Monthly Archives: November 2009

“If the generic company wins the patent challenge, the innovator loses its remaining market exclusivity for that product, while the generic manufacturer gains 180 days of market exclusivity and an average potential payoff of $60 million during that period. Graham added: “”The law is creating incentives to bring challenges on more and different types of drugs.””
Because of this, the researchers argue that a longer exclusivity period is required; the current 5-year period is not usually sufficient to recoup R&D costs. A 2007 report from The National Academies also supported this and explained that the US should at least double the duration of exclusivity to bring it closer to allowances awarded in the EU, Canada and Japan.
There has been a recent surge of Paragraph IV patent challenges by generic companies. Paragraph IV is a provision of the US Hatch-Waxman Act of 1984 that allows generic drugs manufacturers to challenge an innovator’s patents by claiming that either the patent is invalid or that the generic drug does not infringe the patent.

Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way. “

“The path to the Growth of the Indian Clinical Trial market-Slowing global environment in Pharma industry which is expected to be sluggish further. Mainly driven by USA and Europe, both growing slower than the market rate (less than 5%)Pharma companies are faced with declining sales of their existing drugs, followed by the financial crisis in the global economy, Generic threats and biting of their share sales of their branded drugs. Declining spends on R &d and lower success rates of NME’s coupled with investor and regulatory pressures.Net result is –Outsourcing to cost effective nations becomes mandatory which was otherwise an option. Outsourcing to cost effective nations like India becomes the path of choice on account of cost effectiveness and the favorable disease prevalence conditions of the Indian Geography.CT initiations outside the USA have been increasing from 2006 onwards till 2008 and are expected to increase further by double digits.Industry sponsored trails (Phase II-IV) are likely to be placed in India as India is ranked the 3rd among emerging markets for clinical trials.
Veeda Oncology® is dedicated to providing clinical oncology research services internationally for the pharmaceutical and biotech industries. With offices in the US, Europe and India, Veeda Oncology is in the unparalleled position to meet both the regional and global needs of our sponsors. We are one of the few companies whose main focus is oncology. As a result, Veeda Oncology can meet the rigors of local and global requirements of Phase I through Phase IV programs”

“The PE factor in R &D in Pharma is gradually becoming a recognized effort in the Pharma and CRO industry in India. Many private sector banks, financial institutions and venture capitalists have invested in Indian Pharma or their generic or R &d Subsidiaries (Glenmark and Dr. Reddy’s to name a few). The CRO companies which have PE stakes are GVK bio (Sequoi capital) and Siro Clinpharm (Kotak bank) to name few.

The increasing pressures on infrastructure management and followed by increasing need for trained staff in the industry coupled with the rising salary pressures of the industry. The rising salary pressures are because of the rising competition in the industry, emerging CRO’s, pricing pressures and subsequent impact on the profits.
The CRO Industry in India which is primarily/essentially a BA BE sector i.e. Bio –equivalence studies on generic/off patent drugs in India.
Veeda Clinical Research is leading CRO providing outsourcing solutions for Bio-equivalence studies for the drug companies and has been responsible for conducting greater than 250 studies in its Indian unit in Ahmedabad itself since its inception.”

“Many countries especially countries in the recent reckoning like Ecuador have taken the step of declaring that their country will oppose the patents of branded drugs and encourage the usage of generic drugs in their distribution chains. Governments can bypass the patent laws (According the WTO) under certain conditions like national emergency or special conditions. The special conditions can be only implemented only when the concerned nation has settled the WTO clauses with Big Pharma with accurate and mutually agreed compensation.
However this has also been by passed in the interests of public health and the need to make cost effective medicines to all. Big MNC’S in Ecuador like Pfizer and Baxter have “”acknowledged”” this extraordinary democratic decision by the Ecuador government

Generic drugs are off patent versions of branded drugs which are proven bio equivalent by BA BE studies. The Studies are conducted in a defined manner by the company who manufactures the formulation in house or outsources the same to a CRO of choice.
Therefore the market growth of CRO’s is largely dependent on various”” BY pass “”factors as well.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.”

