Santhera Pharmaceuticals and Biovail Corp. have signed a license agreement for Santhera's JP-1730/fipamezole, granting Biovail U.S. and Canadian rights to develop and commercialize the drug for the treatment of dyskinesia in Parkinson's Disease. In a recent Phase IIb study, JP-1730/ fipamezole showed the potential to reduce levodopa-induced dyskinesia.
"Biovail is an emerging key player in the area of neurodegenerative disorders. With its commitment to this therapeutic area and the strong track record it has developed in a short period of time, I am confident that JP-1730/fipamezole will become a key product for the improved management of Parkinson's disease," said Klaus Schollmeier, chief executive officer of Santhera. "Importantly, today's agreement is consistent with our strategy of partnering larger indications whilst retaining co-promotional rights for our commercial operations in the U.S."
Bill Wells, Biovail's chief executive officer said, "This agreement with Santhera is directly on strategy and another important step in our efforts to build a sustainable product-development pipeline in specialty central nervous system disorders."
Santhera will receive an upfront payment of $8 million and a further payment of $4 million upon the successful closing of its acquisition of Oy Juvantia Pharma Ltd. Biovail will pay as much as $35 million in development and regulatory milestones and will make additional sales milestone payments of as much as $145 million. Santhera will also receive royalties on sales of the drug. For a second indication, Santhera is eligible to receive as much as $20 million in success-based milestones.
Biovail will be responsible for the remaining clinical development programs in the U.S. and Canada. Initiation of the first Phase III study is scheduled for 2011. Santhera will retain co-promotion rights in the U.S.
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