口吃新药pagoclone临床试验将重启，2012年前可能上市！ 新药, pagoclone, 临床, 口吃, 试验

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在沉寂将近2年的时间，就在人们认为Indevus因为巨大的前期研究费用将要放弃口吃新药pagoclone的研究时，Indevus制药公司在于Teva制药公司在前期研究费用分担和将来的利润分成达成协议后，宣布将在2009年初重启pagoclone的临床二期b试验，这项试验将会持续6个月包括300多名口吃患者的参与，如果试验的结果是积极的话，Teva制药公司将会开展临床三期的试验，时间大概是2到3年左右，最后由美国FDA审批是否上市。如果一切顺利的话，pagoclone将会作为第一个由FDA认证的治疗口吃的药物在2012年前与口吃患者见面。



        LEXINGTON, Mass., Sept. 26 /PRNewswire/ -- Indevus Pharmaceuticals, Inc.(Nasdaq: IDEV) today 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 aminobutyric 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. 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 U.S.,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 U.S. 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 U.S., 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(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.We are excited that we have partnered pagoclone with a leading pharmaceutical company with a focus on central nervous system conditions,"said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus."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 then early 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.

su2816

药？？？  我愿意用我10年的工资治愈我的口吃