Pharma Bio World August 2013

August 2013 

Vol. 12



Issue 1  Mumbai

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August 2013 

Vol.12

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Issue 1  Mumbai

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Price ` 150

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Pharma Bio 10-12 October 2013 SOUTH 2013

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Contents 6-8.indd 6

Pharma Bio World

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EXPERT’S TAKE 10

Access to Medicine: Moral Imperative and a New Consciousness - Part 2 – Jenik Radon, Maree Newson

FEATURES 14

Case Study: A New Member of the Family – Wallace Wittkoff, Ravi Prasad

17

Pharma Outsourcing: Regulatory Scenario – Dr Milind Antani, Anay Shukla

19

What to Expect from a CRO? – Dr Bhaswat Chakraborty

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Coverage of American Diabetes Association Annual Meeting – Indegene Lifesystems

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MARKET RESEARCH 27

CCS Outsourcing to Grow in India – Sarabjeet Singh

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When Faking Becomes a Way of Earning...

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Pharma News

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Biotech News

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Product Trends

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8 August 2013

Contents 6-8.indd 8

Pharma Bio World

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expert's take

Access to Medicine:

Moral Imperative and a New Consciousness Part 2

Jenik Radon Adjunct Professor of International and Public Affairs, Columbia School of International and Public Affairs

Associate (NZ Qualified) Radon Law Offices, New York

What would it take for every person to have access to life-saving, life-improving drugs when they needed them, at a price they could truly afford? This series of articles explores the issues around making “access to medicine” and in particular, access to medication, a reality.

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n Part 1, we introduced the concept of “access to medicine” as a human right, and discussed some of the key international agreements and decisions that have helped to bring the debate into the public eye. In this issue, we start to address one of the practical issues for realising those rights: what illnesses trigger, or should trigger, the obligation to provide access to medicine?

In relation to certain diseases, over the past decade, there has been a major change in the way the pharmaceutical industry regards access to medicine.

Many agree that the pharmaceutical industry should provide access to critical medicine, but which medicines should be the focus of such efforts? Society is still in the midst of an intense debate on this issue for a number of reasons, in particular it raises the issue of how to finance the high cost of innovation, and a broad consensus is needed for any workable answer.

Rather than proposing an answer, this article focuses on the most important questions that arise, which need to be addressed to build this consensus.

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Maree Newson

People who were sick could not get treatment because patented drugs were too expensive for South Africa’s health care system, and South Africa’s economic situation was unlikely to improve without a healthy work force.

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AIDS and HIV in Developing Countries There has been a significant shift since the South African PMA lawsuit in 1998, discussed in our previous article, to the public and private resources available today to buy AIDS medicine. The Global Fund for AIDS and the President’s Emergency Programme for AIDS Relief are two examples of new initiatives to finance research into AIDS medicine and subsidise the cost of AIDS medicine. In fact, the pharmaceutical industry itself is now developing programmes to deliver medicine to low-income countries and patients that could not otherwise afford life-saving drugs. The shift in the pharma industry’s perspective on this issue demonstrates that this disease is one instance in which the “access to medicine” campaign has gained traction. But why?

What characteristics of the AIDS epidemic led to the public’s rejection of the PMA plaintiff’s claims and to the widespread acknowledgement that there is a moral imperative to supply these drugs?

The best clue to what characteristics of the AIDS disease requires access to medicine can be found in the brief submitted by the Treatment Action Campaign (TAC) in the PMA lawsuit. In its Replying Affidavit, TAC repeatedly emphasizes the extent of the HIV/AIDS epidemic and the life-threatening nature of HIV, citing its “epidemic proportions and catastrophic effects.”

Although TAC “denies any suggestion that the constitutionality of government measures to make essential medicines more affordable depends on the number of people Pharma Bio World

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Looking beyond the contours of the TAC brief, there are other clear reasons why combating AIDS is a concern for people around the world. AIDS affects people universally, in both developing and developed countries. According to the WHO’s 2011 report, around 34 million people are estimated to be living with the disease. Of that number, more than 97 per cent are in low- and middle-income countries. 69 per cent of people living with HIV in the world live in Sub-Saharan Africa.

Importantly, AIDS is capable of crossing political borders and, although transmission can be controlled behaviorally, it continues to spread. In many countries, as was the case in South Africa in 1997, the number of people affected by AIDS was large enough that the disease had a destabilising effect on the economy and hindered development.

People who were sick could not get treatment because patented drugs were too expensive for South Africa’s health care system, and South Africa’s economic situation was unlikely to improve without a healthy work force. The characteristics of AIDS that create a moral imperative to ensure access to medicine may be summed up as: AIDS is deadly; it crosses borders and can cross borders freely; it affects a very large group of people; and these people cannot afford to pay for the medicine.

Anthrax Scare in the United States Treating AIDS in the developing world seems to be the most universally accepted instance in which there is a moral imperative to provide access to medicine. But these same arguments for access permeate pharmaceutical sales related to many other diseases and other markets as well.

A 2001 dispute over compulsory licensing in the United States demonstrates that the 12 August 2013

Experts Take 10-12.indd 12

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whose rights to dignity, life, and health care are thereby protected. In any event… in the realm of HIV/AIDS, these numbers are vast.” Indeed, although a right to health care may not hinge on how many people are affected by a particular ailment, the size and extent of the AIDS epidemic doubtlessly played a role in the world’s recognition of the importance of this health issue.

Wealthy nations can also face health emergencies that could require suspending patent rights.

wealth of the country may not always be an important consideration. In October 2001, the United States faced a potential anthrax attack. Ciprofloxacin (Cipro), the antibiotic drug prescribed for treating patients suffering from anthrax, was under patent until 2003 and was owned by the German drug company, Bayer. As documented by Kavaljit Singh in a 2002 article, the retail price for two months’ treatment of Cipro in the United States was over USD 700.

Bayer also reported that, at most, it would be able to make 200 million pills in two months, much less than the 1.2 billion pills requested by the United States. As a result, some people in the US would not be able to afford Cipro at this price; other people who could afford the medicine might not have had access because of the limited supply. Senator Charles Schumer and health activists including Ralph Nader and James Love (who was cited in TAC’s brief in The Pharmaceutical Manufacturers’ Association of South Africa, et al. v.

South Africa, in the High Court of South Africa, Case Number 4138/98) called for the United States to begin compulsory licensing of Cipro. Although the Bush Administration refused to suspend Bayer’s patent rights, this push for compulsory licensing may have been that hidden hand that contributed to negotiations with Bayer that ultimately resulted in a reduced price for Cipro.

A widespread anthrax outbreak shares certain characteristics with AIDS that may similarly raise it to an emergency level – it is deadly, hard to contain, and potentially destabilising. The controversy over whether the United States should respect and enforce Bayer’s patent rights, demonstrates that compulsory licensing is not a tool reserved solely for the least developed countries. Rather, wealthy nations can also face health emergencies that could require suspending patent rights. The second lesson drawn from this episode is that, although rarely applied,

compulsory licensing is often used as a negotiating tool to reduce the price of patented drugs. The success of using the threat of compulsory licensing to lower drug prices seems to depend on how politically powerful the country wielding the threat is. Unfortunately, as a negotiating chip, compulsory licensing would then make more of a difference for wealthy countries than for poor countries that lack significant international political power or influence.

As evidenced by the Cipro example, a government will use compulsory licensing directly, or indirectly as a negotiation tool with private pharmaceutical companies, in situations where there is a perceived national medical emergency. Even the United States, which traditionally relies on economic market mechanisms to resolve problems and has a culture of respecting laws and the written word, is not able to always resist the pressures to apply the threat of compulsory licensing to patented products. However, if a national moral imperative for acquiring access to medicine at affordable prices is limited to crisis situations, then the extensive medical needs of non-developed nations can never be adequately addressed. So the lingering question is: Should access to medicine be more than a medical emergency response?

In the next issue, we look at medical access for those suffering from nonterminal conditions, and the positive social and economic, and even security, impacts that this could bring. Later in the series, we also discuss different models for funding access to essential medicines, and the opportunities that arise from the unique role and responsibility of pharmaceutical companies, doctors in all but name.

Do Hyung Kim, Research Guide on TRIPS and Compulsory Licensing: Access to Innovative Pharmaceuticals for Least Developed Countries, available at www.nyulawglobal.org/ globalex/TRIPS_Compulsory_Licensing.htm

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Case Study: A New Member of the Family Family-owned and -operated Cotter Brothers finds the answer to the challenges inherent in fabricating biopharm process skid systems in the form of Quattroflow quaternary diaphragm pumps.

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rom a young age, we’ve all been taught to “forgive and forget.” While that’s an admirable idiom to live by, in the world of biopharmaceutical manufacturing, where biologics are being used as a feedstock more and more often, that’s just not possible.

“This industry is the only industry I know that is non-forgiving,” said Randy Cotter, Sr, who is Engineering Manager for Danvers, MA, USA-based Cotter Brothers Corporation, a leading global biopharm process skid system designer and fabricator. “If you make a mistake in this industry, it doesn’t go away—and you don’t get a second chance. So, you have to know what you’re doing and have high confidence going in.” From the start, Cotter was at the forefront of the growth of the biopharm industry and is actually the author of many of the industry’s operating standards that are still in place today.

As opposed to the much more refined and unforgiving industry that biopharm manufacturing has become today, those early years were filled with trial and error, but the successful operators were those that were able to most effectively learn from their errors.

“When we started there was limited documentation of how to do things. We have learned through our experience and from our mistakes,” said Cotter. “It’s hard to say that those who make the most mistakes are the smartest, but with common sense, learning from your mistakes, having a good background, they all help you realise the best way to do things.”

Wallace Wittkoff Director, Global Segment Mktg – Hygienic Pump Solutions Group

Ravi Prasad Director- Sales Pump Solutions Group (PSG) India

14 August 2013

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Finding the best, most efficient and costeffective way to do things is imperative in the biopharm manufacturing industry.

The biopharm industry has grown into a multi-billion dollar global behemoth, with biologically derived drugs (or biologics) playing an increasingly major role in the development of blockbuster drugs that

can provide treatment or cures for any number of diseases and illnesses. These products must be produced in pristine hygienic and sanitary conditions, and in a way that allows them to make their way to the consumer marketplace as quickly as possible so that the value of patent windows can be optimised.

Going With The Flow The harvesting and purification of biologic material is a precise, exacting process.

In what is termed the “upstream” portion of the process, cells are fermented in a bioreactor until they have reached the end of their life cycle and expressed an anticipated amount of therapeutic proteins.

The cells and the protein solutions are then separated by filtration and/or centrifugation before moving on to the “downstream” phase in which the target therapeutic protein is isolated and purified.

Downstream processing will often utilise both of the following unit operations: Tangential Flow Filtration (TFF), which is also known as cross-flow filtration, is a process in which the biologic feed stream flows horizontally with positive pressure across the filter membrane. As it passes across the membrane, the portion of the feed stream that is smaller than the membrane’s pore size passes through the membrane. This is different from what is known as Normal-Flow Filtration (NFF), or “dead-end,” filtration, in which the feed flows entirely through the filter membrane with the size of the pores determining which portion of the feed is allowed to pass through and which will remain trapped in the filter membrane. TFF is different from NFF in biologics applications because the tangential motion of the fluid across the membrane causes any trapped particles to be “rubbed” off, similar to passing your hand across a piece of sandpaper. This mode of operation means that a TFF process can operate continuously with relatively high Pharma Bio World

8/21/2013 6:56:35 PM

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solids loads without fouling the filter, which is also known as filter blinding.

growing need with their customers. Our two companies just work well together.”

Chromatography Columns typically feature a glass, steel or plastic tube that is filled with resins that are compressed in a certain format through which a feed stream product flows to either capture or purify this feed stream. These chromatography columns contain adsorptive media, which selectively can bind product molecules.

This resin needs careful handling, for example, one ounce can cost as much as UISD 10,000, making proper feeding of the resin extremely important.

Meeting A Need

“Early on in this biopharmaceutical industry, people didn’t have a lot of expertise in process systems; they’d just buy a chromatography system or a filtration system,” explained Cotter. “However, our client base and the people in our industry have matured, and the majority of the people now create their own systems, they have internal specs and all of them have requirements and an understanding of what they’re doing and how to do it. Early on, the only pump for chromatography or filtration was a rotary lobe or peristaltic pump, and it was always a challenge to get the right pump for the application.”

In the search for additional pump options to meet some of the diverse requirements of its clients, Cotter Brothers looked to one of its vendors, High Purity New England (HPNE), Smithfield, RI, USA, for solutions.

HPNE specialises in supplying products and services to the biotech, biopharm, pharmaceutical, microelectronics and food industries in the Northeast United States. At the time of Cotter Brothers’ search, HPNE had recently learned of a new positive displacement quaternary diaphragm pump technology for the downstream biopharm industry that was being produced by the German company Quattroflow Fluid Systems GmbH & Co. “Our relationship with Cotter Brothers started when HPNE took on the Quattroflow line here in New England,” said Dave Bianchi, Technical Sales Manager for HPNE. “Cotter Brothers knows the biopharm industry well and they recognise that the Quattroflow pump is one of the best products for a 16 August 2013

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Quattroflow, which was acquired by the Dover Corporation’s Pump Solutions Group (PSG), Oakbrook Terrace, IL, USA, in January 2012, has designed its pumps to be ideal for critical TFF and chromatography applications in biologics production and handling.

The main advantage of a Quattroflow pump in these applications is its unique form of operation: The quaternary diaphragms are driven one after another by a nutating connector plate, which moves back and forth out of its central position in a stroke that is generated by an eccentric shaft, with the length of the stroke determined by the angle of the eccentricity. In other words, the Quattroflow technology has been modeled on the operation of the human heart—which is eminently capable of pumping whole human blood, one of the most shear-sensitive products around— with its four pumping chambers and check valves keeping product flow constantly moving forward.

The Quattroflow’s pump chambers contain no rotating parts that can be subject to friction, meaning that there is no operational heat buildup that can compromise the biologic product. This mode of operation also means that the pumps can run dry, are self-priming and produce little or no shear because of low slip. In addition, they offer low-pulsation, leak-free operation while having great dry/wet suction-lift capabilities.

These pumps can provide constant flows from 16 mL/min (0.54 oz/min) to 360 L/min (95 gpm) with some of the highest turndown capabilities in the industry.

“Many of the systems produced by Cotter Brothers are for either TFF or chromatography. The low pulsation and low shear generated by a Quattroflow pump makes it ideal for those operations,” said Bianchi. “They had been using rotary lobe pumps, which are the old workhorse in the bioprocess industry, but a lot of lobe pumps take a great deal of maintenance and when they go down, they go down spectacularly.

Cotter is finding that an increasing number of its clients are looking at the option of diaphragm pumps for certain applications.”

When Cotter and his sons were made aware of the Quattroflow pump technology and the benefits it could offer the process skid systems they fabricate for the biopharm industry, they had one reaction: These pumps are going to help address a lot of our clients’ concerns with regards to their process.

“All of a sudden, the Quattroflow shows up and you have a pump that is attractively priced with an exceptional turndown ratio, a high level of accuracy and flow rates that are perfect for chromatography and filtration. Quattroflow pumps are a perfect fit for us,” said Cotter. “They also reduced the issue of galling; it’s gone away. A couple issues we had early on were steamability and drainability; they’ve been fixed now.

The perception in the industry was that you couldn’t use a pump with check valves, but that’s been addressed. So, the Quattroflow pump is steamable, cleanable, drainable, accurate and has a high turndown ratio, along with the ability to do low flows with accuracy that we can’t achieve with other pump types.”

Conclusion In an industry as demanding and exacting as biopharm manufacturing, you need channel partners and equipment that you can rely on every time. Cotter Brothers has found both in High Purity New England and the Quattroflow pump.

“Without Dave Bianchi’s knowledge, we would not be where we are today. Dave has bent over backwards for us, I can’t say enough about him and High Purity New England,” said Cotter. “They really brought us a winner in the Quattroflow pumps. We were one of the first ones to use them and over the last three years we have recommended them to our clients when appropriate for their application. Our clients have liked the Quattroflow pumps and we are finding that more are starting to request them.”

Contact: wallace.wittkoff@psgdover.com Pharma Bio World

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Pharma Outsourcing: Regulatory Scenario

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ndia, due to its skilled resource, is able to effectively contribute to contract research and manufacturing process, and due to its large patient population and genetic pool, has become a hub for cost-effective and speedy clinical trials for investigational new drugs. These significant advantages that India offers has compelled multi-national pharma companies to outsource operations in the fields of drug discovery, contract manufacturing and clinical research to organisations in India. In 2012, the Indian pharma outsourcing industry was valued at USD 1.2 billion and is growing annually at a rate 15-20 per cent.

Nature of Work

Dr Milind Antani Head, Pharma & Life Science practices: Nishith Desai Associates

Outsourcing in pharmaceutical industry takes place on two levels: Research and Manufacturing. Research outsourcing covers a wide range of services, including the drug development process, medical writing, pre-clinical and clinical trials, clinical trial monitoring, and clinical data management. The organisations to which research is outsourced carry out research under a contract, and hence, these organisations are popularly referred to as Contract Research Organisations (CROs).

Manufacturing outsourcing includes bio manufacturing and the custom manufacture of pharmaceutical ingredients as well as formulations.

The organisations to which manufacturing is outsourced carry out manufacturing under a contract, and hence these organisations are popularly referred to as Contract Manufacturing Organisations (CMOs). The CRO industry and CMO industry is jointly

Anay Shukla Member, Pharma & Life Science team Nishith Desai Associates

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referred to as Contract Research and Manufacturing Services (CRAMS) Industry.

Legal and Regulatory Compliance The important legislations and regulatory instruments covering various regulatory aspects related to clinical research and manufacture are: 1. Drugs & Cosmetics Act of 1940 and Rules of 1945.

2. Guidelines on Similar Biologics, 2012 prepared by Central Drug Standard Control Organisation (CDSCO) and the Department of Biotechnology.

3. Mashelkar Committee Recommendations, 2006 adopted by Ministry of Environment and Forest (for regulation of organisms modified by r-DNA techniques to be used as pharmaceutical products).

4. Director General of Foreign Trade’s (DGFT) Notification regarding bar- coding of exported pharmaceutical products.

5. Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 issued under Information Technology Act, 2000.

6. Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 issued under the Medical Council Act, 1956.

7. Good Clinical Practice Guidelines issued by CDSCO. 8. Ethical Guidelines for Biomedical Research on Human Participants, 2006 issued by Indian Council for Medical Research (ICMR).

The important regulatory agencies governing clinical research and manufacture are as follows: CDSCO, headed by the

“

The authors craft a background of the current scenario in pharma outsourcing in India and discuss how these outsourcing operations are bound by mandatory agreement with the many regulatory norms in place.

CROs constantly run the risk of being categorised as Sponsors unless appropriate documentation exists to indicate otherwise.

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Drugs Controller General of India (DCGI), is the apex authority under the Ministry of Health and Family Welfare which regulates pharmaceutical and healthcare industry in India. Each State regulates manufacture of drug within its territory through the State Food and Drug Administration (FDA). The Genetic Engineering Approval Committee (GEAC) functions under the Ministry of Environment and Forest as a statutory body for review and approval of activities involving large scale use of genetically engineered organisms (also referred as living modified organisms) and products thereof in research and development, industrial production, environmental release and field applications. All clinical trials involving the use of biotech products would be referred

by DCGI to GEAC for recommendations regarding environmental safety.

Some of the key regulatory requirements which must be borne in mind by CROs are:

have to pay compensation for clinical trial related death or injury to the subject if it has obtained to permission to conduct clinical trial in India on behalf of the sponsor.

Some of the key regulatory requirements which must be borne in mind by CMOs are: 1. Manufacturing of different categories of drug may require separate license from State FDA. 2. All manufacturing records pertaining to each batch of drugs must be maintained for a period of five years.

3. Export of drugs requires primary, secondary and tertiary level bar-coding as prescribed by DGFT. 4. The manufacturing activity must be in compliance with Good Manufacturing Practices prescribed under Schedule M of the Drugs and Cosmetics Rules, 1945.

definition of sponsor of a clinical trial, and CROs constantly run the risk of being categorised as Sponsors unless appropriate documentation exists to indicate otherwise.

Furthermore, though regulatory framework prescribed under the Drugs and Cosmetics Rules, 1945 is applicable only to clinical trial of new drugs; it is possible that the authorities may demand compliance of the Rules to even those clinical studies which do involve a new drug.