“The law of nature shows a dependence of various species of living beings on each other which is primarily a survival phenomenon of the larger animal “”eating”” away the smaller one for survival thus completing the “”food chain””.
Ever heard of a lizard and elephant interdependence? Would be a””rare”” talk as it “”signifies”” the value chain for the pharmaceutical outsourcing to CRO’s of choice.
Imagine the lizard sitting on the elephant’s back like a royal king smoking a pipe on the elephant’s back and taking fresh air form the elephant’s ears. A sight to imagine indeed.!
The lizard is none other than the CRO’s and the elephant’s are the Big pharma. The future of outsourcing to CRO’s is certainly posed to take the most “”valued “” look in the times to come.”

“Yet again, the European Union is trying its level best to “”block”” the entry of off patent/ generic versions of medicines in their geography. The recent example is the seizure of the Macleod’s consignment of at least 2 million tablets of clopidogrel at Paris airport. A few months ago a similar incident of seizure of consignment of off patent manufactured by Dr. Reddy labs was seized by the Dutch Authorities.
This led to a spark of events and tussle between India and the EU. India has decided to sue the EU for such actions but on the diplomatic front this issue is yet to be resolved. If this trend continues and if Indian Pharma continues to be under the lens of the EU , it would be a milestone task for the Indian drug manufacturers to sustain their exports in times to come.
The issue need immediate attention and if it remains unresolved would not allow easy access of cost effective generic medicines freely accessible to the appropriate end user.”

“The Business of CRO’s is a highly competitive market where all the business units/ heads try to step on each other’s share “”thinking “”that they are trying to capture or tap an important client in the process. The nature of the competition resembles a Stock/trading Market”” where every buyer present/operating from a distance cries and yells for attention not knowing what to ask and what to buy.
During recession, this phenomenon is predicted to rise or the same may have risen and it may be difficult to predict. This phenomenon takes a turn towards a more serene platform. Till then, it is likely that the “”bonfire”” of outsourcing to India which is likely to spread its warmth only when the all sit around it will not be able to spread its impact
The nature of the bonfire which when lighted uniformly is likely to be maintained only when the right quantities of wood and fuel is added at regular intervals. The people adding the wood need to be seated and dedicated to ensure that the surrounding weather does not become cold.
The CRO market in India particularly is expected to grow at a “”Double digit”” rate but it needs to be seen as to the players around the “”bonfire of the potential outsourcing market “”are able to sustain their presence in this business.”

“The need to outsource clinical research is being felt by all major pharma companies. The latest example on this is Merck which has completed its merger and acquisition activity with Schering in the week. This has brought in its focus towards the potential markets of oncology vaccines especially breast cancer for which it is conducting trials in Germany. The drug major plans to target the Us$ 48 billion oncology market with a whopping forecast of US$ 1 billion for the development of its breast cancer vaccine.
Hypothesis
As the trials proceed towards its enrollment phase worldwide for women, it remains to be seen as to where the destination for the sites would be. The sites could be the CEE markets (cost effective locations of EU) , Brazil (LA ), China and India.
Future plans
Merck plans to seek approval for the treatment, known as Stimuvax, for lung cancer in 2012 based on studies in that disease begun in 2007, said Wolfgang Wein, head of the company’s oncology business.”

“The expectations from the US healthcare budget to be released shortly by the Obama government are optimistic about the generics in a major way. As the healthcare motto of the government would be to provision for healthcare for the majority of the masses, the need for budgeting cost effective medicines in the budget would be the prime agenda. Needless to say copy cat versions / Generic drugs would be in demand for provision in the healthcare budget for the citizens of the USA.
The Generic drug industry is then likely to reap the benefits of growth in a multi phase way-The Generic drug makers/ companies manufacturing generics in the USA are likely to benefitThe generic drug makers entering the territory of the USA especially the Indian generic makers on patent litigations/Indian generic makers having manufacturing units in the USA

In both of the above mentioned cases, outsourcing is likely to rise with benefits of Drug makers outsourcing their Bio equivalence of their generic drugs products to Indian CRO’s in a major way.
The “”hand’ that governs the law rules the “”growth / rocks”” the growth of the outsourcing market in cost effective destinations like India.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry both for clients with an American and Indian presence.”