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Curis Announces Approval Of Erivedge(R) In Australia

LEXINGTON, Mass., May 10, 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 Erivedge® (vismodegib) was approved for marketing registration by Australia's Therapeutic Goods Administration (TGA) for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate. Erivedge is the first licensed treatment in Australia for patients with advanced basal cell carcinoma (BCC), a rare form of skin cancer which can be disfiguring, debilitating and even fatal.

Curis earned a $4 million milestone payment as a result of the TGA's approval of Erivedge and Curis is also entitled to receive royalties on Roche's future net sales of Erivedge in Australia.

"We are pleased with the TGA's decision to grant Erivedge approval in Australia and we view this milestone as continuing evidence of Roche's broad efforts to expand patient access to Erivedge," said Dan Passeri, Curis Chief Executive Officer. "We expect approval decisions in additional territories in 2013, including in the European Union after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on approvability. We also expect that Roche will continue making global submissions seeking marketing approval for Erivedge in several territories in the coming months."

About Basal Cell Carcinoma (BCC) and the Hedgehog Pathway

Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States. The disease is generally considered curable if the cancer is restricted to a small area of the skin. In advanced BCC, if the disease is left untreated or recurs in the same location after surgery or radiotherapy, it may progress and spread further into surrounding areas such as sensory organs (ears, nose and eyes), bone or other tissues. Depending on the location of the lesion, some cases of advanced BCC can be disfiguring, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.

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