Gilead Sciences, Inc. (NASDAQ:GILD) announced today 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 Medicines Patent Pool plays a critical role in efforts to expand
access to HIV treatment in the developing world,” said Gregg H. Alton,
Executive Vice President for Corporate and Medical Affairs at Gilead
Sciences. “By expanding our partnership to include TAF today, we hope to
lay the groundwork for the rapid introduction of generic versions should
it receive regulatory approval.”
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.
“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 Greg Perry, executive
director of the MPP. “We welcome this expansion of our partnership, and
we look forward to working with our sub-licensees to provide access to
low-cost, high-quality versions of TAF and other Gilead antiretroviral
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 $4.00 per patient per month. Currently 5.4
million people are receiving Gilead HIV medicines in low- and
middle-income countries through the company’s access initiatives – more
than half of all people on HIV therapy in these countries. Ninety-nine
percent of these people receive versions produced by generic partners.
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
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 March 31, 2014, as filed with
the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and
Gilead assumes no obligation to update any such forward-looking
Viread is a registered trademark of Gilead Sciences, Inc.
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
Copyright Business Wire 2014