Pharma Bio World - April 2014

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Contents.indd 6

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21-04-2014 18:20:46

EXPERT’S TAKE 10

Surfing the Waves of Change: Leadership in Action - Dr Sonal U Vora, SYNERGETIK Learning Solutions

INTERVIEW 18

Coded Holograms to Keep the Supply Chain Secure - Ian Lancaster, General Secretary, International Hologram Manufacturers Association

18 FEATURES 22

Clinical Research of Rare Diseases - Focus on Operational Challenges -Vaibhav Pawar, SIRO Clinpharm

25

Novel Research Using HPC - Sandeep Lodha, Tyrone Systems

26

Simplifying Patients’ Lives - Dr Johannes Rauschnabel, Bosch Packaging Technology

28

Skill Development in the Pharmaceutical Industry - GP Chandra Kumar, SkillSonics India Pvt Ltd

22

MARKET RESEARCH 30

Orphan Drugs: A New Opportunity for Pharmaceutical Industry – Pankaj Mandpe,, Deeptymaya Sahu & Mitali Bhagwat, Micro Labs Limited

NEWS UPDATE

25

35

Pharma News

40

Press Releases

47

Biotech News

CORPORATE AFFAIRS 48

Product Trends

52

Events Diary

BACKYARD 26

53

Bookshelf

54

AD Index Next Issue Focus: Quality by Design

8  April 2014

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India Amrish Shah.pdf

2

2/05/11

12:25 PM

expert's take

SURFING THE WAVES OF CHANGE: LEADERSHIP IN ACTION Dr Sonal U Vora

Founder & Director SYNERGETIK Learning Solutions

T

hese are tough times for the clinical research industry in India today. But, as Robert Schuller says: “Tough times never last, but tough people do”! While a lot has been written and spoken about the tough times ie the numerous challenges and issues India is facing in the clinical research space today, this article is dedicated to taking a closer look at what can make us tough (or tougher) people.

If each of us would only sweep our own doorstep, the whole world would be clean.

change. We need to speed up activities in all areas to prepare better for the coming days when research activities resume to the state of “business as usual” and growth returns. Each of us in our own capacity can and must think how we can now contribute differently towards preparing for a ‘new’ work culture while ensuring continuity of future clinical trial business in India.

Some areas of quick checks for further brainstorming and internal discussions are highlighted below.

Areas of Quick Checks

- Mother Teresa

Regulatory uncertainty has temporarily put the brakes on clinical research activities in the country. Meanwhile, how are we preparing ourselves as well as our clinical research teams for dealing with the possible consequences that will emerge from new policies and regulations? How can we gear up as teams and organizations to prevent confusion and chaos resulting after growth in the research industry resumes in the near future? It all begins with the individual – with each one of us.

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New areas of drug research are emerging in Asia – but unfortunately they exclude India at the moment. China, South Korea and even Japan are replacing India which was until recently called the hub for clinical trials in Asia. In these tough times, clinical research stakeholders in India wait with bated breath for clarity on numerous fronts to strategically plan the road ahead and strengthen the specifically identified weak areas. During this period, we can take the opportunity to focus a bit more on ourselves and our teams, to strengthen our own weaknesses, to identify areas of improvement in ourselves, our partners in business and in the way we work as teams. We can sensitize all stakeholders to become more aware of the drivers of

Consolidating learning & development (L & D) initiatives for further empowerment within teams: Before you are a leader, success is all about growing yourself. When you become a leader, success is all about growing others.

- Jack Welch

All good organisations have their L & D plans chalked out for their teams. These would encompass areas ranging from personal to professional development.

Due to various reasons including clinical operational pressures and constant shift in priorities, sometimes specific areas identified for individuals may not be addressed and general training programs are conducted which leave the weak areas

In today’s uncertain current research scenario, we can demonstrate more tenacity in ensuring better outcomes for the trials that are already underway. When this attitude prevails at the top, it becomes ‘infectious’ and soon, each and every team member is keen to do something.

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expert's take of individuals just as they were – weak.

In the clinical research environment we are in, it becomes more important to ensure individuals in the team are empowered to perform their roles to the best they can and also to ensure they learn about and develop critical skills required for survival in business today.

Paying special attention to soft skills will make them tough people. Some of these skills include creative problemsolving and critical thinking – at all stages of clinical trial conduct. Involving the entire team in creative problem solving, irrespective of their hierarchy, role and experience can prove beneficial in arriving at some unusual, unexpected and unidentified possibilities, which can be further explored. One of these possibilities could prove to be a very viable option for maintaining success in today’s tough times. Innovation is the name of the game today. Team members can be developed to think out-of-the-box to explore different ways of ensuring compliance to ethics and good clinical practices (GCP). Consolidating all types of L & D initiatives for 360-degree growth of teams will help them gain selfconfidence and self-esteem, while further empowering them to take ownership of various challenges faced within the team and at clinical sites.

Cultivating a mindset which fosters a “never ever give up” attitude in teams: Life isn’t about waiting for the storm to pass...It’s about learning to dance in the rain. - Vivian Greene We all know that we can choose our attitude to any given circumstance.

Choosing the right attitude during adverse conditions and inspiring others in teams to similarly do so is a decision we need to consciously make. The way we perceive challenges is important. For example, in today’s uncertain current research scenario, we can demonstrate more optimism, determination and 12 April 2014

SURFING THE WAVES OF CHANGE.indd 12

tenacity in ensuring better outcomes for the trials that are already underway.

When this attitude prevails at the top, it becomes ‘infectious’ and soon, each and every team member is keen to do something – however small - to ensure better trial success. Even as we await clarity on various issues, we can ‘infect’ team members with this attitude and immediately see positive results emerge.

This attitude should be extended to clinical sites so that our clinical investigators and site teams catch on and begin to ‘wear’ a new attitude towards clinical trial conduct. No one should ever think the current scenario is ‘hopeless’ or that whatever one does, it will not make any difference to the overall scenario and give up their attempts to quickly bring positive changes. If team members were to make a list of the opportunities in challenges faced in different areas eg documentation, informed consent process etc, they would find they have the potential to do things differently and more diligently. It is to be remembered that the most destructive voice is our own. Hence, self-awareness can bring positive and immediate shifts in attitude. To cite an example, some team members may find they now feel differently towards GCP training or site initiation training for their trials and give more attention than ever to details of study logistics and case record form filling to prevent GCP non compliance.

Areas in which different attitudes can be very powerfully and positively impacted in these anxious times are summarized in Table 1.

Encouraging leadership at all levels within and across teams which influences others to renew their commitment to excellence: A leader takes people where they want to go. A great leader takes people where they don’t necessarily want to go, but ought to be - Rosalynn Carter It may not always be possible to recruit the brightest and best of talent. In these times, it is wise to rely on the collective talent of the team. The talent pool we have today is mixed, comprising of professionals with different levels of knowledge, skill sets, expertise and experience. How we as leaders build our trust on the team and demonstrate this trust will determine the level of commitment and quality of performance.

Specifically, leaders need to be good drivers while travelling on the road of adversity, carefully steering on rough roads and driving their team home safely. Team members will agree to be co-passengers in the journey only if they trust the driver. According to Stephen Covey, the first job of any leader is to inspire trust, which is confidence born of two dimensions: character and competence - both being equally essential. He clarifies this by stating that when we think a person is sincere and honest, we may not trust that person fully if he or she does not get results.

And the opposite is true, too - if a person demonstrates great competency, but if he or she is not honest, we will not trust that person either.

1.

Training of all stakeholders involved in clinical trial conduct

2.

Enlightening teams on audit and inspection learnings in a formal manner

3.

Sharing best practices internally and amongst other companies regularly

4.

Revamping & strengthening the clinical site selection process with customization while adhering to ethics, GCP and applicable SOPs

5.

Utilizing the period of study start-up more effectively

6.

Evaluating US FDA policies and practices more closely to define those that can be adopted or adapted for India

7.

Refining local SOPs and work process flows

Table 1: Old areas and activities which need to be revisited with new attitudes

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expert's take

Conclusion: “Change will not come if we wait for some other person, or if we wait for some other

time. We are the ones we’ve been waiting for. We are the change that we seek.”

- Barack Obama Our environment has forced us to make changes in the way we work. We understand that we need to adapt quickly to the new environment. We already had some areas of change identified and were working on them. We now need to not only work on these areas more speedily but also take accountability to work on the new areas recommended by various stakeholders. We need to make changes in the way we behave with our partners in clinical research. This can only happen when we change our mindsets.

We must not forget that clinical research in India has already contributed significantly to global research – a fact sadly overlooked at these times. Problems or challenges are a given in any country.

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There are problems we inherit as part of our geographical expanse, sociocultural and economic differences, literacy status that varies across our nation. Then there are problems that are man-made by us - as collective partners in the conduct of clinical trials.

Between these two types of challenges, we need to realize what we can control and prevent, what we can control and minimize. For those challenges that we cannot find solutions, we need to have sound risk-management strategies in place to decide how to manage them.

And to help us to achieve this in these troubled times, it may help to keep in mind the Serenity Prayer : God, grant me the serenity to accept the things I cannot change, the courage to change the things I can, and the wisdom to know the difference.

Contact: sonalvora@synergetiklearning.com

INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

Another important factor in leadership is transparency. When both trust and transparency are seen in leaders, it becomes easier for team members to be influenced to move out of comfort zones and take the first steps towards realizing their own potential and redefining their standard of excellence – and furthermore, carrying the new standard across to the entire team. These ‘aha’ moments of insight can contribute to improving the quality of clinical trial conduct both inhouse and at clinical sites. Everyone in the team in day-to-day operations can apply leadership. They can, in turn, prove their trustworthiness and be transparent with site teams, motivating them to perform better than ever.

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16 April 2014

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Pharma Bio World

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interview

IAN LANCASTER

Coded Holograms to Keep the Supply Chain Secure Everyone involved in the goods supply chain has learnt the value of security holograms and will be reassured by their presence on products and/or the packaging, due to the benefits they provide. As coding and serialisation become mandated in various countries for products like medicines, the ability to incorporate different types of codes into holograms further enhances the role they can play in supply chain control says Ian Lancaster, General Secretary, International Hologram Manufacturers Association in an interview to Pharma Bio World.

Why are tracking and tracing systems necessary?

Companies have to contend with challenges stemming from supply chain security lapses (which can result in theft, diversions and product recalls), counterfeiting and regulations. In addition these factors can impair the health and reputation of companies by adversely impacting on profits, brand credibility and research initiatives. With industry, regulatory authorities, security agencies and governments around the world realising the significance of implementing product tracking and tracing systems which build on product serialisation, it becomes mandatory for those in the supply chain to comply with legislation pertaining to the locations in which they operate. Even where this is not mandated by law, tracking and tracing systems improve defences against counterfeiting and other infringements as well as improving distribution and inventory control.

What benefits can be derived out of these track and trace technology?

Typically, distribution systems run the gamut of manufacturers, wholesalers, distributors, stockists and retail outlets before products reach the end user or customer. Ensuring product protection, including authentication capabilities, across various touch points throughout the supply chain through track and trace implementation, is important to address the challenges industry faces. Apart from providing visibility and full traceability from manufacturer to consumer, successful serialisation programs can prove to be a key differentiator and a clear competitive advantage for companies.

How does the technology work?

Today, Quick Response (QR) codes, which use four standardised encoding modes (numeric,

“Apart from providing visibility and full traceability from manufacturer to consumer, successful serialisation programs can prove to be a key differentiator and a clear competitive advantage for companies.�

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8/5/2013 3:23:47 PM

Clinical Research of Rare Diseases - Focus on Operational Challenges This article gives a perspective on growing importance of rare disease drug development and the operational challenges in conducting clinical trials in rare disease.

O

rphan drugs or drugs to treat rare diseases are increasingly becoming a central pillar in the R&D strategy of several pharmaceutical and biotechnology companies. Companies recognise that despite the smaller patient pool for rare disease R&D, the economics of orphan drug development has great potential for commercialisation.

Estimates from the National Institutes of Health and the European Organisation for Rare Diseases indicate that there are approximately 7,000 rare diseases worldwide most of them being genetic in nature. Governments worldwide recognise that these debilitating conditions are highly unmet medical needs. This led to the 1983 U.S. Orphan Drug Act, as well as similar Acts in 1991 in Singapore, 1993 in Japan, 1997 in Australia and in 2000 by the European Union. These Acts provided a significant boost to orphan drug research around the world by offering biopharmaceutical companies incentives to focus on rare diseases.

In 2012, more than 13 orphan drugs were approved by FDA, including therapies for Cushing disease, cystic fibrosis and Gaucher disease. In 2013, a third of the novel drugs (9 of 27) were approved

by USFDA to treat rare diseases. While these figures seem to be staggering there are more than 450 medicines for rare diseases still in various stages of drug development (PhRMA’s report on Medicines in Development for Rare Diseases).

