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European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera
Date:8/19/2007

LIESTAL, Switzerland and OSAKA, Japan, August 16 /PRNewswire-FirstCall/ -- Santhera Pharmaceuticals (SWX: SANN, "Santhera"), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), jointly announced today that the European Medicines Agency (EMEA) has accepted the filing of the Marketing Authorization Application (MAA) for Santhera's lead compound SNT-MC17 (INN: idebenone, originally developed by Takeda) for the treatment of Friedreich's Ataxia (FRDA). SNT-MC17, which has been granted orphan drug designation in the EU, could become the first approved product for the treatment of FRDA and will be marketed in Europe by Santhera's partner Takeda. SNT-MC17 has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far.

In a recently completed clinical trial conducted in collaboration with the US National Institutes of Health (NIH), Santhera tested the efficacy of three doses of SNT-MC17 in patients with FRDA. Study results were announced in fall 2006. The MAA file includes data generated in this collaborative study with the NIH analyzing a variety of neurological and cardiac outcome measures, supported by data from earlier clinical trials in FRDA conducted by academic institutions that demonstrated efficacy primarily in the treatment of the cardiac symptoms of this devastating disease. The MAA recommends a starting dose of 450 mg/day for patients below 45 kg body weight and 900 mg/day for patients of 45 kg or above body weight, with the option for the treating physician to use higher doses if needed.

The MAA file includes safety data generated by Santhera with SNT-MC17 as well as safety data from Takeda generated in its earlier preclinical and clinical development program with idebenone for the treatment of Alzheimer's disease. Santhera believes that the com
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SOURCE Santhera Pharmaceuticals AG

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