The CMOs also face unique regulatory challenges. A simple change in name, or even change in share- holding, is required to be reported immediately to the authorities and must be followed by an application for issuance of fresh license for manufacture.

Many a times, the standards imposed through regulations are India specific and not in tune with the global standards. This poses a concern since a large number of CMOs focus on exports.

Issues and Concerns 1. All clinical trials must be registered with the Clinical Trial Registry of India.

2. Disclosure or transfer of identifiable medical or health related data of trial subjects without their written permission is prohibited.

3. All clinical trial of new drugs requires strict compliance with Good Clinical Practice Guidelines.

4. CROs may become liable for medical management of trial subjects and may

The CRAMS industry faces numerous regulatory challenges today. The regulations governing this sector are evolving rapidly resulting in significant transition cost. Delay in obtaining approvals and permissions is a major cause of concern for the CRO industry.

While 262 clinical trials were approved in 2012, only six clinical trials were approved between January and June this year. More so, there is a cloud of mystery surrounding

Consequently, CMOs are forced to match Indian as well as global standards. There are other concerns which require attention too, like taxation issues connected to transfer pricing, taxation as an association of persons, creation of Indian private establishment of foreign enterprise, service tax liability etc.; IP issues connected to technology transfer, joint ownership, licensing, assignment, royalty payment, honoring of intellectual property etc. and contractual issues connected to sub- contracting, confidentiality, audit rights, indemnity, governing law etc.

Conclusion Non-compliance with the regulatory requirement may have severe consequences ranging from suspension of license to imprisonment and prohibition from conduct of business in India. Therefore, regulatory compliance must be taken seriously. Noncompliance with regulatory requirements is not option for the CRAMS Industry!

As per Times of India news report available o n h t t p : / / a r t icle s. t im e so f i n d i a . i n d i a t i me s . com/2013-02-22/india-business/37241193_1_ contract-research-pe-funds-domestic-market (last accessed August 19, 2013).

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Contact: milinda@nishithdesai.com 18 ď‚ƒAugust 2013

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What to Expect from a CRO? There are organisations who have thoroughly and quantitatively surveyed the various areas of sponsor expectations and whether various CROs meet them or not. Such surveys provide very interesting data that can help strategic alliance and relationship management between sponsor companies and CROs. 1 The author of this article has mainly alluded to his experiential qualitative data in writing this article.

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he title of this article begs another question first. Why a do we need a CRO (Contract Research Organisation) for drug development, is it essential? All pharmaceutical firms including large MNCs require assistance from CROs to expedite development of a new drug or product to reduce costs and in most cases to exploit CROs domain expertise. CROs also provide the variety and number of investigational sites with the required training and qualifications that the investigators ought to have.

Large biotech companies have such complex and back and forth development processes that it pre-requisites a CRO’s support in product characterisation and clinical testing at numerous stages. The mid and small sized pharma companies often do not have either a full-fledged pre-clinical and clinical R&D or the generic pipeline is too huge to be handled on their own.

Thus in addition to provide expertise, knowledge, equipments and facilities, CROs can share the responsibilities (by means of transferred authority) of drug development with favourable timelines and regulatory assistance. There are, however, potential risks involved in all outsourced works to CROs. Other than losing direct control of the projects, there are risks of poor or irrelevant data generated, GXP violations, fraudulent conduct of study and missed timelines.

Poor communication and relational dissatisfaction could be other hassles involved in outsourcing.

Sr Vice President Research & Development Cadila Pharmaceuticals Ltd

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Dr Bhaswat S Chakraborty

Twofold Relationship: Contract and Trust Contracts define the legal and task obligations of a CRO that is expected by the sponsor. Thus, the practical and commercial aspects of the relationship between the sponsor and the CRO revolve around what has been clearly embodied and appended in the contract. Anything that is not clearly written in the contract as a deliverable by the CRO, will be treated as a non responsibility of the latter in a court of law. In fact one of the first things to be expected from a CRO is a contract that is clear and unambiguous in terms of deliverable and has been written in good faith.

The wholesome and long standing relationship between these two entities, however, cannot be entirely contractual in nature. It is actually based on mutual trust as any good relationship is. Trust in and of what? The sponsor trusts that a CRO will deliver quality studies and data as mentioned in the contract within the stipulated timeline. In return, the CRO trusts that the sponsors will co-operate with all necessary information, especially thorough objectives and study protocols, make milestone and final payments on time and will not micro manage their projects while being conducted by the CRO. Asherman and Sagotsky have looked into the potent role of trust in successful to “best” sponsor-CRO relationships. 2 Effective communication plans should be evolved such that detail processes for discussing performance expectations, releasing undue pressures and for escalation of

Anything that is not clearly written in the contract as a deliverable by the CRO, will be treated as a non responsibility of the latter in a court of law.

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review elements are exactly known by the latter. This will reduce overseeing and duplication dramatically.

Many CROs may specialise in process improvement which may culminate into generation of intellectual property rights.

The exact duration of relationship that will lead to improved process efficiency is rather difficult to predict as it depends on a multitude of factors.

Regulatory Compliance Except for a very small percentage of the projects, all activities outsourced to CROs are expected to follow applicable regulatory requirements.

Figure 1: Schematic representation of the satisfaction gained by the sponsors when their needs are met at different levels and cumulatively.

issues through the governance structure are practised honestly.

Expect Value, Quality, Guidance and Satisfaction No matter how genuine the long term relationship between a sponsor and a CRO is, the latter is ethically and legally bound to deliver value and quality in conducting studies. Value in this context is benchmarked science, following the appropriate guidelines, GXP compliance and timely delivery of projects. The quality is the integrity and accuracy of the data. The quality applies to both valid inprocess and analysed data, and its correct interpretation in the reports prepared.

Reports must be in the regulatory friendly formats (eg, CTD). The major expectations and underlying needs met provide the level of expectation that the service receiving sponsor will experience (Figure 1).

The Efficiency Continuum: Meeting Timelines within Scope & Budget Efficiency is a multi-significant term but is mainly used for timeline, supervision and process improvements. Efficiency is also a continuum rather than being discrete, arbitrary numbers on a scale.

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Understanding the continuum is likely to enhance the satisfaction at all levels.

Gains in delivery- and other critical project-timelines constitute the most discernible improvement in efficiency.

Improved timelines are best appreciated when the budget and the scope of the project have not been changed disfavourably for the sponsor.

Improved efficiency over time with monitoring of the CRO activities is a positive sign of a successful sponsorCRO relationship. This also eliminates micro-management of the CRO which often poisons the relationship. Clarity of all milestone activities and the scope of data analysis should be understood by the CRO such that all supervisory or

The good practices including GMP, GLP and GCP must be in compliance with following mutually agreed upon SOPs. QA and QC must be vigilant and assuring to the sponsor.

In addition to championing the compliance with GXPs and other regulatory requirements, all sponsors expect that the CRO, that they have outsourced to, will be able to quickly receive a local trial or manufacturing license.

The CROs are also expected to know the nuances of the local regulatory agencies in terms of pre-requisite data and the time required for receiving the approval for trial conduct in details. The performance standards of regulatory agencies are different in various countries. Slower approval times warrant a better planning and preparation for the projects.

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Competitive cost or clear cost advantage & adherence to budget

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Timelines management within defined scope and budget for the project

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Quality control and quality assurance

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Regulatory compliance & strategic advice

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Documentation in standard (international) formats

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Low attrition rate of CRO personnel

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Availability of adequate number of personnel in all pertinent areas

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Involvement/intervention of senior management whenever necessary

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Scientific and technical advice

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Customer satisfaction assurance, metrics of satisfaction

Table 1: Top 10 Expectations from a CRO

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a partner CRO. However, this is not the general reality. The heart of the problem lies in the lack of an effective implementation of the partnership programme. Frequently, the drive to save resources and costs that led to strategic partnering in the first place inhibits upfront investment in the relationships. For example, while it is acknowledged that frequent communication, face to face meetings, and training programs contribute to the success of implementation of strategic relationships, pressure to conserve costs often prevent these from taking place. 1 Conclusions Learning Together: Mutual Respect

Successfully Met Expectations

T h i s a rt i c l e wo u ld b e in co m p le t e if mutuality of responsibilities and roles is not mentioned even though the theme of this article is kind of unidirectional (sponsors e x p e c t a t i o n o f C R O). As m e n t io n e d in the previous paragraph, successful delivery of a project is not only the CROs’ responsibility it is also an accountability of the sponsor. How so? Firstly, trust, respect and learning together will bring the members of the sponsor and the CRO team together. Finally, in last two decades or so, many refinements came through mutual discussion and subsequent joint designing of the projects by the aforementioned two stakeholders.

In a survey conducted by Avoca group, it was found that nearly half of the sponsors had strategically entered into partnership with CROs. The most common objectives for launching these partnerships included reduced costs, improved quality, improved efficiency in use of internal staff, access to operational expertise, and process improvement. Among sponsor respondents whose relationships spanned a period of more than 3 years, there was considerable variability in whether expectations in each of these areas were met, and in the time it took.

For example, over half of the respondents achieved cost savings in one year or less, although, about a quarter reported never achieving cost savings. Additionally, about half of the sponsors achieved improved quality within one year; however, nearly 20 per cent reported never achieving this. Similarly, process and efficiency improvements were attained by a little more than one third of the respondents. 3

Expectations that Lead to Success Table 1 enlists the main expectations that need to be met for successful CRO projects leading to at least an appropriate regulatory submission. At all stages of a project or multiple projects, robust systems for measuring performance and relationship are very important.

Particularly important are metrics that reflect status in an ongoing manner and that are therefore actionable during the course of a study. 3

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Unmet Expectations It has been observed that in poorly performing strategic relationships, the sponsor management is convinced that they simply made the wrong choice of

Successful delivery of a project is not only the CROs’ responsibility it is also an accountability of the sponsor.

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We have examined the nature and levels of expectations that a sponsor pharmaceutical or Biotech Company or any other relevant entity may have from a contract research organisation. The expectations are based on mainly three parameters, namely, scientifically accurate conduct of the project, regulatory compliance and meeting the success metrics in terms of time, scope and budget. The experiential data and published surveys point out that the relationship between the CRO and a sponsor must be based on honest faith, transparent and well written contract and mutual cooperation. The levels of satisfaction gained by the sponsor will depend not only on the selection of the correct CRO but also on meeting mutual goals, promises and milestones and on excellence of communication.

References 1. The AVOCA Group (2010). 2010 Avoca Report Executive Summary. http://www2. theavocagroup.com/knowledge-center/ reports/2010-avoca-report-executive-summary 2. Asherman IG, Sagotsky B. (2009). TrustBased Influence and the Sponsor/CRO Relationship. The Monitor (Association of Clinical Research Professional Journal), August 2009: 35-39.

3. Applied Clinical Trials Online (2013). 9th Annual Avoca Industry Survey Results. http://www.appliedclinicaltrialsonline.com/ appliedclinicaltrials/article/articleDetail. jsp?id=807740

Contact: drb.chakraborty@cadilapharma.co.in August 2013  21

8/21/2013 11:57:31 AM

Indegene’s Coverage of American Diabetes Association (ADA) Annual Meeting 2013

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ost presentations at the ADA 2013 focused on advancements in basic science, prevention, diagnosis, and treatment of types 1 and 2 diabetes as well as of comorbidities associated w it h the dis eas e. The highlights are as follows:

Lilly highlighted the encouraging safety and efficacy results of dulaglutide against its competitor’s sitagliptin, exenatide, and metformin. Data have been gathered from3 trials of the phase 3 AWARD programme on once-weekly dulaglutide for the treatment of type 2 diabetes mellitus (T2DM).

• Clinical data from extended studies of approved antidiabetic therapies such as Invokana (canagliflozin), Nesina (alogliptin), and Lyxumia (lixisenatide) confirmed their long-term efficacy and safety.

• Dulaglutide (once weekly GLP-1 agonist from Lilly/BI) showed greater HbA1c reduction as compared to metformin, sitagliptin and exenatide.

• IDegLira (fixed-ratio combination of insulin degludec and liraglutide) emerged as the promising molecule, with synergistic HbA1c reduction between the long acting insulin and GLP-1 agonist.

• The outlook on anti-obesity drug Belviq (locarserin) remains encouraging with positive data presented at the meeting.

The 104-week, phase 3, randomised, double-blind AWARD-5 study that compared once-weekly dulaglutide 1.5 mg with sitagliptin and placebo in metformin-treated T2DM patients showed a 1 per cent reduction in hemoglobin A1c (HbA1c) levels from baseline compared to 0.32 per cent reduction observed with sitagliptin. The proportion of patients with HbA1c levels below 7 per cent was higher in the dulaglutide-treated group (54.3 per cent) than in the sitagliptintreated group (31.1 per cent). In addition, dulaglutide resulted in 2.88 kg weight loss from baseline compared to 1.75 kg weight loss observed with sitagliptin.

Dulaglutide Dulaglutide has emerged as a competitor to Novo Nordisk’s liraglutide with encouraging efficacy results. Results from head-to-head trial between the two are expected to be released in 2014 which may prove pivotal.

Dulaglutide, an investigational, long-acting glucagon-like peptide-1 (GLP-1) analog, is Lilly’s strong hope to brace them against patent expirations of Zyprexa (olanzapine) and Cymbalta (citalopram). In this bid,

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The 52-week, phase 3, randomised AWARD-3 study comparing once-weekly dulaglutide 1.5 mg with metformin in patients with early T2DM showed a 0.78 per cent reduction in HbA1c levels at the end of 26 weeks in the dulaglutide group. In contrast, metformin resulted in a 0.56 per cent reduction in HbA1c levels after 26 weeks. After 52 weeks, the proportion of patients with HbA1c levels below 7 per cent was higher in the dulaglutide-treated group than in the sitagliptin-treated group.

The 52-week, phase 3, randomised AWARD-1 study comparing once-weekly dulaglutide 1.5 mg with exenatide and placebo in T2DM patients refractory

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The ADA 73 rd Scientific Sessions, 2013, conference held at Chicago, Illinois, gave a broad picture of the current happenings in the area of diabetes and the emergence of new molecules that have achieved success against their competitors in reducing diabetes burden to a relative extent.

This report captures the key highlights from this five-day conference.

Results show an impressive picture of dulaglutide’s superiority over Januvia (sitagliptin), Byetta (exenatide), and metformin.

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The above results show an impressive picture of dulaglutide’s superiority over Januvia (sitagliptin), Byetta (exenatide), and metformin. Although dulaglutide offers once-weekly dosage advantage over oncedaily Victoza (liraglutide) and Lyxumia (lixisenatide), there is slight difference from the other existing GLP-1 analog Bydureon and late-stage albiglutide. Therefore, it will be interesting to see how dulaglutide positions itself in the GLP-1 space.

Based on the results from this AWARD programme, Lilly/BI is expected to file for regulatory approval late in 2013.• Empagliflozin Apart from HbA1c reduction, significant reduction in blood pressure and body weight were also seen with empagliflozin treatment.

After J&J’s Invokana (canagliflozin) became the first-in-class SGLT-2 inhibitor to be approved by the Food and Drug Administration (FDA), Eli Lilly and Boehringer Ingelheim (BI) have geared up to launch empagliflozin (EMPA) amidst significant interest around this new class and low in-class competition.

Accordingly, Lilly and BI bolstered EMPA at the ADA with 17 clinical and preclinical presentations that included three late breakers. The first late breaker, a pooled analysis of four pivotal placebo-controlled clinical trials on EMPA, investigated the effect of two doses of EMPA (10 and 25 mg) as monotherapy and as an add-on to metformin, metformin and sulfonylurea, and pioglitazone with or without metformin for 24 weeks. In these trials, EMPA 10 and 25 mg lowered HbA1c levels from baseline by 0.70 and 0.76 per cent, respectively, Pharma Bio World

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compared to placebo (reduction of 0.08 per cent).

At the end of the treatment, the proportion of patients achieving HbA1c levels below 7 per cent was 31.5 and 37.2 per cent with EMPA 10 mg and 25 mg, respectively, and 10.5 per cent with placebo. Empagliflozin 10 mg, EMPA 25 mg, and placebo reduced body weight by 2.05, 2.25, and 0.24 kg, respectively. Empagliflozin 10 and 25 mg reduced systolic blood pressure (SBP) by 3.9 and 4.3 mm Hg, respectively, and diastolic blood pressure (DBP) by 1.8 and 2.0 mm Hg, respectively. However EMPA 10 mg, EMPA 25 mg, and placebo increased Low-Density Lipoprotein (LDL) levels by 0.08, 0.1, and 0.02 mmol/L, respectively, and high-density lipoprotein HDL levels by 0.0, 0.07, and 0.07 mmol/L, respectively, which may be of concern to diabetologists.

In addition, this pooled analysis showed that EMPA 10 and 25 mg did not result in urinary tract infections (UTI) but were resulted in more number of genital infections than placebo. Empagliflozin 10 and 25 mg resulted in UTIs in 9.3 and 7.5 per cent patients, respectively. In men, the rates of UTI development with EMPA 10 and 25 mg were 1.9 and 1.1 per cent, respectively, while in women, the rates were 18.5 and 15.9 per cent, respectively.

Women were more prone to UTIs than men.

Although the increase in cholesterol levels and genital infections associated with EMPA use leave scope for debate, EMPA may emerge as a strong competitor to canagliflozin, due to its promising efficacy results. In March 2013, an NDA was submitted to the FDA for the use of EMPA in the treatment of T2DM. Moreover, a Marketing Authorisation Application (MAA) filing review was accepted by the European Medicines Agency (EMA). In addition, regulatory filing for EMPA was initiated in Japan in January 2013.•

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Invokana (Canagliflozin) After its approval for the treatment of T2DM by the FDA earlier this year, canagliflozin continued to be in spotlight at the ADA 2013 because of new data reported from its phase 3 trials. Results of phase 3 studies on canagliflozin in combination with DPP4 inhibitors, GLP-1 agonists, sulfonylureas, thizolidinediones, and metformin continue to show encouraging efficacy benefit over the longer periods of evaluation. In addition, the results showed a reduction in weight and blood pressure (both SBP and DBP).

The increase in cholesterol levels seen with canagliflozin therapy is an area of concern.

In addition, FDA reviewers have highlighted the increased risk of cardiovascular problems with this therapy while providing approval and have mandated future studies on the effect of canagliflozin therapy on cardiovascular outcomes.

Post hoc analysis of the Canagliflozin Cardiovascular Assessment Study (CANVAS) evaluating the response to canagliflozin 100 and 300 mg in combination with DPP-4 inhibitor or GLP-1 agonist in patients with high risk of cardiovascular diseases showed that canagliflozin was generally safe and effective in the 18week trial period. The combination of canagliflozin and a DPP-4 inhibitor or GLP1 agonist with or without other diabetic medication may reduce HbA1C levels by varying degrees. In another study, both the doses of canagliflozin in combination with basal insulin reduced Fasting Plasma Glucose (FPG) from 25 mg/dL to 31 mg/dL and body weight from 1.8 to 2.7 per cent compared to basal insulin alone.

Reduction in HbA1C and FPG levels by canagliflozin in combination with metformin or pioglitazone was similar at 26 and 52 weeks of treatment. Although reduction in body weight and SBP was seen at 52

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to metformin or pioglitazone after 26 weeks, dulaglutide 1.5 mg resulted in a 1.51 per cent reduction in HbA1c levels from baseline compared to 0.99 per cent reduction observed with exenatide and 0.46 per cent reduction observed with placebo. In addition, dulaglutide resulted in 1.3 kg weight loss from baseline compared to 0.71 kg weight loss observed with exenatide. However, patients receiving placebo showed 1.24 kg weight gain from baseline.

Alogliptin monotherapy as well as alogliptin + metformin and alogliptin + pioglitazone combination therapies were associated with loss of weight and lower incidence of hyperglycemia.

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In patients with chronic kidney disease, treatment with canagliflozin increased the rates of osmotic diuresis-related AEs and UTIs and decreased intravascular volume, Blood Urea Nitrogen (BUN), estimated Glomerular Filtration Rate (eGFR), and Albumin/Creatinine Ratio (ACR).

Therefore, the FDA has contradicted this drug in patients with impaired kidneys.

Hypoglycemia was seen in 64, 59, and 46 per cent patients receiving canagliflozin 100 mg, 300 mg, and placebo, respectively.

