Gilead and Japan Tobacco Sign Licensing Agreement for Commercialization of Gilead's HIV Products in Japan

05-Aug-2003

Gilead Sciences, Inc. announced that the company has entered into a licensing agreement with Japan Tobacco Inc. (JT) under which JT will commercialize products in Gilead's HIV portfolio in Japan. The agreement includes Viread® (tenofovir disoproxil fumarate), EmtrivaTM (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.

"We are very pleased to partner with JT for the commercialization of Viread, Emtriva and our future co-formulated product in Japan," said John C. Martin, PhD, President and CEO, Gilead Sciences. "We believe the profiles of these products make them important treatment options for physicians and their patients across all geographies and stages of HIV disease. JT's proven track record of successfully developing and commercializing the HIV protease inhibitor Viracept® (nelfinavir) in Japan makes them an ideal partner for Gilead."

Viread is the first nucleotide analogue reverse transcriptase inhibitor (NtRTI) approved for the treatment of HIV in the United States and Europe. In clinical trials and expanded access programs, approximately 10,000 patients have been treated with Viread alone or in combination with other antiretroviral products for periods up to four years. The drug works by blocking reverse transcriptase, an enzyme involved in the replication of HIV. Viread is dosed as one tablet once daily.

The U.S. Food and Drug Administration (FDA) granted marketing approval for Emtriva in the United States on July 2 of this year. On July 24, the European Union's Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), recommended granting Marketing Authorisation for Emtriva in the 15 member states of the European Union. More than 2000 adult patients have been treated with Emtriva for periods of 10 days to 200 weeks in Phase I, II and III clinical trials. Like Viread, Emtriva works by inhibiting reverse transcriptase. It also is dosed as one capsule taken once daily.

Gilead is developing a co-formulation of Emtriva and Viread, and anticipates a once-daily pill containing both antiretrovirals could reach the U.S. market by early 2005. As part of Gilead's ongoing clinical research of Viread, the company is designing a clinical study to examine the comparative efficacy and safety of Emtriva, Viread and efavirenz compared with Combivir (zidovudine and lamivudine) and efavirenz.

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