Bristol-Myers Squibb (BMS) has entered an agreement for technology transfer and voluntary license with generic manufacturers Aspen PharmaCare of South Africa and Emcure Pharmaceuticals of India for Reyataz (atazanavir sulphate), the company's once-daily protease inhibitor for HIV/AIDS that was initially approved in the US in June 2003 for use in combination therapy with other anti-HIV medicines.
Bristol-Myers Squibb will grant a royalty-free license to Aspen and Emcure to manufacture and sell atazanavir in sub-Saharan Africa. A separate agreement has been concluded with Emcure covering India.
Under the agreement, Bristol-Myers Squibb will transfer to Aspen and Emcure its technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and the finished dosage form of atazanavir. Bristol-Myers Squibb staff will provide technical training at its manufacturing facilities for Emcure and Aspen, and will also travel to Aspen's and Emcure's facilities in South Africa and India to provide further hands-on training. In addition, Bristol-Myers Squibb will provide support for regulatory filings to the two companies, according to the company release.
"This agreement builds on Bristol-Myers Squibb's long-standing commitment to the global fight against AIDS," said Peter R. Dolan, chief executive officer, Bristol-Myers Squibb. ".
"Initiatives such as voluntary licensing are critical to our ability to respond effectively to the AIDS crisis over time. This agreement represents the kind of innovative collaboration needed to increase access to antiretrovirals in the developing world," said Mark Dybul, deputy US global AIDS coordinator.
Some 2.4 million people died of HIV-related illnesses in 2005 in sub-Saharan Africa, and some 3.2 million became infected with HIV. South Africa has the world's highest caseload of HIV and AIDS with some 5 million people infected out of a population of 45 million.
India is home to the second largest number of infections after South Africa, with an HIV/AIDS population also of about 5 million.
Reyataz is a prescription medicine used in combination with other medicines to treat people who are infected with HIV and has been studied in 48-week trials in both patients who have taken or have never taken anti-HIV medicines. Reyataz does not cure HIV or prevent passing HIV to others.
Reyataz was approved in the United States in 2003 for use in combination therapy with other anti-HIV medicines.