Vaibhav Pawar

Project Manager - Clinical Operations SIRO Clinpharm 22 ď‚ƒApril 2014

Rare disease.indd 22

As the pharmaceutical companies eye for a significant competitive and financial advantage through orphan drug development, the process (drug development) itself poses a significant challenge to researchers in both preclinical and clinical phase. Therefore, specific skills in designing, planning and conducting clinical trials, especially in rare diseases, are necessary to get an orphan drug to the market.

Brief about Rare Diseases There is no global definition for rare disease and quite understandably the definition varies as per the health care standards within the country, incidence of disease, treatment availability and sometimes even severity. The aim of these country specific definitions is solely to differentiate these diseases for government support in drug development and approval process. Irrespective of these definitions, it is generally believed that there are about 6000-7000 rare diseases worldwide and 80% of these diseases are genetic in nature.

C h a l l e n g e s i n C l i n i c a l Tr i a l s o f Rare Diseases To better understand the challenges, we can categorise them based on the different phases of clinical trial during which the challenges are more prominent.

Conceptualisation Phase The essence of a good study design lies in avoiding surprises. Most successful trials

The lifelong nature of rare diseases also makes it challenging to select appropriate study durations. Other significant challenges range from finding patients to identifying physicians treating patients with rare diseases.

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are the ones where significant effort is expended in the planning phase of the study and trials in rare diseases are no exception to this rule. Sponsors and CROs must think how the massive difference in prevalence affects their patient recruitment strategies.

Lack of adequate information on the disease, difficulty in defining treatment goals (mostly for genetic disorders), lack of epidemiology data, treatment patterns and existence of sub-population pose fundamental difficulties in protocol writing. For most rare diseases, there is no standardised clinical trial design or efficacy outcome measure, which leads to difficulty in defining appropriate primary or secondary endpoints, outcome measures, tools and biomarkers.

When the known patient pool is small, it is difficult to exclude patients on the basis of co-morbidities, age, concomitant therapies etc. affecting the predictability of the trial. Due to genetic nature of most rare diseases, life expectancy of the patient is short and many such patients do not survive beyond a certain age. The lifelong nature of rare diseases also makes it challenging to select appropriate study durations. Other significant challenges range from finding patients to identifying physicians treating patients with rare diseases, and often logistical problems in setting up a trial where the disease is most prevalent.

Although much of these complications are not unique to rare disease clinical trials, it is the solutions to overcome these challenges that are more difficult to design and sometimes remain un-implementable.

Selecting Partners for Trial Conduct Selecting a right partner is of strategic importance for the success of every clinical trial and the importance only magnifies in case of a rare disease trial.

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Figure 1: Unique factors to lookout when selecting a CRO for in case of a rare disease trial

In rare disease trials, due to delay in patient enrolment the study duration increases making it difficult for sites to maintain the patient on trial till the end of the study.

CRO selection: Surveys show that 75% of rare disease trials are outsourced to clinical research organisations. Generally, sponsors tend to select an experienced international CRO for such trials. However it is essential to understand that rare disease trials require high resource commitment and a group of regional CROs with significant presence within target countries.

Following are few unique factors to lookout for when selecting a CRO: • CROs having an extensive database of research oriented investigators with expertise in genetics • Ability to develop, train and manage new sites throughout the allocated region • Experienced and skilful team which is suitably trained in project management along with risk management and mitigation • Ability and readiness to commit more resources per site per patient, when required To simplify, the CRO should not only be experienced but also agile enough to

provide unique solutions to the challenges.

Site selection: A recent survey involving 50 biotech and pharmaceutical firms in North America and Europe revealed that identifying and setting up investigative sites was one of the most difficult tasks in rare disease clinical trials. Barring a few rare diseases like Cystic Fibrosis, Finnish heritage disease etc. most of the other diseased population is scattered throughout the world and hence it is important to select sites through which the maximum target populations is covered.

Below are few unique challenges with site selection.

• Most physicians who treat rare disease patients are inexperienced in conducting industry sponsored trials. This lack of clinical trial experience manifests itself in limited understanding of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines and sometimes even local trial related regulations • Large medical institutions have negligible experience in treating rare diseases and fail to maintain a database of such patients April 2014 23

22-04-2014 09:58:02

• The diseased population is scattered throughout the country and it is counterproductive to rely on a single site in a metropolitan area. Sites need to build a network of satellite centres or referring physicians in the assigned geographic area • The knowledge base in rare disease is scattered and there is need to identify key opinion leaders for participation in the study Recruitment and Retention Challenges Recruitment has always been and continues to be a key challenge in rare disease trials. Many a times sponsors themselves complicate the situation by running competitive studies where enrolment in one trial makes the patient ineligible for another. Below are few unique challenges which make recruitment a key driver in rare disease trials.

• Few patients spread over a large geographic area and a narrow inclusion and broad exclusion criteria • Almost all rare diseases are difficult to diagnose leading to cases going unrecognised and lack of awareness amongst general population • Poorly maintained patient database at medical centres and even if available,

Every rare disease trial is unique and the clinical trial management team would have to take cognizance of the risks involved and design a unique approach for every phase of the trial. are of limited utility since study inclusion criteria often do not match with standard of care assessments conducted at most hospitals • Due to scarcity of speciality centres patients have to travel hundreds of miles even for a simple standard of care treatment. High frequency of site visits, multiple and continuously required medical assessment often prove to be an entry barrier for such patients • Many rare diseases are disabling and make patients more dependent o n i m m e d i a t e f a m i l y. D i s a b i l i t y, incurable nature of disease and chronic treatment unsettles the socioeconomic balance of the patient’s family leading to physiological distress and frustration towards seeking any further medical help • Due to genetic nature of disease the onset time is early and in many disorders only few patients survive up to adulthood

Patient retention: Most sponsors seek to increase study duration by having long term safety assessment as secondary end point in every study. Also, due to delay in patient enrolment the study duration increases and this makes it difficult for sites to maintain the patient on trial till the end of the study.

Conclusion: As a result of operational difficulties, budgets in rare disease projects tend to go awry. In general sponsors spend 2400% more money per patient in rare disease trial, than any other diseases There is no ‘mantra’ for success in rare disease trials. However, some universal steps can be implemented in every such trial to mitigate certain challenges faced.

• Ascertain disease incidence information for a geographic region before selecting participating countries (Sources: National disease registries, physician surveys, Epidemiology studies etc) • Proper identification of KOLs to build a network of referring physicians • Advertisements at tertiary care hospitals with IRB/EC approval • Arrange for patient travel reimbursements with IRB/EC approval • Interact with patient support groups to keep patient /his family motivated.

• Regular interaction between participating investigators to share knowledge base and recent findings Nevertheless, every rare disease trial is unique and the clinical trial management team would have to take cognizance of the risks involved and design a unique approach for every phase of the trial.

Contact: ruchi.sanganeria@siroclinpharm.com

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Novel Research Using HPC Drug discovery and life sciences domain have random requirement of high performance computing (HPC). HPC suits this kind of variable workload with scale on demand solution.

I

t is estimated that there are over 1,050 chemical molecules in the universe.

This means that an almost infinite number of medicines can be crafted from them. Today, humans are facing a tremendous challenge in the form of new diseases. While we are yet to find cures for them, we are also troubled by older diseases. It has become evident that, going forward, we will need to hasten the pace of development and decrease the costs so that patients can get benefited. High Performance Computing (HPC) or supercomputing is one of the technical tools that can achieve both these objectives.

Every stage of the pharmaceutical process uses HPC in some way or other. While certain processes like clinical trials and regulatory related processes cannot be hurried, the discovery process can be significantly reduced. The discovery phase accounts for almost half the time in the entire process in most cases.

Hence, judicious usage of HPC can help co mpanies to c ut the drug dis c ov ery process by half. Every day you spend discovering drugs adds to the cost and any reduction in time has a direct impact on the expense incurred.

Many drug discovery projects have been shelved after several years of development because of side effects in animal testing. One solution offered by HPC is profiling the products and taking more probable molecules in the first place - this can save tons of green bucks.

Before the pre-clinical development, HPC can help in the identification and optimisation of new molecular entities

Sandeep Lodha Marketing Director Tyrone Systems Pharma Bio World

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by computational methods. By focusing on the probable molecules, the success rate of wet lab investigations increases s u b s t a n t i a l l y. A s a r e s u l t , w h a t t o o k weeks or even months before can now be achieved in a matter of days if not hours.

While HPC promises many benefits, there is one issue- acquiring a HPC facility would require core competency that is different from the traditional expertise that a pharmaceutical organisation possesses.

It will also require investment in an infrastructure which gets obsolete quickly.

There are also challenges in terms of managing the power and cooling requirements and a trained workforce is required to maintain and oversee effective utilization. HPC on Cloud based solutions eliminate a lot of management problems and shift spending from a capital to an operational model.

These solutions are available on demand and with flexible pricing, available to both enterprises and individual customers.

The service can be used for few hours or even for months and is accessible anytime, anywhere .These may also be available as personalised services having an infrastructure and human interface as opposed or could be system driven interfaces.

One solution offered by HPC is profiling the products and taking more probable molecules in the first place-this can save tons of green bucks.

April 2014ď‚„ 25

22-04-2014 09:59:38

Simplifying Patients’ Lives Drug Delivery Devices currently range among the major pharmaceutical trends. Their optimization is largely influenced by the pharmaceutical industry, physicians and patients. Present developments of new devices are increasingly focused on patients’ needs. They give top priority to simplified handling, reduced pain, continuous documentation and facilitated adherence to medication intervals.

Dr Johannes Rauschnabel Chief Pharma Expert Bosch Packaging Technology 26 April 2014

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A

precise definition of Drug Delivery Devices (DDD) is almost impossible to find. In general, DDDs support the transportation of active ingredients to the part of the body where they are needed and therefore can be considered as application facility. Whether they are defined as pharmaceuticals or medical products depends on their purpose. For example, a powder inhaler qualifies as a pharmaceutical, while a catheter dissected with heparin qualifies as a medical product.

Pen Systems: Close to Perfection Due to a significant refinement of most DDDs in recent years, for some appliances currently only little potential for improvement is left. The introduction of pen systems in 1985 considerably enhanced patients’ quality of life. Pens are loaded using cartridges and usually serve as multiple application systems. Several functionalities such as level indication and haptic of pen systems already have been optimized.

Moreover, today’s pen systems feature electronic components like memory control which is mainly an application for children.

In future, further refinement will focus on easier and safer handling, as for instance improved needle protection to help avoid injuries and unintended application. The optimization of other parenteral systems also focuses on the patients’ compliance, reflecting the awareness of fears such as needle phobia. Auto injectors are usually loaded using pre-filled syringes and feature a needle cover keeping the needle hidden as long as possible. This often helps users to overcome fears associated with self-injection.

Diseases such as multiple sclerosis, osteoporosis, hepatitis, rheumatism and anemia are typical fields for the application of auto injectors. Treatment of these requires a singular dose or regular administration during longer intervals and is profitable from the industry’s point of view. Therefore, intensive development of auto injectors is not only justified to improve patients’ quality of life but also from an economical perspective. Further advancements mainly refer to production conditions. With optimized materials and designs, production costs will decrease.

As a result, devices are no longer too expensive to be applied as re-usable items. Some experts believe needle-free injection technology will soon prove to be successful. One of the reasons is the vaccine campaign launched by the World Health Organization (WHO). However, the pharmaceutical market remains cautious on these systems because they are believed to cause similar pain as a puncture does.

Transdermal Devices: More Convenience Transdermal delivery devices are patch systems containing active agents, for instance within matrices, which are diffused through the skin. Recent developments have led to optimized patch sizes and adherence features of the patches for better skin tolerance. A general trend in the western world goes towards the usage of and affinity for electronic devices, influencing also pharmaceutical applications. Exciting new developments comprise a combination of patch and pump, so-called “patch pumps”. This can be illustrated on example of the Insulet Omnipod insulin patch pump. The small

Today’s pen systems feature electronic components like memory control which is mainly an application for children.

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which administers the inhalation liquid in form of fine drops. Patients inhale the medication as a mist generated by different technologies such as ultrasound, piezo crystals or vibrating mesh.

DDD – Key to Success of a New Drug Many established medical devices, and especially applications for children, have been significantly optimized over the past years. From a current perspective, some of them are approaching their improvement limits; others still have much potential for further refinement.

In general, the equipment tends to be The trend towards more convenience of Drug Delivery Devices for patients is expected to continue at a smart pace

device with a wireless Personal Diabetes Manager (PDM) adheres to the skin and delivers insulin for as long as three days.

Subcutaneous delivery, for instance via single-use infusion devices, is based on the patients’ individual bodyweight or surface.

It is easier to administer and application times are significantly reduced. The main functional component of this device is a hybrid container which combines the features of glass vials and cartridges and is controlled via the electronics in the pump. As opposed to multiple injections, patients are more independent in their everyday routine.

