European Commission Grants Conditional Approval to Erivedge

The European Commission has granted conditional approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. The Commission granted the conditional approval based upon the positive recommendation received in April this year from the Committee of Medicinal Products for Human Use of the European Medicines Agency (EMA). The European Commission's decision will be applicable to all 28 European Union member states. Under the provisions of the conditional approval, Roche is expected to provide additional data on Erivedge in advanced BCC from an ongoing global safety study. This conditional approval makes Erivedge the first licensed treatment in Europe for patients with advanced BCC. As a result of this conditional approval, Curis earned a $6 million milestone payment from Genentech, and will continue to be entitled to receive royalties on future sales of Erivedge. Roche is responsible for commercializing Erivedge in the EU.