Monthly Archives: September 2010

”Some side effects will make a medicine too dangerous to keep around. But the decade-long age of mass-market drug recalls – in which an average of one medicine a year has been withdrawn from the U.S. market – looks to be ending thanks to new powers the FDA was granted by a 2007 law, the Food and Drug Administration Amendments Act (FDAAA).

The USFDA can exercise its ability to forcibly change drug labeling and compelling drug companies to publicly register clinical trials. But the most effective new power has been the risk evaluation and mitigation system (REMS).

Statistical outlook
The FDA says there are currently REMS approved for 146 products. Ninety-six of these include only a medication guide, which warns patients about the risks and benefits of a drug. Thirty-three include a communication plan that takes additional steps to approve the drug. Fifteen have what the FDA calls “elements to assure safe use,” which includes much more extreme steps to make sure that the medicine is used properly. As the Avandia case seems likely to show, these requirements can almost eliminate a drug from the market without withdrawing it.”

1. The global biologics market, which saw a 21% compound annual growth rate between 2003 and 2008, has slowed to 8% but revenue will increase from $110 billion in 2008 to $165 billion in 2013 due largely to rapid growth in monoclonal antibodies.
2. The $20 billion bio- production market is growing at a 7% compound annual growth rate and will likely pass the $25 billion market within three years.
3. A significant number of high-value biologics will lose patent protection starting in 20l2. By 20l3, the value of off patent biologic drugs will exceed $20 billion. or almost 13% of the overall market for biologics.
4. By 2017, biologic therapies with total revenue of $37 billion will have lost patient protection suggesting considerable opportunity for bio similars.
5. Monoclonal antibodies are the fastest growing sub segment of biologics with a 13% compound annual growth rate. The segment will be valued at more than $60 billion by 20l3. Vaccines and cell therapies are a few years away from their peak growth. The vaccines segment valued at $17.5 billion in 2008. is experiencing 9% annual growth which could accelerate due to an increase in R&D investment and an expansion into new indications such as oncology.
6. Innovator drug companies, contract manufacturers and generic drug producers are taking action to add the capacity and scientific expertise needed to play in the bio similars market.
7. Potential hurdles include complex and costly manufacturing technologies; heavy competition; stringent regulatory guidelines in Europe, Middle East, and Africa and the still uncertain regulatory framework in the United States.”

“As growth and profitability become difficult to achieve for companies , attention needs to be given to those areas/avenues which are either small in market size and simultaneously niche.

Some of the areas which can be targetted by clinical research service providers particularly in the Bio-Equivalence stream are Hormonal market ( Primarily the women centric market- Post Menopausal market,
Bio similars and Biosimilars for Oncology to name few). These markets have market sizes less than US$ 3 billion and are growing at a CAGR ( 5 year time period) between 6-10 % . These markets show substantial potential in the times to come as these are dominated by selected Pharma/ Generic Drug majors who manufacture products in thses markets and “”outsource”” their bioequivalence studies to their specified niche vendors.
Another market which can be perceived as an excellent niche market for outsourcing companies is the Transdermal Market which is estimated to be at size of US $ 1.2 billion with reasonable growths.

Another factor which can be considered while looking at these markets is- These markets are relatively “”safe”” as risk involved are nearly minimal. Risk factor is in outsourcinmg studies to CRO’s is also one of the primary considerations in the CRO business.

The markets mentioned claerly fall in the “”zero/minimal risk zone”” which make them favourable targets for outsourcing in the long term.”

In the Year 2009, a record Breaking number of ANDA’s were filed by the by the world’s leading generic drug players. In the year 2009, 100 ANDA’s were filed by the top 10 companies. The top 10 companies account for more than 50% of the total filed ANDA’s. Some of the top Indian companies which have driven the growth of the ANDA market are Wockhardt, Glenmark, Dr. Reddy, Aurobindo and Ranbaxy to name a few. The Indian Pharmaceutical Industry accounts for nearly 32% of the total filed ANDA’s in the year 2009.

Based on these statistics, it can be definitely predicted that growth of the Indian Pharmaceutical companies is likely to achieve its desired milestones. This can only happen f the regulatory laws continue to support the submission rates. The Healthcare reimbursement policies highlighted by the US government clearly favour the use of generic drugs. However, the nature by which the Indian Pharmaceutical companies tackle the “Pay for Delay” / patent litigations, will decide the future of the ANDA submissions.

2009 has been a record low year for new drug applications by the USFDA. Only 27 applications have reached the final stages. It can be clearly seen that safety profiles of newer drugs (i.e. the adverse event profile of the drugs has made companies withdraw their pipelines) are major hurdle in the New Chemical entity market. Existing drugs are now being tested for newer indications. These are also some of the factors which will add to the growth of the generic drug market in the USA.
Prescription drugs being costlier than their generic counterparts are likely to face generic drug competition from within the USA as well as outside. Emphasizing the usage of generic drugs would be the long term goals of the healthcare reimbursement policy makers.

Which is the Indian company which has entered into a licensing deal with MNC, Astra for generic drug products?IntasNicholas PiramalAbbotTorrent
 Which is the Indian Life science company which has been issued a warning letter on its antibiotic products in May 2010? CiplaRanbaxyClarisCore Pharma
Which of the following companies are into CT supply Outsourcing business in Ahmedabad:SynchronLambdaThermofisherNone of the above
 Which is the NYSE listed CRO which has recently expanded operations in India?ParexelPPDCRVKendle
12.  Which is the Indian Pharma Company which has declared its IPO plans of greater than 500crs?
·        Glenmark
·        Glenmark Generics
·        Intas
·        Venus Remedies

Q & A- Direct questions:
 Which is the drug and the company which has been warned by the FDA to withdraw their product on account of safety issues in the last 6 months?Which Global CRO came into limelight after their Phase I trial for an mAB brought 6 volunteers to serious ADR’s?Also name the Hospital and countries involved in the trial. What is the code name of the molecule involved in the trial?Which is the Indian CRO which faced heavy penalties when a volunteer expired during felodipine trial last year?Which company came under the DCGI scanner for vaccine trial on neonates AIMMS hospital on informed consent issues? Also this resulted in the death of one of the infants as well. Name the CRO Involved.Which Canadian CRO has recently merged with an Indian CRO? Name the PE involved in the deal.Who is the president of the OPPI? When was the OPPI established?Which the only cancer vaccine approved in 2010? What as the company’s name? What is the indication for the vaccine?

The anticoagulant market is projected to grow from around $6 billion in 2008 to over $9 billion in 2014 .The growth will be driven by demographics of the ageing population and increased incidence of cardiovascular disease, but mainly by the approval of new agents that will offer substantial improvements over the current standards of care. The availability of oral anticoagulants is poised to have the greatest effect on the atrial fibrillation-related stroke prevention segment of the market, in which the use of warfarin is expected to become obsolete.”