Pulmonary Systems: Focus on Asthma and COPD Inhalable insulin seemed to hold a lot of promise. But the large size of the inhaler, increased treatment costs and the requirement for much higher insulin doses led to its withdrawal. The market for pulmonary systems has noticeably slowed down in the developed countries while it is still growing in the emerging markets. Yet pharmaceutical engineers continue with Pharma Bio World

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smaller, and handling is safer, easier and more convenient. At the same time, costs

The so-called “pharmerging markets” currently require more basic and affordable technologies. But pen-systems for insulin delivery show already tremendous growth rates in these countries. the advancement of these systems mainly with respect to asthma and COPD (chronic obstructive pulmonary disease). There are three different types of pulmonary systems. MDI (metered dose inhaler) is the most common technology in the market at low cost level, especially for emergency products. The aerosol based inhaler delivers the required amount of gaseous medicine to the lungs. New products however are rarely developed in the form of MDIs for environmental and compliance reasons such as patients’ coordination problems between breathing and actuation.

The technology of the future – if no oral medication is available – is the DPI (dry powder inhaler) with its simple application and small size. Medication is delivered to the lungs in form of dry powder which patients inhale without any solvent. The third pulmonary system is the nebulizer,

are decreasing for those devices that hardly require any further improvement.

In many fields, the market will not work without DDDs. The compatibility of a device such as a pen, an auto injector or a pump with a new drug is an important precondition for its success, especially in the developed countries. The so-called “pharmerging markets” currently require more basic and affordable technologies.

But pen-systems for insulin delivery show already tremendous growth rates in these countries. Once the average unit cost decreases, the optimized DDDs will also be successfully placed on these markets in large numbers. In the future, the trend towards more convenience with a clear focus on patients’ compliance is expected to continue at a smart pace.

Contact: johannes.rauschnabel@bosch.com April 2014 27

22-04-2014 10:10:29

Skill Development in the Pharmaceutical Industry This article draws focus on the significance of skill development and the necessity of the Pharma industry to be a part of in order to grow bigger.

T

he Indian Pharmaceutical industry grew at an estimated CAGR of 13% (FY 2009-2013), living up to its reputation of being recession proof.

The slowing world economy has impacted this sector too with growth slowing down in CY2013. The industry is also dealing with stringent regulatory and quality norms on the domestic and global front.

The Drug Prices Control Order (DPCO) implemented in 2013 is also looming large on company revenues. However the industry is expected to tide over the obstacles to continue to grow at double digit CAGR in the next few years and reach sales of USD 30 billion by 2016.

This huge projected manpower requirement and prevalent attrition rates are pointers to companies to focus on skilling their people with the right skills. The right skills with good quality will directly impact the profitability of the company by making them more competitive. In the long run the company can sustain its growth and also be viewed as a ‘Best employer’ being able to attract and retain the right talent.

Need for Skilling

Candidates with education in pharmacy and s c ienc es opt for a c a r e e r in th e sector. A bachelor’s degree in pharmacy/ science is required for supervisory levels by pharma manufacturing units. A master’s degree or a few years experience opens up managerial roles. Scientists could have master degrees or are usually PhDs. Operators/workmen are drawn from Industrial training institutes.

While the low cost nature of the Indian economy has fuelled pharma growth on the exports front, the increasing domestic requirement has also contributed to growth. The availability of highly skilled people at a lower cost and a largely English-speaking working population has acted in favour of the industry. However the sector has also seen very high attrition rates with various companies reporting rates of 25-40%. Currently there are around an estimated 4.2 million people employed in the sector. According to the National Skill Development Corporation (NSDC) Skills requirement report on the Pharma sector - incremental requirement of manpower by 2022 is 1.9 million people.

GP Chandra Kumar Co-founder SkillSonics India Pvt Ltd 28 April 2014

Skill Development.indd 28

Current Skill Pool The Skill pyramid for a pharma manufacturing company as per the NSDC report is in indicator for the kind of skilling requirements for the sector:

Around 1500 educational institutes (public a n d p r i v a t e ) o ff e r v a r i o u s p h a r m a c y programmes at undergraduate, post graduate and diploma levels. The National Institutes of Pharmaceutical Education and Research (NIPER) set up by the government helped create manpower for the sector. The government is also in the process of opening more NIPERs.

Function

Percentage of profile wise employment potential in the sector

Production and QC Research/Lab Sales, Marketing Medical Assistance Purchase and Support functions (HR, Finance, etc.)

50 20 10 10 10

Incremental human resource requirement – function-wise by 2022 Source: IMaCS analysis

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5%-6%

44%-45%

25%-30%

20%-25%

Skill Pyramid for the Chemicals and Pharmaceuticals Industry Source: Primary research & IMaCS analysis

Companies should consider skill development as a strategic investment to further boost their position in global markets.

While these numbers drove past growth, industry involvement in skill development is required for future growth. Often students passing out of educational institutes are not ready for industry roles due to the lack of industry exposure. Industry inputs will ensure that students will have the relevant skills to work in a company environment.

By getting involved in skill development companies also ensure that their future workforce is as per the required standards.

This would need training interventions at entry level and for existing employees.

Industry Led Skill Development The functional requirement and skill level required for the sector allow for a skilling approach which is industry-led and supported by government/academia.

Production/QC personnel (Supervisors and workmen) and lab technicians’ roles are ideally suited to this approach. In a manufacturing company these roles account for more than 50% of the workforce.

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In this approach the industry leads by hiring students as apprentices at entry-level for 1-2 years. These apprentices are trained in theoretical and practical aspects and with some more productive work as the training progresses. The training includes company induction and exposure to industry norms.

The government and academia support with capacity inputs (Training of trainers, policy direction and certification).

The apprentices learn while on the job and also earn a stipend. On completion of training students are assessed and certified. These apprentices are valued by the industry for their relevant skills and industry exposure and are usually absorbed by the company providing the training based on need. Apprentices also can choose the role they would like to further their career in, since training also imparts an understanding of how the industry works and what work each role requires. They also would have an option to go back to school to pursue further studies.

Industry involvement in training will ensure that students are geared towards the required standards – For e.g. many pharma plants in India are audited and certified by the US Food and Drug Administration to enable exports to the USA. An understanding of these stringent quality requirements need to be included in the training programmes.

Existing employees also need to be trained to align with company objectives and to be updated with the latest in the sector. These courses can be customised and designed as per individual role requirement.

Training People for Sustainable Growth The National Skill Development Corporation is setting up a pharma Sector Skill Council (SSC) to propagate this industry-led approach. SSCs define the occupation standards for each skill that take into account industry requirement and knowledge requirement for having a particular skill.

Assessment and certification of trainees also falls under the purview of the councils.

These councils also train and certify trainers for various occupations. Training content can be provided by enlisted training providers who offer industry relevant and updated content.

The Pharma industry is poised for growth with global players continuing to invest in India and domestic players meeting global requirements. Companies should consider skill development as a strategic investment to further boost their position in global markets. Investing in people will ensure sustainable growth over a longer period.

Contact: info@skillsonics.com April 2014ď‚„ 29

22-04-2014 10:12:56

market research

Orphan Drugs: A New Opportunity for Pharmaceutical Industry This article throws light on the incidence of orphan diseases in India and builds a bridge between the Orphan regulations in the world with the legal intricacies governing healthcare in the country. It examines the provisions available for Orphan drug protection globally and proposes ideas involving economic, social, regulatory and financial considerations in India. The sensitive issue of profits and patents on one hand and affordability and pricing on the other has been discussed by Pankaj Mandpe - Associate Vice President-R&D, Deeptymaya Sahu - Assistant Manager, IPR and Mitali Bhagwat - Trainee, IPR from Micro Labs Limited.

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medicine for rare diseases is a rare concept in India unlike other developed countries like USA, Europe, and Japan etc. where laws provide adequate provisions for the pharmaceutical industry to invest in this neglected area of healthcare. However, India is not party to any such law or provision which would pay heed to those affected by orphan drugs.

The WHO defines orphan diseases as those which affect 0.65-1 out of every 1000 people.

This is a negligible number when compared to mainstream diseases. America defines orphan diseases as those affecting less than 2, 00,000 of the population. In Europe, a disease is given orphan designation if it affects less than 5 in 10,000, but in Japan the number is 50,000. If the statistics were extrapolated for India, the number of people affected by orphan diseases would be alarming. According to an estimate by the organisation, ‘Rare Diseases and Disorders’, around 72,611,605 people were affected by orphan diseases in 2011. The need for regulation and development of organisations for orphan diseases should be a pressing issue for the healthcare sector in India. The Orphan Drug Act of 1983 and Rare Diseases Act of 2002 facilitate the development and marketing of Orphan Drugs in the USA. Orphan drug designation can be obtained through an approval process under the orphan Drug Act (ODA).

After any particular drug is designated as orphan, the manufacturer is eligible to get certain benefits under the ODA. In Europe, a similar law exists. Committee for Orphan Medical Products (COMP) and EURORDIS also support the orphan drug development.

30 April 2014

Orphan Drugs.indd 30

These organisations also receive social support with patient groups for different diseases.

“Orphan drugs” are medicinal products intended for diagnosis, prevention or treatment of life-threatening or debilitating rare diseases according to EURORDIS. They are ‘orphans’ because the pharmaceutical industry has little interest in developing and marketing drugs intended for only a small number of patients suffering from very rare conditions. Orphan drugs are used to treat diseases that affect less number of individuals or that are used for the diagnosis, prevention, or treatment of life-threatening, seriously debilitating, serious or chronic conditions. The development of such drugs comes with less incentives and profits.

All the leading pharmaceutical companies have been investing a great deal of money into the development of orphan drugs.

Companies like Novartis, Bristol- Myers

Squibb have been developing their orphan portfolio rather aggressively and strongly.

Orphan Drugs Report 2013 by Evaluate Pharma suggests Novartis is at the helm of the orphan drug market with sales of 10.9 billion USD in 2012. It has a strong orphan drug portfolio built around Gleevec, active ingredient as Imatinib mesylate. Imatinib was granted orphan drug designation for the treatment of gastrointestinal stromal tumours. Companies like Roche, Celgene, Pfizer etc. were after Novartis for the sale of the orphan drug portfolio at 9, 4.9, 5.4 billion USD respectively in 2012.

Genesis of the Orphan Drug Act Figure 1 below shows how the orphan designations have sharply increased in US, Europe after the enactment of the orphan drug development policies because of the incentives provided by the same. Although these countries have different rules with respect to orphan drug development, they

Figure1: USA, EU & Japan Orphan Designations per year Source: Orphan Drug Report April 2013, Evaluate Pharma

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market research have been successful in creating a sensitive environment for the patients affected by orphan diseases. Their governments and health regulating agencies have played a crucial role in order to prioritise orphan +drug development.

benefiting the rare disease community in developing countries. Social media can be used as a platform to identify the patient population and study orphan diseases.

Orphan Drug Sales:

It is a common perception that orphan drugs are not as profitable as non orphans. In reality, this is not always a case.

It is estimated that the orphan drug sales will grow exponentially till 2018. Hence, the Indian companies have a good opportunity to diversify their markets and establish their market share. It is suggested that the impact of a smaller treatable patient pool is offset by the higher pricing of many orphan drugs, the increased market share, the longer exclusivity period and faster uptake rate that orphan drugs often garner as a result of the high unmet medical need in many of these diseases.

A panel should be formed to decide the fate of orphan drug development policies and strategies in India. The government should form liaison with the pharmaceutical industry for the same. Policies which provide impetus for research and development for the treatment of orphan diseases are the way forward. Activism from patient support groups may help evolve specific laws Parameter

Clinical Studies of Orphan Drugs:

As it can be seen in the above graph, clinical trials wise, the development of orphan drugs is cheaper than non orphans. This can further be reduced when the company receives tax benefits.

Clinical trials involving orphan drugs are however challenging for a number of reasons including a lack of validated endpoints, difficulties with locating patients and logistical problems in clinical trial organisation. The latter two reasons can contribute significantly to the costs of clinical trials. They also are comparatively less cumbersome than those of non orphans as lesser number of volunteers are involved.

The FDA approval time is also shortened as orphan drug applications are entitled to a fast track approval process.

USA

Changing Industry:

Patterns

of

the

Pharma

According to market analysis, the growth of the generic pharmacy industry has slowed down. The industry is facing ‘patent cliff’ as a result of which, newer business models are being implemented. They involve research targeted towards treatment of orphan diseases. Orphan drug development will help these companies reduce the impact of losses due to patent expiries of their blockbuster drugs. Even though the investment and development cost of such molecules is significantly high and the patient population is limited, the laws in countries like US, Europe, Japan etc. provide significant benefits and incentives for product development and approvals.

Unfortunately, such laws or committees are not a part of the Indian healthcare industry.

The Indian pharmaceutical industry which majorly draws profits by the marketing of generics faces stiff competition due to the market entry of a number of players as well as the patent cliff and a dry pipeline.

