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Santhera, Takeda join hands to develop, market Idebenone in neuromuscular disease

Liestal, SwitzerlandFriday, August 5, 2005, 08:00 Hrs  [IST]

Santhera Pharmaceuticals AG of Switzerland and Takeda Pharmaceutical Company Limited will collaborate to develop and commercialize Idebenone (SNT-MC17), a small molecule drug for the treatment of Friedreich's Ataxia (FRDA). The clinical development for FRDA is about to enter a Phase III clinical study in Europe and will enter a Phase III study in the US shortly thereafter. The product has orphan drug designation in the US and Europe. Under the terms of the collaboration, Santhera will conduct all clinical development for regulatory approval in Europe and in the US. Takeda will support the development work and will obtain an exclusive license to market Idebenone (SNT-MC17) in the European Union and Switzerland. Santhera will in return receive an upfront payment of Euro 5 million, development milestones and royalties from Takeda. Full financial terms were not disclosed. Santhera will supply drug product to Takeda for Europe. In the US, Santhera plans to market Idebenone (SNT-MC17) on its own, release from Santhera said. FRDA is a hereditary and disabling neuromuscular disorder that severely impacts quality of life and reduces patients' life expectancies substantially. Although FRDA is primarily a neurological disease, cardiac symptoms are well recognized to be a life-threatening complication of the disease. The most common cardiac manifestation is hypertrophic cardiomyopathy which ultimately causes death in the majority of FRDA patients.

 
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