July 24, 2014
Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries
- Agreement provides license for generic production of tenofovir alafenamide, an investigational agent for the treatment of HIV and chronic hepatitis B -
Under the agreement, the MPP can sub-license TAF to generic drug
“The Medicines Patent Pool plays a critical role in efforts to expand
access to HIV treatment in the developing world,” said
The new agreement expands on Gilead’s previous licensing partnership
with the MPP. In
“As the Medicines Patent Pool’s first pharmaceutical industry partner,
Gilead has played a vital role in increasing treatment access for people
living with HIV in the developing world,” said
Licensing agreements are a key component of Gilead's efforts to increase
access to the company's therapies in the developing world. In addition
to its agreement with the MPP, Gilead has direct partnerships with 11
generic manufacturers. Due to competition among these generic drug
manufacturers, the lowest price of a Gilead HIV medicine has fallen 80
percent since 2006, to
The full MPP licensing agreement is available at www.medicinespatentpool.org.
About Tenofovir Alafenamide
Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NtRTI). It is a novel prodrug of tenofovir. Phase 1b dose-ranging studies identified a dose of TAF that is ten times lower than Viread® (tenofovir disoproxil fumarate), which may expand its use to broader patient populations. Gilead is currently conducting Phase 3 clinical trials to evaluate the safety and efficacy of TAF as a single agent for the treatment of chronic HBV infection.
For HIV, Gilead is evaluating a single tablet regimen containing TAF 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 TAF in combination with emtricitabine (F/TAF) 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.
Gilead’s Approach to Treatment Access
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. Gilead’s HIV treatment access strategies include tiered pricing, collaboration with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility that licensees will not be able to produce and distribute
generic versions of Gilead medicines, that licensing terms will be
modified or that TAF does not receive regulatory approval. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended
Viread is a registered trademark of
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Nick Francis, 650-288-2514