also accompanied with a certificate that allows Wockhardt to use the trademark ‘Best Enterprise’ for marketing purposes for a period of five years.

EP News Bureau - Mumbai

Shripad Desai joins AmeriCares India as MD Will oversee all of AmeriCares India’s aid programmes APPOINTMENT

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hripad Desai has been named as the Managing Director of AmeriCares India, a non-profit organisation committed to helping people live longer healthier lives. Desai will oversee all of AmeriCares India’s aid programmes including emergency response activities, medical donations to health care providers along with health education and training programmes. He is also responsible for a highly successful mobile clinic programme in Andheri and Chembur slums in Mumbai that serves 36,000 patients

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annually.

“We are proud to have Desai lead the AmeriCares India team in Mumbai,” said Curt Welling, President and CEO, AmeriCares. “Under his leadership, we hope to grow our aid programmes and continue to develop innovative initiatives to help even more people suffering from disasters and chronic poverty.”

Desai has more than 20 years of experience in India’s pharma industry. He most recently served as head of sales, marketing and strategic planning for Chiron www.expresspharmaonline.com

Panacea Vaccines in Mumbai, and previously held positions with Oral CDx

India, Novartis, Sanofi and AstraZeneca in India. Desai earned both his Master of Marketing Management and Bachelor of Science degrees from the University of Mumbai.

Desai said, “AmeriCares India is a great organisation, doing good work all across India. I believe that this is an opportunity for me to learn, contribute and achieve new milestones as an individual and professional. I look forward to leveraging my marketing and strategy experience in the pharma industry to lead this organisation forward.”

EP News Bureau - Mumbai February 1-15, 2013

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