Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries

  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 -

Business Wire

MELBOURNE, Australia -- July 24, 2014

Gilead Sciences, Inc. (NASDAQ:GILD) announced today at the 20^th 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 medicines.”

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 Asia Pacific.

Forward-Looking Statement

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 statements.

          Viread is a registered trademark of Gilead Sciences, Inc.

 For more information onGilead Sciences, please visit the company’s website
 atwww.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
              Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000

Contact:

Gilead Sciences, Inc.
Investors:
Patrick O’Brien, 650-522-1936
Media:
Nick Francis, 650-288-2514
 
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