FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 2, 2012--
Gilead Sciences, Inc. (Nasdaq: GILD), together with Mylan Laboratories,
Ranbaxy Laboratories Limited and Strides Arcolab, announced today that
they have entered into agreements to collaborate on promoting access to
high-quality, low-cost generic versions of Gilead’s HIV medicine
emtricitabine (FTC) in developing countries – including single tablet
regimens containing emtricitabine, and fixed-dose combinations of
emtricitabine co-formulated with other Gilead HIV medicines. Under the
new agreements Gilead will provide a technology transfer for the
manufacture of emtricitabine, together with funding to assist with
investment in process improvements to reduce overall manufacturing costs.
World Health Organization guidelines recommend emtricitabine, as well as
tenofovir disoproxil fumarate (TDF), as preferred components of first-
and second-line HIV therapy. However, cost is currently a barrier to
broadening access to regimens that include emtricitabine when compared
to other regimens, including widely used lamivudine (3TC)-based
regimens. The new agreements are designed to enable Gilead’s Indian
generic partners to produce high volumes of FTC/TDF-based therapies,
thereby establishing sustainable price parity to these alternative
regimens.
“More than 2.7 million patients living with HIV in developing countries
are currently receiving a TDF-containing regimen, a medicine innovated
by Gilead and subsequently licensed to our Indian generic partners as
part of our efforts to increase global access to effective treatment.
India’s pharmaceutical industry is a world leader in process chemistry,
and our ongoing collaboration will be critical for furthering access to
affordable, high-quality, first-line HIV treatment for developing
countries,” said John C. Martin, PhD, Gilead’s Chairman and Chief
Executive Officer.
Heather Bresch, Chief Executive Officer of Mylan Inc., commented: “An
essential component of ensuring access to affordable health care around
the world is providing access to high-quality, cost-effective
medications. Access to affordable medicine continues to be a
particularly acute need in tackling HIV/AIDS, and once again we are
delighted to be collaborating with Gilead in these efforts. Partnerships
like this one ensure that patients in developing markets have access to
important, recommended treatment options, like emtricitabine.”
Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy
Laboratories Limited, commented: “Ranbaxy and Gilead have a strong
collaboration in the area of HIV/AIDS. We are pleased to extend this
association with Gilead that will enable us to offer quality affordable
medicines for the treatment of HIV/AIDS in developing countries.”
Arun Kumar, Managing Director and Group Vice-Chairman, Strides Arcolab
Ltd., commented: “We are pleased to associate with Gilead on this
initiative that will provide access to high quality essential
antiretrovirals in developing markets. This partnership will re-enforce
our commitment to provide affordable drugs in the field of HIV/AIDS,
tuberculosis and malaria to low- and middle-income countries.”
Emtricitabine is marketed by Gilead under the brand name Emtriva®,
and a fixed-dose combination of emtricitabine and tenofovir disoproxil
fumarate is made available under the brand name Truvada®.
Emtricitabine is also an essential component of the Quad, an
investigational treatment that combines four Gilead medicines in a
once-daily, single tablet regimen for the treatment of HIV.
Enabling Affordable Access to HIV Medicines in
Developing Countries
Gilead has a longstanding commitment to make its antiretroviral products
available at significantly reduced prices in developing countries. A key
component of this commitment is non-exclusive generic licensing
agreements established with Indian manufacturers to produce and sell
high-quality, low-cost versions of Gilead’s HIV medicines. A total of 13
Indian companies now have licensed Gilead HIV medicines.
Mylan Laboratories (formerly Matrix), Ranbaxy Laboratories and Strides
Arcolab have had direct licensing partnerships with Gilead since 2006.
Today’s announcement follows an agreement signed in July 2011, to also
grant them future rights to elvitegravir, an investigational integrase
inhibitor; cobicistat, an investigational antiretroviral boosting agent;
and the Quad. As these are all investigational products, their safety
and efficacy have not yet been established.
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.
About Mylan Laboratories
Mylan is a global pharmaceutical company committed to setting new
standards in health care. Working together around the world to provide 7
billion people access to high quality medicine, we innovate to satisfy
unmet needs; make reliability and service a habit, do what's right, not
what's easy and impact the future through passionate global leadership.
We offer a growing portfolio of more than 1,100 generic pharmaceuticals
and several brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately one-third of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and currently
market products in approximately 150 countries and territories. Our
workforce of more than 18,000 people is dedicated to improving the
customer experience and increasing pharmaceutical access to consumers
around the world. But don't take our word for it. See for yourself. See
inside www.mylan.com.
About Ranbaxy Laboratories
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is
an integrated, research-based, international pharmaceutical company
producing a wide range of quality, affordable generic medicines, trusted
by healthcare professionals and patients across geographies. Ranbaxy’s
continued focus on R&D has resulted in several approvals in developed
and emerging markets, many of which incorporate proprietary Novel Drug
Delivery Systems (NDDS) and technologies developed at its own labs. The
company has further strengthened its focus on generics research and is
increasingly working on more complex and specialty areas. Ranbaxy serves
its customers in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances, ground operations
in 43 countries and manufacturing operations in 8 countries. Ranbaxy is
a member of the Daiichi Sankyo Group. Through strategic in-licensing
opportunities and its hybrid business model with Daiichi Sankyo, a
leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy
is introducing many innovator products in markets around the world,
where it has a strong presence. This is in line with the company’s
commitment to increase penetration and improve access to medicines
across the globe. For more information, please visit www.ranbaxy.com.
About Strides Arcolab
Strides Arcolab is a global pharmaceutical company headquartered in
Bangalore, India that develops and manufactures a wide range of IP-led
niche pharmaceutical products with an emphasis on sterile injectables &
difficult-to-make oral dosage forms. The company has 14 manufacturing
facilities across 6 countries, ably supported by a 350-scientist strong
global R&D Centre located in Bangalore. Strides Arcolab offers a large
portfolio of drugs in anti-retroviral, anti TB and anti malarial
therapies. Additional information is available on the company website www.stridesarco.com.
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
risk that the new collaboration agreements with Indian generic companies
will be unsuccessful in reducing manufacturing costs of and providing
increased access to FTC-based therapies in developing countries. 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 June 30, 2012, 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.
Emtriva and Truvada are registered trademarks 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.
Source: Gilead Sciences, Inc.
Gilead SciencesNick Francis, +44 208 587 2412 (Media)Amy
Flood, 650-522-5643 (Media)Patrick O’Brien, 650-522-1936
(Investors)
