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Santhera and Takeda Extend European Marketing Collaboration for SNT-MC17 into Duchenne Muscular Dystrophy

06 Aug 2007 - Santhera Pharmaceuticals and Takeda Pharmaceutical Company Limited announced they have extended their existing commercialization partnership for SNT-MC17 (INN: idebenone) in the European Union and Switzerland to cover the compound's second indication of Duchenne Muscular Dystrophy (DMD). SNT-MC17 is currently in a Phase II clinical trial in Europe for DMD. Results of this trial are expected to be released later this year.
 
Under the agreement, Santhera grants exclusive marketing rights in the EU and Switzerland to Takeda and will receive an upfront payment of EUR 2 million and milestone payments upon initiation of a Phase III pivotal trial and further milestones upon filing and granting of marketing authorization in Europe, totaling EUR 18 million. In addition, Santhera will receive running royalty income from Takeda once the product is marketed, on terms which are identical to those in the earlier agreement covering SNT-MC17 in Friedreich's Ataxia (FRDA), signed by the two companies in July 2005.
 
In addition, to support its planned regulatory filings for SNT-MC17 for DMD in the US and Canada, Santhera will reference the preclinical and clinical data generated by Takeda in its earlier development programs of the compound. In North America, Santhera plans to market SNT-MC17 for FRDA and DMD, as well as other possible indications, via its own specialty sales force. Santhera has been granted orphan drug designation for SNT-MC17 in DMD in both the EU and the US. SNT-MC17 is currently in a Phase II clinical trial for DMD at the University of Leuven, Belgium. Results from this study are expected later in 2007.
 
Preclinical data demonstrate that long-term administration of SNT-MC17 shows improvement in several clinically relevant functional cardiac parameters as well as an increase in endurance exercise performance in the mdx mouse, a well characterized animal model for DMD. These data were recently presented at the American Academy of Neurology's 59th Annual Meeting in Boston/MA.