Santhera Regains Full Rights to Fipamezole in North America

25-Oct-2010 - Switzerland

Santhera Pharmaceuticals announced that as of January 2011 it regains the US and Canadian rights for fipamezole from Biovail Laboratories International, now a wholly-owned subsidiary of Valeant Pharmaceuticals International. Fipamezole is being prepared for Phase III development for the treatment of dyskinesia in Parkinson's disease. Santhera previously established a collaboration and licensing agreement with Biovail to develop and commercialize fipamezole in North America, for which Santhera received USD 12 million upfront and milestone payments. As part of the post-merger review, Biovail has decided to return the fipamezole project solely due to a shift in strategic focus of the new Valeant group. Based on the comprehensive clinical development already completed, Santhera is committed to take on the Phase III development of the product for the North American markets. In September 2010, Santhera and Ipsen signed a separate collaboration agreement for the development and commercialization of fipamezole outside North America and Japan.

"The North American rights to fipamezole enhance Santhera's existing portfolio of late-stage assets and represent an opportunity to bring to market the potentially first therapy to treat levodopa-induced Dyskinesia in Parkinson's Disease," commented Klaus Schollmeier, CEO of Santhera. "While we would have been pleased to continue with Biovail being part of this partnership, we accept their strategic decision. We are now preparing ourselves for the transition of the work and data from Biovail back to us and will discuss our next steps with Ipsen."

https://www.bionity.com/en/news/125002/santhera-regains-full-rights-to-fipamezole-in-north-america.html