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BMS Licenses Reyataz to Generic Drug Companies: to be sold cheaply
  NY Times
By DONALD G. McNEIL Jr. Published: February 15, 2006
AP By THERESA AGOVINO , 02.15.2006, 01:48 AM
Wall St Jnl
In a deal to be announced today, one of the newest and most powerful AIDS drugs will be licensed to generic drug makers in India and South Africa so that it can be made inexpensively for patients in many poor countries.
The drug is atanazavir, made by the Bristol-Myers Squibb Company under the brand name Reyataz and introduced only last year in many wealthy countries. It is a protease inhibitor, which is useful in second-line treatments for patients who have developed resistance to their first antiretroviral cocktails.
Currently, more than one million people receive first-line AIDS medicines in the developing world, according to World Health Organization estimates.
Patients usually develop resistance to first-line drugs within a year and need second-line treatments after that to keep the virus at bay.
It will be licensed, without charge, to Emcure Pharmaceuticals Ltd. of India and Aspen PharmaCare of South Africa. Under the deal, the generic companies will set the pricing for atanazavir in Africa and India.
At the moment, second-line treatments in Africa cost $3,000 to $6,000 a year for each patient, compared to about $200 for first-line treatments.
Atanazavir is easy for patients to take, said Dr. Michel Kazatchkine, France's global AIDS coordinator, who said he was pleased to hear of the announcement.
However, there are some limitations, said Daniel Berman, an expert on AIDS drugs at the medical charity Doctors Without Borders.
Guidelines from the World Health Organization require that protease inhibitors be given with what is called a booster drug \ usually ritonavir, sold under the brand name Norvir.
Ritonavir must be refrigerated, especially in hot climates.
As a result, several experts said, the move by Bristol-Myers puts pressure on Abbott Laboratories, the maker of ritonavir, to make a heat-stable version.
Bristol-Myers will also provide technical training to the companies so they learn how to manufacture, test, package, store and handle the drug's active ingredient.
Reyataz was approved in the United States in 2003, and last year its sales totaled $696 million.
Bristol-Myers does sell Reyataz at no profit sub-Saharan Africa as it does its other two AIDS medications. It didn't include those medications in this deal because generic versions are already available.
Reyataz is not available in India.
Bristol-Myers said by giving local companies the rights and knowledge to make drugs locally it will expand supply. The company couldn't say if the price charged by Aspen would be less than its price.
Other drug companies including Roche Holding Ltd. and Gilead Sciences Inc. have recently announced similar arrangements.
Bristol-Myers received approval from the Food and Drug Administration to market Reyataz in the U.S. in 2003. Its patent runs out in 2017.
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