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Fipamezole Transition from Biovail Completed - Program Well Advanced Towards Phase III

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Santhera Pharmaceuticals has 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.

Fipamezole is widely perceived by clinicians as one of the most promising drug candidates to treat Dyskinesia in Parkinson's Disease, the second most common and a severely debilitating neurodegenerative disorder. The majority of Parkinson's patients will develop dyskinesia over time.

Two Phase II studies with fipamezole showed that dyskinesia symptoms could be significantly reduced while suggesting a reduction in "off time", i.e. the hours spent with diminished mobility. Furthermore, the reduction in dyskinesia was found to be well correlated with the clinical global impression of improvement.

In August 2009, Biovail acquired the rights to develop and commercialize fipamezole in the US and Canada. The work conducted includes numerous nonclinical and clinical studies required prior to the start of Phase III development. These studies confirm the favorable profile of fipamezole.

Furthermore, the development of a synthesis route for the drug substance which is suitable for commercial supply and technical process optimization for supply of proprietary drug product have been completed. Following termination of the agreement by Valeant after its merger with Biovail, Santhera recently regained all US and Canadian rights to the program.

In September 2010, Santhera and Ipsen closed a separate collaboration for the development and commercialization of fipamezole outside North America and Japan. This agreement stipulates a data sharing arrangement, under which Santhera and its licensees share all clinical and nonclinical data generated in their respective development programs.

"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."

Since August 2009, Santhera received a total of USD 31 million licensing fees. In parallel to the preparation of Phase III development, Santhera has initiated a process to partner the rights to develop and commercialize fipamezole in North America. The closing of such an agreement is anticipated during 2011.