Mumbai, Aug. 16: Gilead Sciences has tied up with three Indian companies to manufacture and distribute the generic version of anti-HIV drug Truvada.
Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab will have the rights to produce and distribute generic versions of the drug to 95 low-income countries around the world, including India, at lower cost.
The non-exclusive licence agreements allow the three manufacturers in India to make generic versions of tenofovir disoproxil fumarate (sold by Gilead under the brand name Viread).
However, the companies have to meet certain national and international regulatory standards and also include a technology transfer to be able to produce large volumes of high-quality generic versions of tenofovir.
The agreements also allow the manufacture of commercial quantities of both active pharmaceutical ingredients (API) and the finished product.
Gilead is also pursuing licence agreements with other Indian generic manufacturers.
“We are pleased to have signed the agreements with Emcure, Hetero, and Strides Arcolab. We expect to grant additional licences over time to help meet the needs of patients in the developing world,” said John C. Martin, president and CEO of Gilead Sciences. He added that competition among multiple manufacturers would result in lower prices for Viread in the developing world than what Gilead is currently offering.
Gilead Sciences discovers, develops and commercialises innovative therapeutics in areas of what it calls unmet medical need. It has launched the Gilead Access Programme, which is designed to expand access, in a sustainable manner, to the once-daily anti-HIV medications Truvada and Viread in developing countries. A 30-day supply of these anti-HIV drugs are now sold by the company at “no-profit prices”. While Truvada is now sold to African nations at 87 cents per day, Viread is available at 57 cents per day. Gilead’s move to help generic companies manufacture its products is unusual in the pharmaceutical industry where companies defend their innovations aggressively. However, reports say a few other companies too are engaged in the process of handing out proprietary data to generic manufacturers.
Arun Kumar, vice-chairman and group CEO of Strides Arcolab, said: “The agreement highlights our ability to leverage global opportunities.”
