Date: 2014-07-24
Type of information: Licensing agreement
Compound: tenofovir alafenamide
Company: Gilead (USA - CA) Medicines Patent Pool
Therapeutic area: Infectious diseases
Type agreement: licensing
Action mechanism: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI). It is a novel prodrug of tenofovir. Phase 1b dose-ranging studies identified a dose of tenofovir alafenamide that is ten times lower than Viread® (tenofovir disoproxil fumarate) and may expand its use to broader patient populations. Gilead is currently conducting Phase 3 clinical trials to evaluate the safety and efficacy of tenofovir alafenamide as a single agent for the treatment of chronic HBV infection. For HIV, Gilead is evaluating a single tablet regimen containing tenofovir alafenamide in combination with elvitegravir, cobicistat and emtricitabine (E/C/F/TAF). This single tablet regimen is being evaluated in a comprehensive Phase 3 program in treatment-naïve, treatment-experienced and renally-impaired patients. Additionally, Phase 3 studies evaluating fixed-dose combinations of two doses of tenofovir alafenamide in combination with emtricitabine are underway; a lower 10mg dose is being studied for use with boosted protease inhibitors and a 25mg dose is being evaluated for use with other classes of HIV medications.
Disease: hepatitis B, HIV
Details: * On July 24, 2014, Gilead Sciences announced at the 20th International AIDS Conference in Melbourne, Australia, a new agreement with the Medicines Patent Pool (MPP) to expand access to Gilead’s investigational drug tenofovir alafenamide (TAF) for HIV and hepatitis B, contingent on the medicine’s U.S. regulatory approval. Under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries. The new agreement expands on Gilead’s previous licensing partnership with the MPP. In July 2011, Gilead became the first pharmaceutical company to join the MPP, and today six Indian pharmaceutical companies hold MPP sub-licenses for Gilead HIV medicines.
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