Gilead, Mylan expand license deal for HIV/AIDS medicines

Mylan Inc. (Nasdaq: MYL) today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited. Matrix has licensed the rights to produce and market generic versions of three Gilead HIV/AIDS therapies, if and when they receive regulatory approval. The Gilead products, which are currently in late-stage clinical development, include: Elvitegravir, an investigational integrase inhibitor; Cobicistat, an investigational antiretroviral (ARV) boosting agent; and the "Quad," a once-daily, single-tablet combination of four separate Gilead medicines.  

Mylan President Heather Bresch commented: "Every patient living with HIV/AIDS has a right to treatment. Matrix has made a significant contribution to dramatically lowering the cost of HIV/AIDS medicines, and we are now focused on expanding access to high-quality treatment to more people who need it. We are pleased to expand our collaboration with Gilead as it will enable more individuals living with HIV/AIDS in resource-limited countries to access the newest innovative medicines."  

Under previous licensing agreements with Gilead, Matrix has obtained non-exclusive rights to produce and market active pharmaceutical ingredients and finished products, including generic versions of Viread® (Tenofovir Disoproxil Fumarate or TDF), Truvada® (Emtricitabine/Tenofovir Disoproxil Fumarate) and other TDF-based combinations in 95 developing countries including India. The expanded agreement allows for the sale of Viread, Truvada and other TDF-based combinations in 16 additional countries and for the production and sale of Viread as a treatment for chronic hepatitis B in an expanded territory.

This contract with Gilead follows the announcement last month by Bristol-Myers Squibb (BMS) of an "immunity-from-suit" agreement with Mylan related to expanded access in sub-Saharan Africa and India for Atazanavir Sulfate, the generic version of BMS' Reyataz®; Stavudine, the generic version of BMS's Zerit®; and Didanosine, the generic version of BMS's VIDEX®.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 35 first- and second-line finished doses, nine of which are pediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.

SOURCE Mylan Inc.