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Gilead Sciences, Inc.

Drug Names(s): tenofovir disoproxil fumarate, Tenofovir DF, TDF, GSK548470, GSK-4331, Tenozet

Description: Viread (tenofovir disoproxil fumarate) is a nucleoside analog of adenosine monophosphate. It requires initial diester hydrolysis for conversion to tenofovir diphosphate, an obligate chain terminator. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase and HBV polymerase by competing with the natural substrate deoxyadenosine 5'-triphosphate and, after incorporation into DNA, by DNA chain termination. Viread is a weak inhibitor of mammalian DNA polymerase a, b, and mitochondrial DNA polymerase g.

The oral powder formulation of Viread uses Aptalis's Microcaps taste-masking technology. Gilead will be responsible for the product commercialization, while Aptalis will manufacture and supply the oral powder to Gilead.

Deal Structure: Gilead and Japan Tobacco
In July 2003, Gilead announced that the company has entered into a licensing agreement with Japan Tobacco (JT) under which JT will commercialize products in Gilead's HIV portfolio in Japan. The agreement includes Viread (tenofovir disoproxil fumarate), Emtriva (emtricitabine) and a future co-formulation of the two products. Under the terms of the agreement, Gilead will receive an up-front fee and is entitled to receive additional cash payments upon achievement of certain milestones. JT also will make payments to Gilead based on product sales. JT will submit applications for Viread and Emtriva to Japanese regulatory authorities in the near future.

Under the terms of the agreement, JT paid Gilead an up-front licensing fee, and Gilead is entitled to receive additional cash payments upon the achievement of certain milestones. Upon successful commercialization of the products in Japan, JT will make payments to Gilead based on product...See full deal structure in Biomedtracker

Partners: Japan Tobacco Inc. GlaxoSmithKline plc Mylan Inc.

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