Across all studies, canagliflozin was associated with higher rates of genital mycotic infections in T2DM patients than other therapies; however, this AE was generally manageable and very rarely led to discontinuation of the drug.•

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weeks, an increase in LDL-C, HDL-C, and triglyceride levels was also observed. In addition, higher incidence of genital mycotic infection- and osmotic diuresis- related Adverse Events (AEs) was observed. The combination of canagliflozin and metformin was effective in reducing HbA1C, FPG, body weight, and SBP compared to the combination of glimepiride and metformin and glimepiride alone.

IDegLira was one of the most touted molecules presented at the ADA, with positive responses from key opinion leaders.

compared to those with glipizide (47.4 per cent) (P<.001). Higher reduction in FPG levels was also seen with both the doses of alogliptin (-5.0 mg/ dL for alogliptin 12.5 mg and -7.2 mg/dL for alogliptin 25 mg) than that with glipizide (0.9 mg/dL). Both the doses of alogliptin showed a significant change in weight from baseline (-0.64 and -0.91, respectively) compared to glipizide (0.89). Hypoglycemic events and other AEs leading to treatment discontinuation were comparable in all the three groups.

A study in Japanese diabetic patients receiving alogliptin monotherapy or combination therapy of alogliptin and metformin or pioglitazone showed that alogliptin monotherapy was associated with higher reduction in HbA1C levels at week 16 (0.99 per cent) than combination therapies (0.91 per cent reduction in the alogliptin + metformin group and 0.76 per cent reduction in the alogliptin + pioglitazone group).

Nesina (Alogliptin) Nesina (alogliptin), a DPP-4 inhibitor developed by Takeda Pharmaceutical, has been approved for use in the US for the treatment of T2DM in adults (January 2013). In Japan, alogliptin alone or in combination with an alpha glucosidase inhibitor, thiazolidinedione, sulfonylurea, or biguanide has been approved for the treatment of T2DM patients who are poorly controlled by diet and exercise.

Comparison of diabetic patients receiving a combination of alogliptin 12.5 mg and metformin, alogliptin 25 mg and metformin, and glipizide 5 to 20 mg and metformin for 1 year showed higher reduction in HbA1c levels at week 52 in the alogliptin 12.5 mg arm (-0.62 per cent) compared to that in the alogliptin 25 mg (-0.61 per cent) and glipizide arms (-0.52 per cent).

Significant number of patients was able to achieve HbA1c levels below 7 per cent with alogliptin 25 mg (55.3 per cent) 24 August 2013

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Significantly higher proportion of patients in the alogliptin monotherapy and both the combination therapy groups achieved HbA1c targets of ≤6.5 per cent, ≤7.0 per cent, and ≤7.5 per cent (P <.001) than those in the placebo group. Alogliptin monotherapy as well as alogliptin + metformin and alogliptin + pioglitazone combination therapies were associated with loss of weight and lower incidence of hyperglycemia.

Concurrently, Takeda launched fixeddose combinations Kazano (alogliptin + metformin) and Oseni (alogliptin + pioglitazone) in January 2013 in the US for the treatment of adults with T2DM.• Lyxumia (Lixisenatide) Lixisenatide showed an acceptable riskbenefit ratio in patients aged ≥65 years; therefore, it may serve as a potential treatment option for patients within this

age group. Lyxumia (lixisenatide), a GLP1 agonist developed by Sanofi, has been approved in the EU and Japan to achieve glycemic control in T2DM patients who are refractory to oral hypoglycaemic agents and/or basal insulin along with diet and exercise. Lixisenatide in combination with insulin has also been approved in Japan for the treatment of T2DM patients who are unable to achieve adequate glycemic control with diet and exercise; sulfonylureas (with and without biguanides); or diet, exercise, and soluble prolonged-acting or intermediate-acting insulin (with and without sulfonylureas).

Analysis of five randomised trials on lixisenatide showed that higher percentage of patients receiving a combination of lixisenatide and insulin achieved HbA1c levels below 7 per cent than those receiving basal-plus regimen (combination of basal insulin + 1 dose of prandial insulin).

Patients receiving basal-plus regimen also showed weight gain (estimated weight difference, 1.38 kg; P <.0001) and hypoglycemia (P = .045). In T2DM patients refractory to HbA1c goals of basal insulin, the combination of lixisenatide and basal insulin was 2.5 times more effective than the basal- plus regimen (22.5 per cent and 15.8 per cent for reducing HbA1c levels to <7 per cent with no weight gain and symptoms of hypoglycemia, respectively) in reducing HbA1c levels to <7 per cent with no weight gain (27.9 per cent) and three times more effective in reducing HbA1c levels to <7 per cent with no hypoglycemia symptoms and weight gain (19.6 per cent).

Post hoc analysis of five randomised phase 3 studies (GetGoal-M, GetGoal-P, GetGoal-S, GetGoal-M-Asia, and GetGoal-F1) in elderly T2DM patients showed that lixisenatide along with other oral anti-diabetics (OADs) significantly improved glycemic control, particularly the composite end points such as HbA1C Pharma Bio World

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<7 per cent, with no weight gain and documented symptomatic hypoglycemia compared to OAD alone. Lixisenatide was more efficacious than placebo in reducing HbA1C levels to <7 per cent (49.3 per cent vs. 22.8 per cent, P <.0001) and in reducing HbA1C levels to <7 per cent with no weight gain (41.8 per cent vs. 18.8 per cent, P <.0001) and with no documented symptomatic hypoglycemia (44.4 per cent vs. 22.3 per cent, P <.0001). However, higher inclination towards documented symptomatic hypoglycemia was seen with lixisenatide than with placebo (P = .09), but the incidence of severe hypoglycemia was not documented in either of the groups.

Pooled analysis of three randomised phase 3 studies showed that oncedaily lixisenatide along with OADs and basal insulin was effective in regulating postprandial hyperglycemia (PPHG) by reducing HbA1c levels, with no weight gain.

The adjusted LS mean HbA1C change with lixisenatide OADs, and basal insulin after 24 weeks of treatment was -0.77 per cent and that with placebo, OADs, and insulin was -0.29 per cent (P <.0001).

Although basal hyperglycemia exposure levels were similar between the lixisenatide and placebo groups, PPHG exposure levels were lower in the lixisenatide group than in the placebo group (adjusted LS mean change, -21 mmol/L*h vs. -10 mmol/ L*h; P <.0001). Basal and postprandial hyperglycemia increased blood glucose levels to 46 and 54 per cent, respectively, in the lixisenatide (with OADs + basal insulin) group and 39 and 61 per cent, respectively, in the placebo (with OADs + insulin) group.• Syncaria (Albiglutide) Albiglutide showed significant HbA1c reduction as compared to insulin, sulphonylurea and DPP4-inhibitors.

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However it failed to show non-inferiority in comparison with pioglitazone.

After an initial failure of Syncria (albiglutide), the once-weekly GLP-1 receptor agonist developed by GSK, to meet its primary end point of noninferiority to liraglutide in 2011 (Harmony 7 study), 5 phase 3 studies (Harmony 1-5) comparing albiglutide with placebo and a range of active comparators (insulin, sulfonylurea, thiazolidinedione, and DPP-4 inhibitor) presented at the ADA 2013 showed promising results.

Albiglutide (with metformin), in comparison to placebo, resulted in a statistically significant reduction in HbA1C levels from baseline (treatment difference of -0.8 per cent, P <.0001) at the end of 52 weeks of treatment in the Harmony 1 study. Approximately 44 per cent patients receiving albiglutide achieved the HbA1C target of <7 per cent compared to 15 per cent patients receiving placebo; however, there was a nonsignificant change in weight in the two groups.

In the Harmony 2 study, patients on diet and exercise regimen who received two different doses of albiglutide (30 and 50 mg) showed a significant objective response in HbA1C reductions compared to those receiving placebo (-0.84 per cent for 30 mg albiglutide and -1.0 per cent for 50 mg albiglutide; P <.0001). In addition, patients in all the groups showed weight reductions (-0.9, -0.4, and -0.7 kg reduction with placebo, 30 mg albiglutide, and 50 mg albiglutide, respectively).

The significant objective response was also observed in the Harmony 3 study, where albiglutide resulted in higher HbA1C reduction than placebo (-0.9 per cent, P <.0001), sitagliptin (-0.4 per cent, P = .0001), or glimepiride (-0.3 per cent, P = .003). In addition, weight loss observed in the albiglutide group was more significant than that observed in the glimepiride group

Currently, Lorcaserin in combination with one or more other drugs is being investigated for use in smoking cessation.

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(-2.4 kg, P <.0001) and similar to that observed in the sitagliptin (-0.4 kg) and placebo (-0.2 kg) groups.

Patients in both albiglutide and insulin glargine groups in the Harmony 4 study, achieved similar reductions in HbA1c levels (-0.7 and -0.8 per cent in albiglutide and insulin glargine groups, respectively).

Patients receiving albiglutide showed weight reduction (-1.1 kg) while those receiving insulin glargine showed weight gain (+1.6 kg), with a treatment difference of 2.6 kg (P <.001).

An impressive synergistic effect on the primary end point of HbA1c without nausea and acceptable risk of hypoglycemia has createda positive hype for this combination among physicians.

The Harmony 5 study comparing albiglutide with placebo and pioglitazone in patients receiving metformin and glimepiride showed a statistically significant reduction in HbA1c levels in the albiglutide group compared to that in the placebo group (-0.9 per cent, P <.001).

The Harmony 8 study showed that albiglutide was superior to sitagliptin and placebo in reducing HbA1c levels by 0.83 per cent at week 26. A similar reduction in weight was observed in the albiglutide and placebo groups (reduction by 0.79 and 0.19 kg, respectively). Gastrointestinal symptoms such as nausea, vomiting, and diarrhea and injection site reactions were the most common AEs in the albiglutide group.

GSK submitted a Biologics License Application (BLA) to the FDA in January 2013 and an MAA to the EMA in March 2013 for the use of albiglutide in the treatment of T2DM inadults.• IDegLira IDegLira-the fixed dose combination of GLP-1 agonist and long acting insulin showed significant synergy in terms of HbA1c reduction and a reduced risk of nausea and hypoglycemia. This makes it one of the most promising molecules to watch out for in the near future.

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The combination of GLP-1 analogs and long- acting insulins has been in discussion among physicians due to their synergistic effects that are expected to be better than either of the monotherapies.

itself in the minds of physicians. The MAA for IDegLira was filed in the EU on May 31, 2013.•

Novo Nordisk presented the results of IDegLira, a fixed-ratio combination of Novo Nordisk’s Victoza (liraglutide), a GLP-1 analog, and Tresiba (insulin degludec).

Lorcaserin in combination with lifestyle modification is a strong predictor of achievable weight loss (in 1 year) in obese and overweight patients with a minimum comorbidity.

In the study, IDegLira reduced HbA1C levels by 1.9 per cent (from 8.3 to 6.4 per cent) compared to Tresiba (-1.4 per cent) or Victoza (-1.3 per cent) from a similar baseline. More people receiving IDegLira showed HbA1C levels below 7 per cent (81 per cent) compared to those receiving Tresiba (65 per cent) and Victoza (60 per cent). Hypoglycemia events with IDegLira were 32 per cent lower than those with Tresiba.

IDegLira resulted in 0.5 kg weight loss compared to Tresiba, which resulted in 2.7 kg weight gain, and Victoza, which resulted in 2.9 kg weight loss.

Gastrointestinal side effects observed with IDegLira were lesser than those observed with Victoza (nausea: 8.8 per cent vs. 19.7 per cent; vomiting: 3.9 per cent vs. 8.5 per cent).

IDegLira was one of the most touted molecules presented at the ADA, with positive responses from key opinion leaders. With an encouraging efficacy profile and seemingly acceptable AE profile, IDegLira is expected to entrench

“

Belviq (Lorcaserin)

Lorcaserin, popularly known as ‘Belviq’, is a known orally active, small-molecule, selective 5-HT2C agonist developed by Arena Pharmaceuticals. Although its exact mechanism of action is unknown, it is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain.

Lorcaserin was launched in the US in June 2013 by Arena Pharmaceuticals and is approved for use in the US as an adjunct to reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of ≥30 kg/m 2 (obese) or ≥27 kg/m2 (overweight) in the presence of at least one weightrelated comorbid condition.

A paper presented at the ADA 2013 showed that compared to placebo, lorcaserin monotherapy resulted in ≥5 per cent weight reduction in 47 and 23 per cent patients without diabetes. At 52 weeks, absolute weight loss in the same patients was 5.8 and 2.5 kg, respectively. The percentage of weight reduction and absolute weight loss in T2DM patients were 38 and 16 per cent and 4.7 and 1.6 kg, respectively.

Although Arena had submitted a MAA with the EMA in 2012, it was later withdrawn in May 2013, with the intention to file again at a later date. The Committee for Medicinal Products for Human Use (CHMP) report also stated that the benefits of the product did not outweigh the risks because lorcaserin use was associated with a risk of tumor development and psychiatric disorders.

Studies have also shown that in addition to weight loss, lorcaserin in combination with diet and exercise improved HbA1c levels in nondiabetic patients compared to placebo.

Experts are of the opinion that 26.3 per cent of the treatment effect of lorcaserin on HbA1c levels is not accompanied by weight loss. Currently, this drug in combination with one or more other drugs is being investigated for use in smoking cessation.• Source: ADA 73 rd Scientific Sessions June 21 to 25, 2013 McCormick Place, Chicago, Illinois

Contact: tmukherjee@webershandwick.com

Approximately 49.3 per cent nondiabetic patients in the lorcaserin group responded to the treatment compared to 22.6 per cent patients in the placebo group. At 52 weeks,

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Results of DUAL-I, a phase 3a study was presented. The study was designed to evaluate the superiority of IDegLira over Victoza and its noninferiority over Tresiba.

It was a randomised, open-label study involving 1663 T2DM patients who were inadequately controlled on metformin with or without pioglitazone.

86 per cent nondiabetic responders lost at least 5 per cent weight, and approximately 50 per cent of these lost at least 10 per cent weight.

Although the increase in cholesterol levels and genital infections associated with EMPA use leave scope for debate, EMPA may emerge as a strong competitor to canagliflozin.

26 August 2013

Indegene 22-26.indd 26

Pharma Bio World

8/21/2013 5:01:40 PM

Market Research

CCS Outsourcing to Grow in India India is well-established in Custom Chemical Synthesis (CSS) space; this article will focus on outsourcing of custom synthesis work to suppliers in India.

O

ver the years, increased development time, decline in the rate of new approvals and higher development costs have resulted to decline in R&D productivity of large pharma companies. This has resulted in Innovator pharmaceutical companies outsourcing large portion of their R&D to CROs including synthesis of molecules.

increase in global pharmaceutical R&D outsourcing market, which was USD 74 billion in 2012 where Custom Chemical Synthesis (CCS) has shown 100 per cent growth in the last 5 years. 1

Indian Suppliers over the years have developed strong chemistry skills through their CRAMS (Contract Research and Manufacturing Services) model and are focusing on this apart from the contract manufacturing, which involves supply of material at gram or kilogram level where-in the profit margins are high when compared to contract manufacturing.

•

Large Pharmaceutical companies are looking to focus on their core activities in R&D therefore outsourcing major portion of non-core activities, which has led to

Industry View: Pharma Custom Synthesis industry is expected to have a turnover of USD 120 billion by 2015, where the outsourcing to contract players would

With high-cost operations in USA and Europe, the focus is gradually shifting to India due to the following advantages:-

•

•

Sarabjeet Singh Sharad Senior Research Analyst Beroe Consulting (I) Pvt Ltd

Figure 2

India has the highest number of USFDA approved facilities outside USA. Indian suppliers account for almost 25-30 per cent of the total DMFs filed with the USFDA. Lately with the implementation of the WTO TRIPS-mandated product patents (1 January 2005) has led to gaining more outsourcing from developed markets.

Figure 3 Source: Industry/MOSL1

contribute around USD 48 billion which is already increasing at rate of 16-18 per cent annually. 2 Regional View: The CCS demand in Asia –pacific is expected to grow at 8 per cent where India is having good expertise in chemistry skills, compliance to strict international regulatory norms and scientific skills when compared to other Asian countries specially China.

Figure 1

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MARKET RESEARCH 27-28.indd 27

Supplier View: CCS is one of the major outsourcing opportunities available to India, which will help the Indian suppliers attract huge volume of outsourcing from the large pharmaceutical companies, and August 2013  27

8/21/2013 12:48:07 PM

Custom Chemical Synthesis Parameters

India

China

Manufacturing focus

Advanced Intermediates, APIs, Formulations

Bulk chemicals, Intermediates, Fermentation-based products

Chemistry skills for pharma products

Well developed

Moderately developed

Regulatory skills & compliance

Well established

Evolving

Labour costs

Cheap

Less than India

Scientific skills

Good

Moderate

US FDA approved facilities

>100 – highest outside USA

Very few

DMFs filed

25-30% of global filings

Very few

Product basket offered

Broad

Narrow

Figure 4 Source: http://www.piindustries.com

•

•

MNC Outsourcing stance Favorable

Favorable

MNC confidence for technology transfer

Moderate

Moderate

MNC relationships

Scaling up

Scaling up

IPR Protection

Product patent regime Product patent regime implemented in Jan-05 but implemented long back but still some grey areas loosely implemented

Rockdale Enterprise Pvt Ltd has collaboration with Universities and educational institution like IICT, NCL Pune and IIT Mumbai.

Shasun Pharmaceuticals Ltd has tieups with several leading institution such as Harvard University.

Domestic pharmaceutical Well developed industry

Moderately developed

Communication (English language)

Well established

Weak

TCG, Sai Advantium,Innogent (GVK), Syngene, Anthem ,Divis’s Labs, Piramal Healthcare, Jubilant Organosys, Shasun Chemicals and Dishman had invested significantly to build strategic relationship with the large pharmaceutical companies for these services in India. They have developed significant capabilities in this space and have been able to provide services to the top 10 global innovator companies over the last few years.

Overall Infrastructure

Weak

Well developed

Source: Primary Research

Table 1

Custom Chemistry CROs are having in-house capabilities and are value driven to enhance their capabilities through these collaborations. Therefore subcontracting

“

forms the major percentage of the total cost in India.

Indian CRO Research and Development Collaboration • Jubilant group subsidiary Jubilant Chemsys offers dedicated custom chemical synthesis (CCS) services.

• Dr Reddy's group have two Technology Development Centers (TDC) in Hyderabad, R&D centre Chi Rotech in Cambridge which specialise in Chiral Chemistry, PEGs, and Prostaglandins.

Custom Chemical Synthesis is one of the major outsourcing opportunities which will help the Indian suppliers attract huge volume of outsourcing from the large pharmaceutical companies, and become their strategic preferred partner in the future.

28 August 2013

MARKET RESEARCH 27-28.indd 28

Outsourcing these activities provides the innovator an opportunity to focus on discovery research. While the custom synthesis business cannot scale up to a large scale (supplies are generally in a few kilograms), it offers an opportunity to lock-in with the customer from early development stage and generally leads to large contract manufacturing orders once the drug is successfully commercialised.

References •

•

“

become their strategic preferred partner in the future. CCS is part of the CRAMS (Contract Research and Manufacturing Services) value chain, which delivers high margins on low volumes ie, opposite from the traditional contract manufacturing model where the margin is very less for the suppliers, which is attracting Indian suppliers.

• • •

h t t p : / / x a . y i m g . c o m / k q / groups/15246641/1076818852/name/ Pharma+Sector+Scan+-+11th+March.pdf – (1) http://www.piindustries.com/sites/default/ files/Investor%20Presenation_June%20 2012_new.pdf –(2) http://www.jubl.com/pdfs/q4fy12-investorpresentation.pdf - (3) https://ventura1.acesphere.com/Pdf/Equity/ StockIdeas/Initiating - (4) Primary – Supplier & Expert Interactions

Contact: sarabjeet.singh@beroe-inc.com Pharma Bio World

8/21/2013 12:51:31 PM

news features

When Faking Becomes a Way of Earning…

Ananya Sen

A

ccording to World Health Organisation (WHO) “a counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source”.

This includes all fake, spurious and unauthentic drugs which may not contain the stated amount of API or may be mixed with other substances. The list of counterfeits doesn’t end here, in addition there are pass-offs which are sold to the rural population resembling another drug in a manner likely to deceive with the same packaging and get-up. On an average the pass-offs account for about 75 per cent of the total counterfeit market as against spurious or fake drugs that contribute to 25 per cent of this filthy trade.

