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Gilead kickstarts patent pool for AIDS drugs
 
 
  "By issuing licenses for pipeline products in advance of regulatory approval, we hope to avoid significant delays in the global availability of new therapies once they are approved in the United States or Europe. We have also expanded the number of countries, from 95 to 111, where our partners can distribute their generic versions of Viread and Truvada."

By Ben Hirschler

LONDON | Tue Jul 12, 2011 3:28am EDT

LONDON (Reuters) - Gilead Sciences, the leading maker of HIV drugs, is to share intellectual property rights on its medicines in a patent pool designed to make treatments more widely available to the poor.

The California-based group is the first drugmaker to sign up to the new Medicines Patent Pool, whose organizers now expect other major pharmaceutical manufacturers to join the initiative.

Ellen 't Hoen, the pool's executive director, told Reuters she was negotiating terms for similar deals with ViiV Healthcare -- a GlaxoSmithKline and Pfizer joint venture -- as well as with Bristol-Myers Squibb, Roche, Boehringer Ingelheim and Sequoia Pharmaceuticals.

"This is not just a one-off. The whole field is changing ... there will be more to follow," she said.

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Most live in Africa and Asia, where medicines have to be very cheap to allow those who need them to be able to afford them.

The Medicines Patent Pool, launched by the UNITAID health financing system that is funded by a tax on airline tickets, aims to address this problem by creating a system for patent holders to license technology to makers of cheap generics in exchange for modest royalties.

In the case of Gilead, the agreement allows for the production of generic copies of tenofovir, emtricitabine, cobicistat and elvitegravir, as well as a combination of these products in a single HIV pill known as the "Quad."

Significantly, cobicistat, elvitegravir and the Quad are still in clinical development, and their inclusion in the deal should speed the flow of new treatments in poor countries.

"Through systematic licensing of intellectual property related to HIV products, people in developing countries will have access to low-cost versions of those products almost at the same time that people in rich countries do," 't Hoen said.

Traditionally, patients in developing countries have to wait for years before they can get access to new drugs.

CHANGE IN ATTITUDE

Gilead will receive a 3 percent royalty on generic sales of tenofovir, which is also approved for use in hepatitis B, and 5 percent on the other products.

The licenses will allow for the supply of tenofovir and emtricitabine in 111 countries, for cobicistat in 102 countries, and for elvitegravir and the Quad in 99 countries.

Assuming other companies come on board, the patent pool could save poor countries more than $1 billion a year in drug costs.

But the revenue stream to Gilead and other patent holders is likely to be small, since generic drug prices in Africa could be just 1 or 2 percent of those in high-income countries.

The decision by Gilead and others to work with UNITAID on the new patent pool marks an evolution in thinking by Big Pharma toward the thorny problem of drug access in the developing world.

Ten years ago, the world's pharmaceutical industry took a very different stance when it sued South Africa over legislation that was passed by former President Nelson Mandela and which favored generics.

That battle proved a public relations disaster, and since then individual companies have struck a series of voluntary licensing deals, allowing generic copies of HIV products on a case-by-case basis.

The patent pool system, however, goes beyond this by providing an effective "one-stop shop" for generic firms to secure rights to manufacture patent-protected drugs.

The U.S. National Institutes of Health became the first organization to sign up to the pool last September. The concept has been harder for some drugmakers to swallow.

ViiV, for example, was initially unwilling to consider pooling its patents -- and Abbott Laboratories, Merck & Co and Johnson & Johnson have yet to enter formal negotiations, although 't Hoen said her team was now discussing the idea with all three companies.

(Reporting by Ben Hirschler; Editing by David Hulmes)

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press release

July 12, 2011, 3:01 a.m. EDT

Gilead Expands Access Program for Medications in Developing World

- Licenses Rights to HIV Pipeline Products to Indian Partners
-

LONDON & HYDERABAD, India, Jul 12, 2011 (BUSINESS WIRE) -- --- First Company to Enter Licensing Agreement with Medicines Patent Pool -

Gilead Sciences, Inc. 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(R) (tenofovir disoproxil fumarate, or TDF) and Truvada(R) (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.