Hence, generic companies should now be strategically looking for a provision of long term profits and diversification of their

Europe

Japan

Legal framework

Orphan Drug Act (1983)

Regulation (CE) No141/2000

Orphan Drug Regulation (1993)

Incidence

Fewer than 200,000 patients

A life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons

Fewer than 50,000 patients

Administrative authorities

FDA/OOPD

EMEA/COMP (2000)

MHLW/OPSR

Market exclusivity

7 years

10 years

10 years

Tax credit

50% for clinical studies

Managed by the member states

6% of any type of study + limited to 10% of the company’s corporation tax

Reconsideration of applications for orphan designation

No

Yes (every 6 years)

Yes

Technical assistance

Yes

Yes

Yes

Accelerated procedures

Yes

Yes (via the centralized procedure)

Yes

Legal framework

Yes

Yes

Yes

Table 1: Comparative analysis of orphan drug development benefits in USA, Europe and Japan

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April 2014 31

22-04-2014 10:14:52

market research Orphan Drugs: An Indian Context It was reported that the percentage of patients suffering from ‘Orphan Diseases’ in India is higher than the world average.

However, the perception of orphan drug is still orphan in India. Also, the Indian government is not really keen about looking into the alarming situation.

Need of Orphan Drug provisions in India: Figure 2: Worldwide Orphan Drug Sales & Share of prescription drug markets Source: Orphan Drug Report April 2013, Evaluate Pharma

Figure 3: Clinical Studies & Regulatory status of orphan drugs Source: Orphan Drug Report April 2013, Evaluate Pharma

markets. Opportunities in orphan drug development will not only provide an impetus for research and development but will also result in a patient focused portfolio. However, without a proper system and guidance from the regulatory bodies or pharmacological associations, it is impossible for a pharmaceutical company to invest in the development of orphan molecules from scratch.

India is yet stuck on manufacturing copies of essential medicines. The difference between orphan drugs and essential medicines is that the latter comes with a huge profit margin. They differ in drug and disease orientation. The neglected patient is at loss as the industry is hesitant to invest in orphan drug development. A sense of hopelessness prevails in the minds of the neglected patient population as they do not receive any help from the industry or the government. It is the need of the hour to develop Orphan provisions.

32 April 2014

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Orphan drugs and pharmacogenomics: Pharmacogenomics is the study of establishing a link between the human genome, diseases and drug response.

It studies the patient’s genetic profile for drug discovery and involves a new concept which is personalized medication. It can serve as a diagnostic tool to screen orphan drugs as it can uncover underlying disease pathways.

Drug discovery programs along with pharmacogenomics studies might lead to better results in less time.

Pharmacogenomics offers features like stratifying the patient population on the basis of genetic make-up into smaller groups for which specific treatment can be developed. This in turn can be the basis for discovery and development of orphan drugs. Phenomenal growth is estimated from the orphan drug market as newer orphan diseases are being discovered.

It is estimated that 72,611,605 people are affected by rare diseases in India (2011).

About 6000 to 8000 rare diseases, mostly genetic in nature have been identified.

Recent news about orphan diseases in India was tracked and the data was compiled.

Table 2 outlines few orphan diseases which were observed in India recently. This table is only a glimpse of the sufferings of the neglected patient population in India. No specific primary medication is available for orphan disease in India. However, secondary medications are being used for preventive treatment of these diseases.

A group of pharmacologists requested the Indian government to enact the Orphan Drug Act in India at a conference held by the Indian Drug Manufacturers Association in 2001. However, this was a dead end as no such provisions have been initiated by the government till date. It is necessary on the part of the Indian government and regulatory bodies to implement such provisions and Country

Rare disease and disorders population

Afghanistan

1,530,006

Bangladesh

9,151,081

Bhutan

44,099

India

72,611,605

Maldives

19,037

Nepal

1,589,670

Pakistan

10,999,800

Sri Lanka

1,216,656

Table 2: Incidence of rare diseases in the Indian subcontinent.

Source: Orphan Drug Report April 2013, Evaluate Pharma

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market research Disease

Incidence

Cause

Description

City

Year

Shone's Syndrome

0.5% of all congenital heart diseases

Congenital

CV defects

Kolkata

2013

Melioidosis

Endemic to Thailand and northern Australia. Not in India

Gram-negative bacterium, Burkholderia pseudomallei

Pain in chest, bones, or joints; cough; skin infections, lung nodules and pneumonia

Yavatmal

2013

Hunter’s syndrome

2,000 people worldwide

Lysosomal storage disease caused by a deficient (or absent) enzyme, iduronate-2sulfatase (I2S).

Distinctive coarseness in their facial features, including a prominent forehead, a nose with a flattened bridge, and an enlarged tongue

Kolkata

2012

Ankylosing Spondylitis/ Bechterew's disease and Marie-Strümpell disease

0.25 percent

Inflammatory disease of the axial skeleton with variable involvement of peripheral joints and nonarticular structures

Stiffness, pain, vision related problems

Bangalore

2008

Duchenne Muscular Dystrophy (DMD)

30 per 1,00,000

X-linked form of muscular dystrophy

Muscle degeneration and Nagpur eventual death

2012

Table 3: Incidences of various rare diseases in India

bring about a whirlwind of change by enacting provisions related to orphan drugs.

Rare Disease Day is observed all over the world on the last day of February. India joins the world on this particular day to show solidarity to those afflicted by orphan diseases since 2010.

A Suggestion: Formation of an Orphan Drug Committee in India A committee may be formed within the ambit of the Health Ministry, consisting of a parliamentary panel, along with a group of Industry expert professionals. A team of medical/clinical experts may be appointed on the committee for their opinions. This committee may have a regulatory body which would be intricately associated with the working of the orphan drug provisions. Key initiation needs to be taken for workability of Orphan Drug provisions in India.

1) Identify various orphan diseases in India 2) Organize social awareness programs to educate people about orphan diseases Pharma Bio World

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3) Bridging the gap between patients and support groups 4) Periodically drug applications

review

the

orphan

5) Public awareness drives through electronic media involvement for orphan diseases The orphan drug committee needs to publish a list of the orphan diseases and their incidences. Any new disease must be reported to the committee of orphan diseases or any such designated office. Relevant study can be conducted by the concerned office/committee regarding the particular disease. Clinical, medical, experimental and regulatory attributes need to be evaluated with respect to its developmental cost; regulatory review periods and post marketing benefits. Generic manufacturer should be awarded with incentives and ease of research and development options for these drugs. Regulatory approvals of these drugs must be followed on a fast track review process. Marketing/regulatory

exclusivity may be sought for these drugs if required to encourage financial benefits to the generic company.

Exclusive licenses may be granted to the inventor/ assignee of the orphan drug which could be compulsory or non compulsory depending on the market situation and workability of the orphan drug. In case the drug is protected by a patent, then the different obligations need to be validated by the concerned patent office in India to pave the way for the approval. The much debated section 84 of the Indian Patent Act 1970 may be interpreted for this patent protected life saving orphan drug. These patent protected orphan drugs must fulfill requirements of the public and must work effectively within the territory of India. The orphan drug committee may establish a robust patent linkage system between orphan drug committee with the Indian Patent Office (IPO) for easy grant. Specific guidelines need to be framed by the committee for manufacturers for ease of pre/post development of orphan drugs.

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market research Incentives in India if Orphan Drug Act (ODA) is enacted: Following incentives can be expected for the pharmaceutical industry if a law regarding orphan drugs is enacted in India.

1)Tax incentives 2)Clinical trials study grants 3)Exemption from application filing fees 4)Marketing exclusivity from the date of grant of Orphan Drug (OD) status 5)Better incentives than product patents 6)Priority Review and Fast-track designations Price Control: Section 340B of the Public Health Services Act in the USA requires the drug manufacturers of America to sell outpatient drugs to covered entities at an affordable cost. This price should not be greater than the statutory ceiling price. The intent is to provide prescription drug assistance to vulnerable uninsured patients. The list of covered entities, as expanded by the Affordable Care Act, includes certain federally subsidized clinics and certain safety net hospitals, including disproportionate share hospitals, children’s hospitals, certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals. However, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) has filed a complaint and an application for a preliminary injunction in the U.S. District Court for the District of Columbia. Their claim is that HRSA’s orphan drug rule violates the Administrative Procedures Act (“APA”). PhRMA alleges that the Affordable Care Act exempts all the uses of designated orphan drugs from the ceiling price.

The inclusion of orphan drugs under the Section 340B is unclear. Since orphan drug status is granted for a particular indication; the question arises whether this drug should be eligible for 340B discounting for other indications.

The Health Resources Services Administration has proposed an approach 34 April 2014

Orphan Drugs.indd 34

under which the inclusion of orphan drugs for non orphan indications will be subject to Section 340B discounting. However, the implementation of this rule will rely on the honour system. Under the proposal, the responsibility rests with the hospital to ensure that orphan drugs purchased at the 340B price will not be prescribed or used for a non-orphan condition.

In European Union (EU) the orphan drugs share the common platform for fixing the pricing strategy in general i.e. by a manufacturer or proprietor in an effort to recover research and development (R&D) costs and certain profit margin. However, different price data show this price always varies in different European countries.

Unlike US and EU India has Drug Price Control Order (DPCO) with National Pharmaceutical Pricing Authority to regulate the price of drugs. As discussed above drugs treating specifically orphan diseases must not be included under the price control in order to promote research & development in the concerned field.

Concerns Regarding Development:

Orphan

Drug

A dual approach was adapted to study more about orphan drug development.

The cons of the Orphan Drug Act and strategies were studied. They are as follows: 1)Previously approved drug could be given an orphan designation for a particular indication for the industry to reap in extensive profits.

2)Discontinued drugs have been given orphan designation. Thalidomide which was banned after it caused serious genetic malformations was given OD status for the treatment of side effects associated with leprosy.

3)The cost of orphan drugs is very high and common man cannot afford it.

4)Old common drugs become profitable.

Albendazole was given OD status for the treatment of neurocysticercosis due to Taenia solium.

5)They can show greater incidences of adverse effects than non-orphans as sufficient clinical testing cannot be performed due to limited patient population.

Conclusion People with rare diseases must also have equal access to medicines as like patients for any other disease. Common principle of social justice and equality of essential commodities like medicines must be established for people affected with rare diseases. The issue of rare disease needs individual concern irrespective of the business demands of the industry.

Like US and Europe, India needs a strong Orphan drug reform or legislation to meet the need of this alarming situation. Studies show more than 70 lakh people have been affected by rare diseases till 2011 in India, which is highest in this subcontinent. A glimpse at these cases shows sufferings of this neglected population of the society due to lack of efforts by core research institutes, pharmaceutical industry as well as government. Pharmaceutical industries or research organisations in developing countries like India should shift focus towards core research and development rather than only developing copycat generic versions of approved medicines. However, due to lack of government support, it is obvious that pharma companies are not left with many options but to develop only profitable medicines for a larger patient population.

It is high time the Indian government takes initiative to encourage these industries by means of different special lucrative provisions and policies. This may include offering exclusivity provisions, exclusive/ non-exclusive licensing opportunities and different developmental incentives. Further, there is a need of a transparent evidencebased approach towards orphan drug pricing and exemption. However, including these drugs in the DPCO may not make development of the same lucrative for the manufactures. Care should be taken such that interests like profitability and affordability are balanced on the scale.

Contact: mumipr@microlabs.in Pharma Bio World

22-04-2014 10:19:02

pharma news Sun Pharma to Acquire Ranbaxy India’s biggest drug manufacturer Sun Pharmaceutical Industries Ltd signed a deal to buy Ranbaxy Laboratories Ltd from Japan’s Daiichi Sankyo Co Ltd for USD 3.2 billion in stock and a net debt of USD 800 million on Ranbaxy’s books will also be part of the transaction.

The combined entity will create the largest Indian pharmaceutical company and the world’s fifth-largest specialty generics company with operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products marketed globally, including 629 ANDAs. As per the agreement, Ranbaxy shareholders will receive 0.8 share of Sun Pharma for each share of Ranbaxy. This exchange ratio represents an implied value of ` 457 for each Ranbaxy share, a premium of 18 per cent to Ranbaxy’s 30-day volumeweighted average share price and a premium of 24.3 per cent to Ranbaxy’s 60-day volume-weighted average share price, in each case, as of the close of business on April 4, 2014.

Dilip Shanghvi, Managing Director of Sun Pharma said, “Ranbaxy has a significant presence in the Indian pharma market and in the US where it offers a broad portfolio of ANDAs and first-to-file opportunities. In high-growth emerging markets, it provides a strong platform which is highly complementary to Sun Pharma’s strengths.”

B i o g e n ’s A l p r o l i x G e t s H e a l t h Canada Approval Biogen Idec announced that Health Canada has approved ALPROLIX, for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B. ALPROLIX is the first approved longacting hemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic (protective) infusions starting at once weekly or once every 10-14 days.

This is the first regulatory approval worldwide for ALPROLIX, which is currently under review by regulatory authorities in several other countries, including the United States, Australia and Japan.

Concordia to Acquire Donnatal Concordia Healthcare Corp, has entered into a definitive agreement to acquire Donnatal, an adjunctive therapy in the treatment of Irritable Bowel Syndrome (IBS) and acute Pharma Bio World

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enterocolitis, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals.

Donnatal comes in two formulations: immediate release Donnatal Tablets, and immediate release Donnatal Elixir, a fast acting liquid. For over forty years, Donnatal has delivered gentle, symptomatic relief from the symptoms of IBS. In addition to the drug, Concordia is acquiring the sales and marketing infrastructure related to the product.