India is considered to be a chief dealer in pharmaceutical counterfeiting. Zaheer

“

Khan, CEO, Enforcers of Intellectual Property Rights (EIPR), a leading investigation agency in India specialising in anti-counterfeiting solutions, points out that majority of the pharmaceutical counterfeiting activities in India is attributed to the contract manufacturers especially export manufacturers.

This practice of producing counterfeit products alongside contract manufacturing is rampant in places like Baddi and Solan in Himachal Pradesh, India. He also added that within the Indian pharma regulatory framework it is possible for these manufacturers to carry out such illegal activities only with the assistance of the regulatory officials. Another reason cited by Khan for increased counterfeiting in India is the easy availability of APIs, even those that are supposed to have restricted distribution.

These counterfeit products manufactured in countries like China, Pakistan, Thailand etc. besides India find their way through online pharma retail in the United States, Canada, United Kingdom and many more.

Khan emphasizes that since the Customs Control in the developed nations are stiff and well in place, the counterfeit products are not sent in bulk but in small quantities through mail orders. Even if these are detected by the Customs officials, since small consignments, they are destroyed and let off.

Within India, majority of the counterfeit products invade the distribution channels and enter the rural markets. They are also traded to suppliers who mix them with unadulterated drugs and they are

“

In an attempt to divulge the filth of a business called Pharma Counterfeiting, Pharma Bio World brings out the many secrets of this trade with the help of Zaheer Khan, CEO, (EIPR).

Since the Customs Control in the developed nations are stiff and well in place, the counterfeit products are not sent in bulk but in small quantities through mail orders.

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A visit to Dawa Bazaar, a market for generic drugs located on Princess Street in Mumbai, ascertains yet again the very fact that Pharma Counterfeiting today has become an indispensable part of the Pharma trade.

On being asked about their Pharma Wholesale and Distribution business, the traders refuse to open up. Most of them are part of Associations which work for their interest. sold in wholesale markets in many Indian cities. It is practically unmanageable to carry out and refine this business without the cooperation of those involved in the pharma supply chain points out Khan.

Pharma counterfeiting is not restricted to oral solid dosage delivery systems in fact it extends to parenterals as well in addition to several other dosage forms thus augmenting the level of risk associated with all of them. The players of this business have refined this industry very well and today its market value stands in some multi million USD says Khan.

Controlling counterfeiting in India seems to be difficult. Today the growth of these counterfeits is possible because of the assistance of those involved in the pharma trade and the regulatory officials. How else would they sustain?

It is therefore a threat from within which makes curbing this practice all the more challenging. Although there were talks in the Parliament of heavily penalizing those found guilty of pharma counterfeiting, no such Act was finally passed.

Blocking the product at its entry point is the best way to restrict counterfeiting opines Khan. EU, he says has been successful in doing this to quite an extent.

However India has not been able to work out any mechanism in place as of yet to stop this.

August 2013  31

8/21/2013 12:59:40 PM

pharma news Low Cost Pharma Code Readers from Cognex Cognex Corporation has introduced a range of Low Cost Pharma Code Readers. The ‘L (Linear)- Series’ of Cognex low cost readers has quickly become the preferred barcode reader due to its outstanding read rate performance, ease of use and cost effectiveness.

Carl Gerst, Vice President & Business Unit Manager, ID Products, Cognex

“We have come up with this range keeping in mind about the price- conscious customers.

The L- series is carefully designed after a lot of thorough research, meeting both the demands (cost and quality) of the customers,” said Carl Gerst, Vice President and Business Unit Manager, ID Products.

Pharma code reading plays an integral part in the Pharma industry.

Within the pharmaceutical industry, stringent legislation exists to combat counterfeit goods by ensuring each product can be traced throughout the supply chain. In order to achieve the required levels of traceability, manufacturers are increasingly reliant on printed 2-D codes combined with advanced code reading technology.

Cognex DataMan 50L & 300L series has quickly become the preferred barcode reader due to its outstanding read rate performance and ease of use.

IMS Health Unveils IMS Health Physician and Chemist Census

Amit Backliwal, MD, IMS Health South Asia & Kumar Hinduja, Sr Director, IMS Health

IMS Health, the leading global provider of information, technology, and services for healthcare, unveiled the IMS Health Physician and Chemist Census, India’s largest-ever collection of market intelligence on this stakeholder group.

The IMS Health Physician and Chemist Census covers 120 cities (metro and non-metro) and includes rich insights into over 3.73 lakh doctors and 99,000 chemists across multiple parameters. The scope of information will help maximise the commercial and strategic potential for pharmaceutical, consumer health, medical devices and diagnostic companies. It will also provide critical insights for government policy-makers to develop better policies and a stronger healthcare infrastructure in India.

At the announcement of the census, Amit Backliwal, Managing Director, IMS Health - South Asia, explained, “This census helps close important information gaps in the healthcare value chain in 32  August 2013

Pharma News 32-44.indd 32

India. Our Commercial Effectiveness Services team will use these new insights to enable stakeholders across healthcare to make better-informed decisions and to sharply increase the ROI from their commercial strategies. In addition, government and public bodies will now be armed with the market intelligence they need to design more relevant, more targeted programmes that drive superior health outcomes.”

The census reveals a number of new insights about physicians and chemists across India, particularly about the relative density and coverage of services across the country. For instance, the cities of North India account for 31 per cent of doctors in the country, but only 28 per cent of the country’s population resides there, highlighting the extent to which these cities are over-served by the healthcare system. On the contrary, East and South India have a significantly lower density of GPs (non-MBBS) compared to the Indian average.

Cole-Parmer’s 7 th Annual Catalog Released A new resource is available to help laboratory staff and manufacturers meet everyday challenges. Cole-Parmer, a global leader with more than 50 years of experience in fluid handling, life science, general laboratory products, instrumentation, and equipment, released its 7 th annual catalog for the Scientific and Process industries. The company has also released its second annual catalog dedicated to the Food and Beverage industry.

The new 2013/14 Catalog from Cole-Parmer offers a full selection of products and services to enhance efficiency and produce best practices. The 300+ page catalog has numerous unique and new products, as well as returning favorites. Users can select from highly efficient laboratory essentials, lab equipment, fluid handling, and process equipment and find exactly what they need for their application—from research and development to pilot plants to scale-up. The catalog also has convenient dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts.

At the catalog launch, Rakesh Aggarwal, Director, Cole-Parmer India, said, “The new 2013/14 catalog underscores the company’s reputation of bringing the latest, hard-to-find products to customers.

It is designed in such a way that products are positioned based on features and areas of application. Sufficient information is available in the catalog—both technical and commercial—to make buying and using products much easier. The dual pricing provided also helps the user make a buying decision quicker. All of this makes our catalog a complete resource for users.”

The catalog includes a wide portfolio of products to address customers’ demanding manufacturing and process applications needs. Featured products in the catalog include the Masterflex I/P Digital Process Drive, Oakton pH 700 Benchtop Meter, Rotational Viscometer, IKA EUROSTAR 100 Control Digital Mixer, Centrifan PE Small-Volume Evaporators, to name a few.

Pharma Bio World

8/21/2013 3:11:06 PM

Piramal Gets IND Approval for P7435

Dr Swati Piramal Vice Chairperson Piramal Enterprises Limited

Piramal Enterprises Limited has received approval from the USFDA for its Investigational New Drug (IND) P7435. This is a novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor. P7435 has been developed by the NCE Research Division of PEL for the management of metabolic disorders such as lipid abnormalitiesand diabetes. It is well-established that increasedlipid levels’ (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD).

cost-effectively. iMCM has the additional advantages of being an out-of-the-box, multi-platform and mobile-ready platform, Sales and Marketing departments at global pharmaceutical organisations are under increased pressures arising from shrinking pipeline, patent cliffs, increasing compliance requirements from regulatory bodies, dwindling med-rep effectiveness, and surge of digital channels to engage physicians.

Companies have started to look to IT to help exploit inherent opportunities as well as mitigate new risks arising from these market shifts. This has also put unconventional pressures on CIO offices to meet these changing business needs and to deploy enterprise-wide solutions that enable new commercial models.

It has been reported by the World Health Organisation, that CVD, is the number one cause of deaths globally, representing approximately 30 per cent of all deaths. Currently, there is asignificant medical need for effective and safe drugs for the management of lipid abnormalities and metabolic disorders.

Indegene’s Integrated Multichannel Marketing (iMCM) framework provides CIOs with an enterprise-wide architecture that services all pharma stakeholders effectively. The framework puts HCPs at the center of focus and increases the effectiveness of engagement through optimisations, resulting from the integration of applications within the technology stack.

P7435 has demonstrated its lipid lowering potential in various preclinical studies by showingsignificant reduction in triglyceride levels, glucose and insulin levels,and decrease in food intake and body weight gain -factorswhich areassociatedwith lipid abnormalities and metabolic disorders.

Jubilant Biosys, Endo Pharmaceuticals File IND with FDA

PEL has established the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the US will further evaluate the safety and efficacy of P7435 in a larger population.

Dr Swati Piramal, Vice Chairperson, Piramal Enterprises Limited said, “The NCE Research division of PEL continues its ambitious diabetes/metabolic disorders programme to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. With P7435 we are looking at addressing a serious need for effective and well-tolerated drugs that treat lipid disorders, which are commonly associated with diabetes and CVDs. Expansion of this trial will allow testing this NCE in a wider population, which is critical to the development of this drugand will provide therapeutic solutions not just to India but also to the rest of the world.”

Indegene’s iBTS Launches New iMCM Framework for Pharma Organisations Indegene, a leading provider of R&D, commercial and marketing solutions to top global pharmaceutical and healthcare organisations, announced that its’ Information Business Technology Services (iBTS) business unit has launched a robust and innovative Enterprise-ready Multichannel Marketing Framework (iMCM) for Pharmaceutical organisations. iMCM will help clients deploy enterprise-ready consistent, multi-message MCM programmes across brands efficiently and Pharma Bio World

Pharma News 32-44.indd 33

Jubilant Biosys Ltd, a Bengaluru-based subsidiary of Jubilant Life Sciences Ltd, announced the US FDA acceptance of the IND filing for a novel molecule targeting prostate cancer with Endo Pharmaceuticals of the US. This molecule will now progress towards the next phase of development and is anticipated to go into clinical trials by late 2013.

“We are very pleased and elated with this successful outcome, which is the result of excellent collaboration between the scientists at Endo and Jubilant Biosys. Being at the forefront of pharmaceutical, life sciences and healthcare innovation, Jubilant pursues its goal to enable affordable healthcare to patients worldwide,” said Dr SubirKumar Basak, President, Global Drug Discovery Services, Jubilant Life Sciences.

Added Dr Sandeep Gupta, Senior Vice President, Discovery & Early Development, Endo Pharmaceuticals, “I congratulate the Jubilant and Endo teams on achieving this important milestone. It was their outstanding collaborative work and ingenuity that enabled the successful filing and acceptance of an IND in less than three years.

The IND filing and progression of the molecule to the next stage of development further validates Endo’s unique collaborative drug discovery approach which aims to address unmet medical needs and improve patient outcomes.”

The multi-target oncology collaboration between Jubilant and Endo began four years ago, and is focused on developing best-in-class, differentiated therapies that address the unmet needs of cancer patients worldwide. The collaboration has delivered on multiple milestones across the discovery continuum.

August 2013  33

8/21/2013 3:20:16 PM

Sciformix Expands in Philippines Sciformix Corporation, a leading Scientific Process Organisation (SPO), announces the opening of their new offices located in Manila, the Philippines. The expansion into Manila comes as part of From L to R: Randy Canal Sciformix‘s continued growth and Janice Gimenez-Mendoza and provides the opportunity from Johnson & Johnson with Sciformix President and CEO for the company to utilise the Manish Soman. region’s extensive resource of talented medical professionals. Philippine Labor and Employment Secretary, Rosalinda Baldoz, welcomed the move by Sciformix and the opportunity for medical professionals to remain in the Philippines with attractive salaries and career opportunities.

“Sciformix’s continued growth and success has created an opportunity for our expansion into Manila, which is an important piece of our strategy and global footprint. As a leading SPO, this move takes us forward with the goal of adding more than 200 highly skilled employees in the Philippines”, said Manish Vinayak Soman, Sciformix President and Chief Executive Officer (CEO).

Sciformix, recent winner of Frost & Sullivan’s Pharmaceutical Knowledge Process Outsourcing (KPO) Entrepreneurial Company of the Year award, has experienced remarkable growth to become an SPO, a sub-category of KPO specialising in life sciences. The company’s investment in its people and technologies has enabled the business to deliver its clients differentiated services, resulting in rapid double digit revenue growth. Sciformix has a unique positioning as a SPO, in that it combines deep expertise in workflow processes optimisation with scientific knowledge, which delivers in line with their cost efficiency model.

Harris, managing director, Thomson Reuters Life Sciences.

“Our coalition with GenoSpace and PathGroup leverages each organisation’s unique assets, making a huge leap forward in the treatment of cancer.”

PathGroup’s industry-leading anatomic, clinical and molecular pathology services are integrated with the unparalleled information on genes, variants and therapeutic implications from Thomson Reuters. These are then overlaid with GenoSpace’s advanced analytical and information integration capabilities to place this diverse data into context. Oncologists will soon start receiving individualised reports that provide targeted information to help identify the best possible therapy for their patients.

“We have entered a new age of personalised medicine,” said Ben Davis, MD, Chairman, President and CEO of PathGroup.

“It is one in which the unique genetic profile of each patient’s tumor, placed in the context of their disease, can help physicians select treatment options and improve outcomes. The GenoSpace and Thomson Reuters contributions to our SmartGenomics analyses add a highly sophisticated tool to our pathologist’s armamentarium in developing a patient genomic dossier.”

John Quackenbush, PhD, CEO of GenoSpace, said, “The GenoSpace FullView and GenoSpace for Clinical platforms integrate the vast pathology resources available at PathGroup with sequence and array data and information, tying in the extensive knowledgebase available through Thomson Reuters, and deliver concise, relevant and actionable reports to oncologists in a format that they find useful in making treatment decisions. By bringing together the complementary strengths of each company, we will be able to deliver a market-leading solution in personalised genomic medicine.”

Creation of Separate Drug Controller Innovative Life Sciences Treaty to Develop for Ayush may get Delayed Despite an allocation of ` 102 crore to set up Central Drug More Precise Oncology Treatment

GenoSpace, PathGroup and the IP & Science business of Thomson Reuters announced an innovative initiative to develop and deliver a best-in-class personalised medicine service in oncology, the result of which will enable physicians to make more precise therapeutic recommendations for cancer patients.

This partnership combines resources, technology and expertise a c r o s s t h e t h r e e o r g a n i s a t i o n s t o i n t e g r a t e P a t h G r o u p ’s SmartGenomics Next Generation DNA Sequencing and Cytogenomic Array with traditional pathology assays, providing a unique window into disease and patient treatment options through genetic profiling.

“Collaboration is essential to deliver more precise medical solutions in today’s Big Data environment,” said Jon Brett34  August 2013

Pharma News 32-44.indd 34

Controller of Ayurveda, Siddha, Unani and Homoeopathy (Ayush) drugs, the proposal is still stuck with Finance Ministry.The proposal in this regard was sent to Department of Expenditure, Ministry of Finance. The proposal was made way back in June 2010 to create Central Drug Controller for ASU drugs, along with drug control infrastructure at the Central and State levels by appointing separate drug controllers and drug inspectors. Though the bill came up to set up Central Drugs Authority with separate division for Ayush, it did not materialise. Though CDSCO was strengthened by appointing more drug inspectors, no posts were sanctioned for the regulation of drugs of Indian Systems of Medicine & Homoeopathy.

Minister of State for Health and Family Welfare Santosh Chowdhary told the Parliament recently that a number measures were taken to establish the safety and efficacy of Ayush drugs/ medicines and develop their standards.

Pharma Bio World

8/21/2013 3:20:40 PM

A ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India B i o c o n , A s i a ’s p r e m i e r b i o t e c h n o l o g y company, announced the launch of its ‘first in class’ novel biologic ALZUMAb (Itolizumab), the world’s first anti-CD6 monoclonal antibody to be introduced for treating patients with chronic plaque psoriasis, in India.

ALZUMAb with a unique Mechanism of Action (MOA) offers superior safety and similar efficacy profile compared to other existing therapies, and has a long remission period with very low opportunistic infection rate. Psoriasis is a socially debilitating disease affecting 2-3 per cent of world population. The global Psoriasis market size is estimated to cross USD 8 bn by 2016.

Kiran MazumdarShaw, Chairperson & MD, Biocon

Commenting on this development Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, “Biocon’s ALZUMAb (Itolizumab) is the first anti-CD6 monoclonal antibody to be commercialised, an outcome of path breaking research in India .This new line of treatment will usher in a paradigm shift in the management of psoriasis. We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world.”

Rakesh Bamzai President-Marketing, Biocon said: “Biocon is committed to address the huge unmet need of patients suffering from Psoriasis through its ‘first in class’ biologic ALZUMAb. Compared to existing therapies, ALZUMAb offers a better safety and efficacy profile to the patients with longer remission periods and lower infection rates that will lead to better patient compliance and overall reduction in the cost burden to the patient.”

Indicated for the treatment of Moderate-to-Severe Psoriasis, ALZUMAb is being introduced in India by Biocon’s Immunotherapy Division. Formulated as an infusion drug it is manufactured at Biocon’s Biopharma manufacturing facility at Biocon Park, Asia’s largest biotech hub in Bengaluru.

Zotefoams to Supply T-TUBES for Pfizer’s Grange Castle Facility

T-Tubes® with stainless steel pipe inserts

Pharma Bio World

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Zotefoams plc, the world’s leading manufacturer of closedcell cross-linked polyolefin foams, has been awarded a contract to supply their T-TUBES high performance clean room insulation system for Pfizer ’s Grange Castle facility in Dublin. Initial

deliveries of T-TUBES will be supplied during July 2013, in conjunction with ESI Technologies Ltd, Zotefoams exclusive distributor in Ireland. A total of 6.6 km of the inherently pure and chemically resistant T-TUBES product will be installed in the purification, cell culture and harvest and recovery suites, for heat and energy conservation, personal protection and the elimination of condensation and risk of bacteria growth. This combination of features makes T-TUBES the clean room insulation of choice at Pfizer’s major European Bio-pharmaceutical plant.

T-TUBES simple, thermoformed construction reduces installation time, which will assist in the rapid completion and commissioning of the expanded Grange Castle facility that is to host the manufacture of an Active Pharmaceutical Ingredient (API) for Pfizer’s biologic drug programme.

The unique KYNAR PVDF closed cell structure of the foam inhibits moisture and vapour ingress while thermoforming provides a durable, cleanable, puncture resistant skin that helps reduce maintenance and operating costs; further benefits that influenced Pfizer’s decision to use it throughout its expanded clean room facilities at the USD 2.25 million plant. The Grange Castle development is one of the largest integrated biopharmaceutical campuses in the world and is the only facility in Europe to manufacture biopharmaceuticals, pharmaceuticals and vaccines within the same facility.

Waters Acquires Nonlinear Dynamics Waters Corporation announced the acquisition of Nonlinear Dynamics Ltd, a world leader in proteomics and metabolomics analysis software based in Newcastle upon Tyne, UK. Nonlinear Dynamics is best known for its highly-acclaimed Progenesis software which offers researchers unique ways to analyse and visualise the raw proteomic data. Waters and Nonlinear Dynamics previously collaborated on the development of Waters’ TransOmics Informatics, a scalable solution for proteomics, metabolomics, and lipidomics analysis that has seen excellent market acceptance since it was first introduced at the American Society of Mass Spectrometry Conference in 2012.

“The opportunity to combine Nonlinear Dynamics informatics expertise with Waters worldwide leadership in chromatography and mass spectrometry will continue to create significant benefits for omics-focused scientists and laboratories,” said Dr Rohit Khanna, Vice President of Informatics and Worldwide Marketing for the Waters Division. “Proteomics, metabolomics, and lipidomics hold vast potential for understanding the mechanisms of diseases, the development of innovative therapeutics, and discovering biomarkers for translational research.” With complex biological samples and ever more sensitive analytical techniques, managing experimental data continues to be a challenge. Through its acquisition of Nonlinear Dynamics, Waters Corporation hopes to address this challenge to advance the pace of discovery as the world’s leading provider of analytical solutions for proteomics, metabolomics and lipidomics.

