Mylan To Manufacture, Distribute Gilead's TAF Treatment For HIV In 112 Countries

Mylan and its subsidiary Mylan Laboratories have entered into an agreement with Gilead Sciences regarding the manufacturing and distribution of Tenofovir Alafenamide (TAF) for the treatment of HIV-1 infection. The companies announced the deal in a press release, stating that Gilead has extended the non-exclusive rights to Mylan for TAF as a single agent and in combination with other drugs.

Heather Bresch, Mylan CEO, said, "By working with partners like Gilead to help ensure access to innovative new products, such as Tenofovir Alafenamide (TAF) in the countries hardest hit by this disease, we can help stem the tide of HIV/AIDS around the world."

The Food and Drug Administration (FDA) must approve the licensing agreement. When it does, Gilead will transfer the technology needed for manufacturing and distribution. Mylan will then produce a low-cost generic version of TAF. The license includes 112 countries or 85 percent of HIV patients, according to Mylan.

Tenofovir Alafenamide

Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NtRTI), an antiretroviral drug being investigated for HIV-1 infection and chronic hepatitis B. In July 2014, Gilead announced that it would allow the Medicines Patent Pool (MPP) to sub-license TAF treatment. The MPP is to license the agent to Chinese and Indian generic drug companies, who would distribute it to 112 countries.

Mylan Generics

Mylan has over 1,300 generic pharmaceuticals, brand medications, and active pharmaceutical ingredients (APIs). The company markets its products in 140 countries and employs over 20,000 people. Its generics clients include retail, wholesale, government, and institutional customers. Mylan estimates that in the U.S., generic medicines saved the health care system approximately $1.2 trillion from 2003 to 2012.

Generics Industry

The generics industry is growing quickly due to many factors, including an aging population and the patent expirations of branded drugs. According to an Ibis World report, while competition is strong in generics, favorable conditions in the U.S. include easier regulatory processes for both drugs and biologics. Biologic generics will experience some growing pains because, unlike drugs, biologics cannot be precisely duplicated. The European Medicines Agency (EMA) recently released guidance for the industry on biosimilar regulation.