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www.fdanews.com/articles/62758-gilead-signs-agreements-with-indian-firms-for-generic-hiv-drug

GILEAD SIGNS AGREEMENTS WITH INDIAN FIRMS FOR GENERIC HIV DRUG

September 25, 2006

Gilead Sciences announced it has signed eight new non-exclusive license agreements with generic companies in India. The agreements grant to Alkem Laboratories, Aurobindo Pharma, FDC, J.B. Chemicals & Pharmaceuticals, Matrix Laboratories, Medchem International, Ranbaxy Laboratories and Shasun Chemicals & Drugs the rights to produce generic versions of the HIV drug Viread (tenofovir disoproxil fumarate) and distribute it to 95 low-income countries, including India.

The license agreements require that the generic companies meet certain national and international regulatory standards and include a technology transfer to enable expeditious production of large volumes of the drug. In addition, the agreements allow the manufacture of commercial quantities of both active pharmaceutical ingredient and finished product. Gilead announced in August similar agreements with Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab.

"We hope that these agreements will expedite access to therapy for patients in resource-limited parts of the world where the HIV epidemic has hit the hardest," said John Martin, president and CEO of Gilead.