August 2013  35

8/21/2013 3:20:50 PM

Sripada Chandrasekhar is New HR Head for Dr Reddy’s

Dr Sripada Chandrasekhar President and Global Head of HR, Dr Reddy’s

Dr Reddy’s has announced the appointment of Dr Sripada Chandrasekhar as the President and Global Head of Human Resources; he will also be a member of Dr Reddy’s Management Council. With over 30 years of experience, Dr Chandrasekhar brings a rare blend of experience across India’s leading firms in Public, Private and Multi-National sectors - both in the early economy areas of steel and manufacturing as well as in the more recent domains of Telecom, IT Services and Consulting.

Prior to joining Dr Reddy’s, Dr Chandrasekhar worked with IBM in India as Vice President and Head of Human Resources for the India/ South Asia region. He was a key member of their India Leadership Team and a Director on the Board of IBM India.

Glenmark Gets FDA Nod for Acamprosate Calcium Delayed Release Tabs Glenmark Generics Inc, USA the subsidiary of Glenmark Generics Limited has been granted final Abbreviated New Drug Approval (ANDA) from the United States Food and Drug Administration (US FDA) for Acamprosate Calcium Delayed Release Tablets its generic version of Forest Laboratories’ Campral Delayed Release Tablets.

Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence. Based on IMS Health sales data for the 12 month period ending March 2013, Acamprosate garnered sales of USD 21 million. Glenmark’s current portfolio consists of 88 products authorised for distribution in the US marketplace and 53 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Breckenridge Pharma to Buy Cypress Assets Breckenridge Pharmaceutical Inc has entered into an agreement to acquire from Pernix Therapeutics, certain assets from its subsidiary, Cypress Pharmaceuticals, for USD 30 million. The assets include 11 Abbreviated New Drug Applications (ANDAs) filed with the FDA, certain ANDAs in various stages of development, as well as 7 previously marketed products.

In addition to solid-oral products, the assets include various unique dosage forms, such as ophthalmic, nasal spray, oral solution, syrup, and powder products. Breckenridge will continue to market the 36  August 2013

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approved products and to prosecute those ANDAs currently filed and pending with FDA. “Breckenridge sees this acquisition as an opportunity to expand our current portfolio, as well as our R&D pipeline. The Cypress assets are a natural fit to and complement the Breckenridge portfolio.” stated Larry Lapila, Executive Vice President of Breckenridge Pharmaceutical, Inc. The closing is expected to occur by midSeptember 2013.

Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognised by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 70 products in a variety of dosage forms.

KemPharm’s Novel Pain Drug Gets USPTO Patent KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, “Phenylethanoic Acid, Phenylpropanoic Acid and Phenylpropenoic Acid Conjugates and Prodrugs of Hydrocodone, Method of Making and Use Thereof.”

The most recent Notice of Allowance pertains to additional composition of matter claims in support of KP201 and other novel prodrugs of hydrocodone, and adds to the intellectual property portfolio governing KP201, which was granted USPTO Patent No. 8,461,137 in June 2013 providing composition of matter protection for benzhydrocodone. KP201, KemPharm’s lead product candidate, is in development for the treatment of acute moderate to moderately severe pain with a New Drug Application (NDA) expected to be filed in Q2 2014. KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of OpioidInduced Constipation (OIC).

Travis C Mickle, PhD, president and CEO of KemPharm, commented, “The allowance of this patent strengthens KemPharm’s intellectual property surrounding the development of KP201 as a prodrug of hydrocodone. This second USPTO patent in the opioid space will provide additional claims related to our first patent for benzhydrocodone, which issued less than two months ago. It also underscores the versatility and prolificacy of our LAT technology in generating new, unique molecules with therapeutic benefits, in particular with regard to abuse deterrent and side effect reducing properties when compared to currently marketed hydrocodone products.”

Pharma Bio World

8/21/2013 3:20:55 PM

Onyx, Idis to Start Carfilzomib Managed Bavarian Nordic to Market Imvanex Access Programme in EU in Europe Onyx Pharmaceuticals, Inc,a global biopharmaceutical company, has partnered with Idis Limited to start a managed access programme for carfilzomib in certain countries in Europe for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory Tony Dutta, MD, Idis agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

The managed access programmes provide biopharmaceutical companies with a way to allow eligible patients ethical access to medicines for unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available.

“Idis is the recognised leader in managed access programmes, making them an ideal partner to oversee this important initiative on behalf of Onyx,” said Pablo J Cagnoni, MD, executive vice president, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.

Idis, a UK-based global company, is partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs.

“Patients with advanced cancer face unique challenges, among them, gaining timely access to innovative new therapies,” said Tony Dutta, managing director of Idis. “Through our work with Onyx Pharmaceuticals, we will share our expertise in successfully addressing access challenges and help educate a broad range of stakeholders on navigating the options and obstacles that exist for these patients.”

Carfilzomib, marketed in the US under the brand name Kyprolis (carfilozmib) for injection, is approved by the US Food and Drug Administration for treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Onyx Pharmaceuticals, Inc is a global biopharmaceutical company engaged in the development and commercialisation of innovative therapies for improving the lives of people with cancer.

The company is focused on developing novel medicines that target key molecular pathways.

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Bavarian Nordic A/S announced that the European Commission has granted marketing authorisation for Imvanex for active immunisation against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis). The authorisation covers all 27 European Union member states and European Economic Area countries Iceland, Liechtenstein and Norway.

Imvanex will be made available for governments to purchase and use in accordance with official national recommendations.

“The marketing authorisation of Imvanex marks a significant milestone for our company and our MVA-BN vaccine technology platform, which we have taken from early research through regulatory approval and now serves as the foundation for multiple candidates in our development pipeline,” said Anders Hedegaard, President and CEO of Bavarian Nordic. “We are delighted to receive our first regulatory product approval, and we look forward to working with the European governments to address the requirements for their national preparedness plans, focusing on the advantages that Imvanex brings in terms of safety and administration for people at risk.”

Imvanex is the only smallpox vaccine approved through the centralised procedure and available to all EU member states. Known as Imvamune in the US, it has been developed under contracts with the US Government. To-date, Bavarian Nordic has manufactured and delivered 17 million doses of the vaccine to the US Strategic National Stockpile for emergency use in immune compromised individuals, such as people with atopic dermatitis and HIV who are not recommended to receive conventional, replicating smallpox vaccines. Imvanex has also been supplied to other government stockpiles around the world.

Sagent Re-launches Amiodarone Sagent Pharmaceuticals, Inc announced the reintroduction of Amiodarone HCl Injection, an antiarrhythmic agent, now in an improved prefilled plastic syringe that is compatible with most standard I.V. pumps. According to IMS, for the 12 months ending June 2013, the US market for Amiodarone HCl Injection approximated USD 16 million. As with all products in Sagent’s portfolio, Amiodarone features Sagent’s PreventIV Measures packaging and labeling, designed to help reduce medication errors.

Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy.

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8/21/2013 3:20:59 PM

AMAG Pharma’s Ferumoxytol Gets US Patent AMAG Pharmaceuticals, Inc announced that the United States Patent and Trademark Office (USPTO) has issued a new US patent to AMAG for ferumoxytol, US Patent No. 8,501,158, Polyol and Polyether Iron Oxide Complexes as Pharmacological and/or MRI Contrast Agents, expiring in 2020. This Orange Book listed patent covers the use of 500 mg -600 mg of ferumoxytol for the treatment of patients with iron deficiency anemia.

“We believe that this issued patent complements and expands our intellectual property protection for ferumoxytol, providing further specific claims related to approved dosing and formulation,” commented Frank Thomas, chief operating officer of AMAG.

Dr Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: “Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients.”

ScinoPharm, Sundia MediTech Tie-up to Expand CRAMS in China ScinoPharm (Changshu) Pharmaceuticals and Sundia MediTech Company Ltd have formed a strategic alliance to seek more opportunities for collaboration on Contract Research and Manufacturing Services (CRAMS) in mainland China and to tap into this large and growing business potential.

AMAG now has four Orange Book listed patents for ferumoxytol, with patent protection through 2020, without patent term extension.

AMAG has applied for a patent term extension for an Orange Book listed ferumoxytol patent, which would lengthen that patent term through June 2023.

Teva Pharma to Market Lonquex in EU Teva Pharmaceutical Industries Ltd announced that the European Commission has granted marketing authorisation for Lonquex (lipegfilgrastim). This approval provides the regulatory framework for the commercialisation of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.

Lonquex is a long-acting recombinant granulocyte colonystimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

“This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer” said Dr Rob Koremans, President and CEO of Teva Specialty Medicines. “Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states.”

Lonquex has undergone a full clinical development programme, including pre-clinical to clinical in vivostudies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

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Dr Jo Shen, CEO of ScinoPharm Taiwan & chairman of ScinoPharm Changshu

Dr Jo Shen, CEO of ScinoPharm Taiwan and chairman of ScinoPharm Changshu, stated, “Resources from our Changshu site in Jiangsu province, China, and the Shanghaibased CRO company Sundia will be combined to establish a robust collaboration with single-source solutions to address the increasing number of multinational companies shifting their drug development research and clinical trials in China.”

“Sundia has established long-standing and strong relationships with a number of big pharmaceuticals and small/medium-sized biotech companies from the US, Europe, Japan and South Korea in the fields of chemistry, biology, preclinical, formulation and API manufacture, helping our clients and partners to bring drugs to the market efficiently,” said Dr Chen Chen, Sundia’s CEO. “Sundia is very pleased to have the opportunity to work with ScinoPharm, a world-leading process R&D and API manufacturing service provider. I am sure that the strategic partnership between Sundia and ScinoPharm will have mutual benefits, helping each other to thrive in both international and China Market.”

This cooperation combines Sundia’s diversified technical know-how and capabilities in new drug R&D with ScinoPharm’s process R&D and commercial production advantages, especially in the field of highly potent oncological APIs. Under the alliance, both parties will be able to further support customer needs with one-stop solutions for integrated services such as drug development, research, clinical trials and commercial manufacturing. Presently, China is one of the most preferred CRAMS destinations in Asia and is likely to witness substantial growth in this field as global R&D expenditures increase in outsourcing services, especially to China.

Pharma Bio World

8/21/2013 3:21:06 PM

Alpha Expands HDPE Manufacturing Facility Alpha Packaging has just qualified seven new injection blow molded high density polyethylene (HDPE) packers as part of its new HDPE Pharma Line. When completed later this fall, Alpha’s Pharma Line will consist of more than a dozen injection blow molded and extrusion blow molded bottles that replicate the HDPE round bottles most prevalent in the pharmaceutical industry. The new line is also ideal for Alpha’s core customer base of nutritional supplement manufacturers and fillers – many of which are located on the East Coast near Alpha’s Bethlehem, Pennsylvania, manufacturing site.

Rather than replicating its own existing HDPE lines or simply moving assets from other plants, Alpha is investing in brand-new IBM and EBM machines and new molds for more than a dozen sizes of bottles, ranging from 50cc to 950cc. Sizes up to 300cc will be manufactured on brand new equipment using the Injection Blow Molding process. Larger sizes will be Extrusion Blow Molded on new equipment with brand new blow molds. Production lines will also feature state-of-the art vision systems and leak detectors. Alpha is investing more than USD 3.5 million in new machines, molds and downstream equipment for phase I of the new HDPE cell, and is prepared to double or triple that investment in 2014.

Karnataka is also home to the internationally compliant pharma production houses and the state is also the first in the country to have a dedicated pharma policy.

Post his election, Sheth told that the Karnataka pharma industry was in a tenuous situation as it is bogged down with issues of the new pharmaceutical pricing policy and fixed dose combinations where now retrospectively the industry needed to submit the safety and efficacy profiles of the FDCs available in the market.

Soho Group, Fresenius Kabi Ink Partnership Deal SOHO Group, as one of the largest pharmaceutical companies in Indonesia, manufactures and markets a broad range of consumer health products, natural as well as generic medicines, medical devices and equipment, officially announced a joint venture partnership with Fresenius Kabi, a leading international health care company focusing on products for the therapy and care of critically and chronically ill patients. This company’s products comprise I.V. generic drugs, infusion therapies, clinical nutrition products and related medical devices. Moreover, Fresenius Kabi offers transfusion technology products.

In addition to the new line of HDPE packers, the high-cavity, large output extrusion platform will allow Alpha to capture custom packaging projects for personal care, household chemicals and automotive products. Alpha’s manufacturing processes integrate the finest Food and Drug Administration-approved raw materials with state-of-the-art equipment and stringent quality control processes.

All manufacturing and warehousing is conducted in sealed, clean, controlled environments. Most manufacturing lines include leak detectors and vision systems installed in-line.

According to Marcus Pitt, President Director of SOHO Group, the JV will expand and differentiate SOHO Group’s products to be ready for the introduction of the ‘universal health coverage’ due to commence in 2014. Furthermore, it will strengthen SOHO Group’s research and development capabilities and introduce new technologies, investment in state of the art of manufacturing facilities and greater access to regional markets within South East Asia. Marcus added that this is the key strategy of SOHO Group in developing our generic products and will place SOHO Group in a stronger position in the fast growing market.

Jatish N Sheth to Take Over as KDPMA President

After a long and thorough process established to identify the most strategic partner, it was clear that Fresenius Kabi was our preference as the best partner. Barclays acted as sole financial advisor to the SOHO Group for this transaction. The joint venture will focus on SOHO Group’s generic prescription drugs and will utilize its entity PT. ETHICA Industri Farmasi, one of SOHO Group’s subsidiaries, which was established in 1946 and was the first company to manufacture sterile injection products in Indonesia. Fresenius Kabi will take an equity position and contribute its I.V. generic medicines, oncology medicines, and infusion solutions to the JV. This JV will provide SOHO Group a foundation to implement its strategic plan and also is in line with the Group’s vision to become one of the leading global corporations in the field of manufacturing, distributing and providing quality healthcare products and services.

Fresenius Kabi is 100 per cent owned by Fresenius SE & Co KGaA with its head office in Bad Homburg, near Frankfurt – Germany.

Fresenius was established by Dr Eduard Fresenius on 1 st October 1912 and celebrated its 100 years anniversary in 2012. Fresenius Kabi employs around 30,000 employees worldwide and operates more than 65 production sites and compounding centers.

Srushti Pharmaceuticals P Ltd director Jatish N Sheth has now been elected as the president of the Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA) taking over SG Biligiri, vice president, (Technical), Jaggat Pharma.

Jatish N Sheth President, KDPMA

Incidentally Sheth is also the vice chairman of Confederation of Indian Pharmaceutical Industry (CIPI).

A couple of years ago, Seth was also the secretary of KDPMA. As a first generation pharma entrepreneur, Seth is adept in handling not just fiscal and monetary aspects of the drug research and manufacturing business but going straight out straight on for global regulatory clearances.

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8/21/2013 3:22:35 PM

MorphoSys, Celgene Tie up for MOR202

Jens Holstein, Chief Financial Officer, ofMorphoSys AG

MorphoSys AG announced that its MOR202 alliance with Celgene Corporation has become effective upon receiving anti-trust clearance under the US Hart-Scott-Rodino Act. In conjunction with deal closure, MorphoSys increased its financial guidance for fiscal year 2013 and the management board and supervisory board of MorphoSys resolved on a capital increase from authorised capital to issue 797,150 new shares to Celgene Alpine Investment Co, LLC.

Jens Holstein, Chief Financial Officer of MorphoSys AG, commented: “We are very pleased about receiving regulatory clearance and will now put our strategic alliance with Celgene into action. The upfront payment plus the equity further strengthens our financial position, enabling us to expand our proprietary portfolio of promising development candidates through targeted investments”.

As a result of the Celgene transaction, MorphoSys has increased its financial guidance for fiscal year 2013. MorphoSys now expects revenues of approximately EUR 74 million to EUR 78 million (previously EUR 68 million to EUR 72 million) and an EBIT of EUR 2 million to EUR 6 million (previously EUR -2 million to EUR +2 million). In the capital increase Celgene will invest EUR 46.2 million to subscribe for 797,150 new shares of MorphoSys at a share price of EUR 57.90 per share. This represents 3.4 per cent of MorphoSys’s registered share capital and a premium of 5.0 per cent on the share’s closing price on August 9, 2013.

Apricus’ Vitaros Gets 4 National Phase Approval Apricus Biosciences Inc has received national phase approvals from the Irish Medicines Board and the Netherlands’ Medicines Evaluations Board to Vitaros, indicated for the treatment of patients with erectile dysfunction (ED). The company has now received a total of four national phase approvals for Vitaros including Ireland, the Netherlands, Sweden and the United Kingdom (UK).

In June 2013, Apricus Bio announced that its marketing application for Vitaros was approved through the European Decentralised Procedure (DCP). Under the DCP, Apricus Bio filed its application for marketing approval designating Netherlands as the Reference Member State (RMS) on behalf of nine other European Concerned Member States (CMS) participating in the procedure. The company continues to work independently, as well as with its commercialisation partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Germany, Italy, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros can then be initiated in each country by Apricus Bio’s commercialisation partners.

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“Vitaros has now received national approvals in four of the ten European countries where marketing authorisation applications are being pursued,” said Richard Pascoe, chief executive officer of Apricus Bio. “We believe that Vitaros is on track to obtain the remaining European approvals beginning in the third quarter of this year and continuing through the first quarter of 2014. Our regulatory efforts, along with the actions taken by our existing European partners, Takeda, Sandoz and Bracco, continue to move successfully toward making Vitaros ready to launch in each of the included territories across Europe.” Vitaros is currently partnered in key markets, including with Takeda in the UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio recently launched a comprehensive partnering process with the goal of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America and North Africa. The Company is reviewing bids recently received from multiple interested parties for the available territories and Company expects the Vitaros partnering process to be completed in the fourth quarter of 2013.

Once launched, Vitaros will become the first new and novel erectile dysfunction product in nearly a decade, and with its unique product profile that addresses a large number of patients who cannot or do not respond well to these existing therapies, or who are intolerant to the systematic effects of PDE5 inhibitors, it is well-positioned for commercial success. In Europe alone, the existing erectile dysfunction products generated over USD 1 billion in sales in 2012. Apricus Bio believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros.

Verastem Bags Key US Patent Verastem, Inc has received a key patent No. 8,501,763 from the US Patent and Trademark Office claiming composition of matter for VS-4718, the Company’s novel, small molecule inhibitor of cancer stem cells through blockade of focal adhesion kinase (FAK). The US patent grants coverage of VS-4718 into 2029.

Corresponding patent applications are pending in major markets throughout the world including Europe, Japan, Australia and Canada.

Preclinical models of multiple tumour types have established the FAK pathway as critical for the growth and survival of cancer stem cells, which are an underlying cause of tumour metastasis and recurrence.

Verastem recently initiated a phase I open-label, multi-centre, doseescalation study of VS-4718 in patients with advanced cancer. The study is expected to enroll up to 40 patients at three US locations.

“This patent is the cornerstone of our intellectual property estate for VS-4718, a potent inhibitor of FAK which we believe holds significant potential in the treatment of a variety of cancers,” said Robert Forrester, Verastem president and chief executive officer.

“VS-4718 is our second drug candidate targeting cancer stem cells to enter the clinic, following defactinib (VS-6063), which is entering a registration-directed clinical trial in patients with malignant pleural mesothelioma. We believe treatments targeting cancer stem cells will be critical to achieving durable clinical benefit in cancer.”

Pharma Bio World

8/21/2013 3:24:01 PM

Biofortuna to Expand Manufacturing Business Biofortuna, a UK based molecular diagnostics company with a proprietary stabilisation technology for molecular reagents, is expanding its custom service and manufacturing business with a 1.3 million pound investment.

The new funds will enable the business to expand its freeze drying analysis and manufacturing capability to support both its custom service clients and the USA launch of its SSPGo HLA range of products through Abbott Molecular.

The company’s strategic rationale for the Transaction includes securing a long-term fixed-cost supply of critical active pharmaceutical ingredients for two flagship OTC brands Arbidol and Aphobazolum as well as significantly increasing the company’s profitability. It is expected that Bever will be included in a proposed spin-off of the company’s branded over-the-counter business.

