Monthly Archives: January 2010

Children who do not have parents are termed as orphans and are catered by social organizations or government funded organizations. Once suitable foster parents are found for them, they continue to grow up in the custody of their existing environment.
Global Pharma is now moving to focus on the orphan drug area for clinical development. The times and the regulatory requirements for the same are more flexible. The investments in the clinical trials are conducted for rare diseases for smaller/ miniscule section of the population. The incidence of diseases for orphan drugs is generally lower than expected and can be claimed as a drug for a higher pricing while placing the trial results post Phase III.

GMD- Mr. Apurva Shah GMD-Mr. Binoy Gardi
Veeda Clinical Research is a global Indian CRO which brings to you a progressive blend of tangible and intangible reading in a series of quarterly newsletter. This edition, the first for the year 2010 starts with the Message from the founders and Group managing directors, Mr. Binoy Gardi and Mr. Apurva Shah. The Founders are the pioneers in a new generation of entrepreneurship in clinical research where they have dared to dream of the skies. The founders have achieved the fastest growth in the Indian CRO market. With their dynamic corporate strategies the founders placed the foundations of Veeda in the Indian geography in Ahmedabad in the year 2004 followed by an acquisition in the United Kingdom in the subsequent year. The strategy to implement the concept of outsourcing clinical research to India has been the prime focus of Mr. Gardi and Mr. Shah. The stepping stone to growth establishment in clinical research was Bio equivalence studies in India and NCE development in the United Kingdom. With a clear vision and sound understanding of their business goals in a market with double digit growth, the founders have taken the company to the levels of the fastest growing Indian CRO in the business achieving a growth (organic and inorganic) at least double of the market rates. Veeda CR has achieved what no other company has achieved in the present and that too without a corporate backing.
Since its inception, Veeda CR has been in an expanding phase under the able leadership of its founders. Data management services were started by Veeda CR with an acquisition of a DM (DICE CRO) unit in 2006-2007 followed by the establishment of an oncology division with acquisitions in the year 2008.Veeda CR has an impeccable track record has overcome major challenges and believes in team augmentation. Veeda CR offers Lab services, DM services, BA BE studies and Oncology services and has achieved milestones by working with at least Top 5 of the Big Pharma companies for studies in major therapeutic areas of interest mainly Women’s health, elderly subjects , CV studies and CNS to name a few.

“Global multinational drug companies’ need to outsource manufacturing to low-cost destinations like India has turned out to be a boon for leading drug companies in India such as Ranbaxy, Cipla, Dr Reddy’s Laboratories and Aurobindo. Thanks to such deals, these drug companies are now well poised to post growth in excess of 20 per cent every year for the next five to 10 years, say industry analysts. Most of these players, who follow different generic business models, were growing organically at an above industry-average growth rate of 12 per cent for the past five years. More such deals, which also include equity investments, are being discussed in the boardrooms of multinationals and Indian generic companies, said industry circles.
In the changing global drug manufacturing landscape, profitability in multinational drug companies is under pressure from patent expirations, pricing challenges and falling research and development productivity. As a result, companies like Pfizer, GlaxoSmithKline (GSK), Sanofi-aventis, Astra Zeneca and Merck & Co are closing their manufacturing units in the developed world and moving production to low-cost destinations. “

SMO

The market for the Site management organizations in India till date has been an area of clinical research with a presence which has yet to take to a place in the calculators of the forecasters. With cancer due to the most potential and growing area of interest for conducting clinical trials in India, the need to classify this market as a growth driver to the already existing clinical research arises in the current scenario.
Below is a hypothetical model which signifies the presence of the””proposed’ SMO market in India. The SMO market in India is predicted to be major driver of the Indian Clinical research market in the times to come (estimations based on the pre recession period indicate the market to be growing in the range of 25-50%).

