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Curis Announces Initiation Of A Roche-Sponsored Phase 1b/2 Study Of Erivedge(R) (vismodegib) In Relapsed/Refractory AML And High Risk MDS

Roche has developed Erivedge under a collaboration agreement with Curis. Erivedge was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies. Through this collaboration, Genentech (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals (Japan) are responsible for the clinical development and commercialization of Erivedge. Curis is eligible to receive cash payments assuming the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge.

In January 2012, Erivedge became the first licensed medicine for patients with advanced basal cell carcinoma when the U.S. Food and Drug Administration (FDA) approved it following a priority review. Erivedge has since also been approved in other countries, including Australia, Canada, Ecuador, European Union, Norway, Israel, Mexico, South Korea, Switzerland and Uruguay.

About Acute Myeloid Leukemia (AML)

AML is the most common acute leukemia in adults, accounting for approximately 25% of all leukemias in adults in the Western world with the highest incidence in the U.S., Australia and Western Europe. Approximately 14,500 new cases and more than 10,000 deaths from the disease are expected in the U.S. in 2013 according to the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) research data.

About Curis, Inc.

Curis is an oncology-focused company seeking to develop novel drug candidates for the treatment of human cancers. Erivedge is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor. For more information, visit Curis' website at

Cautionary Note Regarding Forward-Looking Statement s

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the potential benefits of treating AML and MDS patients with Erivedge, and clinical development plans and timelines for the Phase 1b/2 trial of Erivedge in AML and MDS. Forward-looking statements used in this press release may contain the words "believes," "expects," "anticipates," "plans," "seeks," "estimates," "assumes," "will," "may," "could" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis and its collaborators may experience adverse results, delays and/or failures in their preclinical and clinical drug development programs. Curis and its collaborators' drug candidates may cause unexpected toxicities and/or fail to demonstrate sufficient safety and efficacy in clinical trials and may never achieve the requisite regulatory approval needed for commercialization. Curis and its collaborators may not achieve projected research, development and commercialization goals in the time frames that they publicly announce. Curis will require substantial additional capital to fund the research and development of its drug development programs. Curis may not obtain or maintain necessary patent protection for its programs and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis and its collaborators face substantial competition. Curis is dependent upon its key collaborators and these collaborations may not be scientifically or commercially successful. Unstable market and economic conditions and other factors may adversely affect Curis' financial condition and its ability to access capital to fund the growth of its business. Curis could lose its rights to Erivedge royalties and related royalty payments if its wholly-owned subsidiary defaults under its secured credit agreement with BioPharma-II. Curis' stock price may not appreciate in value. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and other filings that it periodically makes with the Securities and Exchange Commission. 

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