Bever is 100 per cent controlled by Bristley Enterprises Limited (Bristley), which is owned by Dr Alexander Shuster, the company’s non-executive member of the board of directors. Upon completion, Bristley will become the Company’s second largest shareholder with an approximately 18.74 per cent stake.

The funding was supported by all of the company’s current investors; the Foresight Group (UK), EV Group, Catapult Venture Managers, Merseyside Special Investment Fund, private investors and management.

Completion of the Transaction is subject to approval at the company’s extraordinary shareholder meeting (EGM), which is scheduled for August 17, 2013. Board of directors of Pharmstandard-Leksredstva OJSC made the decision to abstain from voting at the EGM.

Biofortuna has developed a unique method to stabilise molecular diagnostic products using proprietary freeze-dried technology.

Current DNA tests are stored and transported when frozen and are required to be carefully thawed and mixed prior to the addition of patient DNA.

Baker & McKenzie is advising Pharmstandard on the Transaction and is engaged to provide legal opinion. Citigroup Global Markets Limited is engaged to provide fairness opinion to the board of directors of Pharmstandard in relation to the Transaction.

Biofortuna’s unique stabilisation approach means that all reagents are premixed and freeze dried so that the end user is only required to add the patient’s DNA sample which makes the test simple, quick and easy whilst reducing cost and manual errors. Additionally the kits can be stored and transported at ambient temperature, eliminating the need for fridges, freezers and temperature controlled shipping.

Cell Therapeutics’ Pixuvri Gets Market Access in France

The company is offering its technology, together with its design, development and manufacturing capability, on a custom service basis to clients who want to convert kits to a stabilised format and are working with a wide range of companies to give them a competitive edge in the market place.

Pharmstandard OJSC to Acquire Bever Pharma P h a r m s t a n d a r d O J S C , R u s s i a ’s l e a d i n g p h a r m a c e u t i c a l company which develops and manufactures high-quality modern pharmaceutical products, has agreed to acquire 100 per cent share capital of Singapore-based Bever Pharmaceutical Pte Ltd (Bever).

Total consideration for the acquisition of Bever is agreed at USD 590 million and will be funded by the combination of Pharmstandard’s shares and GDRs owned by Pharmstandard-Leksredstva OJSC in the amount of USD 542 million (price per share of RUB 2,235.4 and price per GDR of USD 20.76) and cash of USD 48 million, which may be financed from external sources. PharmstandardLeksredstva OJSC currently holds Pharmstandard’s shares and GDRs on its balance sheet at approximately USD 475 million.

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Cell Therapeutics, Inc (CTI) reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access for the medicinal product PIXUVRI (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy).

The next and final step in France’s pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France, which CTI now intends to pursue. The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease. All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6. The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use. The CT will reassess the ASMR rating for PIXUVRI within two years.

“We are pleased to receive the CT’s favorable opinion for reimbursement of PIXUVRI and look forward to bringing this new approved therapy to patients in France with aggressive NHL,” said James A. Bianco, MD, President and CEO of CTI. August 2013  43

8/21/2013 3:24:09 PM

Altor to Begin IL-15 Superagonist ALT-803 Trial Altor BioScience Corporation (Altor), a leading developer of immunotherapeutics, announced that the US Food and Drug Administration (FDA) has allowed the Investigational New Drug (IND) application for Altor’s novel interleukin-15 (IL-15) superagonist protein complex, ALT-803, against metastatic melanoma. IL-15 is a critical factor for the development, proliferation and activation of cellular immune responses and is considered one of the most promising cancer immunotherapeutic agents by the National Cancer Institute (NCI) of the National Institutes of Health. In preclinical studies, ALT-803 has been shown to have significantly greater biological activity and a longer half-life compared to IL-15. The clinical trial of ALT-803 against incurable melanoma will be jointly sponsored by the Melanoma Research Alliance (MRA), Cancer Immunotherapeutic Trial Network and Altor. Dr Kim Margolin at the Fred Hutchinson Cancer Research Center at the University of Washington will be the leading Principal Investigator of this first-inhuman safety and efficacy clinical trial of ALT-803. Results from this trial will further guide Altor’s development of ALT-803 against other metastatic malignancies and viral infections. Patient enrollment for this trial is expected to start within two months.

Altor’s scientists have also revealed the novel T-cell-based antitumor mechanism of action of ALT-803 in experimental hematological tumor models. The results of these findings have been published in the May 15 issue of the peer-reviewed journal Cancer Research, the world’s most frequently cited cancer journal. Altor is currently collaborating with more than a dozen leading universities and research institutes to evaluate ALT-803 as an immunotherapeutic against various cancers and infectious diseases. The preliminary results from these collaborations are very encouraging and indicate that ALT-803 has substantial potency against a variety of solid tumors as well as HIV infection in experimental models.

Altor also announced that the US Patent and Trademark Office has issued a composition-of-matter patent covering ALT-803 (US Patent No. 8,507,222, entitled “Multimeric IL-15 Soluble Fusion Molecules and Methods of Making and Using Same”).

Abbott Closes Acquisition of OptiMedica Abbott has completed its acquisition of OptiMedica Corporation, a privately-held, Silicon Valley-based ophthalmic device company.

The acquisition expands Abbott’s vision care business into the femtosecond laser-assisted cataract surgery market. Most cataract procedures are performed manually with the surgeon making incisions into the eye by hand. OptiMedica’s Catalys Precision Laser System is designed to allow surgeons to replace some of the technically demanding manual steps in cataract surgery with precise, imageguided, femtosecond laser technology. A femtosecond laser can be used to create an anterior capsulotomy, 44  August 2013

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effect phacofragmentation, and make a variety of incisions during cataract surgery. The Catalys laser system has both CE Mark in Europe and clearance from the US Food and Drug Administration.

“OptiMedica’s Catalys system enhances Abbott’s leadership position in vision care with the addition of a state-of-the-art laser cataract technology to our portfolio,” said Murthy Simhambhatla, senior vice president, medical optics, Abbott. “OptiMedica’s technology combined with Abbott’s global market presence, offer the potential to provide advanced cataract treatment options to more patients around the world.” Abbott acquired OptiMedica for USD 250 million, net of cash. Additional amounts totaling up to USD 150 million will be payable upon completion of certain development, regulatory and sales milestones.

Venus Remedies Gets Approval to Market Meropenem in France Venus Pharma GmbH, a subsidiary of Venus Remedies Limited, one of India’s fastest growing research-based pharmaceutical companies, has made big strides in the global market by bagging marketing authorisation (MA) approval from France for meropenem, a generic broad spectrum antibiotic injectable. It has signed a nonexclusive marketing rights deal with generic giant Mylan to sell meropenem in France, world’s fifth largest pharmaceutical market with a market share of 3.8 per cent.

Terming it as a major achievement, Ashutosh Jain, Executive Director-cum-Chief Operating Officer (COO), Venus Pharma GmbH, said, “We are proud of our drug regulatory capabilities, which have enabled the company to emerge as a key player in the European Union (EU)markets. Driven by our MA grants, we are all set to grab the maximum share in the USD 270-million meropenem market in the EU in the near future.”Meropenem is an off-patented generic broad spectrum anti-bacterial agent of carbapenem family, which fights diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.

“Currently, Venus is generating good revenue from the export of meropenem to EU markets. In FY2012-13, we generated a business of about Euro 5 million from meropenem exports. This figure is expected to double by the end of this fiscal year. We have plans to capture the meropenem share in other lucrative markets as well, including Australia, Spain, Switzerland, South Africa, Malaysia and Gulf Central Committee (GCC) countries where the registration process is in advanced stages,” said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies Limited.

Venus has already received marketing authorisation for meropenem from the UK (Medicines and Healthcare products Regulatory Agency), Austria, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. It has also achieved a major breakthrough in Balkan countries by getting marketing approvals from Bosnia & Herzegovina and Croatia.

Pharma Bio World

8/21/2013 3:24:10 PM

biotech news XstalBio Introduces CentuRecon XstalBio Ltd announced the launch of CentuRecon, a new patented reconstitution technology that has the potential to revolutionise the preparation of high concentration protein solutions from dry powders and make delivery faster and safer.

Biologic drugs such as monoclonal antibodies are a major growth area for the pharmaceutical industry but their delivery by subcutaneous administration provides unique challenges.

CentuRecon enables dry formulations of therapeutic proteins to be prepared for injection at high concentration in minutes, rather than hours, and produces foam-free solutions that maximise the deliverable dose.

Barry D Moore , R&D Director, XstalBio

CentuRecon works well with standard lyophilised formulations and diluents and with normal vials, cartridges or dual-chamber syringes. It is particularly beneficial for very high concentration and/ or viscous solutions that may need to be delivered with injection devices. Medical practitioners will find CentuRecon straightforward and cost-effective to implement with patients benefiting from fewer injections and shorter visits. Further developments are expected to make self-administration simpler and more convenient.

XstalBio’s R&D Director, Barry D Moore, commented “We believe CentuRecon is a game-changing technology; uniquely it provides a rapid, safe and reproducible method for preparing very high concentration protein solutions from dry powder formulations. We believe it will open up new clinical opportunities for biologics and become the reconstitution method of choice for R&D scientists.

CentuRecon is a good example of how XstalBio’s R&D teams are able to develop technologies that provide simple solutions to complex problems.”

BIND Doses First Patient in Phase 2 Study of BIND-014 BIND Therapeutics, a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, announced that it has dosed the first patient in a Phase 2 clinical trial to assess the safety and efficacy of BIND014, a PSMA-targeted Accurin containing docetaxel, as secondline therapy in patients with non-small cell lung cancer. “There are limited options for patients with advanced non-small cell lung cancer in the second-line setting. We are pleased our Phase 1 trial of BIND-014 established the safety profile and appropriate Phase 2 dose for this drug candidate, and we are advancing BIND-014 into Phase 2 development to further evaluate its clinical activity as a potential treatment option for patients who are in need of more effective therapies,” said Gregory Berk, MD, Chief Medical Officer of BIND Therapeutics.

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This 40 patient, open label, single arm, multi-center study is designed to determine the efficacy of BIND-014 as measured by objective response rate in patients with Stage III/IV non-small cell lung cancer who have failed one prior platinum-containing chemotherapy regimen for advanced or metastatic disease. For more specific information on the trial, including patient eligibility and clinical trial endpoints, please visit www.clinicaltrials.gov (NCT01792479).

BIND-014 represents the first Accurin nanomedicine to reach the clinic from BIND’s Medicinal Nanoengineering platform. BIND014 targets prostate-specific membrane antigen (PSMA), a target expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, and contains docetaxel, a clinically-validated and widely used chemotherapy drug. Docetaxel is currently FDA-approved for the treatment of breast cancer, non-small cell lung cancer, metastatic castrate-resistant prostate cancer, head and neck cancer, and gastric cancer.

Adimab Inks Antibody Deals with GSK and Biogen Idec Adimab, LLC, a leader in the discovery of fully human monoclonal and bispecific antibodies, announced its first platform technology transfer and license agreement with GlaxoSmithKline (GSK).

Adimab to receive significant upfront payments, annual licensing fees, and royalties on resulting commercialised products. Under the agreement, GSK has been granted a non-exclusive license to use Adimab’s antibody platform for the discovery, and optimization of all antibody formats, including bispecific antibodies.

Under the terms of the agreement, GSK will have a broad license to the Adimab antibody discovery platform and a unique custom antibody library that is exclusive to GSK. In another development, Adimab announced an expanded collaboration with Biogen Idec for the discovery of antibody based therapeutics. Under the terms of the agreement Adimab will license and transfer its proprietary antibody discovery platform to Biogen Idec and enable Biogen Idec researchers to utilise the Adimab technology for the discovery, optimisation of all antibody formats, including bispecific antibodies. Following GSK, Biogen Idec will be the second pharmaceutical company to internalise the Adimab platform. Biogen Idec will receive a custom human antibody library that is unique and exclusive to Biogen Idec and will obtain a license to the Adimab Platform for use in Biogen Idec’s targeted therapeutic areas.

In addition, both GSK and Biogen Idec has secured an option to receive continued improvements to the Adimab Platform, including access to new antibody libraries. Adimab will receive an undisclosed upfront, signing fee, plus future payments upon achievement of specified preclinical and clinical milestones, as well as royalties and additional future payments upon achievement of specified commercial milestones on therapeutic products.

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8/21/2013 3:47:45 PM

Scientists Develop Carbohydratebased Cancer Vaccine Researchers from Academia Sinica and Genomics Research Center (GRC) have developed vaccine candidates against prostate cancer and the pathogen that causes meningococcal meningitis.

The research team led by Academia Sinica President, Dr Chi-Huey Wong, and associate Dr Chi-Huey Wong President, Academia research fellow, Dr Chung-Yi Wu of GRC Sinica has made further progress in understanding the connection between molecule of interest SSEA4 and the spread of cancer cells. Cell surfaces are coated by sugar structures (glycans), which often differ on normal human cells and on bacteria or diseased cells. The differences in these sugar structures help disease cells to evade attacks from host immune systems and make diseases more deadly. They can also be exploited to develop anti-bacterial/anti-cancer vaccines, or used as early cancer detection tools; therefore, identifying and understanding these molecules has become an important topic in glycoscience research.

Prostate cancer is the most common cancer for men in developed countries such as the US. As the fatality rate increases gradually every year, prevention and treatment for the prostate cancer are urgently needed. In 2005, Dr Hakomori discovered that the amount of RM2 antigen increases as prostate cancer progresses; therefore, RM2 antigen is an excellent biomarker for prostate cancer staging and a good target for developing prostate cancer vaccine. The research team from the GRC is the first ever to successfully synthesize this complex glycan molecule and further attach it to carrier protein CRM197 to create a prostate cancer vaccine candidate, which was combined the previously developed glycolipid adjuvant C34 for vaccine tests in a mice animal model.

New Developments on Bird Flu A group of scientists have proposed to conduct a highly controversial ‘gain-of-function’ bird flu research that has already generated some harsh criticism. In a letter first published in leading science journals, the group has outlined the types of studies it believes should be conducted. Only a year back the H5N1 gain-of-function controversy caused a raging debate in the scientists’ circle, some of who highlighted the grave dangers associated with such kind of research. One of the authors, Dutch virologist Ron Fouchier has explained that the idea behind the letter is for researchers to be transparent about what they plan to do in the hope of fending off some of the concerns that emerged in the H5N1 controversy. A gain-of-function research involves adding mutations of a virus to see if it can gain features it doesn’t currently have, such as the ability to resist flu drugs or spread easily from person to person. Such a research is aimed at identifying changes that would give a virus these capacities so 46  August 2013

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that public health laboratories could be on the lookout for viruses with these changes that emerge in nature.

Furthermore, a recently published study in the British Medical Journal (BMJ), revealed that the world’s first human-to-human avian influenza transmission might have taken place. A Chinese father is suspected to have transmitted the novel avian influenza A (H7N9) virus to his daughter who had tended to him during the illness in early March 2013. The proposed research would revolve around the latest deadly strain of avian infleunza (H7N9 bird flu) that sent ripples of fear in China earlier this year. This strain of influenza virus, H7N9 has so far infected 134 humans, out of which 43 lost their lives. In July this year, the World Health Organization (WHO) had said that there have been 633 known cases of H5N1 flu and 377 of the cases have died from the infection.

India, Germany Tie up for Health, Biomedical Research

In an effort to stimulate new collaborations, India and Germany will soon begin a joint research in the fields of health research and biomedical sciences, under the Indo-German Cooperation.

Both the nations will be cooperating in the priority areas in health research and biomedical sciences like regenerative medicine, neurology and mother and child health.

The programme will focus on the preparation of joint projects under national funding programmes and will facilitate bilateral cooperation between the scientific communities of India and Germany by way of joint research projects, bilateral workshops/seminars, exchange visits of scientists, scientific delegations and composite (scientific and industrial) delegations. Both sides will explore the possibility of funding from European Union research programmes.

Evaluation and selection criteria of the programme will be based on relevance to German and Indian national programmes and multinational programmes, preparation of new projects in applied fields of mutual benefit and justification for collaboration, quality and originality of research approach, qualification of applicant and availability of infrastructure, expected results and outcomes and the proposals should include young scientists.

The Indian Council of Medical Research (ICMR) under the Department of Health Research (DHR) of the Ministry of Health & Family Welfare, Government of India, and the Project Management Agency at the German Aerospace Centre (PT-DLR, European and International Cooperation), Bonn are the nodal implementing agencies from the Indian and German side respectively.

Pharma Bio World

8/21/2013 3:53:14 PM

CTL, Zhongyuan Union JV for Stem Cell Therapies UK based Cell Therapy Limited (CTL) , entered into a joint venture (JV) agreement with Chinese firm Zhongyuan Union Stem Cell Bio-engineering to develop stem cell therapies in order to combat life-threatening ailments such as heart disease and diabetes. The new deal will see the two firms form JV in multiple cities across China and developing large operational hubs near Shanghai and Beijing. The JV will also see the two firms share half of the revenues generated in China and will provide first option to all of Zhongyuan Union’s products outside China. CTL was founded in Cardiff in 2009 by Nobel Laureate professor Sir Martin Evans and executive director Ajan Reginald. The JV agreement was signed

by Sir Martin in Tianjin, China, along with Li Defu, chairman of Zhongyuan Union’s parent company Tianjin Vcanland.

Reginald, while speaking about the JV, said that, the partnership will enables CTL to accelerate development of treatments for heart disease and diabetes while accessing the growing China market.

Prana Closes PBT2 Phase 2 Trial Prana Biotechnology announced the successful completion of Reach2HD, a phase 2 clinical trial in patients with early to midstage Huntington disease. The Company expects to announce the results arising from the trial in October.

Reach2HD is a double blind placebo controlled Phase 2 trial testing the safety and efficacy of PBT2, the Company’s lead compound under development for both Huntington disease and Alzheimer’s disease. “We have been extremely pleased with the conduct of the trial, at all levels including recruitment and patient retention,” said Dr Ray Dorsey, Principal Investigator of the Reach2HD study and Director of the Huntington Study Group Coordination Center.

Reach2HD had planned to recruit 100 patients with Huntington disease in 9 months. In fact, 109 participants were enrolled in the trial within that period. “The strong rate of recruitment reflects support for the Reach2HD trial within the Huntington disease clinical research community,” said Dr Dorsey. Of the 109 enrolled, 104 patients completed the trial, reflecting a 96 per cent retention rate.

A Data Safety Monitoring Board met on five occasions throughout the trial and on each occasion recommended that no changes or modifications to the study protocol be made based on their review of the safety data. The primary outcome of the trial is safety and tolerability. The trial also includes a number of secondary outcome measures from the cognitive, motor and behavioural domains affected in Huntington disease. A positive result of Reach2HD will identify signals of therapeutic benefit in one or more of the domains measured, which will inform the design of the next clinical trial.

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Huntington disease is a complex and severely debilitating genetic, neurodegenerative disease, for which there is no cure. The disease often affects young adults and, whilst associated with severe physical movement symptoms, progressively impacts the mind and emotions as well.

The disease causes incapacitation and death about 15-25 years after onset. The disease affects over 30,000 people in the US and 70,000 worldwide. The Huntington Study Group (HSG) collaborated with Prana to coordinate the Reach2HD trial across 20 sites in the USA and Australia.

Japan OKs Pioneering Stem Cell Clinical Trials Japanese scientists have got approval from the government to begin world’s first clinical trials using stem cells harvested from a patient’s own body.

The research is aimed at treating age-related macular degeneration (AMD), a common medical condition that causes blindness in older people, using “induced Pluripotent Stem (iPS) cells”.

Stem cell research is a pioneering field that may offer a cure for conditions that are presently incurable, and scientists hope these clinical trials on a treatment for AMD may offer hope to millions of people robbed of their sight. A government committee last month approved proposals for the tests, which will be jointly conducted by the Riken Center for Developmental Biology and the Institute of Biomedical Research and Innovation (IBRI) Hospital in the western city of Kobe.

Riken will harvest stem cells, using skin cells taken from patients, a spokesman said. The trial treatment will attempt to create retinal cells that can be transplanted into the eyes of six patients suffering from AMD, replacing the damaged part of the eye. The transplant may be conducted as early as the middle of next year at the IBRI Hospital, he said.

AMD, a condition that is incurable at present, affects mostly middle-aged and older people and can lead to blindness. It afflicts around 700,000 people in Japan alone. Stem cells are infant cells that can develop into any part of the body.

