Indevus (IDEV) Announces Agreement With Teva (TEVA) to Develop Pagoclone for the Treatment of Stuttering

September 26, 2008 10:56 AM EDT

Indevus Pharmaceuticals (Nasdaq: IDEV) announced that it has signed a development, license and commercialization agreement with Teva Pharmaceuticals (Nasdaq: TEVA) for the exclusive, worldwide rights to pagoclone. Indevus previously announced promising data from its 8-week, placebo controlled, double-blind, multi-center Phase II trial in patients with persistent stuttering which showed that pagoclone produced a statistically significant benefit in multiple primary and secondary stuttering endpoints compared to placebo. Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma amino butyric acid (GABA) selective receptor modulator.

Under the terms of the Agreement, which is subject to applicable regulatory clearances and customary conditions, Indevus will conduct and Teva will reimburse Indevus for its expenses for a Phase IIb study. The placebo- controlled study will involve approximately 300 patients with stuttering in the U.S. treated for a period of six months and is expected to commence enrollment by Q1 2009.

Under the 50/50 participation, Indevus could receive up to $92.5 million (including the Phase IIb study expenses) in U.S. and European development milestones and R&D reimbursement. In the event of a conversion to the royalty structure, in addition to the $92.5 million of milestones and reimbursements, Indevus could receive up to $50.0 million in U.S. based sales threshold milestones.

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