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Under the terms of the Agreement, which is subject to applicableregulatory clearances and customary conditions, Indevus will conduct and Tevawill reimburse Indevus for its expenses for a Phase IIb study. The placebo-controlled study will involve approximately 300 patients with stuttering inthe U.S. treated for a period of six months and is expected to commenceenrollment by Q1 2009.
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Following the completion of a successful Phase IIb study, the Agreementprovides for Indevus to participate on a 50/50 basis with Teva in the U.S.,sharing development and marketing costs, and splitting future profits, inaddition to receiving milestone payments. Under certain circumstances, eitherparty may convert the Agreement from the 50/50 arrangement to a royaltystructure where Teva will be responsible for all development and commercialcosts in the U.S. and Indevus would receive royalties on net sales, inaddition to milestones. In either case, if the arrangement continues, Tevawill be responsible for the conduct of the Phase III program.
For territories outside of the U.S., Teva will be responsible for allfuture development and commercialization and Indevus will receive milestonesand 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 developmentmilestones and R&D reimbursement. In the event of a conversion to the royaltystructure, in addition to the $92.5 million of milestones and reimbursements,Indevus could receive up to $50.0 million in U.S. based sales thresholdmilestones.
"We are excited that we have partnered pagoclone with a leadingpharmaceutical 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 withstuttering. Pagoclone has tremendous potential to become a highly significantcommercial product, as well as to provide a ground-breaking therapy to thenearly three million Americans and millions of patients around the world whoare afflicted with this condition. The deal we have negotiated with Tevaallows us to conduct a definitive Phase IIb trial, funded by our partner. Ifthe trial is positive, we believe that both companies will have a uniqueopportunity to commercialize the first pharmaceutical product for the millionsof patients who stutter."
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical companyengaged in the acquisition, development, and commercialization of products totreat conditions in urology and endocrinology. The Company's approved productsinclude SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) foradvanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, andDELATESTRYL(R) to treat male hypogonadism. The Indevus development pipelinecontains multiple compounds within the Company's core therapeutic areas inaddition to several partnered or partnerable programs. The most advancedcompounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R)for male hypogonadism, PRO 2000 for the prevention of infect
