Gilead Sciences, Inc. (Nasdaq:GILD) announced today an expansion
of its global access program in an effort to provide accelerated
access to Gilead medicines for the treatment of HIV/AIDS. The
changes announced today include new licensing terms with four
India-based drug manufacturers – Hetero Drugs Ltd., Matrix
Laboratories Ltd., Ranbaxy Laboratories Ltd. and Strides Arcolab
Ltd. – for three drugs which are currently in late-stage clinical
development. These Indian partners have played an active role in
supplying treatment to patients in the developing world. In
addition, Gilead is the first pharmaceutical company to enter a
licensing agreement with the Medicines Patent Pool Foundation (the
Pool).
The expanded licensing terms grant to the company’s Indian
partners and the Pool future rights to elvitegravir, an
investigational integrase inhibitor; cobicistat, an investigational
antiretroviral boosting agent; and the “Quad,” which combines four
Gilead HIV medicines in a once-daily, single-tablet regimen. Gilead
licensed rights to commercialize elvitegravir from Japan Tobacco
(JT), and JT is working in close partnership with Gilead to ensure
future access to elvitegravir in the developing world.
“Gilead is proud to engage in innovative partnerships to expand
access for patients in the developing world, and we welcome new
opportunities to work with Indian manufacturers and the Medicines
Patent Pool,” said Gregg H. Alton, Gilead’s executive vice
president for corporate and medical affairs. “Our goal is to ensure
that as new Gilead HIV therapies are developed and approved,
low-cost versions will be rapidly accessible in developing
countries without delay.”
Licensing agreements are a cornerstone of Gilead’s efforts to
increase access to the company’s therapies in the developing world.
Since 2006, when Gilead initially established licensing agreements
with Indian partners, the lowest available price of a Gilead
antiretroviral has decreased to US$6.15 per patient per month, or
21 cents per day. Today, more than 1.1 million patients in
developing countries receive Gilead HIV medication produced by
Indian partners.
Gilead also makes branded versions of its HIV medicines
available at significantly discounted prices (at the company’s cost
of manufacturing) in developing countries. A total of 1.6 million
patients in developing countries are currently receiving either
generic or branded Gilead HIV medicines – representing nearly
one-fourth of the 6.6 million patients receiving HIV therapy in the
developing world. Gilead’s regional distribution partners help to
manage pharmacovigilance and medical education efforts, and work to
secure product registration in individual countries [for a full
report on registration status visit www.gilead.com].
Medicines Patent Pool
Gilead has granted the Medicines Patent Pool similar licensing
terms as its Indian partners. The Pool, established in July 2010
with the support of UNITAID, is working to collaborate with a
number of pharmaceutical companies to expand global access to
quality, low-cost antiretroviral therapy through the licensing of
patents. Companies interested in producing generic versions of
Gilead medicines for developing countries will be able to approach
the Patent Pool to negotiate licensing terms.
“The Medicines Patent Pool is a creative new approach for
increasing access to treatment by facilitating access to IP on
essential medicines, and we appreciate Gilead’s willingness to be
engaged and involved with us from the beginning,” said Ellen ’t
Hoen, executive director, Medicines Patent Pool Foundation. “We
look forward to working together to expand access to much-needed
antiretrovirals and fixed-dose combinations for patients in the
developing world. Our expectation now is that other companies will
follow Gilead’s lead and join the Pool.”
Global Access Licensing
Terms
Gilead’s original licensing agreements provided Indian
manufacturers with non-exclusive rights to produce active
pharmaceutical ingredient and finished product and sell generic
versions of Gilead’s HIV medicines Viread® (tenofovir disoproxil
fumarate, or TDF) and Truvada® (emtricitabine/tenofovir disoproxil
fumarate) in 95 developing countries, including India.
The expanded agreements include future rights to produce and
sell generic versions of three Gilead HIV therapies, if and when
they are approved. Elvitegravir, cobicistat and the Quad are
investigational products and have not yet been determined safe or
efficacious in humans. The agreements also allow the sale of Viread
and Truvada in an additional 16 countries, and also allow Viread to
be produced and sold for the treatment of chronic hepatitis B in
the expanded territory.
Licensees will receive a complete technology transfer of the
Gilead manufacturing process to support their efforts to obtain
local regulatory approvals and scale up production as soon as
possible following U.S. Food and Drug Administration approval of
the pipeline products covered under the agreement.
“India’s pharmaceutical industry has the scientific expertise
and large-scale production capacity that are critical for
addressing the challenges of the HIV epidemic – both in India and
around the world,” said Rajiv Malik, Director, Matrix Laboratories
Ltd. and COO, Mylan Inc, which was one of the first partners to
sign an expanded licensing agreement with Gilead. “We are pleased
to expand our innovative collaboration with Gilead as we seek to
help more individuals living with HIV in resource-limited
countries.”
Under the terms of the agreements, licensees are allowed to
establish their own price and will pay a royalty on sales of
finished product, which supports product registration, medical
education and training, safety monitoring and other critical
activities. In an effort to accelerate the development of pediatric
formulations of HIV medicines and address growing treatment needs
among children, Gilead will waive royalty payments on any pediatric
formulations of Viread, Truvada or pipeline products that are
successfully developed and brought to market.
Global Impact of HIV and Hepatitis
B
According to the World Health Organization, significant progress
has been made in recent years in increasing access to HIV treatment
in the developing world. Between 2002 and 2010, the number of
people in developing countries receiving antiretroviral therapy
increased by more than 2,100 percent, from fewer than 300,000 to
6.6 million. However, HIV treatment needs continue to grow, with as
many as 15 million people requiring treatment now, and an estimated
30 million expected to require treatment within the next five
years.
Chronic hepatitis B is a common and potentially fatal liver
disease caused by the hepatitis B virus (HBV), which is up to 100
times more easily transmitted than HIV. Approximately 350 million
people are estimated to be chronically infected with HBV
worldwide.
Tenofovir disoproxil fumarate, the active ingredient of Viread,
is a prodrug of tenofovir. Tenofovir was discovered through a
collaborative research effort between Dr. Antonin Holy, Institute
for Organic Chemistry and Biochemistry, Academy of Sciences of the
Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega
Institute for Medical Research, Katholic University in Leuven,
Belgium.
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 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 risks that the U.S. Food and Drug Administration and
other regulatory approvals may not approve elvitegravir, cobicistat
or the Quad for the treatment of HIV, and marketing approval, if
granted, may have significant limitations on its use. 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, 2011, 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.
Truvada and Viread are registered trademarks of
Gilead Sciences, Inc.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From May 2024 to Jun 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jun 2023 to Jun 2024