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news.Santhera Pharmaceuticals has stated that as of January 2011 it regains the US and Canadian rights for Fipamezole from Biovail Laboratories, a wholly-owned subsidiary of Valeant Pharmaceuticals.
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Fipamezole is being prepared for Phase III development for the treatment of Dyskinesia in Parkinson’s Disease.
Previously, Santhera has entered into a collaboration and licensing agreement with Biovail to develop and commercialise Fipamezole in North America, for which Santhera received $12m upfront and milestone payments.
In September 2010, Santhera and Ipsen signed a separate collaboration agreement for the development and commercialisation of Fipamezole outside North America and Japan.
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.
Santhera CEO Klaus Schollmeier said that the North American rights to Fipamezole enhance the company’s existing portfolio of late-stage assets and represent an opportunity to bring to market a therapy to treat levodopa-induced Dyskinesia in Parkinson’s disease.
"While we would have been pleased to continue with Biovail being part of this partnership, we accept their strategic decision," Schollmeier said.
"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."