Until the discovery of iPS cells several years ago, the only way to obtain stem cells was to harvest them from human embryos. This is controversial because it requires the destruction of the embryo, a process that religious conservatives, among others, oppose.

Groundbreaking work done in 2006 by Shinya Yamanaka at Kyoto University, a Nobel laureate in medicine last year, succeeded in generating stem cells from adult skin tissue.

August 2013  47

8/21/2013 3:54:00 PM

Cellceutix to Initiate Clinical Study of Prurisol

Leo Ehrlich, CEO Cellceutix

Cellceutix Corporation announces that the Company is on track to commence a clinical study for its anti-psoriasis drug Prurisol.

The Company has completed and submitted all regulatory documents necessary for the clinical study and anticipates receiving the regulatory documents this week allowing for the importation of Prurisol into Europe to begin the clinical study.

“We are pleased to inform shareholders that we have now completed the regulatory matters necessary for a clinical study of Prurisol and that we have been notified by our contract manufacturer, Dr. Reddy’s Laboratories (RDY), that Prurisol is ready for shipping to the clinical site,” Leo Ehrlich, CEO at Cellceutix stated. “We are planning to have the drug shipped in August and the trial to commence shortly thereafter. The clinical site has been notified to begin patient recruitment. We are optimistic about the potential for Prurisol to reproduce the laboratory results which showed the drug to effectively eliminate all signs of psoriasis.”

In other news, Cellceutix’s clinical trial of its anti-cancer drug Kevetrin is progressing and is presently in the dose escalation phase as maximum tolerated dose (MTD) has not yet been reached. The testing for p21, a biomarker study at the Harvard Cancer Center lab has not yet begun.

Inovio Malaria DNA Vaccine Shows Strong Efficacy Inovio Pharmaceuticals, Inc announced that its SynCon DNA vaccine containing multiple malaria antigens delivered via its CELLECTRA electroporation device demonstrated strong and durable antibody and T-cell immune responses in small animals and non-human primates. With these strong preclinical results, Inovio plans to initiate a phase I/IIa clinical trial next year.

These results appear in the American Society for Microbiology’s peer-reviewed journal, Infection & Immunity, in a paper entitled: “Inducing humoral and cellular responses to multiple sporozoite and liver-stage malaria antigens using pDNA,” authored by Inovio researchers and collaborators.

The World Health Organization estimated that in 2010 there were more than 200 million cases of malaria and almost 700,000 deaths due to malaria infection, the majority affecting young children in Africa. To date, the most advanced malaria vaccine candidate RTS,S, an adjuvanted recombinant protein vaccine, has not shown substantial protection in the key trial age group of infants. Scientists believe that a more effective malaria vaccine should generate both strong antibody and potent T-cell immune responses.

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In this study, Inovio researchers and collaborators designed a highly optimised DNA vaccine composed of four sporozoite and liver-stage malaria antigens using Inovio’s SynCon technology.

These antigens were chosen because of their important role in the control or elimination of malaria infection. Delivered using Inovio’s CELLECTRA delivery system, this malaria vaccine generated robust and long-lasting T-cell responses in both mice and non-human primates. Moreover, these vaccine-produced T-cells exhibited the functional ability to kill and eliminate malariainfected cells. Researchers also found vaccine-induced CD8+, or “killer T-cells,” in the liver, which is essential for rapid elimination of liver-stage malaria parasites. The Inovio DNA/electroporation platform has demonstrated in prior preclinical and human studies the ability to induce potent immune responses to multiple antigens; in this study, robust and sustained antibody responses to all four malaria antigens were observed, a strong indication for a preventive response in humans.

Inovio plans to initiate a phase I/IIa clinical trial in 2014 to test Inovio’s DNA vaccine and electroporation technology in approximately 30 individuals as part of a “challenge trial” involving controlled human malaria infection. Volunteers will be administered Inovio’s vaccine, then exposed to the malaria parasite through the bite of infected mosquitoes to see whether this approach prevents infection. If deemed successful, this trial would provide valuable information that may further the development of a vaccine against malaria and lead to larger efficacy studies in the field.

Australia Approves Novartis MenB Vaccine Novartis announced that the Australian Therapeutic Goods Administration (TGA) has added Bexsero, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest risk of infection.

Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen. The introduction of vaccines for other strains of bacterial meningitis has been successful in reducing the disease burden in Australia; specifically, following the rollout of a national meningococcal serogroup C vaccination programme in Australia, cases decreased from 162 in 2002 to nine by 2011. MenB is a potentially deadly disease which is easily misdiagnosed and can kill within 24 hours of onset. About one in 10 of those who contract the disease will die despite appropriate treatment. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss. The consequences for those affected and the healthcare system are significant.

Pharma Bio World

8/21/2013 3:54:13 PM

Biocon Brings a Novel Biologic Treatment for Psoriasis Biocon, Asia’s premier biotechnology company, announced the launch of its ‘first in class’ novel biologic ALZUMAb (Itolizumab), the world’s first anti-CD6 monoclonal antibody to be introduced for treating patients with chronic plaque psoriasis, in India.

ALZUMAb with a unique Mechanism of Action (MOA) offers superior safety and similar efficacy profile compared to other existing therapies, and has a long remission period with very low opportunistic infection rate. Psoriasis is a socially debilitating disease affecting 2-3 per cent of world population. The global Psoriasis market size is estimated to cross USD 8 bn by 2016.

Commenting on this development Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, “Biocon’s ALZUMAb (Itolizumab) is the first anti-CD6 monoclonal antibody to be commercialized, an outcome of path breaking research in India .This new line of treatment will usher in a paradigm shift in the management of psoriasis. We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world.” Indicated for the treatment of Moderate-to-Severe Psoriasis, ALZUMAb is being introduced in India by Biocon’s Immunotherapy Division.

Formulated as an infusion drug it is manufactured at Biocon’s Biopharma manufacturing facility at Biocon Park, Asia’s largest biotech hub in Bangalore.

ALZUMAb is the world’s first anti -CD6 biologic addressing the Th 17 pathway that has completed its ‘Lab to Market’ journey.

Emerging data shows that in addition to Th 1, Th17 cells play a critical role in autoimmune diseases, and Biocon is a frontrunner in the race to develop biologics targeting the Th17 pathway with ALZUMAb (Itolizumab). This differentiated MOA positions Itolizumab as a potentially ‘best-in-class’ treatment for psoriasis, and other autoimmune diseases.

ALZUMAb is an outcome of breakthrough innovation at Biocon which has the potential to transform the treatment options for several autoimmune diseases besides psoriasis like rheumatoid arthritis, multiple sclerosis and others. It is potentially a pipeline within a product. Its launch in India for psoriasis is the first milestone on a promising and exciting journey towards new treatment options for life-changing autoimmune diseases. Biocon is committed to taking ALZUMAb (Itolizumab) from India to patients worldwide with a global partner.

PharmAthene and Theraclone Sciences Merge Together PharmAthene, Inc. and Theraclone Sciences, Inc, a privately-held monoclonal antibody (mAb) discovery and development company, Pharma Bio World

Biotech News 45-49.indd 49

announced today the signing of a definitive agreement for the merger of PharmAthene and Theraclone in an all-stock transaction.

The combined company will be a fully-integrated and diversified biologics company with four clinical-stage product candidates targeting high-value commercial and government markets. The merged company will combine vaccine and human monoclonal antibody expertise with a focus on infectious diseases and oncology, and will feature a robust discovery pipeline with four pre-clinical programmes and multiple discovery candidates, along with three partnered products.

“A merger with Theraclone will significantly advance PharmAthene’s goal of achieving broader portfolio diversification,” said Eric I Richman, President and Chief Executive Officer of PharmAthene. “As a company with multiple clinical, pre-clinical and discovery candidates targeting important indications, the combined company will have the potential to generate substantial value for stockholders through both corporate collaborations and the development of its own proprietary therapeutic mAbs targeting high-value commercial markets.”

Clifford J Stocks, Chief Executive Officer of Theraclone, who will head the new company, commented, “By combining PharmAthene’s strong vaccine and biologics development capabilities and government contracting experience, with our clinical antibody candidates and novel discovery platform we are establishing a premier biologics organisation with multiple product candidates possessing significant near- and longer-term revenue potential in high-value commercial markets.”

New Technology to Accelerate Delivery of Biologic Drugs at High Concentration XstalBio Ltd announced the launch of CentuRecon, a new patented reconstitution technology that has the potential to revolutionise the preparation of high concentration protein solutions from dry powders and make delivery faster and safer.

Biologic drugs such as monoclonal antibodies are a major growth area for the pharmaceutical industry but their delivery by subcutaneous administration provides unique challenges. CentuRecon enables dry formulations of therapeutic proteins to be prepared for injection at high concentration in minutes, rather than hours, and produces foam-free solutions that maximise the deliverable dose.

CentuRecon™ works well with standard lyophilised formulations and diluents and with normal vials, cartridges or dual-chamber syringes. It is particularly beneficial for very high concentration and/ or viscous solutions that may need to be delivered with injection devices. Medical practitioners will find CentuRecon straightforward and cost-effective to implement with patients benefiting from fewer injections and shorter visits. Further developments are expected to make self-administration simpler and more convenient.

August 2013  49

8/21/2013 3:54:25 PM

Seal-less Drive Eccentric Disc Pumps Mouvex offers SLC4 and SLC8 models of its seal-less drive eccentric disc pumps for use in general industry applications, as well as the handling of numerous chemical-based compounds, including isocyanates, polyols, additives, solvents, glues (starches and latex), paints and coatings (inks and resins), methacrylates and detergents.

The major technological advancement in the SLC4 and SLC8 pumps is the incorporation of double-wall bellows into the design, along with monitoring that is done by pressure switch. By mounting the pressure switch on the bellows flange, the bellows becomes an independent sub-assembly within the pump, making for safer and easier operation. Other improvements in the SLC4 and SLC8 pumps includes the ability to handle differential pressures up to 10 bar (145 psi) in the SLC4 and 6 bar (87 psi) in the SLC8, and high-quality sand castings that are integrated into the manifold flange and bracket, which are compatible with ISOPN16 and ANSI150 flanges.

Phree Phospholipid Removal Plates Phree Phospholipid Removal Plates provide fast cleanup of plasma samples in pharmaceutical and clinical research laboratories. In onestep, Phree removes both proteins and phospholipids and delivers the prepared plasma to a collection plate. The high-capacity Phree sorbent can process up to 400 μL per well and remove 99.0 to 100 percent of lysophosphatidyl and phosphatidyl cholines, which are not removed when a simple protein precipitation is performed.

Successful chromatographic analysis of plasma samples requires the removal of both proteins and phospholipids, which can clog HPLC/UHPLC columns. Phospholipids can also cause ion suppression and over time will reduce sensitivity due to buildup on the mass spec source. Phree removes both proteins and phospholipids in one step, eliminating time-consuming method development. The plate format enables the simultaneous processing of 96 samples, for significant time savings.

For more information, please contact:

For more information, please contact:

Dover India Pvt Ltd - PSG 40 Poonamallee By-pass, Senneerkuppam, Chennai 600 056 Tel: 044-26271020 E-mail: sales.psgindia@psgdover.com

Phenomenex India Laxmi Cyber City, B Block, Survey No: 10 Kondapur, Hyderabad, Bengaluru 500 084 Tel: 040-3012 2400; Fax: 91-040-3012 2411 E-mail: RajK@phenomenex.com / info@phenomenex.com

Analytical Instrument The Viscosizer 200 helps solve key analytical challenges at the preformulation stage of pharma and particularly biopharma, development. It delivers viscosity and molecular size data on UV-active samples, using volumes of < 10 μL. The temp-controlled Viscosizer 200 measures viscosity from 0.9 to 120 cP and hydrodynamic radius from 0.2 to 100 nm, in samples at concentrations from 0.1 to >300 mg/mL. Its integrated carousel autosampler can be configured with a max of 45 vial positions. The technology at the heart of the Viscosizer 200 is UV area imaging. This is used to monitor the time-dependent absorbance profile of UV-active samples such as proteins, peptides and other chromophore-containing molecules as they migrate through a microcapillary. The Viscosizer 200 has a dual-pass capillary design whereby sample is detected at two windows along the capillary. This enables precise measurement of the transit time between windows and therefore of the sample’s viscosity relative to a reference, with demonstrable improvements over single-pass capillary systems. The Viscosizer 200 calculates mass-weighted mean hydrodynamic radius from the standard deviation of the sample profile at the two windows. UV wavelength selectivity means that the Viscosizer 200 can accurately measure the size of molecules of interest even within an excipient-laden formulation. The Viscosizer 200 delivers to the demanding requirements of early biopharmaceutical development. It provides a unique analytical tool to support rapid understanding of the behavior of candidate molecules in various formulations, enabling important decisions on suitable formulations to be made as early as possible.

For more information, please contact: Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park, B Wing – 906, Sector 30A Opp: Vashi Railway Station, Vashi, Navi Mumbai 400 705 Tel: 022-39183596; Fax: 91-022-39183562; E-mail: Stuart.Wakefield@malvern.com

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8/21/2013 4:06:33 PM

Laboratory Temperature Controllers Oven Industries Inc offers laboratory temperature controllers with ramp/soak capabilities. The 5R6-900 benchtop controller has many outstanding user-friendly benefits. The device can be plugged into the wall as a selfcontained temperature control system, which has its own power supply. This distinctive detail makes the device unique, as well as highly convenient for users. As a solid-state MOSFET bidirectional compact unit featuring an internal power supply, it is also capable of loading currents up to 10 A. The electronic controller easily connects to a computer through the electrically isolated RS232 communications port. The computer can be utilised as a connector and the unit can stand alone, once the desired parameter settings are in place. These settings are kept in the non-volatile memory. The controller features an easy-toread digital display for controlling functions, including adjusting output voltage and setting the desired temperature. Complete with an auto output shutdown if the sensor is opened or shorted; the unit also includes high, low and no alarm settings.

High-speed Liquid Filling Machine The Macofar LF 200 ST was developed by Romaco in response to the growing demand for high-speed machines that can be used to fill sterile liquids into vials. The machine achieves a maximum output of 12,000 vials an hour with a filling volume of up to five millilitres.

The LF 200 ST complies with the rigorous cGMP requirements for processing parenteral pharmaceutical liquids, which are administered to the patient in the form of injections or infusions. The filling process is servo-controlled and involves an intermittent vertical motion that prevents turbulent air movements in the vicinity of the open vials.

Thanks to its balcony structure and the strict separation between “white” (cleanroom) and “grey” (technical) areas, the Macofar LF 200 ST combines maximum product safety with premium quality.

The glass or plastic vials are sealed with a rubber stopper after filling. Besides the use of standard liquid stoppers, the closing system is also suitable for subsequent freeze drying.

For more information, please contact:

For more information, please contact:

Oven Industries, Inc 5060 Ritter Rd, Bldg C, Suite 8, Mechanicsburg, PA 17055, USA Tel: (717) 766-0721 Fax: (717) 766-4786 E-mail: sales@ovenind.com / r.wescott@ovenind.com

Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel: +49 (0) 721 4804 0 Fax: +49 (0) 721 4804 225 E-mail: susanne.silva@romaco.com

Test Strip-based Water Analyzer and Dosing System Blue I Water Technologies has been granted yet another patent for the PRIZMA water analyzer and controller, a technology for residential swimming pools, water tanks and wells. The patent is based on an innovative electro-optic test strip technology that has introduced automation to the litmus paper test for monitoring chemicals in water. The system assures chemical balancing for the pool’s water, features automatic calibration and provides real-time online reports. The new Canadian patent, entitled “Indicator Strip and a Device for Automatic Testing of Liquids”, further protects the technology that is already patented in many other countries.

PRIZMA’s system is particularly suited for use in residential and private swimming pools and spas, ensuring pool sanitation and clear water. It works by applying electro-optic capabilities to accurately analyse test pads that automatically monitor water quality at regular intervals. A continuous indicator strip is run across a series of individual test sections, each providing analysis for a different chemical, such as chlorine and pH. Pool owners and pool service companies benefit from the simple-to-use, probe-less (no calibration)and low maintenance technology that helps to significantly reduce work load and unnecessary pool maintenance, and are updated with online reports.

For more information, please contact: Blue I Water Technologies 23 Hamelacha St, Rosh Ha’ayin 48091, Israel Tel: 972-9-768-0004, Fax: 972-9-765-2331 E-mail: Amilo@blueitechnologies.com

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High-speed Liquid Filling Machine Romaco will extend its Macofar LF 200 product family with two more models for filling liquids into glass and plastic bottles at high speeds. The new Macofar LF 200 FD and LF 200 FS Series were specially developed for bottling pharmaceutical liquids. The LF 200 family meanwhile comprises five different models for filling a variety of applications of almost any viscosity gently and efficiently.

The Macofar LF 200 FS is another new model belonging to the same family as the Macofar LF 200 FD. Romacoâ&#x20AC;&#x2122;s FS machines were specially designed for applications with a single closure system such as pump, pilfer-proof, child-proof, screw or presson caps. The Macofar LF 200 FS likewise fills the containers in a continuous process at a maximum rate of 12,000 bottles an hour.

It is particularly suited for processing pharmaceutical liquids that are orally administered or applied to mucous membranes.

Servo-controlled processes assure safe and reliable handling throughout the filling and closing operations.

IQ & OQ Verification for LiquiSonic Analyzers SensoTech offers special qualification and validation procedures for its LiquiSonic concentration analyzers. To ensure a proper system installation, an implementation of the Installation Qualification (IQ) is recommended. A subsequent Operational Qualification (OQ) completes the qualification and validation process.

The test procedures of OQ include a review of temperature and sonic velocity measurement. This will ensure that the equipment operates as specified. The test results and any follow-up action will be documented in the qualification report. The report serves as evidence for correct concentration measurement, which depends on the temperature and sonic velocity of a fluid. The qualification and validation procedures meet the guidelines of GMP (Good Manufacturing Practice) and contribute to implement and run processes cost-efficient and on the highest level of security.

For more information, please contact:

For more information, please contact:

Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel: +49 (0) 721 4804 0 Fax: +49 (0) 721 4804 225 E-mail: susanne.silva@romaco.com

SensoTech GmbH Steinfeldstr 1 D-39179 Magdeburg-Barleben, Germany Tel: +49 39203 514 100; Fax: +49 39203 514 109 E-mail: info@sensotech.com

Accurate Flowmeters Cole-Parmer offers accurate flowmeters for process plant applications, providing precise readings even in aggressive plant environment. Its correlated variable area is available in 65-mm or 150-mm scales. Common applications for these low cost variable area flowmeters include air-sampling equipment, chemical processing, metering of gases in chromatography systems, desalinisation equipment, gas analyzers and water treatment systems. They can be used with gas or liquids, and are available in a choice of materials, with or without control valves, and range of flow tube sizes.

The 65-mm models are compact in size, ideal for tight measuring areas. The longer 150-mm models are perfect for applications demanding high resolution/ Aluminum body flowmeters are economical and good for general use with non-corrosive gases and liquids. Brass body flowmeters are economical and good for use with water. SS-316 body flowmeters feature excellent chemical compatibility. High-precision valve flowmeter for superior flow rate control is ideal for low-flow applications or for any application where you need precise flow control. Correlated flowmeters use a universal millimeter scale to allow the flowmeter to be used with a number of different fluids, at changeable pressure and temperature conditions, by cross-referencing the scale against a correlation data sheet. Variable area flowmeters are simple to install and offer cost effective solutions for applications requiring visual indication of flow or flow rate. Cole-Parmer offers flowmeters for measuring liquids flow from 0.0002 ml/min to over 400 LPM and for gases from 0.02 ml/min to 700 m 3/hour.

For more information, please contact: Cole-Parmer India Pvt Ltd 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai, Mumbai 400 076 Tel: 022-67162209, 67162222 E-mail: response@coleparmer.in

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5-Micron C8 Kinetex Core-Shell Media

Variable Inlet Vane Dampers

The Kinetex C8 5-micron core-shell HPLC column is used to deliver optimum retention for the analysis of hydrophobic and sticky compounds. In combination with Kinetex Core-Shell Technology, this phase gives analysts an excellent high-performance reversed phase alternative for HPLC methods. As with the existing Kinetex 5-micron C18 and XB-C18 phases, the new 5-micron C8 coreshell column can be easily substituted into methods that meet USP and European Pharmacopoeia requirements. Specifically the Kinetex C8 meets USP specifications for Classification Code L7, enabling laboratories using 5-micron L7 columns to realize the performance benefits of Kinetex Core-Shell Technology without adjusting their USP methodology. The largest dia particle in the family, Kinetex 5-micron core-shell media delivers better performance than 3 and 5-micron fully porous offerings, with no increase in backpressure. They are scalable to or from the 1.7and 2.6-micron particles, enabling easy method transferability.

