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We work with a network of regional business partners, generic licensing partners, the Medicines Patent Pool and other stakeholders to expand treatment globally.
Regional business partners serve as our on-the-ground interface with local governments, medical organizations and other stakeholders. In addition to delivering Gilead treatments, partners are instrumental in registering medicines with regulatory authorities and assisting with medical and clinical education.
Generic licensing partners play a major role in expanding treatment in developing countries. Today, 96 percent of Gilead HIV therapy used in low- and middle-income countries is produced and sold by licensing partners, who have applied their skills in process chemistry and large-scale manufacturing to lower prices 80 percent over the past six years.
Since 2006, partners have been licensed to produce generic versions of Viread® (tenofovir disoproxil fumarate) and Viread-containing regimens for HIV. In 2011 we expanded licenses to include Viread for chronic hepatitis B and three new HIV medicines once they receive U.S. regulatory approval, including the Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) single tablet regimen.
Licensees receive a full transfer of the Gilead manufacturing process and obtain approval from the U.S. Food and Drug Administration or the World Health Organization for their products.
2006 original license agreement (PDF) 2011 expanded license agreement (PDF)
In August 2012, we signed a collaboration agreement with key Indian manufacturers to help lower the cost of producing generic emtricitabine (FTC) for developing countries.
Gilead was the first innovator pharmaceutical company to join the Medicines Patent Pool (MPP), established by UNITAID in 2009 to expand access to medicines through the sharing of drug patents. Details on the Gilead-MPP license for HIV and hepatitis B medicines are available here.
We support collaborative research on the optimal use of medicines in developing-country settings by donating study drug for clinical trials. We also support policy dialogue on health issues and have worked with the Wilton Park group to convene global leaders to discuss HIV treatment scale-up.