SOURCE: Gilead Sciences, Inc.

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Mylan and Gilead broaden their licensing deal

By Mia Lamar
July 12, 2011, 8:13 a.m. EDT
www.marketwatch.com

Mylan Inc. /quotes/zigman/75764/quotes/nls/myl MYL -2.60% struck a deal Monday to broaden a licensing arrangement with Gilead Sciences Inc. /quotes/zigman/72849/quotes/nls/gild GILD +0.63% , a move that will allow the generic drug maker to offer products in a handful of new markets.

Under terms of the deal, Mylan now holds the right to produce and market generic versions of Gilead's HIV/AIDS therapies if they are approved by regulators. In addition, the broadened arrangement allows Mylan to expand production and marketing of several other Gilead products to 16 additional countries.

"We are pleased to expand our collaboration with Gilead as it will enable more individuals living with HIV/AIDS in resource-limited countries to access the newest innovative medicines," said Mylan President Heather Bresch.

Under the previous agreement, Mylan had non-exclusive rights to market active pharmaceutical ingredients and products, including generic versions of Viread, Truvada and other drugs in 95 developing countries.

As the world's third-largest generic-drug maker by sales, Mylan has posted rising revenue in recent quarters, helped by strong sales in North America and the Asia Pacific region.

Shares of Mylan closed Monday at $24.33 and were inactive premarket. The stock is up 15% since the start of the year.

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NY Times: The pool was created last year, but drugmakers resisted it, wanting to control quality and protect rights to future profits from middle-income countries. Until this week, the only participant was the National Institutes of Health, which turned over a partial patent on an obscure AIDS drug. The move is particularly important because it includes tenofovir and emtricitabine, which have emerged as important components of AIDS therapy and new prophylaxis regimens, like vaginal microbicides for women and once-a-day pills protecting gay men. Many poor countries now have only older drugs, some of which have harsh side effects.

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Gilead okays new terms with Ranbaxy on HIV drugs

Gilead Sciences Inc. has agreed on new licensing terms with Ranbaxy Laboratories and three other companies to produce generic versions of three HIV/AIDS drugs

Prabhu Mallikarjunan
Tue, Jul 12 2011. 4:10 PM IST
www.livemint.com

Hyderabad: US drug maker Gilead Sciences Inc. has agreed on new licensing terms with Ranbaxy Laboratories Ltd, India's biggest pharmaceutical firm by sales, and three other companies to produce generic versions of three HIV/AIDS drugs that are in late-stage clinical development, as part of an effort to provide faster access to its treatments to patients in developing countries.

Besides Ranbaxy, new terms were agreed with Hetero Drugs Ltd, Matrix Laboratories Ltd and Strides Arcolab Ltd, the company said in an announcement in Hyderabad on Tuesday.

"Our goal is to ensure that the new Gilead HIV therapies are developed and approved and make the low-cost versions rapidly accessible in developing countries without delay," Gregg H. Alton, executive vice president for corporate and medical affairs at the California-based firm, told a news conference.

Gilead's original licensing agreements provided the Indian drug makers with non-exclusive rights to produce active pharmaceutical ingredients and finished products and sell generic versions of Gilead's HIV medicines Viread(R) and Truvada(R) in 95 developing countries, including India.

The expanded agreements include future rights to produce and sell generic versions of three HIV therapies, "if and when they are approved," the company said in a statement.

The three drugs -- Elvitegravir, Cobicistat and the Quad -- are investigational products. 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, Gilead said.

Gilead, which earns 80% of its revenue from HIV/AIDS drugs, also became the first pharmaceutical firm to enter a licensing agreement with the Medicines Patent Pool Foundation, a Geneva-based United Nations body, to allow sales of generic versions of the HIV/AIDS drugs on similar licensing terms as its Indian partners.

"The licensees will receive 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 US Food and Drug Administration approval of the products," Gilead said.

 
 
 
 
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