Variable inlet vane dampers from Vacunair Engineering Company Private Limited, Gujarat are used for capacity modulation. They give accurate modulation and power saving over other styles of dampers at reduced airflow.

When an inlet vane is partially closed, each blade directs the air into the wheel in the direction of rotation and so the air is prespun.

This brings about determined by the fan-vane combination.

a reduction in type of system

For more information, please contact:

For more information, please contact:

Phenomenex India Laxmi Cyber City ,B Block, Survey No: 10 Kondapur, Hyderabad ,Andhra Pradesh 500 084 Tel: 040-3012 2400 / Fax: 91-040-3012 2411 E-mail: RajK@phenomenex.com

Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling ,Rakhial, Ahmedabad Gujarat 380 023 Tel: 079-22910771, 22910772 / Fax: 91-079-22910770 E-mail: info@vacunair.com

the and

capacity type of

High-purity Water Generation Systems Hydropure high-purity water generation systems are designed and manufactured for treating different types of water depending on its source and quality. These plants are available as pre-engineered packaged standard plants or custom-built as per the project requirements. Hydropure RO-EDI plants used for generation of high purity water for pharmaceutical, biotechnology, semiconductor, cosmetic and food and beverages industry.

These plants manufactured according to cGMP requirements and all the plant built designed for absolute control of microbial activity thereby minimising the need for system sanitisation. All the equipment and the plant is manufactured using sanitary AISI 316L stainless steel electro-polished tubes and fittings with surface finish of RA 0.4 um. All piping and fittings are welded using latest orbital welding machines.

All other fittings and equipments including valves, pumps and instruments selected are of sanitary type. Optionally plants can also be supplied with PVDF piping systems.

For more information, please contact: Hydropure Systems 412 Diamond Estate Off W E Highway, Dahisar (E), Mumbai 400 068 Tel: 022-28978725, 28979097 E-mail: info@hydropure.in

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Pharma Metal Detector

High speed Clean Room Doors High-speed clean room doors from Avians Innovations Technology Private Limited, Pune, are well-suited to clean room isolation in accordance with DIN EN ISO 14644-1 Class 5.

It air keeps the pressure at a minimum.

drop

provides tightness through closed

Pharma metal detector metaltrap SS 30 is an eddy current DSP based digital metal detection system designed for pharmaceutical industry for detecting metal contamination in tablets/capsules, preferably installed after deduster.

high and door

Pharma metal detector can also be used in confectionary industry for detecting metal contamination in candles.

Its fast opening and closing ensures very low air loss and minimise air exchange, which results in a low filter burden and increased clean room cost-effectiveness.

The system is designed and manufactured by Technofour Electronics Pvt Ltd, Pune, to meet the stringent requirement and hygienic standards of pharmaceutical industry.

For more information, please contact:

For more information, please contact:

Avians Innovations Technology Pvt Ltd 615/25 Pradhikaran Nigdi, Pune, Maharashtra 411 044 Tel: 020-65112222 / Fax: 91-020-27490570 E-mail: sales@avians.co.in

Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba), Khed ShivapurSaswad Road, Taluka: Bhor, Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246; Fax: 91-02113-305250 E-mail: sales@tepl.co.in

Oakton Waterproof Multiparameter Testr 35-Series Meters Cole-Parmer offers Oakton Waterproof Multiparameter Testr 35-Series Meters. One convenient pocketsized meter measures pH, conductivity, TDS, salinity and temperature.

Get precision and portability with the versatile OAKTON waterproof multiparameter Testr 35-Series meters. Perfect for water, wastewater, laboratory, and plant use, these pocket-sized meters have longlife pH electrodes and stainless steel conductivity sensors for a wider range of sample compatibility.

Easy-to-replace sensor modules save money, allowing one to reuse the meter body.

Convenient, fast and simple—just dip, measure, and scan through up to five parameters with the push of a button. No complicated operating procedures and no need to change sensors for different measurements.

These meters offer multiple calibration options—choose single or multipoint, automatic or manual. Measure conductivity or TDS more accurately at varying temperatures with an adjustable temperature coefficient feature. Auto-ranging feature makes it more convenient for users with applications across broad measurement ranges. Unique sensor design provides faster ATC response and faster readings.

For more information, please contact: Cole-Parmer India Pvt. Ltd. 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai, Mumbai 400 076 Tel: 022-67162209, 67162222 / Fax: 91-022-67162211 E-mail: response@coleparmer.in

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Temperature Controller for Embedded Applications 5R7-001 temp controller creates a seamless transition between heating and cooling devices, as it serves as the commander of thermoelectric modules.

With a bi-directional or unidirectional H-bridge configuration, the temp controller has many benefits. The included, user-friendly PC software makes it quick and simple for users to change any temp control configurations, which eliminates signal interference or errant signals. The software also enables the temp controller to operate as a stand-alone unit.

A computer can also be connected to the device, for retrieving data. The 5R7-001 offers temp setting and control through the remote potentiometer and the optional display. The controller has several other features that make it appealing, including being RoHS compliant, allowing for a set temp range of -40 to 250 oC, having a large program memory space for customisation, being PC programmable and having 0-36 V DC output using a split power supply system.

Self Cleaning Filter – Disc Type Sharplex has launched self cleaning filter – disc type specially designed for applications in food, pharmaceutical, chemical, edible oil, fertiliser, petroleum and mining industries. The SFC series autoclean liquid filters are designed to remove suspended solids of 10 microns and larger from all types of liquids like oils, resins, paints, coatings, adhesives, pigments and crude vegetable oils. The SFC filter system incorporates a stainless steel/carbon steel housing which contains tubular wedge wire filter element screen in stainless steel construction. The screen used is 50 to 80 microns. The SFC Series auto-clean liquid filters are available in three different models; SFC-400 (Capacity up to 7 m 3 /hr), SFC-800 (capacity up to 14 m 3 /hr), SFC-1600 (capacity up to 25 m 3 / hr). These models are available with contact parts in SS 304, SS 316l or carbon steel. The widge wire element is SS 304 or SS 316L.

For more information, please contact:

For more information, please contact:

Oven Industries, Inc

Sharplex Filters (India) Pvt Ltd R-664, Rabale, MIDC, TTC Industrial Area Thane Belapur Road, Navi Mumbai 400 701 Tel :022-27696322 / 27696339 / 27696331 / Fax: 91-022-27696325 E-mail: sharplex@vsnl.com

5060 Ritter Rd, Bldg C, Suite 8, Mechanicsburg, PA 17055 ,U.S.A. Tel: (717) 766-0721 / Fax: (717) 766-4786 E-mail: sales@ovenind.com / r.wescott@ovenind.com

New Laboratory Device With the new FHM 1000 Series, Bosch Packaging Technology offer semi-automated, modular laboratory devices for liquid pharmaceutical filling operations. Its filling parameters can be easily scaled-up to production systems: all relevant parameters are specified in the laboratory and can then be transferred to production machines without further settings. The FHM Series significantly facilitates the design of experiments (DoE) for customers.

Recording parameters makes it possible to precisely determine cause-effect relations between influencing factors and target variables by involving customers’ experience. The laboratory device series currently consist of four different modules, the Human Machine Interface (HMI), the filling module, the weighing module and the needle movement. All automation processes are operated from the HMI, which is the centrepiece of the laboratory device FHM 1000. The filling process with its filling needle movement and in-process control (IPC) weighing are parameter sized via the HMI, whereas input and output of the containers is done manually. The prototype operat4es with a peristaltic pump. Further filling modules are planned, for instance with a rotary slide piston pump. According to demand, the different filling systems can then be flexibly exchanged. The integration of a closing module is also planned, enabling containers to be equipped with different types of stoppers. A protective housing for both the filling module and the needle movement ensure product and operator safety. All modules conform to the EU Machinery Directive 2006/42/EG. For more information, please contact: Robert Bosch GmbH Postfach 106050, D-70049 Stuttgart, Germany Tel: + 49 711 811-58502 Fax: +49 711 811-58509

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API Type Oil Separators, Oil Skimmers Environ make oil skimmers are designed to remove the separable oil, viz, waste oils, vegetable oils, animal fats, waste scum fats, etc, from the effluent. The recovered oil can be used as raw material for other products.

The oil skimmer tank is designed as per API. The oil is collected through the deoiler pipe mechanism.

Motorised trolley with four wheels with anti-friction bearings travels to and fro on MS rails having electrical limit switches on either side. PP/HDPE/Neoprene rubber skimmer place.

Control panel consists of air break reversing contactors, timer, etc. Hand operated slotted pipe mechanism would be there to collect the oil. We are also manufacutirng API type oil skimmer where top oil skimming is also done along with the bottom settled sludge scrapping.

Butterfly Valves Butterfly valves from Advance Valves are designed to have optimal mix of structural stability, flow efficiency and effective seating coupled with advantage of lightweight, compact design and ease of operation. Only a quarter turn is needed to fully open or close the valves.

The valves are provided with integrally moulded elastomer body liner to provide perfect seating and complete isolation of body material from media to prevent it from any corrosive and abrasive impact of fluid. The body liner material can be provided to suit specific fluid service for long maintenance-free life.

The valves are easy to install in any position between horizontal to vertical piping. No gaskets are required.

For more information, please contact:

For more information, please contact:

Environ Engg Co 864/B/3 GIDC Indl Estate, Makarpura Vadodara, Gujarat 390 010 Tel: 0265-2643870, 6536670 Fax: 91-0265-2653458

Advance Valves 142 A & B, NSEZ, Noida Uttar Pradesh 201 305 Tel: 0120-2462374 / Fax: 91-0120-2462376 E-mail: global@advnacevalves.com

NIST-Traceable pH Buffers Cole-Parmer offers new NIST-Traceable pH buffers. Higher quality standard pH buffers are used in applications that demand higher precision and reliability.

Each bottle includes a NIST-Traceable calibration report from an ISO Guide 34 and ISO 17025 accredited laboratory. The series includes colorless buffers for pH 4, pH 7 and pH 10 available in 500-mL, 1-L or 4-L packaging sizes. All pH buffers are to be stored at room temperature.

For best accuracy, perform standardizations with fresh buffer solutions and never pour used buffer back into the bottle. These solutions of known pH value allow the user to adjust the system to read accurate measurements.

For best accuracy, standardization should be performed with fresh buffer solutions; buffers used should frame the range of pH for the samples being tested; buffer values are dependent upon temperature. Buffers should be at the same temperature as the samples (eg; if all your samples are at 50°C, warm your buffers to 50°C using a beaker in a water bath).

For more information, please contact: Cole-Parmer India Pvt Ltd 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai, Mumbai 400 076 Tel: 022-67162209, 67162222; Fax: 91-022-67162211 E-mail: response@coleparmer.in

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events diary Pharmac India Dates: 05 – 07 September 2013 Venue: HITEX Exhibition Centre, Hyderabad Hosting by Orbitz Exhibitions Private Limited for three days at HITEX Exhibition Centre, India, Pharmac India is recognised as a focused exhibition for Pharma & Health care industry. It is three day exhibition which is aiming towards highlighting varied related medical products. It will prove to be a large hub of reputed professionals from pharmaceutical formulation, herbal products, veterinary drug, medical & disposal, pharmaceutical machinery and many other sectors.

Contact: Orbitz Exhibitions Pvt Ltd 101, Navyug Indl Estate, Sewri (W), Mumbai Tel: +(91)-(22)-24102801/02/03/04/39504586 Fax: +(91)-(22)-24102805

Pharmabiotika Dates: 16 – 18 September, 2013 Venue: Mahatma Mandir Convention & Exhibition Centre Gandhinagar, Gujarat India Pharmabiotika is an international exhibition and conference which will bring together US, Europe and Asian Pharmaceutical, Biotechnology, Clinical Research, Vaccine and Contract Research & Manufacturing organisations under one platform. Pharmabiotika event provides an excellent platform for convergence of pharmaceutical, biotechnologist, nanotechnologists, clinical trial associates, analysts & consultants, product specialists, key decision makers, industrialists, drug developers, dealers, scientists, marketing professionals, academicians and researchers.

Pharmabiotika will help review and discuss discovery, delivery clinical and manufacturing aspects of drugs, vaccines and many others. Pharmabiotika exhibition & conference will also help in integrating scientific knowledge from the perspectives of design, material synthesis, drug discovery, formulation, processing technology, manufacturing design, clinical trial etc. and will provide an opportunity for the local and foreign participants to share research finding, explore research collaborations and licensing agreements.

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Pharma Bio South 2013 Dates: 9 – 11 October 2013 Venue: Chennai Trade Centre, Guindy, Chennai CHEMTECH announces CHEMTECH World Expo 2013 - SOUTH of its flagship event from 9th to 11th October 2013 in Chennai Trade Centre, Guindy, India. Pharma Bio World Expo & conferences will concurrently be organised during the Expo.

The international exhibition will have display of state-of-the-art technologies, equipment, accessories and services from national and international players in each sector. Concurrent International conferences EPC World Expo, ChemPetro World Expo, Industry Automation and Process Control World Expo and WaterEX World Expo will have deliberations on topical issues by industry leaders, experts and influencers and offer high level networking opportunities to take the businesses to newer heights.

Contact: Chemtech Secretariat 26, Maker Chambers VI Nariman Point, Mumbai 400 021 Tel: + (91)-(22)-40373737 | Fax: +(91)-(22)-22870502 E-mail: sales@jasubhai.com; conferences@jasubhai.com Contact: Atanu Bhattacharya Human Crayon Management Services Pvt. Ltd. C-28, Sector -4, Noida - 201301, India Mobile: +91-9810303916 Tel +91- 120 – 6528801, +91 - 11-65378800 Email: info@crayon4.com | atanu@crayon4.com

Indian Pharma Expo 2013 Dates: 20 – 21 September 2013 Venue: Shakuntalam Hall, Pragati Maidan, Delhi Indian Pharma Expo will witness IPCON, a special two day conference on “Export Market Development” on 20th -21st September 2013 at Shakuntalam Hall, Pragati Maidan, Delhi.

This conference is committed to provide you several industry experts with a focus on practical issues and experiences. Be sure August 2013  57

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to gain first hand information on market opportunities, regulatory requirement, documentation procedures, financial hurdles and intellectual property barriers that can affect your business. Get inspired with success stories of Indian companies and learn from the best case studies & practices. Also, take back skills and practical tips that will enable you to add upon your performance & profitability. It is a must attend event for SME’s and their Export Managers to enhance their knowledge and network.

Contact: Alok Sharma Tel: +91-22-66122646 Mobile: +91-9819224222 Email: alok.sharma@cims.co.in

Pharma Legal & Compliance Summit 2013 Dates: 27 September, 2013 Venue: The Leela, Mumbai The recent changes in regulation and agencies involved in regulatory oversight means a catch up game to analyse business impact on short and long term strategy for legal, regulatory, compliance and commercial professionals operating in the Pharma space. With increasing management expectations on business strategy formulation from senior professionals, especially in a complex regulatory environment, the 2nd Edition of Pharma Legal and Compliance Summit is the best investment of time to analyse, interpret and strategise your current and future response to legal, regulatory and compliance challenges.

Contact: Bhupinder Kaur Sr Executive- Special Initiatives Team Lex Witness, B 1/6, Hauz Khas New Delhi – 110016 Tel: +(91)-9654155065, +(91)-11-43440013 Fax: +(91)-11-43440099 E-mail: Bhupinder@witnesslive.in

Drug Discovery India 2013 Dates: 27 – 28 September 2013 Venue: Sheraton Bangalore Hotel, Brigade Gateway, Bangalore With Dr Rathnam Chatgutru, (Senior Director, SRI International, USA) serving as Chairperson, Drug Discovery India 2013, will provide an excellent platform for researchers from all facets of drug discovery research an unprecedented opportunity to explore the contract research and collaborative options amongst various research fraternities. Planned open panel discussions and breakout sessions on key thematic areas are sure to energize the participants in defining the drug discovery landscape, especially in the Indian context, and offer ways and means to de-risk the patent cliff experienced by the pharmaceutical industry in recent years.

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Contact: Ira Sood Exhibition Manager Mobile: +917696225050 Email: i.sood@selectbio.com

16 th Pharmaceutical Analysts’ Convention Dates: 27 – 28 September 2013 Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) announces the 16th Pharmaceutical Analysts’ Convention (PAC) 2013 on Friday & Saturday, 27th & 28th September2013. The main theme for this year is “Generics the Game Changer”. IDMA is recognised as the Voice of the National Sector with over 700 members comprising large, medium and small manufacturers spread across the length and breadth of the country.

IDMA works with the Government on the industry’s development plans and various public matters, also conducts seminars, workshops, training programmes etc. At this prestigious Convention, Eminent experts in Analysis, Research, Academia and Regulatory spheres from the Indian Pharmaceutical Industry, will converge and gettogether to interact on various recent developments.

Contact: Prachi Senior Manager- Publications & PR, I D M A 102-B, Poonam Chambers, A Wing Dr A B Road, Worli, Mumbai – 400018, India Mobile: +91 9867634383) email: ppr@idmaindia.com

India Diagnostic Expo Dates:21– 23 November 2013 Venue: HITEX Exhibition Centre, NAC campus, Madhapur Hyderabad India Diagnostic Expo is going to be held for a period of three days in Hyderabad, India. This expo will attract diagnostic labs, clinical lab professionals, chemists and biochemists from all over the world to discuss about the modern market trends and future market prospective associated with the diagnostic industry.

By taking an active part in this expo technical and professional experts related to diagnostic industry will get a scope to share their expertise with the attendees.

Contact: SD (India) Corporation 14, Mall Road, 1 st Floor, Hudson Lane, GTB Nagar New Delhi Tel: +(91)-(11)-47034600/43003757 | Fax: +(91)-(11)-47056500 Pharma Bio World

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bookshelf Clinical Trials in Latin America: Where Ethics and Business Clash (Research Ethics Forum) [Hardcover] Authors: Nuria Homedes (Editor), Antonio Ugalde (Editor) Price: USD 189.00 No of pages: 295 pages About the book: The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80 per cent of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.

Central and Eastern Europe: Outsourcing Trends and Growth Opportunities in Clinical Trials [Paperback] Authors: Sara Gambrill (Author), Steve Zisson (Editor) Price: USD 937.62 No of pages: 163 pages About the book: CenterWatch presents its latest report in a series on emerging markets in the clinical trials industry Central and Eastern Europe: Outsourcing Trends and Growth Opportunities in Clinical Trials. The number of clinical trials initiated in Central and Eastern Europe more than tripled from 2002 to 2007, making the region a key part of global clinical research. This comprehensive analysis focuses on the evolution of the clinical trials industry in the CEE region and the outsourcing strategies that CROs and emerging pharmaceutical and biotech companies need to operate there.

Outsourcing Biopharma R&D to India (Woodhead Publishing Series in Biomedicine) [Hardcover] Author: Probir Roy Chowdhury (Author) Price: USD 194.75 No of pages: 130 pages About the book: Outsourcing is the process in which two companies enter into a long-term, result-oriented relationship. Pharmaceutical companies are now adopting outsourcing as a cost effective method as a way to gain access and proximity to other countries. This shift has opened up new prospects for India, as it is perfectly situated to be an ideal destination for global pharmaceutical companies to outsource R&D and manufacturing processes. This book is the first ever comprehensive insight on the Indian biopharma sector. It provides a perspective based on practical, hands-on legal experience and is simply structured, clearly presented and free from excessive legal jargon.

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ad index Sr No

Client’s Name

Page No

1

B & R Automation

2

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3

Citizen Industries

4

CRI Pumps

Opening Page

5

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Inside Cover I

6

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7

Pharma Bio Tech World Expo 2013

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Praj Industries

9

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Front Cover Inside Cover I 11

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Ad Template 01.indd 22

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R.N.I. No.: MAHENG/2002/08502 Date of Publication: 1â&#x20AC;&#x2122;st of every month Postal Registration No: MH/MR/SOUTH-284/2011-13 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month.

Total Pages :- 62

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