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news.Gilead Sciences and Navitas Assets have entered into an agreement under which Gilead has acquired all of Navitas's assets related to its cicletanine business.
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Under the terms of the agreement, Gilead will pay Navitas an upfront payment and contingent payments on future net sales. Navitas also could earn additional payments based upon the achievement of certain development and regulatory milestones.
Gilead has acquired the exclusive rights to regulatory data and filings for development of cicletanine as a monotherapy for pulmonary arterial hypertension (PAH) and for other indications in the US.
Cicletanine is an off-patent compound. Navitas has applied for orphan drug status for cicletanine for treatment of PAH. If orphan status is granted, Gilead would retain cicletanine US market exclusivity for seven years from the time of FDA approval as a treatment for PAH.
Cicletanine is an oral, once-daily agent that is approved in certain European countries for the treatment of hypertension. Gilead plans to evaluate cicletanine for the treatment of PAH in a Phase II study which is expected to commence prior to the end of 2008.