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Gilead Sciences, Inc. (GILD) Inks Deals With 3 Indian Companies Including Ranbaxy Laboratories (RANBAXY.BO) for Low-Cost HIV Drug



8/2/2012 10:35:12 AM

FOSTER CITY, Calif.--(BUSINESS WIRE)--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.




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