Drug for Treatment of AIDS Awaits FDA Approval

Banglore-based Strides Arcolab and Gilead Sciences have signed a licensing agreement under which Gilead has extended non-exclusive rights to Strides to make and distribute Tenofovir Alafenamide (TAF), both as a single agent product and in combination with other drugs. TAF is a novel nucleotide reverse transcriptase inhibitor used in human immunodeficiency virus (HIV) patients in the treatment of acquired immunodeficiency syndrome (AIDS).

TAF is awaiting U.S. Food and Drug Administration (FDA) approval, and is expected to go to market by year-end.

Strides will receive a technology transfer from Gilead, enabling it to make low-cost versions of TAF for developing countries.

A statement from Strides said the licence extends to 112 countries, which together account for more than 30 million people living with HIV.

Strides will be able to launch its product by mid-2016. TAF has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile, the statement said.

In September, 2014, Gilead signed agreements with seven Indian generic drug manufacturers licensing them to make sofosbuvir to supply it to 90 countries. Sofosbuvir is priced at $84,000 per patient in the U.S., and the effective price for generic version is around $900 and a 10 percent royalty.

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D.G. Shah, Secretary-General, Indian Pharmaceutical Alliance said, "Gilead’s chosen voluntary licensing model is refreshing, and will certainly earn it goodwill. It ensures protection of intellectual property and simultaneously ensures access to medicines. Today, its TAF licensing announcement is just an extension of its existing model for developing markets."

"Pharmaceutical multinational prefer Indian manufacturers over other generic manufacturing destinations like South Africa and Brazil because India is already supplying generics to 200 countries and has proven capability, cost-effectiveness and quality," Mr. Shah said.

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Source-Medindia