The Medicines Patent Pool (MPP) has announced six new sub-licences with Aurobindo, Cipla, Emcure, Hetero Labs, Laurus Labs and Desano to allow generic manufacture of anti-AIDS drug tenofovir alafenamide (TAF). This follows MPP’s signing a licence with U.S. pharmaceutical major Gilead Sciences Inc. for the company’s TAF, which is a novel investigational medicine.
A statement from MPP said the announcement comes a day after Gilead released positive results on two of its TAF Phase III studies which suggest that the medicine has the potential to play a large role in the international community’s efforts to scale up HIV treatment. The sub-licence is for the generic manufacturers to make the generic versions of TAF for 112 developing countries.
Development plans“The generic companies will begin development plans for a promising, HIV product simultaneous with the U.S. Food and Drug Administration’s review to expedite access to low and middle-income countries once the medicine is approved,’’ Greg Perry, Executive Director, MPP, said in a statement. “This is revolutionary in its approach to ensuring more people living with HIV have access to newer options for treating the disease.’’
In studies, TAF had demonstrated comparable antiviral efficacy to that of 300 milligram tenofovir disoproxil fumarate (TDF) — a World Health Organization-preferred HIV therapy — but at a dose that is one-tenth. “The smaller milligram dose may also allow lower production costs, as well as greater ease in developing new fixed-dose combinations and single table regimens,’’ the statement said.
Geneva-based MPP was created to increase access to quality, appropriate, affordable medicines for people living with HIV in developing countries. It facilitates the production of low-cost versions of existing medicines as well as the development of new formulations. The MPP was formed through innovative financing mechanism UNITAID.
