Fipamezole Transition from Biovail completed
Program Well Advanced Towards Phase III
Santhera Pharmaceuticals announced that the transition of the fipamezole program back from Biovail was successfully completed. Fipamezole is being developed as a potential first treatment of dyskinesia in Parkinson's disease. During its partnership with Santhera and in preparation for Phase III development, Biovail generated additional data in numerous clinical and nonclinical studies. The additional data confirm and build upon the excellent profile of fipamezole established in two previous Phase II studies. The agreement was terminated following the merger between Valeant and Biovail. Santhera has the right to use all data generated by Biovail for further development and commercialization worldwide. Whilst it continues with the preparation for Phase III development, Santhera intends to license the US and Canadian rights to a new partner. Rights to fipamezole outside North America and Japan are licensed to Ipsen.
"An analysis of all data including those generated by Biovail confirms the excellent efficacy and safety profile of fipamezole. Importantly, the program has advanced very well since we entered the partnership in fall 2009. We continue to work towards initiation of the Phase III development", said Klaus Schollmeier, Chief Executive Officer of Santhera. "The high level of interest we are receiving for the North American rights confirms the medical and commercial attractiveness of this innovative drug. Fipamezole holds the potential to be the first approved therapy to treat Dyskinesia in Parkinson's Disease."
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