CAMBRIDGE, Mass., Nov 13, 2008 (BUSINESS WIRE) -- Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, Inc. granted a license to F. Hoffmann-LaRoche, Ltd (Roche) for ex-U.S. rights to GDC-0449, an orally-administered small molecule Hedgehog pathway inhibitor. Roche received this license pursuant to an agreement between Genentech and Roche under which Genentech granted Roche an option to obtain a license to commercialize certain Genentech products in non-U.S. markets.
“We are pleased with Roche’s exercise of its option to license ex-U.S. rights to GDC-0449 from Genentech. We believe the collaborative worldwide development activities of Genentech and Roche could greatly expand the potential value of this compound,” said Curis President and CEO Dan Passeri. “Roche brings its significant clinical development and commercialization experience to advance and market GDC-0449 outside of the U.S. We are extremely pleased with our collaborator Genentech’s progress in advancing GDC-0449 and we believe that Roche’s experience will complement Genentech’s ongoing development efforts.”
About GDC-0449
Under the ongoing collaboration agreement between Genentech and Curis, GDC-0449 was discovered by Genentech and was jointly validated through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. This announcement does not change the terms of Curis’ collaboration agreement with Genentech, under which Curis is eligible to receive cash payments upon the successful achievement of certain clinical development and regulatory approval milestones, as well as royalties upon commercialization of GDC-0449 worldwide.
GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate additional Phase II clinical trials, including in advanced ovarian cancer in the fourth quarter of 2008 and in advanced basal cell carcinoma in the first half of 2009.
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. In expanding its drug development efforts in the field of cancer through its proprietary targeted cancer programs, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. 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 Genentech’s plans to initiate additional Phase II clinical trials of GDC-0449, the expected benefits of Roche and Genentech’s abilities in the worldwide development of GDC-0449), and the Company’s expectations regarding the potential to receive future milestone and royalty payments under its collaboration with Genentech. The Company may use words such as “believes”, “expects”, “anticipates”, “plans”, “seeks”, “estimates”, “will”, “may” or similar expressions to identify these forward-looking statements. There are important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things, risks relating to: the potential for adverse results, delays and/or failures in the Company’s targeted cancer drug development program, including without limitation unplanned delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company’s collaboration with Genentech, including the risks that Genentech may experience adverse results, delays and/or failures in the Hedgehog pathway inhibitor program currently under clinical development, including with respect to GDC-0449, and that the Company may have no control over, or foreknowledge of, the progress of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaboration; the Company’s ability to obtain or maintain necessary intellectual property protection; adverse changes in the Company’s ability to successfully execute its business plan, including the Company’s ability to obtain the substantial additional funding required for such execution; unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have cash to fund its operations and which could also adversely affect the Company’s estimated operating expenses for 2008 and beyond; risks relating to the Company’s ability to enter into and maintain planned collaborations and maintain its current collaborations with Genentech; and competitive pressures. The Company also faces other risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 and other filings that it periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the Company’s views only as of today and should not be relied upon as representing the views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.
SOURCE: Curis, Inc. Curis, Inc. Michael P. Gray, 617-503-6632 Chief Financial Officer mgray@curis.com
