Curis (CRIS) Reports Submission of MAA for Vismodegib to EMA

December 22, 2011 7:01 AM EST
Curis, Inc. (Nasdaq: CRIS), announced that its collaborator Roche has submitted a Marketing Authorization Application (MAA) for vismodegib (GDC-0449, RG3616) to the European Medicines Agency (EMA). The MAA is currently under review for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Vismodegib is a first-in-class, investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway and is being developed by Roche and Genentech, under a collaboration agreement between Curis and Genentech, a member of the Roche Group (OTCBB: RHHBY).

Curis earned a $6 million milestone payment from Genentech as a result of the MAA submission to the EMA. If vismodegib receives Marketing Authorization by the EMA , Curis will also be entitled to receive an additional milestone payment as well as royalties on any future sales.


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