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Curis Announces Erivedge(R) Receives Positive CHMP Opinion For Conditional Approval In European Union

Stocks in this article: CRIS

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 under the priority review program that provides for an expedited six-month review of drugs that offer major advances in treatment. Erivedge has since also been approved in Mexico, Israel and South Korea. 

About the ERIVANCE BCC Study

The CHMP opinion is based on findings from the pivotal ERIVANCE BCC study which enrolled 104 advanced basal cell carcinoma patients (71 had locally advanced and 33 had metastatic disease) from 31 study centers in the US, Australia and Europe.

The study showed that Erivedge substantially shrank tumors or healed visible lesions, as defined by objective response rate, in 42.9 percent of patients with locally advanced and 30.3 percent of patients with metastatic basal cell carcinoma as assessed by independent review.

The most common adverse events included muscle spasms, hair loss, altered taste sensation, fatigue and weight loss. Serious adverse events (SAEs) were observed in 26 patients (25 percent), however of these only four patients (4 percent) had SAEs that were considered to be related to treatment with vismodegib. Fatal events were reported in seven patients (7 percent) although none were considered by investigators to be related to treatment with Erivedge. In all cases, patients had other pre-existing diseases or symptoms that were related to their presumed cause of death.

About Curis, Inc.

Curis is an oncology-focused company seeking to develop and commercialize next generation targeted drug candidates for cancer treatment. Erivedge® is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized and developed by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also developing its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins; CUDC-907, a dual PI3K and HDAC inhibitor; and CUDC-101, an EGFR/HER2 and HDAC inhibitor. For more information, visit Curis' website at www.curis.com .

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding Curis' expectations regarding the timing for an approval decision in Europe, Roche's expected regulatory plans, and the potential expansion of patient access to Erivedge.   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, the European Commission or other foreign regulatory agencies may not view favorably the safety and efficacy profile of Erivedge in the treatment of advanced BCC, in which case Erivedge will not be approved for sales and marketing for the treatment of such indication in markets outside of the US, Mexico or Israel. Genentech and Roche may experience delays or failures in the manufacture and/or commercial launch of Erivedge. Erivedge's benefit/risk profile may not be widely accepted by the medical community or third party payors for the treatment of advanced BCC. Regulatory and administrative governmental authorities may determine to delay or restrict Genentech's ability to continue to develop or commercialize Erivedge. Competing drugs may be developed that are superior to Erivedge. Any of the foregoing risks could adversely affect the royalty revenue that Curis may receive from sales of Erivedge. Unstable market and economic conditions may adversely affect Curis' financial conditions and its ability to access capital to fund the growth of its business. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Annual Report on Form 10-K for the year ended December 31, 2012 and other filings that it periodically makes with the Securities and Exchange Commission. 

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