Keywords: Gilead, GSK, GlaxoSmithKline, hepatitis B, Viread

Gilead and GlaxoSmithKline to commercialize Viread for chronic hepatitis B in key Asian countries; update on Avodart

Article | 26 November 2009

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The USA’s Gilead Sciences and UK drug giant GlaxoSmithKline have signed a licensing agreement to commercialize the former’s Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialization activities will expand access to Viread for the treatment of HBV, once approved, to patients in Asia where the prevalence in most countries is more than 8%.

Under the deal, Gilead will retain exclusive rights for commercializing Viread for HBV in Hong Kong, Singapore, South Korea and Taiwan. In China, GSK will have exclusive rights and registration responsibilities for Viread for HBV. Each company will pay royalties to the other on sales of Viread for HBV in their respective Asian territories. Further financial terms were not disclosed. The companies are working to expand this agreement to include Japan and other countries.

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The Viread accord modifies the terms of the April 2002 licensing agreement between the two firms under which GSK received exclusive rights to Hepsera (adefovir dipivoxil), Gilead’s first hepatitis B treatment, in various territories including China, Japan, South Korea and Taiwan, as well as the right to commercialize Viread for the treatment of HBV under certain circumstances.

GSK pulls Avodart sNDA

Meantime, GSK announced on November 23 that, in order to provide an update to the supplemental New Drug Application, it is temporarily withdrawing its sNDA for Avodart (dutasteride) for the reduction of prostate cancer risk among men at increased risk of developing the disease, because of what was described as an “administrative error” and not the result of new findings related to safety or efficacy of the drug.
The company plans to resubmit the filing shortly and confirmed that this action is not the result of new findings related to safety or efficacy. Review of European Union filings will begin once the same update is provided to EU regulatory agencies.