The Company has agreed to acquire Donnatal for USD 200 million in cash and an aggregate of 4,605,833 common shares of Concordia. The common shares issuable have an aggregate value of approximately USD 65.3 million based on the closing trading price of the Company’s common shares on the Toronto Stock Exchange on March 18, 2014, and represent approximately 16.19 per cent of the Company’s outstanding common shares on a non-diluted basis (approximately 14.99 per cent on a fullydiluted basis) after giving effect to the acquisition.

Bivalent rLP2086 Gets US FDA Breakthrough Therapy Designation Pfizer Inc announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10–25 years of age.

Disease caused by Neisseria meningitidis serogroup B has been estimated at between 20,000 and 80,000 cases per year globally, and can result in death or significant long-term disabilities, including brain damage and hearing loss.

Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of potential new medicines for serious and life-threatening diseases.

A Breakthrough Therapy designation conveys FDA’s existing fast track development programme features, as well as more intensive FDA guidance on an efficient drug development programme.

Pfizer is conducting a global clinical development programme for rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20,000 participants, about 14,000 of whom will receive the investigational vaccine. Following interactions that we have had with the FDA, Pfizer intends to submit a Biologics License Application (BLA) to the FDA for bivalent rLP2086 by mid-2014.

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22-04-2014 10:21:38

pharma news Samsca Gets Japanese Approval as A M R I t o A c q u i r e C e d a r b u r g the World’s First ADPKD Drug Pharmaceuticals Otsuka Pharmaceutical Co, Ltd has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD). Samsca has been approved in Japan in 7.5-mg and 15-mg tablet forms for extended use for the additional indication of ADPKD. Also, the new dosage form of 30-mg Samsca tablets has received approval for the indication of ADPKD. Samsca was developed over the past 26 years by the efforts of many researchers in Otsuka’s Tokushima, Japan research facility. It is currently used in 14 countries and territories around the world as an aquaretic drug, which facilitates excretion of only free water without electrolyte loss due to its antagonist action on vasopressin V2 receptors.

Glenmark Gets Research Fee Payment from Forest Laboratories Glenmark Pharmaceuticals Ltd, through its Swiss subsidiary, has received USD 4 million as research fee payment from Forest Laboratories Inc on a collaboration for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain.

AMRI has signed a definitive agreement to acquire all the outstanding shares of Cedarburg Pharmaceuticals, Inc for USD 38.2 million in cash. The transaction, including USD 2.8 million of assumed liabilities, is valued at USD 41 million. Cedarburg Pharmaceuticals is a contract developer and manufacturer of technically complex active pharmaceutical ingredients (API’s) for both generic and branded customers. The transaction is consistent with AMRI’s strategy to be the preeminent supplier of custom and complex drug development services and product to both the branded and generic pharmaceutical industry.

Located in Grafton Wisconsin, Cedarburg Pharmaceuticals is a trusted, long-time partner to many of the industry’s leading pharmaceutical companies and is well respected for its expertise in developing technically differentiated APIs, its reliability of supply and track record of quality. Cedarburg’s core capabilities include controlled substances, steroids, prostaglandins, vitamin D analogs, conjugation chemistry and inorganics for the analgesic, ophthalmology and oncology therapeutic areas.

GSK Withdraws MAA for Mekinist in Combo with Tafinlar

Mylan Wins Lawsuit Against GSK

GlaxoSmithKline plc (GSK) has withdrawn its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of Mekinist (trametinib) in combination with the previously approved BRAF inhibitor Tafinlar (dabrafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The application for the use of Mekinist as a single agent in the same patient population, submitted simultaneously with the MAA for the combination, is still undergoing review by the EMA.

Mylan Inc announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride Extended-release (ER) Tablets. The jury decided that GSK owes Mylan USD 106.7 million in damages.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has indicated that the data provided to date by GSK did not allow the Committee to conclude on a positive benefit-risk balance of the combination. GSK intends to re-submit the MAA for the combined use of Tafinlar and Mekinist when additional data from the ongoing Phase III programme become available.

Mylan’s claims were based on 2007 agreements with GSK relating to Mylan’s Abbreviated New Drug Application (ANDA) for Paroxetine Hydrochloride ER Tablets. Pursuant to those agreements, Mylan obtained certain intellectual property rights from GSK. Mylan then launched its generic Paroxetine Hydrochloride ER Tablets in May 2008 and, to date, is the only company to have received FDA approval of an ANDA for this product.

The regulatory submission for the combination was based on the results from an open-label randomised three-arm phase II study, provided to EMA in 2012. The study aimed to assess the safety and efficacy of dabrafenib in combination with two different doses of trametinib compared to dabrafenib monotherapy in patients with unresectable or metastatic BRAF V600 E or K mutation-positive melanoma.

Under the terms of the agreement signed in FY 2012-13, Forest made USD 6 million upfront payment and also provided an additional USD 3 million to support the next phase of work. In September 2013, Glenmark received an additional amount of USD 2 million as research fee payment from Forest Laboratories Inc.

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22-04-2014 10:22:11

pharma news D r R e d d y ’s I n t r o d u c e s G e n e r i c AstraZeneca, MRC to Create a Joint Caduet to US MSarket Research Facility in Cambridge Dr Reddy’s Laboratories has launched amlodipine besylate and atorvastatin calcium tablets 2.5/10mg, 2.5/20mg, 2.5/40mg, 5/10mg, 5/20mg, 5/40mg, 5/80mg, 10/10mg, 10/20mg, 10/40mg and 10/80 mg a therapeutic equivalent generic version of Caduet (amlodipine besylate and atorvastatin calcium) tablets, in the US market, following the approval by the United States Food & Drug Administration (US FDA).

The Caduet tablets brand and generic had US sales of approximately USD 163 million MAT for the most recent twelve months ending in January 2014 according to IMS Health.

Dr Reddy’s amlodipine besylate and atorvastatin calcium tablets are available in bottle counts of 30 and 90.

Lupin Buys Laboratorios Grin Pharma Major Lupin Limited has announced the acquisition of 100 per cent equity stake in Laboratorios Grin, SA De CV, Mexico, subject to certain closing conditions. The acquisition marks Lupin’s foray into the high growth Mexican and the larger Latin American pharmaceuticals market. Mexico is one of the fastest growing pharmaceutical markets in the world valued at over USD 13.5 billion and growing at 9-10 per cent annually.

Incorporated in 1955, Grin is a specialty pharmaceutical company engaged in the development, manufacturing & commercialisation of branded Ophthalmic products. Grin is a leading Ophthalmic player and a trusted brand in Mexico.

AstraZeneca and the Medical Research Council (MRC) have entered into a groundbreaking collaboration aimed at better understanding the mechanisms of human disease. The collaboration will see the creation of a joint research facility at AstraZeneca’s new R&D centre in Cambridge in the UK. The AstraZeneca MRC UK Centre for Lead Discovery will sit within the new AstraZeneca site at the Cambridge Biomedical Campus, due to be completed in 2016. It will see world class MRC-supported researchers working side-by-side with scientists in AstraZeneca’s high throughput screening group, identifying new methods to better understand a range of diseases and potential treatment options.

BioAlliance, Penn Pharma to Jointly Manufacture Validive BioAlliance Pharma SA, an innovative Company specialised in the development of drugs in orphan oncology diseases, announced an agreement with Penn Pharma to manufacture Validive, currently in a late phase II trial for the prevention and treatment of severe oral mucositis induced by radiotherapy and/ or chemotherapy in head and neck cancer patients.

Under this agreement, BioAlliance Pharma entrusts the pharmaceutical development of Validive to Penn Pharma, including the production of phase III clinical batches and the commercial production. This new step of industrialisation fits with the overall development programme of Validive.

Actavis Wins Generic Lialda Patent Suit Convergence Ally with Evotec to Actavis plc has confirmed that the United States Court of Appeals Develop Novel Analgesic Drugs for the Federal Circuit has reversed a lower court ruling that Actavis’ generic version of Shire’s Lialda (mesalamine extendedrelease tablets) infringes United States Patent No. 6,773,720 (the ‘720 Patent).

The Appeals Court found that the US District Court for the Southern District of Florida did not correctly construe the claims of the ‘720 Patent, and remanded the case to the District Court for further proceedings using claim constructions consistent with the Appeals Court’s ruling.

Actavis’ Abbreviated New Drug Application for its generic version of Lialda is currently pending with the US Food and Drug Administration (FDA).

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Convergence Pharmaceuticals Holdings Limited has entered into a research alliance with Evotec.

A Convergence subsidiary, Panion Ltd, has been awarded a Technology Strategy Board Biomedical Catalyst Early Stage Round two 2.4 million pound grant, in order to discover and develop compounds against a novel GPCR pain target. Evotec will be responsible for undertaking key drug discovery activities and will work closely with Panion over a three year period to identify suitable pre-clinical candidates, subsequently taking a lead candidate to Phase I ready status. Convergence and Evotec will then jointly progress the assets into the clinic or via partnering collaborations.

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22-04-2014 10:22:11

pharma news Clinigen Acquires Savene from A u r o b i n d o A c q u i r e s A c t a v i s ’ SpePharm Operations in Western Europe Clinigen Group plc has announced the acquisition of Savene (dexrazoxane) from SpePharm AG. The Financial terms of the acquisition are not being disclosed.

Aurobindo Pharma Limited announced the completion of the previously announced acquisition of certain commercial operations in Western Europe from Actavis plc.

Savene is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. Savene is the only authorised treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment.

Aurobindo acquires personnel, commercial infrastructure, products, marketing authorisations and dossier licence rights in seven European countries. Actavis and Aurobindo have also entered into a long term commercial and supply arrangement.

Savene has Orphan Drug status and protection until late 2016 with a worldwide method of use patent until 2020. Under the terms of the agreement, Clinigen will assume full responsibility for Savene’s manufacturing, registration, distribution, and commercialisation in all markets globally excluding the Americas, Israel and South Africa.

Eisai Transfers Dacogen Marketing Rights to Otsuka Eisai Inc, US subsidiary of Eisai Co Ltd, has entered into an agreement to sell and assign its rights to develop and market the DNA methylation inhibitor Dacogen (decitabine) in all countries excluding Mexico to Otsuka Pharmaceutical Co Ltd. In addition, Eisai Inc has assigned the patent right for its metabolic enzyme inhibitor E7727 to Otsuka.

Under this agreement, Eisai Inc will transfer to Otsuka its rights to exclusively develop and market Dacogen in the United States, Canada and Japan, as well as the licensing rights for this product in all other countries excluding Mexico, in which Eisai Inc will retain its rights for Dacogen.

Dacogen is a DNA methylation inhibitor that induces cell differentiation and is indicated for the treatment of myelodysplastic syndromes (MDS). The product was originally developed by Otsuka’s US subsidiary Astex Pharmaceuticals, Inc (formerly SuperGen, Inc) and in 2008, Eisai Inc obtained an exclusive license for its development, manufacture and marketing worldwide.

Eisai believes that this agreement, which gives the original developer, the Otsuka Group, the exclusive right to develop and commercialise Dacogen, will lead to maximisation of Dacogen’s product and patient value.

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Following receipt of clearances from competent authorities, Aurobindo now intends to combine the strength of both enterprises (including its vertically integrated platform and existing commercial infrastructure) in these markets and to identify and maximise all opportunities to improve performance.

Sagent Pharmaceuticals Introduces Adenosine Injection, USP Sagent Pharmaceuticals, Inc announced the launch of Adenosine Injection, USP, a pharmacologic stress agent, in two preservative-free vial presentations. According to IMS, for the 12 months ending January 2014, the US market for Adenosine Injection, USP approximated USD 43 million. As with all products in Sagent’s portfolio, Adenosine features the company’s Prevent IV Measures packaging and labeling, designed to help reduce medication errors.

Adenosine Injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

US FDA Approves ‘Suite C’ for Pacira’s Expare Pacira Pharmaceuticals, Inc announced that the US FDA approved an additional bulk manufacturing suite, referred to as Suite C, for Exparel. The suite is housed at the company’s Science Centre Campus in San Diego.

“We believe the approval of an additional suite to manufacture Exparel marks an important milestone for the company,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Expansion of our manufacturing capacity will enable us to meet the growing demands of both existing and future customers seeking an Exparel-based multimodal pain management regimen to reduce the use of narcotics, with the ultimate goal of decreasing narcotic-related adverse events.”

Pharma Bio World

22-04-2014 10:22:12

pharma news Perrigo Launches Generic Taclonex Mallinckrodt to Buy Questcor Ointment Mallinckrodt plc, a leading global specialty pharmaceuticals Perrigo Company plc has initiated market launch and made its first shipments of the authorised generic version of LEO Pharma A/S’ Taclonex Ointment (calcipotriene 0.005% / betamethasone dipropionate 0.064%).

Taclonex Ointment (calcipotriene 0.005% / betamethasone dipropionate 0.064%) is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older. Brand sales were approximately USD 110 million over the last 52-weeks according to Symphony Health Solutions.

