Liestal, Switzerland, February 18, 2011 - Santhera Pharmaceuticals (SIX: SANN) announced today 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 (Euronext: IPN; ADR: IPSEY).
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.
About Fipamezole and Dyskinesia in Parkinson's Disease
Parkinson's disease is the second most common neurodegenerative disease. Doctors prescribe levodopa and other dopaminergic compounds as standard therapy. Over time, as the disease progresses, the beneficial effects of this medication often diminish and additional movement disorders can appear (sometimes quite severely). These movement disorders include dyskinesia which can be described as sudden uncontrollable, often chaotic movements of limbs, face, tongue and body. These complications derive principally from long-term levodopa use, but there is currently no alternative to using levodopa or dopamine agonists.
Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode of action in the treatment of Dyskinesia in Parkinson's disease. The rationale behind the development is to increase noradrenergic release in certain areas of the brain resulting in the rebalance of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations and other disturbing symptoms without exacerbating the underlying parkinsonian features of the disease. Encouraging clinical data from Santhera's FJORD Phase IIb study support this rationale. Loss of motor control and dyskinesia is feature of the majority of Parkinson patients after 5 years of levodopa therapy, and remains a high unmet medical need.
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About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of severe neuromuscular diseases, an area of high unmet medical need which includes many orphan indications with no current therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is marketed in Canada. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier@santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
