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news.Gilead Sciences has announced the early termination of the Hart-Scott-Rodino waiting period for the Japan Tobacco license for JTK-303, giving Gilead exclusive rights to develop and commercialize the product candidate.
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A licensing agreement was signed between the two companies in March this year, granting Gilead the exclusive rights to Japan Tobacco’s novel HIV integrase inhibitor, JTK-303, in all countries of the world, excluding Japan, where Japan Tobacco will retain rights.
The JTK-303 license agreement, which was subject to clearance by the US Federal Trade Commission (the FTC), is now effective as a result of the FTC’s early termination of the required waiting period without any request for additional information.
JTK-303 has previously been evaluated in a phase I study in Japan to assess bioavailability and pharmacokinetics in healthy volunteers. Gilead plans to initiate phase I/II clinical studies in HIV-positive patients by mid-year.
Under the terms of the licensing agreement, Gilead agreed to make an upfront payment of $15 million to Japan Tobacco, with additional cash payments of up to $90 million possible upon the achievement of certain milestones. Gilead will also pay a royalty based on future product sales in the territories where Gilead will market the drug.