I found this on http://www.marketwatch.com/ today:
Indevus Announces Agreement With Teva to Develop Pagoclone for the Treatment of Stuttering
10:30 a.m. EDT Sept. 26, 2008
Indevus announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. 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 the first quarter of 2009.
If the arrangement continues, Teva will be responsible for the conduct of the Phase III program.
"There are currently no approved drugs anywhere in the world for patients with stuttering. Pagoclone has tremendous potential to become a highly significant commercial product, as well as to provide a ground-breaking therapy to the nearly three million Americans and millions of patients around the world who are afflicted with this condition. 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."
Pagoclone is a novel, non-benzodiazepine, selective GABA-A receptor agonist. In clinical studies in anxiety disorders, it has been shown to reduce the symptoms of panic disorder and generalized anxiety disorder without causing the sedation or withdrawal effects seen with benzodiazepine agents. Pagoclone trials have enrolled over 1,500 patients to date. In early 2005, Indevus was granted a new U.S. patent covering the use of pagoclone for the treatment of stuttering.
Read the full story here: http://www.marketwatch.com/news/story/indevus-announces-agreement-teva-develop/story.aspx?guid=%7BD1C01E20-BB6C-479C-94F7-909C41AA72EF%7D&dist=hppr