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- Recommended as Treatment for Advanced Basal Cell Carcinoma -
- Curis Eligible for $6 Million Milestone on European Commission Approval -
LEXINGTON, Mass., April 26, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused company seeking to develop next generation targeted drug candidates for cancer treatment, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a conditional approval of Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy. Conditional approval would make Erivedge the first licensed treatment in Europe for patients with advanced basal cell carcinoma, a rare form of skin cancer which can be disfiguring, debilitating and even fatal.
"We are extremely pleased that the CHMP has recommended the conditional approval of Erivedge in the EU and we hope that this important medicine will soon be available to patients in Europe," said Dan Passeri, Chief Executive Officer of Curis. "We continue to be pleased by the strength of Roche's global regulatory and commercialization efforts regarding Erivedge, which we anticipate will significantly broaden patient access to Erivedge globally. Erivedge is currently under review for approval by health authorities in several countries outside of Europe, and regulatory submissions are planned in many additional countries. We view Roche's broad efforts to expand patient access to Erivedge as a testament to its commitment to this important, first-in-class molecule."
The European Commission, which has the authority to approve medicines for use in the European Union, generally delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 27 EU member states. A European Commission conditional approval would result in Curis earning a $6 million milestone payment from Genentech, a member of the Roche Group. Roche is responsible for commercializing Erivedge in the EU.