Two months after signing a license with Gilead Sciences for the biopharmaceutical company's novel investigational medicine tenofovir alafenamide (TAF), the Medicines Patent Pool (MPP) announced six new sublicenses with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs to allow generic manufacture of TAF for 112 developing countries.
Founded in 2010, the MPP supports generic low-cost production of HIV therapies by creating a pool of patents for sublicensing and product development.
After signing licenses with patent holders (such as Gilead Sciences), the MPP negotiates sublicenses with generic drug manufacturers, which then pay royalties to patent holders.
This fast-tracks the availability of new medicines in developing countries, helps bring prices down by encouraging competition among manufacturers, and facilitates innovation, including fixed-dose combinations and formulations suitable for children.
The MPP announcement came one day after Gilead Sciences released positive results from TAF Phase III clinical trials evaluating the safety and effectiveness of the drug, which has yet to be approved by the U.S. Food and Drug Administration (FDA).
"The generic companies will begin development plans for a promising, new HIV product simultaneous with the FDA's review to expedite access to low- and middle-income countries once the medicine is approved,” said Greg Perry, executive director of the MPP, in a press release.
"This is revolutionary in its approach to ensuring more people living with HIV have access to newer options for treating the disease.”
TAF belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It is a novel prodrug of Viread (tenofovir disoproxil fumarate, or TDF).
Studies suggest TAF may be more effective at lowering viral load than TDF, and cause fewer side effects.
The MPP release explains:
In studies, TAF has demonstrated comparable antiviral efficacy to that of 300 milligram TDF -- a World Health Organization-preferred HIV therapy -- but at a dose that is 10 times lower.
The smaller milligram dose may also allow lower production costs, as well as greater ease in developing new fixed-dose combinations and single tablet regimens.
Katherine Moriarty is a consultant and freelance writer, based in Vancouver. She has 10 years of experience in the intersecting fields of public health and community development, with a focus on bloodborne virus policy and programming.