Perrigo’s Chairman, President and CEO Joseph C Papa stated, “This product was the result of the continued hard work and dedication of our Perrigo Rx team. This launch is another example of Perrigo’s investment and commitment to making quality healthcare more affordable for consumers.”

ViiV Healthcare Partner with MPP to Expand Dolutegravir Reach ViiV Healthcare, a global specialist HIV company, announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug Administration (US FDA). Through an agreement with the Medicines Patent Pool (MPP), ViiV Healthcare will accelerate access to dolutegravir where the need is the greatest, in the countries where 99 per cent of children and 93.4 per cent of adults with HIV in the developing world live.

company, and Questcor Pharmaceuticals, Inc, a high-growth biopharmaceutical company, have entered into a definitive merger agreement under which Mallinckrodt will acquire Questcor in a transaction valued at approximately USD 5.6 billion. The transaction was unanimously approved by the Boards of Directors of both companies. Subject to customary closing conditions, the transaction is currently expected to be completed in the third calendar quarter of 2014.

Under the terms of the transaction, Questcor shareholders will receive USD 30.00 per share in cash and 0.897 Mallinckrodt shares for each share of Questcor common stock they own, for a total approximate consideration of USD 86.10 per Questcor share.

US FDA Okays Boehringer’s Pradaxa Boehringer Ingelheim has announced that the US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate) for the treatment of DVT and PE in patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

“Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke.

About one-third of patients with a DVT or PE will suffer a recurrence within 10 years,” said Samuel Z Goldhaber, MD, Director of Brigham and Women’s Hospital’s Thrombosis Research Group and Professor of Medicine, Harvard Medical School.

Newron, Zambon Files for Swissmedic Julphar, MSD Ink 5-Year Licensing Approval of Safinamide Deal Newron Pharmaceuticals, a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A, a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, announced that the application for authorisation for safinamide has been submitted to Swissmedic.

The submission covers the indications “safinamide as addon therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as addon therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.

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UAE-based pharmaceutical company Julphar announced that it has signed a five-year licensing deal with global healthcare provider MSD (Merck in the US and Canada).

Under the agreement, Julphar will have exclusive rights to produce, market, distribute and sell certain MSD medicines in UAE, Kuwait, Bahrain, Oman, Qatar and Iraq, the company said in a statement.

The UAE pharmaceutical company will manufacture some MSD products for the first time in this region, including therapies for diabetes, asthma, allergy, pain and inflammation. Both companies will seek the relevant authorities’ prior approvals on registration and production of the products locally, the statement added.

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22-04-2014 10:22:12

press release Avantor Appoints Helen Evans as Bionomics Wins Innovative Asian Executive VP, Laboratory Products Biotech of the Year Award Avantor Performance Materials, a global manufacturer and supplier of high-performance chemistries, announces the appointment of Helen Evans as executive vice president, laboratory products.

Evans brings nearly 25 years of life sciences experience to this role. Most recently, she served as General Manager – Research Markets, US and Canada, for GE Healthcare, where she led sales and marketing activities for the GE Life Sciences Research Markets business. Prior to that time, Evans held various leadership positions with Whatman, Inc, a manufacturer and supplier of laboratory products that was acquired by GE Healthcare in 2008, including positions in business development, strategic marketing, sales and product management.

She holds a master’s degree in Marketing from Greenwich University, United Kingdom, and an Executive MBA from the University of London, Ashridge Management College.

Glenmark Gets USD 5 Million Milestone Payment from Sanofi Glenmark Pharmaceuticals Ltd, through its Swiss subsidiary, has received USD 5 million as milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta1) integrin monoclonal antibody. GBR 500 is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders.

Glenmark has received from Sanofi already USD 50 Mn as an upfront payment in FY2011-12. Hence, the total amount received

by Glenmark from Sanofi for its first in class VLA-2 monoclonal antibody is USD 55 million

Jubilant Life Sciences Increase Price of Niacin by 18% Jubilant Life Sciences, a significant player in the Nutrition market and ranked amongst the largest manufacturers of Vitamin B3 (Niacin & Niacinamide) in the world announces a price-increase of 18 per cent for Niacin feed-grade, with immediate effect, for non-contract customers and wherever existing contracts permit.

Jubilant delivers unmatched advantages of consistent quality and availability of Vitamin B3 (Niacin & Niacinamide) to its customers globally. The Company’s nutrition business is backward integrated up to the initial raw material stage with global scale of operations.

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Bionomics Limited has been named as the Innovative Asian Biotech of the Year at this week’s BioPharma Asia Industry Awards during the BioPharma Asia Convention, at the Suntec Convention and Exhibition Centre in Singapore.

BioPharma Asia Convention is Asia’s largest biopharmaceutical event drawing almost 3,000 attendees from across the world with interests in biotech and pharmaceutical company partnering, industry trends and investment opportunities.

The citation underpinning the Innovative Asian Biotech of the Year award made reference to Bionomics’ ability to adopt innovative technologies to develop novel drugs. It is also acknowledged the company’s approach to drug development including the implementation of new processes, technologies or applications that achieve quantifiable and sustainable results.

Further, CEO & Managing Director Dr Deborah Rathjen was awarded the Life Science Woman Executive of the Year award for her contribution to both the biopharma industry and society.

Conference leaders cited achievement of excellent results while demonstrating high levels of professionalism.

Intertek Organises Seminar on Extractable & Leachables Intertek, a leading quality solutions provider to industries worldwide organised and presented a seminar “Manage your Extractable & Leachables Risk” on Wednesday, 9 th April 2014 at The Lalit, Mumbai. This one day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies. An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product.

The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.

Pharma Bio World

22-04-2014 10:25:57

press release STA Gets TGA Approval for Abraxane Piramal Imaging’s Neuraceq Gets in Combination with Gemcitabine FDA Nod Australian biopharmaceutical company Specialised Therapeutics Australia (STA) is pleased to announce that Abraxane (nanoparticle albumin-bound paclitaxel) in combination with gemcitabine in now approved by the Therapeutic Goods Administration (TGA) for the first-line treatment of metastatic pancreatic cancer.

Abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

TGA approval was based on the pivotal randomised phase III trial, MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), published in the New England Journal of Medicine (NEJM) in October 20132. The study reported that patients treated with ABRAXANE plus gemcitabine had a statistically significant improvement in overall survival (OS) compared to patients receiving the current standard of care, gemcitabine monotherapy (OS; median 8.5 months vs. 6.7 months; HR 0.72, P<0.001). An updated analysis of OS presented at a recent international cancer conference in January 2014 (ASCO GI) showed the survival benefit was further extended in the ABRAXANE plus gemcitabine arm, with a 2.1 month median OS improvement compared to gemcitabine alone (OS; median 8.7 months vs 6.6 months; HR=0.72; p<0.0001).

Piramal Imaging announced that the US Food and Drug Administration (FDA) has approved Neurace. This approval comes only four weeks after receiving marketing authorisation for Neuraceq from the European Commission.

Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.

There are an estimated 7.7 million new cases of dementia each year worldwide. Alzheimer’s disease accounts for 60-80 per cent of all dementia diagnoses. However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10–30 per cent of cases.

The Centers for Medicare & Medicaid Services will cover a betaamyloid PET scan for patients under Coverage with Evidence Development programmes. The objective of these programmes is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.

EMA Begins Adaptive Licensing M a c r o e c o n o m i c D e v e l o p m e n t s Pilot Project Looming Over Turkey’s Pharma Market The European Medicines Agency (EMA) is inviting companies to Business Monitor has just released its latest findings on Turkey’s Pharmaceuticals & Healthcare sector in its newly-published Turkey Pharmaceuticals & Healthcare Report.

Turkey’s pharmaceutical market has faced stifling regulatory control over the last five years, which drugmakers have largely borne in return for access to a growing market. With market growth in question over the short-term and Business Monitor’s 2014 forecast posing downside risk, macroeconomic developments are currently looming over pharmaceutical market development.

In Business Monitor’s Pharmaceutical Risk/Reward Rating table Turkey is ranked the ninth most attractive business environment out of the 20 markets surveyed in Emerging Europe, declining from fifth in the previous quarter on account of a declining assessment of both market potential and regulatory risk. Turkey’s large drug market, coupled with the sector’s long-term growth potential, means that the country scores above the average for the region in spite of a slight downward adjustment to Business Monitor’s appraisal.

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participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases. A framework to guide discussions of individual pilot studies has been published.

The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines.

It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.

As a holistic approach, adaptive licensing requires the involvement of all stakeholders who have a role in determining patient access, including the EMA, the industry, health technology assessment (HTA) bodies, organisations issuing clinical treatment guidelines and patient organisations.

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22-04-2014 10:26:46

press release BioClinica Signs eClinical Contracts StemCyte to Expand Operations with 2 Major Pharma Companies in India BioClinica, Inc, a leading provider of specialised outsourced clinical trial services, recently penned USD 30 million in multi-year contract renewals with two major pharmaceutical companies. Collectively these engagements encompass cloudbased technologies and professional services and training across BioClinica’s full eClinical product suite: OnPoint CTMS, Express EDC, Trident IRT, and clinical supplies Optimiser.

StemCyte India Therapeutics, a unit of StemCyte Inc - USA, has emerged as the only company in India in stem cell business to offer private banking, public banking and stem cell transplants with Umbilical Cord Blood (UCB) stem cells. Company plans to expand its operations in India by opening new collection centres across the country and build 5,000 plus public inventory of UCB units with focus on more transplants in next 2-3 years.

Under the contracts BioClinica will support several hundred clinical studies annually through 2017.

StemCyte India Therapeutics Pvt Ltd is a joint venture between StemCyte Inc - USA, Apollo Hospitals Enterprises Ltd and Cadila Pharmaceuticals Ltd. Company started its operations in India in 2010 and has stored 1000 plus public umbilical cord blood units till date.

The contracts extend partnering arrangements that originated a decade ago. Since then, BioClinica has supported the two organisations in clinical trials across thousands of investigative sites worldwide.

GSK’s Eperzan Uses Novozymes Praj Renames NeelaSystems as Technology Praj HiPurity Systems Novozymes Biopharma DK A/S, a subsidiary of Novozymes A/S, Praj Industries, global process solutions Company has changed the name of its subsidiary Neela Systems as Praj HiPurity Systems Limited. Praj Industries had acquired majority stake in Mumbai headquartered Neela Systems in 2012. The change of identity is in line with the growth plan of Praj HiPurity to go beyond pure water solutions for Pharma Industry to end-to-end, integrated solutions for pharma, biotech and cosmetics industriesand the enhanced shareholding of Praj in the subsidiary.

As part of the integrated solutions, Praj HiPurity will also offer wastewater treatment systems and Zero Liquid Discharge Systems in association with Praj Industries Limited.

Jubilant Chemsys, IDRI Extends Partnership Jubilant Chemsys, a wholly-owned subsidiary of Jubilant Life Sciences, announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. Jubilant Chemsys offers drug discovery research services on Full Time Equivalent and Fees- for-services basis.

The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs) – some of which have now been identified for further exploration.

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a world leader in bioinnovation, has announced that its albuminbased VELTIS half-life extension technology is being used by GlaxoSmithKline in the recently authorised Eperzan (albiglutide) for the treatment of type 2 diabetes in Europe. The application of Novozymes’ VELTIS technology in the drug delivers an extended half-life which will enable patients to inject only once per week.

“The first approval for a product based on Novozymes’ VELTIS technology, and marketed by one of the largest pharmaceutical companies in the world, marks a significant milestone for our half-life extension platform”, said Thomas Videbæk, Executive Vice President, Business Development, Novozymes. “We consider this authorisation real proof that VELTIS can offer true benefits to patients, reducing the inconvenience with daily drug dosing.”

HRA Pharma, Afaxys to Supply UPA to US Market HRA Pharma and Afaxys Pharmaceuticals have formed a commercial partnership to supply ulipristal acetate (UPA), a selective progesterone receptor modulator, to the US market.

The product is commonly known as ella in the US where it has been available since 2010. Ella is a next-generation emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use. Ella was originally approved as an emergency contraceptive by the European Medicines Agency in 2009 and subsequently by the FDA in 2010.

Pharma Bio World

22-04-2014 10:27:21

press release Piramal’s Mumbai R&D Facility Wins Ashland Opens New Pharmaceutical GLP Certification from NGCMA Centre of Excellence in Hyderabad Piramal Enterprises Limited (PEL) announced that its Good Laboratory Practices (GLP) Department at Research & Development (R&D) facility in Goregaon, Mumbai has received the GLP Compliance Certification from the National Good Laboratory Practice Compliance Monitoring Authority (NGCMA), Government of India.

GLP is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are performed. The R&D facility in Goregaon, Mumbai is engaged in drug discovery and development of New Chemical Entities (NCE) in the area of Oncology and Metabolic Disorders.

Dr Owe Orwar, President – NCE Research, Piramal Enterprises Limited said, “The GLP certification is a testament to high quality research through thorough SOP-driven Good Laboratory Practices, competent well-trained personnel and systematic documentation at Piramal’s NCE R&D facility in Mumbai.

