Indevus signs licensing and development agreement with Teva

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 US treated for a period of six months and is expected to commence enrollment by first quarter of 2009.

Following the completion of a successful Phase IIb study, the agreement provides for Indevus to participate on a 50/50 basis with Teva in the US, sharing development and marketing costs, and splitting future profits, in addition to receiving milestone payments.

Under certain circumstances, either party may convert the agreement from the 50/50 arrangement to a royalty structure where Teva will be responsible for all development and commercial costs in the US and Indevus would receive royalties on net sales, in addition to milestones. In either case, if the arrangement continues, Teva will be responsible for the conduct of the Phase III program.

For territories outside of the US, Teva will be responsible for all future development and commercialization and Indevus will receive milestones and royalties on net sales.

Under the 50/50 participation, Indevus could receive up to $92.5 million in US 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 million in US based sales threshold milestones.

Glenn Cooper, CEO and chairman of Indevus, said: “The deal we have negotiated with Teva allows us to conduct a definitive Phase IIb trial, funded by our partner. If the trial is positive, we believe that both companies will have a unique opportunity to commercialize the first pharmaceutical product for the millions of patients who stutter.”