[Ip-health] Gilead Sciences Announces New Collaboration with Indian Partners to Reduce Manufacturing Cost and Improve Availability of Emtricitabine-Based Antiretroviral Therapy in Developing Countries

Tahir Amin tahir at i-mak.org
Thu Aug 2 12:28:49 PDT 2012

An interesting announcement from Gilead. Is this an effort to undermine
those unbundling the TDF/(FTC) license i.e Hetero/Aurobindo?


Gilead Sciences Announces New Collaboration with Indian Partners to
ReduceManufacturing Cost and Improve Availability of Emtricitabine-Based
Antiretroviral Therapy in Developing Countries

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

*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

*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

*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

*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
*) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.*

 Source: Gilead Sciences, Inc.

Gilead Sciences
Nick Francis, +44 208 587 2412 (Media)
Amy Flood, 650-522-5643 (Media)
Patrick O’Brien, 650-522-1936 (Investors)

Tahir Amin
Co-Founder and Director of IP
Initiative for Medicines, Access & Knowledge (I-MAK)
Email: tahir at i-mak.org

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