Piramal’s NCE R&D unit is committed to realise its mission towards serving patients globally with medicines that matter.”

DIA Conference to Address Current Situation of New Drug Development Professionals from across East Asia will discuss the latest hot topics in all stages of drug development at the 8 th DIA Annual Conference in Japan for Asian New Drug Development.

The event will return for its eighth year on May 22 to 23, at Sola City Hall, Ochanomizu in Tokyo. Expert speakers will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs. Sessions will focus on the latest regulatory information, early phase clinical trial, collaboration between academic organisations, regulatory inspection, regional study communications and late phase development strategy.

The conference will feature presentations on the latest regulatory trends and regional clinical trials in Asia from industry leaders and high-profile representatives from Asian regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA), China Food and Drug Administration (CFDA), and the Ministry of Food and Drug Safety in Republic of Korea.

Academic speakers from Japan, China and Korea will also provide their future visions of new drug development and the role of academia collaboration in East Asia.

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Ashland Specialty Ingredients, a commercial unit of Ashland Inc, held a grand opening ceremony for the opening of a new pharmaceutical centre of excellence in Hyderabad, India. This is the ninth centre of excellence that Ashland Specialty Ingredients has opened, and it joins Ashland’s global network of three dozen research and development and technical centres. The state-ofthe-art facility specialises in oral soliddosage form research and expands Ashland’s global reach, pharmaceutical research and footprint outside of North America.

Ashland Specialty Ingredients offers comprehensive and innovative solutions for today’s global pharmaceutical and nutraceutical industries.

Venus to Market Meropenem in Venezuela Venus Remedies Ltd has extended its footprint in Latin America with marketing authorisation for meropenem from Venezuela.

Meropenem, which accounts for annual global sales of USD 906 million which are estimated to go up to USD 1,006 million in the next one year, is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.

Venus has received marketing approval for meropenem from more than 35 countries and is exporting the product to 22 of them, including European Union member-nations. Venus is now eying lucrative and regulated markets where the registration process is in advanced stages.

Piramal Honored with Two CMO Leadership Awards Piramal Enterprises’ Pharma Solutions Division, a global pharmaceutical contract development and manufacturing organisation (CDMO), has received CMO Leadership Awards 2013 in two categories – Quality and Reliability, at a prestigious ceremony at DCAT in New York. Within the Reliability category, Piramal has been recognised as the most “Reliable” CMO among the 5 CMO’s shortlisted for this award.

The CMO Leadership Awards are given by Life Science Leader based on the industry leading research conducted by Nice Insight.

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press release Sunshine Enhances Adva-27a

EMA to Launch Clinical Trial Data Policy

Sunshine Biopharma Inc has resolved the two isomeric forms of its lead anticancer compound, Adva-27a, and as a result the specific activity of the drug candidate has increased 9.5fold. Sunshine Biopharma had previously announced that the concentration at which Adva-27a inhibited 50 per cent of the activity of Topoisomerase II (IC50) was 13.7 micromolar. As a result of these development Adva-27a’s IC50 has dropped 9.5fold, to 1.44 micromolar. This implies that significantly lower quantities of the drug can be used to achieve the same effect.

The European Medicines Agency (EMA) will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical trial data at the beginning of May. This will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s Management Board for endorsement in June 2014.

“Isomeric forms of a compound refer to the fact that the compound has different arrangements of its atoms in space,” said Dr Steve N Slilaty, Chief Executive Officer of Sunshine Biopharma. “Isomeric forms do not have identical properties.

In the case of Adva-27a, the molecule exists in the alpha or beta form. This is a lot like a person’s left hand and right hand.

While the two hands look identical, they actually are not. They are mirror images of each other but are not superimposable.

The fact that they are not superimposable means that they are not identical. Similarly, the alpha and beta forms of Adva27a are not superimposable. The implications of all of this for our future breast cancer and pancreatic cancer patients are lower therapeutic dosages, which theoretically should result in reduced side-effects.”

Minomic to Start Overseas Trials of MiStat Private Australian biotechnology company Minomic International Ltd will launch two overseas trials of its MiStat prostate cancer screening test, following an agreement with the prestigious CUSP Group, LLC a Uro-Oncology Trials Management Organisation in the United States.

An initial pilot study to be launched in April will examine 300 patient samples and is designed to verify the accuracy and reliability of the existing MiStat test in differentiating normal, benign and malignant prostate cancer samples.

Preliminary data from this trial will be available by August and will inform a larger pivotal study examining 1200 patient samples. This second trial is expected to begin in September and will source subjects from 12 large urology practices across the USA. Data from this trial will be available by early 2015.

Both trials will provide critical, late stage evaluation of Minomic’s proprietary MiStat technology, which is capable of identifying the presence of a proprietary biomarker. This biomarker is present on the surface of prostate cancer cells.

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This consultation is meant to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy. The targeted discussions will focus on the presentation by the EMA of the principles set for the possible redaction of the clinical study reports to be published.

If applied, the redactions will be based on the criteria identified by the Agency for those parts of clinical trial data that exceptionally contain commercially confidential information.

They will also aim to clarify how the concerned data-owners (eg, marketing authorisation holders) will be consulted before publication of their clinical study reports, and user-friendly technical measures to make the data accessible under the new policy including their terms of use.

South Korean Pharma Industry to Achieve $24.3 Bln Value by 2020 Thanks to a high level of access to healthcare insurance and reimbursement, coupled with increasing demand for healthcare services from an expanding elderly population, the South Korean pharmaceutical market is expected to climb in value from USD 19.3 billion in 2013 to USD 24.3 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 3.9 per cent, says research and consulting firm GlobalData.

According to the company’s latest report, the South Korean pharmaceutical industry is also expected to be influenced by various government initiatives over the coming years, such as the Korean Small Business Innovation Research programme.

These projects are aimed at encouraging Research and Development activities and sustaining growth in the pharmaceutical sector.

However, South Korea is maintaining its focus on generics as a cost-containment measure to slow the rise of its healthcare expenditure, which could hurt branded-drugs profits. In fact, the country’s generic market value has increased from USD 3.5 billion in 2008 to an estimated USD 4.9 billion in 2013, at a CAGR of 7 per cent, according to GlobalData.

Pharma Bio World

22-04-2014 10:27:21

biotech news Novartis’ Bexsero Gets Breakthrough Alimera Resubmits NDA for Iluvien to US FDA Therapy Designation Novartis announced that Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a Breakthrough Therapy designation from the United States Food and Drug Administration (FDA). Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B (meningitis B).

Novartis plans to file for US licensure of Bexsero as early as Q2 2014; exact timing will depend on guidance from the FDA. This is the fourth Breakthrough Therapy designation for Novartis, underscoring leadership in developing innovative therapies and vaccines.

This announcement comes on the heels of a landmark decision from regulators in the UK, where the Joint Committee on Vaccination and Immunisation (JCVI) recommended the inclusion of Bexsero in the country’s National Immunisation Programme (NIP) for routine use in infants from two months of age.

In the last four months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the FDA. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.

US FDA Okays Biogen’s Alprolix Biogen Idec announced that the US Food and Drug Administration (FDA) has approved Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.

The approval of Alprolix is the first significant advance in hemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favorable safety and tolerability profile. It is developed using a process called Fc fusion and is the first hemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with hemophilia to extend the time between prophylactic infusions.

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Alimera Sciences, Inc, a biopharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, has resubmitted its New Drug Application for Iluvien to the US Food and Drug Administration (FDA). At this time, Alimera awaits the FDA’s acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. Alimera intends to provide that information when it becomes available.

In the resubmission, Alimera responded to questions raised in the FDA’s October 2013 complete response letter and provided a safety update, which included commercial experience with Iluvien in Europe.

Inova, Personalis Join Forces for Advance Genomic Medicineg Inova Translational Medicine Institute and Personalis Inc have announced a partnership to advance genomic medicine for Inova’s patient population. Personalis will collaborate with Inova on whole genome analysis and interpretation for undiagnosed syndromes in an effort to provide patients and their families an answer for these difficult cases.

Epirus, Zalicus Ink Merger Deal Epirus Biopharmaceuticals, Inc and Zalicus Inc have entered into a definitive agreement under which Epirus will merge with a whollyowned subsidiary of Zalicus in an all-stock transaction. Following closing, Zalicus will be re-named Epirus Biopharmaceuticals, Inc, and will operate under the leadership of the Epirus management team with Amit Munshi serving as the president and chief executive officer. In addition, Dr Mark H N Corrigan will serve as chairman of the company’s board of directors, which will have representatives from both the existing Epirus and Zalicus boards.

Bemfola Gets EC Marketing Nod Finox Biotech (FINOX AG) announced that the European Commission (EC) has granted Marketing Authorisation (MA) for bemfola (follitropin alfa solution for injection in pre-filled pens), a recombinant follicle stimulating hormone used for the treatment of infertility. This marketing authorisation follows a positive opinion by the European Medicines Agency, and allows for the marketing of bemfola in all of the 31 countries of the European Union (EU) and European Economic Area (EEA).

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UV-Vis Diode Array Spectrophotometer The Cary 8454 UV-Vis includes a new version of UV-Vis ChemStation software that integrates with OpenLAB Enterprise Content Manager (ECM).

Together they provide the secure data management needed in pharma and other highly regulated industries. The system can collect a complete spectrum in less than one second. It is the succcessor to Agilent’s 8453 UV-Vis, which has long been the UV-Vis spectrophotometer of choice for laboratories conducting pharma quality assurance and quality control, and for academic and chemical lab conducting time-based kinetics analysis. It incorporates robust PDA detector technology used in Agilent’s liquid chromatography instruments with pre-aligned light sources for easy maintenance and high levels of reliability required in QA/QC labs. Its compact design and open sampling area improve ergonomics for accessory installation and enable easy, error-free sample preparation and results.

Handheld FTIR Spectrometer The ergonomic 4300 Handheld Fourier transform infrared (FTIR) spectrometer enables the direct identification and assessment of high-value materials without sample extraction, making FTIR a true non-destructive testing solution. Two versions are available: one equipped with a deuterated triglycine sulfate infrared detector that covers wide range of materials analysis applications, and a high-performance version, equipped with a thermoelectrically cooled mercury cadmium telluride detector. The latter system is ideal for measuring numerous locations over a surface or in a field. The FTIR is available with five interchangeable sample interfaces for handling the broadest range of applications. Each interface is equipped with RFID sensors, enabling full integration with Agilent’s method-driven Microlab mobile software. The FTIR spectrometer is the newest in Agilent’s line of specially designed solutions comprising a range of GC, GC/MS and FTIR systems for use in food, agriculture, forensics, mining, biofuels, chemical and other environmental and material applications.

For more information, please contact:

For more information, please contact:

Agilent Technologies India Pvt Ltd G01. Prime Corporate Park, 230/231 Sahar Road Opp: Blue Dart Centre, Andheri (E), Mumbai 400 099 Tel: 022-30648287 | Fax: 91-022-30648250 E-mail: rajendra.jathar@agilent.com / cag_india@agilent.com

Agilent Technologies India Pvt Ltd G01. Prime Corporate Park, 230/231 Sahar Road, Opp: Blue Dart Centre ,Andheri (E), Mumbai 400 099 Tel: 022-30648287 | Fax: 91-22-30648250 E-mail: rajendra.jathar@agilent.com / cag_india@agilent.com

Online Monitoring of Concentration and Contamination To measure the concentration of the cleaner and the degree of contamination in the bath continuously, accurately and quickly, the LiquiSonic analyzer of SensoTech will be directly integrated into the process.

The automatic real-time measurements every second show immediately how much cleaner must be replenished to keep the cleaning result constant, eg, the analyzer Is used in cleaning and degreasing baths, in rinsing baths, pickling and etching baths, and coating and plating baths as well. Installing the LiquiSonic sensor into the plant is easy and suitable for every cleaning or surface processing plant.

This eliminates time-consuming manual measurements, which provide delayed and often inaccurate results by titration analysis.

LiquiSonic technology measures inline and accurately in various bath fluids, because the measuring method is independent of the turbidity and conductivity of the fluid and has a high tolerance of soiling.

For more information, please contact: SensoTech GmbH Steinfeldstr 1, D-39179 Magdeburg-Barleben Germany Tel: +49 39203 514 100 | Fax: +49 39203 514 109 E-mail: info@sensotech.com

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Non-electric Water Purification Tata Swach offers Tata Swach Silver Boost. While chlorine only provides protection from bacteria and virus, and does not protect from the harmful cyst Cryptosporidium, which causes health related issues such as substantial weight loss, nausea and even malnutrition - highly detrimental to growing children. Other non-electric purification technologies which use only membrane purification do not provide protection against virus, which may cause harmful diseases like Polio, Hepatitis A and Hepatitis E. The all-new Tata Swach Silver Boost combines the power of MF membrane with Silver nanotechnology to make water microbiologically safe from virus, bacteria and parasites/cyst along with safety from algae, fungi, rust, metal particles and turbidity. It provides double protection from bacteria through Tata Swach Bulb and Tata Swach MF membrane.

