Santhera and Takeda extend European marketing collaboration

Published: 2-Aug-2007
Regulatory Research & Development

Swiss specialty pharma company Santhera Pharmaceuticals and Takeda Pharmaceutical Company have extended their existing commercialisation partnership for SNT-MC17 (idebenone) in the EU and Switzerland to cover the compound\'s second indication of Duchenne Muscular Dystrophy (DMD).


Swiss specialty pharma company Santhera Pharmaceuticals and Takeda Pharmaceutical Company have extended their existing commercialisation partnership for SNT-MC17 (idebenone) in the EU 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 which 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 Euro 2m and milestone payments upon initiation of a Phase III pivotal trial and further milestones upon filing and granting of marketing authorisation in Europe, totalling €18m.

In addition, Santhera will receive running royalty income from Takeda once the product is marketed, on terms that are identical to those in the earlier agreement covering SNT-MC17 in Friedreich's Ataxia (FRDA), signed by the two companies in July 2005.

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.

"Takeda's desire to secure marketing rights to SNT-MC17 for DMD in Europe at this stage of development reflects our shared confidence in the product for this second indication," said Klaus Schollmeier, ceo of Santhera. "Given our positive existing partnership with Takeda, this second agreeement is a logical next step to further explore the therapeutic and commercial potential of our lead compound SNT-MC17."

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