Teva licenses Indevus' stutter drug

Israeli drug giant Teva has licensed the global rights to Indevus' pagoclone for stuttering. The US originator recently reported data from a mid-stage trial which showed that the GABA-A agonist produced a statistically-significant benefit in multiple primary and secondary stuttering endpoints compared to placebo.

Under the terms of the agreement, Indevus will conduct a Phase IIb study of the agent, and Teva will reimburse the costs. The placebo-controlled trial will involve 300 US patients treated for a period of six months. It is expected to start enrolling by first-quarter 2009.

Following a successful evaluation, Indevus will participate on a 50/50 basis with Teva in the USA, sharing development and marketing costs, and splitting future profits, in addition to receiving milestones. Under certain circumstances, either party may convert the agreement to a royalty structure where Teva will be responsible for all development and commercial costs in the USA 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 late-stage program.