Detection of Pharma Products in Water Bruker has released an application note detailing a simple and convenient method for the quantification of trace pharma and personal care products in clean water, using Bruker’s EVOQ triple quadrupole liquid chromatography mass spectrometer (LC-MS/MS). PPCPs in environmental and potable water are potentially harmful for both humans and the environment, so are strictly regulated by environmental bodies such as the US EPA. Bruker’s technique proved simpler than traditional solid phase extraction (SPE) based methods and the EVOQ showed excellent sensitivity and robustness throughout.

The application note is available to download at http://bit.ly/ BCA582. The application note explores the high sensitivity of the EVOQ in detecting PPCPs in clean water. All PPCPs were detected at 2 ppt or better within 0.4 mL samples. Their unique innovations, including the EVOQ’s Active Exhaust and IQ Dual Funnel, deliver sustained high sensitivity. Their PACER software provides faster data-to-report times by reducing unnecessary review.

For more information, please contact:

For more information, please contact:

Tata Chemicals Bombay House , 24 Homi Mody Street Fort, Mumbai 400 001 Tel: 022-6665 8282 E-mail: cjoshi@tatachemicals.com

Bruker Daltonics 3500 West Warren Avenue, Fremont, CA 94538, U,S.A. Tel: +1 905 691 2724 E-mail: Joe.anacleto@bruker.com

Submerged Ultrafiltration Membranes QUA, offers EnviQ submerged ultrafiltration membranes for wastewater treatment and recycle applications as part of the Membrane Bioreactor (MBR) process. QUA’s EnviQ membranes have been specially developed to improve the ease of operation and maintenance of MBR facilities. EnviQ’s innovative design offers ultrafiltration quality product water with a stronger and more rugged PVDF flat sheet membrane. EnviQ’s unique features such as reverse diffusion and specially designed air diffusers maximize scrubbing efficiency resulting in reduced cleaning.Additionally, EnviQ significantly lowers the total installed cost of biological wastewater treatment and recycle systems as compared to conventional activated sludge processes with tertiary filtration.

EnviQ is currently offered in three configurations: E-8C, 16C and 32C, each having surface area of 80, 160 and 320 m2, respectively.EnviQ is the latest innovation from QUA, which in the past year also introduced CeraQ® ceramic membranes as well as MEGA FEDI and FEDI-Rx products for heavy industrial and pharmaceutical industry applications.

For more information, please contact: Qua Water Technologies Pvt Ltd Plot No.35,t-block,, MIDC, Bhosari Pune, Maharashtra 411 026 Tel: 020-67318000 | Fax: 91-020 -67318080 E-mail: puranika@quagroup.com / sales@quagroup.com

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Lifting Columns The LC Series are ideal for providing telescopic motion in medical and ergonomic applications. The Lifting Columns consist of anodised extruded aluminium profiles, which slide into each other. The design provides a high moment load capacity without compromise on speed of operation along with a large lift capacity to frame size ratio.

Their robustness and performance is complemented by the ability to link multiple units together for flexibility in design configuration. Thomson Lifting Columns are available in three model variations, which provide different performance in extension to retraction ratio, load capacity, speed and cost to best match application needs. As with all Thomson solutions, the lifting columns can also be customised.

For more information, please contact: Thomson Sigma Building, 10th Floor, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022 42270300 | Fax: 91-022-4227 0338 E-mail: sales.india@thomsonlinear.com

Heat Exchanger Tube Cleaner To function efficiently every tube of heat exchanger must be kept clean in order to maintain production efficiency and to prevent permanent damages from overheating. As one of the pioneers in the development of tube cleaning equipment DBX Tool developed new heat exchanger tube cleaner. This heat exchanger tube cleaner consists of pneumatic or electric motor with water feeding attachment. The motor drive various cleaning tools by means of driven shafts, drive shaft, cutter, and brush. Water is supplied through shafting by a feed attachment on the motor and is used to flush away the deposit removed by the tool.

Best for removing extremely hard scale from condensers and heat exchangers from 9 to 28 mm ID. For more information, please contact: DH Boiler Exchangers Tools Pvt Ltd 3101 Bhandup Indl Estate, Pannalal Silk Mill Compound LBS Marg, Bhandup (W), Mumbai 400 078 Tel: 022-66711682, 25948419, 25948420 | Fax: 91-022-25948419 E-mail: dh.boilertools@gmail.com / info@dbxtool.com

Safety Valve Fainger LESER offers safety valve, Type FL 237, for industrial applications. It is designed to protect systems with low to medium capacities. Typical applications include thermal expansion, utility steam or compressors. The safety valve is suitable for pressures from 0.1 to 93 bar and temperatures from -273 to 280°C. It is supplied with threaded connection according to different standards, eg, BSP, NPT, BSPT. The material used, AISI 316 stainless steel, gives it a wide area of application.The safety valve is notable for its small size and high capacity relative to the safety valve size. It has a wide operating range because the valve can be used for steam, gas or liquid applications without any modifications to the internal components. This feature, known as single trim, reduces the number of spares and brings down costs for the customer. Fainger LESER has also designed the outlet body in such a way that no media residues remain in the valve after it has been activated.

The safety valve has been successfully tested in accordance with the guidelines of DIN EN ISO 4126 and ASME Section VIII Div. 1. With complete opening within a 10 % pressure increase and closing within 10% or 20% for liquid applications, the valve complies with the requirements of the major international guidelines. It also has the IBR approval.The company supplies safety valves for applications in the chemical, petrochemical, pharma, energy supply and food industries, but also for the oil and gas industry.

For more information, please contact: Fainger Leser Valves (P) Ltd 136/137, Sanjay Bldg No: 3, Mittal Estate, Marol Andheri Kurla Road, Andheri (E), Mumbai 400 059 Tel: 022-28501692, 28504277, 28503617, 28509747, 28509751 | Fax: 91-022-28504470, 28510918 E-mail: info@faingerleser.com

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Pneumatic Boiler Tube Cleaner The tubes and piping of boiler, heat exchangers and condensers must be kept clean in order to maintain 100 per cent production efficiency and to prevent damage to the boiler due to overheating. Being one of the pioneers in tube cleaning field, DBX tool has developed new pneumatic boiler and heat exchanger tube cleaner, which cleans tubes thoroughly by mechanical means. This air motor along with cutter or brush goes inside the tubes of vessels and cleans the tubes. This system consist of few moveable parts and easy to operate. It saves manpower and time for handling tube cleaning jobs, gives polished inner surface, can clean straight and bent tubes, even U-bents, of any length from tube ID 25 up to 150 mm. Air pressures required is 6 kg.

For more information, please contact: DH Boiler Exchangers Tools Pvt Ltd 3101 Bhandup Indl Estate, Pannalal Silk Mill Compound LBS Marg, Bhandup (W), Mumbai 400 078 Tel: 022-66711682, 25948419, 25948420 | Fax: 91-022-25948419 E-mail: dh.boilertools@gmail.com / info@dbxtool.com

Rotational Viscometer Series The Cole-Parmer rotational viscometer series offers greater chemical resistance, enabling the instruments to handle chemically corrosive materials. Each is designed with SS-316 spindles, a sealed keypad and over/under range alarms.

You can determine the dynamic viscosity of samples in applications such as food, adhesives, petroleum products, biofuels, paints, pharma, chemicals, etc. Over/under range alarm sounds when your sample is too high / low for the spindle selected. All models feature 10 language options, pushbutton control with easy-to-use menu system, motor selftest, user enabled calibration to a known standard and universal power supply.Select from basic, intermediate, and advanced models.

For more information, please contact: Cole-Parmer India 403-404, Delphi-B, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67162253, 6716222, 67162209, Fax: 91-022-67162211 E-mail: response@coleparmer.in / vinita.singh@coleparmer.in

Circulator Pump Grundfos Pumps India Pvt Ltd (Grundfos India) offers the MAGNA3 circulator pump. The Grundfos MAGNA3 pumps are designed for circulating liquids in heating systems, domestic hot-water systems and air-conditioning and cooling systems. Designed for commercial hydronic applications, MAGNA3 is an energy - optimized, variable-speed wet rotor circulator that features a permanent magnet motor design. It cuts power consumption up to 85 per cent through its innovative AUTOADAPT function which automatically analyses the heating system, finds the optimum setting and then continuously adjust its operation to changes in demand. This also features an in-built energy/heat meter that not only avoids the need for a separate energy meter but also monitors the system heat energy distribution and consumption. The result is optimum comfort and minimum energy consumption MAGNA3 is also equipped with the new FLOWADAPT control mode that reduces the need for pump throttling valves. In addition, MAGNA3 pumps are fitted with radio communication (15 mts from line of sight) and can offer external control and monitoring via expansion modules. Furthermore, wireless connectivity enables handheld pump control and monitoring capabilities by Grundfos GO, a mobile toolbox available on Apple and Android devices. The MAGNA3 range of pumps can also be used for solar-heating systems. Another important feature of MAGNA3 is its GENIair connection (wireless) which helps control the pump/s (up to two pumps connected in parallel).

For more information, please contact: Grundfos India Pvt Ltd 118 Old Mahabalipuram Road, Thoraipakkam, Chennai 600 097 Tel: 044-45966800 | Fax: 91-044-45966969 E-mail: salesindia@grundfos.com

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events diary BIOtech Japan - ABLE India Pavilion

5 th Annual Clinical Trials Summit 2014

Date: 14 th -16 th May, 2014 Venue: Tokyo Big Sight, Japan

Dates: 10 th & 11 th June 2014

Biotech Japan, an International Biotechnology Exhibition & Conference, is the Asia’s largest trade show for Biotechnology.

2014 Edition is expecting 650 exhibitors, 250 presentations and 15,000 visitors with a wide scope for all players in the field with Interactive networking opportunity involving academics, biotech companies & pharma companies!

Contact: Brinda Rajendran Association of Biotechnology Led Enterprises – ABLE Tel: +91-80-4163 6853 / 2563 3853 E-mail:info@ableindia.org

Managing Risks for Quality Compliance 2014 Date: 16 th May 2014 Venue: Hotel Suba International, Mumbai, India At this Seminar, eminent experts in technology, quality assurance, regulatory affairs, engineering, production and packaging spheres from the Indian Pharmaceutical Industry will converge and interact on various recent developments.

IDMA has successfully organised many Industry specific events. This seminar on risk assessment and management will update and exceed the current quality system approach in Pharmaceutical Industry.

Contact: Prachi Rane IDMA Mobile: +91 9867634383 Tel: +91-22-24944624 / 24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Web: www.idma-assn.org 52 April 2014

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Venue: Kohinoor Continental Hotel, Mumbai, India 5 th Annual clinical trials Summit 2014 will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. This summit will discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent &investigators management in order to improve & optimize the overall drug development effectiveness and ROI. Discover on how to implement and benefit from electronic data management & monitoring cost effectively.

Contact: Deepak Raj Virtue Insight Mobile: +91-9171350244 Email - deepak@virtueinsight.net , deepakrajvirtueinsight@gmail.com

BIO International Convention - ABLE India Pavilion Date: 23 th -26 th June 2014 Venue: San Deigo, California, USA The BIO International Convention 2014, San Diego happening this June 23 rd - 26 th , brings together life science leaders and policy makers from around the globe covering the wide spectrum of life science innovations and application areas.

Key elements of the event include education, networking, BIO Business Forum partnering and the 1,700 companies showcasing the latest technologies, products and services in the BIO Exhibition.

Contact: Brinda Rajendran Association of Biotechnology Led Enterprises – ABLE Tel: +91-80-4163 6853 / 2563 3853 E-mail:info@ableindia.org Pharma Bio World

22-04-2014 10:41:01

bookshelf Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators [Paperback] Author: Judy Stone Price: USD 49.19 No of Pages: 624 pages About the Book: This book is a step-by-step how-to manual for both experienced medical professionals and novices looking to enter the field of clinical studies. It explains how to land a study on good terms, provides tips for recruiting patient volunteers - and keeping them happy, offers easy strategies for coordinating studies, demystifies regulatory requirements.

With a comprehensive index and appendices, this book keep readers abreast of changes in the rapidly shifting global drug development industry, including new regulations affecting research, subject injury clauses, the unique needs of device and vaccine trials, the impact of HIPAA on US research, cultural competency and health literacy, ethical considerations in clinical research, and how to survive audits.

Clinical Trials: A Methodologic Perspective Second Edition (Wiley Series in Probability and Statistics) [Hardcover] Author: Steven Piantadosi Price: USD 140.48 No of Pages: 720 pages About the Book: This Second Edition of the critically hailed ‘Clinical Trials: A Methodologic Perspective Second Edition (Wiley Series in Probability and Statistics)’ builds on the text’s reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results.

Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions.

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines [Hardcover] Author: Tom Brody Price: USD 71.24 No of Pages: 672 pages About the Book: ‘Clinical Trials - Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines’ is a practical guidebook for those engaged in clinical trial design.

This book details the organisations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls.

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