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Mylan's Matrix Receives Tentative FDA Approval Through PEPFAR for Novel "Co-Packaged" Version of HIV/AIDS Treatment: HIV Generics coformulated TDF/3TC/NVP, Reyataz
 
 
  press release
Sept. 20, 2011

Matrix received approval to market lamivudine/tenofovir disoproxil fumarate tablets, co-packaged with nevirapine tablets, which will be available for purchase in certain developing countries. The product is the first generic, co-packaged medicine that can be used alone or in combination with other medicines for the treatment of HIV/AIDS.

Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies, Mylan President Heather Bresch said in a prepared statement. For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first line ARV cocktail.

PITTSBURGH, Sept. 20, 2011 /PRNewswire via COMTEX/ -- Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg, co-packaged with Nevirapine Tablets, 200 mg. The product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan President Heather Bresch said: "The approval of Lamivudine / Tenofovir Disoproxil Fumarate Tablets co-packaged with Nevirapine Tablets is an important product developed by Matrix for the treatment of HIV/AIDS. For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first-line ARV cocktail. Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies."

This product offering is the first generic ARV drug product in a co-pack form and can be used alone or in combination with other ARVs for the treatment of HIV/AIDS. The FDA's tentative approval through PEPFAR signifies that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are the generic versions of GlaxoSmithKline's Epivir, Gilead Sciences' Viread and Boehringer Ingelheim's Viramune, respectively. This particular co-pack of ARV products also is suitable for the treatment of pregnant women with HIV/AIDS in certain countries where Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are approved for use during pregnancy. Nevirapine is preferred over other drugs in the same class, such as Efavirenz, for pregnant women with HIV/AIDS.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 36 first- and second-line finished doses, eight 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.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com . For more information about generic drugs, please visit www.ChoosingGenerics.com

SOURCE Mylan Inc.

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press release
July 12, 2011

Mylan Receives Voluntary License Rights to Gilead's HIV/AIDS Pipeline Products in Developing World

Follows recent agreement with Bristol-Myers Squibb to expand access togeneric Reyataz in Sub-Saharan Africa and India

PITTSBURGH and HYDERABAD, India, July 12, 2011 /PRNewswire via COMTEX/ -- Mylan Inc. 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.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com . For more information about generic drugs, please visit www.ChoosingGenerics.com

SOURCE Mylan Inc.

 
 
 
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