EU regulators accept SNT-MC17 for review

Swiss drugmaker Santhera Pharmaceuticals and Japan's Takeda Pharmaceuticals say that the European Medicines Agency (EMEA) has accepted the developmental Friedreich's Ataxia treatment SNT-MC17 for review. The drug, which has also been granted Orphan Drug designation, has demonstrated clinical efficacy on both the neuro- and cardiological symptoms of the disease.

European acceptance of the Marketing Authorization Application triggers the payment of a 3.0 million-euro ($4.0 million) milestone to Santhera, as stipulated by the marketing agreement signed by the firms in August 2005 (Marketletters passim). Last month, the companies announced that they would extend the marketing deal to include European sale of the drug in its second potential indication, Duchenne Muscular Dystrophy.