October 25, 2010: Santhera Regains Full Rights to Fipamezole in North America

Liestal, Switzerland, October 25, 2010 - Santhera Pharmaceuticals (SIX: SANN) announced today 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."

 

Fipamezole is widely perceived by clinicians as one of the most promising drug candidates to treat dyskinesia in Parkinson's Disease, a severely debilitating movement disorder. In two Phase II studies, fipamezole was shown to reduce levodopa-induced dyskinesia with this beneficial effect not being associated with a clinically meaningful worsening of parkinsonian features of the disease. The results also suggest that fipamezole potentially improves cognitive functions of patients and reduces their "off time", i.e. the hours they spend with diminished mobility. Furthermore, the reduction in dyskinesia was found to be well correlated with the clinical global impression of improvement.

 

In August 2009, Santhera granted Biovail the right to develop and commercialize fipamezole in North America and received a total of USD 12 million licensing fees consisting of an upfront and a first milestone payment. Importantly, the program has advanced significantly over the past year including technical process optimization for supply of product and the completion of important nonclinical and clinical studies, which were all performed by Biovail. Following a strategic review of the combined Biovail/Valeant development portfolio, Santhera now regains all US and Canadian rights including all data generated by Biovail.

 

At the end of September 2010, Santhera's cash and cash equivalents amounted to approximately CHF 50 million, which gives the Company enough flexibility to invest in its key programs while keeping a comfortable cash runway. The financial impact of the in-house development of fipamezole for the North American markets is currently being analyzed as Santhera looks into the various options.

 

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About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of specialty niche products for the treatment of neurodegenerative and neuromuscular diseases, areas 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.