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Curis Announces The Conditional Approval Of Erivedge(R) In The European Union

LEXINGTON, Mass., July 15, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced that 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. This conditional approval makes Erivedge the first licensed treatment in Europe for patients with advanced BCC, a rare form of skin cancer which can be disfiguring, debilitating and even fatal.

"We are extremely pleased that Erivedge will now be available as the first approved medicine in the European Union (EU) for patients with advanced basal cell carcinoma, a serious medical condition," stated Dan Passeri, Curis' Chief Executive Officer. "Roche's development and commercialization efforts have significantly expanded global patient access and the market opportunity for Erivedge, with regulatory approvals for Erivedge in the United States, Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador, in addition to the EU. We expect that Roche will seek approval of Erivedge in several other territories and anticipate that these efforts will continue to expand the number of patients that will have access to this important medicine in the near future."

The European 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. As a result of this conditional approval, Curis earned a $6 million milestone payment from Genentech, a member of the Roche Group, and will continue to be entitled to receive royalties on future sales of Erivedge. Roche is responsible for commercializing Erivedge in the EU. A conditional marketing authorization is granted to medicinal products with a positive benefit/risk assessment that satisfy an unmet medical need and whose availability would result in a significant public health benefit. 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.

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