Monthly Archives: March 2010

“The Market for global CRO’s has taken dynamic change after the recession. Many CRO’s in the western world have faced problems relating to projects getting cancelled / late payments followed by takeovers by private equities. the shift of Global pharma cutting down on the clinical development pipeline and shifting towards “”generic drugs “” and off patent bio similar drugs has made the local pharma industries particularly like India face a phenomenal pressure.
Most of the Pharma companies’ earnings in the west today are placed with medium earnings, ‘low profits, and pressure from patent litigations from generic makers which has forced many to proceed on layoffs particularly in the month of January 2010. With the intention of changing focus towards the emerging markets and generics, it is likely that the scene of outsourcing to CRO’s in the world is likely to change. Outsourcing budgets are likely to be defined mainly on pricing and inflation trends in the geography of interest for Big Pharma.
The “”structured”” outsourcing market will definitely “”migrate”” to a new form altogether. ”

“Patent Infringement followed by Para IV filings have been on the rise in the decade and have increased in the USA from 50 to more than 65 litigations. Consequently, the rate of settlements between branded and generic drug companies has also spiked. This indicates an increase of 27% in the year 2009 over the previous year and trends have shown that there has been a rising trend over the years particularly from 2006 (28-30) , 2007 (40-41) , 2008 (50) and finally more than 65 in 2009.
The rate of settlements in patent litigations has also been increasing at a 100% rate particularly from the year 2007 (20) to 45 in 2008 and more than 50% of the litigations in 2009 got settled outside the courts. This could be attributed particularly as a pay for delay phenomenon as well as recession in the period of 2008.
Generic drugs are produced and distributed, usually at much lower prices, after patent protection on the drug’s active ingredientexpires.”

“Yes, the outsourcing market is likely to take turn towards a different bend. The fragmented market of CRO’s is currently operating in a vicious circle. All players are trying to grab their share of outsourcing in their own way as the market is extremely competitive on account of pricing pressures and the related inflationary factors. The regulators add to the stiff competition and move the market to a further “”slow growth”” with both anticipated and unanticipated delays.
Therefore Pharma companies look alternatively towards outsourcing providers in other geographic regions like India which are conductive to their requirements which could be outsourcing of bio equivalence studies (completely) or in parts (DM, lab services, Project management, clinical trials etc.)
This could be one of the only ways which could “”boost”” the outsourcing market in India. However the market for CRO’s In India has also acquired a very fragmented look and the competition is equally high particularly in the period post 2008. ”

“Companies a few years ago used to spend their investment energies in mega clinical development projects with active hype particularly the Indian Pharma companies. Many Indian Pharma majors with a mega research plan like Dr. Reddys’, have suffered setbacks on account of “”negative”” end points received in some of their project pipelines especially in the last few years. With the””shrinking “”response to clinical development in India, Companies have decided to work quietly and sensibly only. The companies have shifted their focus to generic drug promotion in rural markets, focusing on generic filings in emerging markets and in terms of core research and development move on the lines of drug discovery and biotech for surviving in the long term. ”

“The need to be creative is increasingly becoming the need of the hour. This holds true for all sectors, be it the Pharmaceutical industry or the CRO industry. Being creative does not necessarily mean developing and maintaining infrastructural or intellectual expertise in house, the same can apply to many other company activities as well. This applies to tie –ups, licensing, tie ups, joint ventures to name few. The most common types of alliances are generally related to the Pharma- Pharma, Pharma-CRO, Pharma- Biotech, Biotech-CRO, etc to name few.
Sometimes sectors which are related to the industry indirectly can also be important to the value added growth of the Pharma or the CRO industry.
Pharmaceutical companies will need to rethink their strategies as the world in which they operate undergoes dramatic changes. Patients, armed with unprecedented access to information, are being transformed from passive participants to super consumers of healthcare services. Drug makers will need to rethink not only how they approach them, but how to forge partnerships with nontraditional healthcare players that are helping to usher in this new era from telecommunications carriers to information technology device makers. “