Clinical trials are the preferred market of interest for SMO’s. Out of the total of around 60,500 Clinical Trials conducted across the globe, 58 percent are in North America, 19 percent in Europe, 5 percent in Central and South America, 5 percent in China, 3 percent in Arab & Middle East Countries, 2 percent in Africa, a little above 1 percent (616) in India and only 0.1 percent (80) in Pakistan. Biopharmaceutical Clinical Trials is highest in Asia after Eastern Europe

Pharma investment is generally a long term investment for all viable reasons because diseases are going to rise and medicines will always be needed. So pharmaceuticals will always be in demand.
At this point in time, as you are aware most major MNC’s are trying to increase stake in Indian Subsidiaries especially Novartis (71% to 90% approx), Pfizer has nearly taken over Aurobindo, Sanofi is likely to go for some Indian Pharma major any time in the next few months and Glaxo may manage to place a little stake in Dr. Reddy’s share. The situation is technically volatile.
If you are really going for Pharma today, Zydus cadila stock or its subsidiary may be okay for the time being. Lupin is another company which is both Long and short term. Lupin generaly targets the EU and makes money in the EU. If the EU market opens up to India again depending if a resolution is arrived on the recent drug seizures, then Lupin is good bet. Just check JB chemicals and Cipla, Mumbai. It has been quiet for a while from their side. Cipla generally gets Government contracts for exports to African countries (AIDS drugs) . So this company’s stock postion will always be credible in the long and short term.
Generic manufacturers like Dishman or may be Troika ( if it is listed, I am not aware) can be taken because these companies function on short term market gains only.( based on the nature of their press releases)
For Outsourcing manufacturing business like Biocon (Syngene and Clingene) once again benefits are likely.
A “”new “”thought”” that came to my mind if you allow some money to be “”risked””, is to buy a stock of a company with an office which is also a local threat to China. Many Chinese companies are listed on the NYSE.
These are only advisory statements based on the nature of press releases of various companies. Actual figures and market performance at the BSE should be analysed from a pre recession (before 2007) perspective and current scene before investing.
Sometimes Pharma may be as volatile as mutual funds!

“As 2010-2011 approaches and the scene for the a record breaking expiries of patented drugs as compared to any year since the last 5 years, it remains to be seen as if the cliff hanger for Big Pharma.

The important thing as this can be viewed as the most strategic opportunity for CRO’s conducting bio equivalence studies for generic drugs especially the emerging regions with significant projected growths for their outsourcing budgets. The cliff hanger trend is an indicator of the trend for which Big Pharma will have to take cautionary approach but for those companies which are in the CRO business of BA Be studies for generic drugs the “growth line ” (In blue). It would be always projected towards profits only.

“What will happen in the upcoming years for Pharma? Pharma R&D spending is slowing – 0-5% annual growth which is likely the reality. Patent cliff is coming – increasing the need for more compounds. There is a need to continue to spend and find opportunities for new drugs- Post M&A restructuring will likely result in substantial R&D synergies.CRO industry growth is increasingly and biotech funding decreasing, CROs are more dependent on greater outsourcing – strategic alliances will be key going forward. Expect share shift towards larger CROs in the future, larger CROs are putting up larger booking numbers-Outsourcing will continue to movie ex-US

“Street” view – tough 2009 but improvement in 2010 CROs will be valued differently from the future.
Outsourcing stocks have performed nicely, but underperformed since September 2008.”

“Global Pharma is on a cost saving spree by using and utilizing data management services to its best possible advantage. Not forgetting to mention that their DM outsourcing providers are all out to place the DM tools to their pharma clients in such a way which fit the budgets in a manner which resembles the exact size and match of a glove in one’s hand.
The data management savings for big pharma are aimed at efficiency through systems standardization and better data management for clinical trials. Outsourcing providers’ of clinical data management aim at labour-intensive process for collecting and reporting clinical trial data from 150 yearly studies involving 50,000 patients across 50 countries by employing more than 1000 staff just for the process. An example of this is the Astra –Cognizant strategic alliance for 5 years which was formed in the year 2007.

“The FDA issues draft guidance on therapeutic cancer vaccine trials in the first 10 days of October 2009. The guidelines have aimed to focus on the difference in therapeutic considerations in comparison to other products for oncology indications.
The efficacy of the cancer vaccine in while performing its action on the on the tumour cell will take a considerable time keeping in mind the fact that the vaccine administration requires many doses to be injected in the plasma.
The document looks at the key clinical considerations spanning both early-phase (defined as Phases I and II) and late-phase (Phase III) clinical trials of therapeutic cancer vaccines, such as the relevant patient population (including disease setting, tumour heterogeneity and co-development of cancer vaccines with tests for the targeted antigen); monitoring the immune response; and disease progression/recurrence immediately or shortly after initial administration of the vaccine.