Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries

Agreement provides license for generic production of tenofovir alafenamide, an investigational agent for the treatment of HIV and chronic hepatitis B

MELBOURNE, Australia–(BUSINESS WIRE)–Jul. 24, 2014– Gilead Sciences, Inc. (NASDAQ:GILD) announced today at the 20th International AIDS Conference in Melbourne, Australia, a new agreement with the Medicines Patent Pool (MPP) to expand access to Gilead’s investigational drug tenofovir alafenamide (TAF) for HIV and hepatitis B, contingent on the medicine’s U.S. regulatory approval.

Under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries.

“The Medicines Patent Pool plays a critical role in efforts to expand access to HIV treatment in the developing world,” said Gregg H. Alton, Executive Vice President for Corporate and Medical Affairs at Gilead Sciences. “By expanding our partnership to include TAF today, we hope to lay the groundwork for the rapid introduction of generic versions should it receive regulatory approval.”

The new agreement expands on Gilead’s previous licensing partnership with the MPP. In July 2011, Gilead became the first pharmaceutical company to join the MPP, and today six Indian pharmaceutical companies hold MPP sub-licenses for Gilead HIV medicines.

“As the Medicines Patent Pool’s first pharmaceutical industry partner, Gilead has played a vital role in increasing treatment access for people living with HIV in the developing world,” said Greg Perry, executive director of the MPP. “We welcome this expansion of our partnership, and we look forward to working with our sub-licensees to provide access to low-cost, high-quality versions of TAF and other Gilead antiretroviral medicines.”

Licensing agreements are a key component of Gilead’s efforts to increase access to the company’s therapies in the developing world. In addition to its agreement with the MPP, Gilead has direct partnerships with 11 generic manufacturers. Due to competition among these generic drug manufacturers, the lowest price of a Gilead HIV medicine has fallen 80 percent since 2006, to $4.00 per patient per month. Currently 5.4 million people are receiving Gilead HIV medicines in low- and middle-income countries through the company’s access initiatives – more than half of all people on HIV therapy in these countries. Ninety-nine percent of these people receive versions produced by generic partners.

The full MPP licensing agreement is available at www.medicinespatentpool.org.

 

About Tenofovir Alafenamide
Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NtRTI). It is a novel prodrug of tenofovir. Phase 1b dose-ranging studies identified a dose of TAF that is ten times lower than Viread® (tenofovir disoproxil fumarate), which may expand its use to broader patient populations. Gilead is currently conducting Phase 3 clinical trials to evaluate the safety and efficacy of TAF as a single agent for the treatment of chronic HBV infection.

For HIV, Gilead is evaluating a single tablet regimen containing TAF in combination with elvitegravir, cobicistat and emtricitabine (E/C/F/TAF). This single tablet regimen is being evaluated in a comprehensive Phase 3 program in treatment-naïve, treatment-experienced and renally-impaired patients. Additionally, Phase 3 studies evaluating fixed-dose combinations of two doses of TAF in combination with emtricitabine (F/TAF) are underway; a lower 10mg dose is being studied for use with boosted protease inhibitors and a 25mg dose is being evaluated for use with other classes of HIV medications.

 

Gilead’s Approach to Treatment Access
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. Gilead’s HIV treatment access strategies include tiered pricing, collaboration with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations.

 

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 and South 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 the possibility that licensees will not be able to produce and distribute generic versions of Gilead medicines, that licensing terms will be modified or that TAF does not receive regulatory approval. 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, 2014, 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.

Viread is a registered trademark of Gilead Sciences, Inc.

Source: Gilead Sciences, Inc.