“One of the hubs for oncology biotechnology today is San Francisco. The reasons for this are the availability of ideal infrastructure, qualified experts and the nearness of academic institutions coupled with good logistic connections.
Sunesis, Poniard, Bipar Sciences and Exelixis are some of the companies which are developing drugs in licensing agreements with Big Pharma like BMS, GSK, Sanofi- Aventis and Genentech. These are some of the potential companies in the San Francisco bay area (3 of them being listed) are active cancer compounds in Phase II and Phase III phases of drug development. ”

“The drug companies today are completely on the lookout for change in business platforms. This is keeping in view the fact that the recession is still keeping its toll on the economy especially in terms of manufacturing costs, staffing costs, maintaining profitability of the branded drug sales etc.
The need of the hour for Pharmaceutical industry today is to focus on the current and contemporary disease forum like the flu and diseases of the tropical region especially malaria, tuberculosis etc. For doing so, the companies need to shift from their existing manufacturing standards to a “”different”” region of interest as well as revamping the existing staff to different roles.
The changing roles of the people in the organization move with the changing requirements of the organization.”

”The Pharma world space of 3 major global players has united to form the world’s FIRST cancer group to focus towards the emerging markets of Asia to target Stomach and Lung cancer. The news release has got flashed at 6-7 major web sites. An individual news clip was flashed by Elli Lilly in the late evening hours yesterday as well which spoke of its initiatives to start the research work form Singapore. There were mentions of mainly the people from Elli Lilly in Singapore and China in the News release.
The world of the Pharmaceutical Industry has changed. The drug majors are uniting themselves with the changing times, have decided to “”mutually share”” database s for cancer drug development and move in unison towards the emerging markets.
If this is so, then what should be the subsequent strategic initiatives at the CRO’s (the outsourcing providers) in the emerging markets?
Should the CRO’s “”act”” in a similar manner as the Pharma companies or prepare to understand the market on their own with individual capabilities?
This is question which can be answered only when the outsourcing market takes a DECISIVE turn in a direction which today many forecasting experts are trying to understand. ”

“The numbers of new drugs developed for diabetes have been very less in the decade. The proven and effective treatments for Type I diabetes is insulin and the leaders of this therapeutic domain are Novo Nordisk, Sanofi and Elli Lilly. For type II diabetes, the most effective drugs are metformin and its analogues.
Other add on drugs for Type II diabetes with proven efficacy are gliclazide, glimepride, etc to name few. After these followed the “” glitazones”” namely Pioglitazone and rosiglitazone as further add on drugs to cure diabetes. Although rosiglitazone came to the market along pioglitazone in the pharma world, the same occupied lesser popularity in terms of its efficacy. However that was “”subjective”” matter and MNC brands like Glaxo’s Avandia occupied the forefront of the Type II diabetes market with Avandia.
Today a certain section of medical experts are pointing towards the following:
Millions of diabetics have been prescribed Avandia sold by GlaxoSmithKline PLC since it came on the market in 1999. In May 2007, Avandia was linked to a 43 percent greater risk of heart attack and death in a scientific analysis published by the New England Journal of Medicine. Upon the release of the 2007 study, GlaxoSmithKline downplayed the report and encouraged continued use of Avandia. Dr. Lawson McCartney, who led Glaxo’s diabetes drug development, said, “”We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine.”” However, a new report in today’s New York Times says that hundreds of people taking Avandia needlessly suffer heart attacks and heart failure every month, according to confidential Food and Drug Administration reports obtained by the newspaper that recommend the drug be removed from the market. The reports say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.
But the important question is: Are there “”many “”treatment options left for diabetic patients today? This is a question which only time will tell because the FDA is in the process of “”slowing”” down approvals of “”newer diabetic dugs like Victoza (liraglutide). The U.S. Food and Drug Administration is defending its decision in late January to approve a new diabetes drug, Victoza (liraglutide), even though animal studies suggest it might increase the risk for a rare thyroid cancer. Victoza, among a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists, is meant to be used along with diet and exercise to control blood sugar by helping the pancreas make more insulin after a person eats. FDA officials explained the agency’s stance on the drug in a Perspective article published online Feb. 17 in the New England Journal of Medicine.”