Cambridge, Mass., and Lausanne Switzerland, August 6, 2009 (BUSINESS WIRE) — Curis, Inc. (NASDAQ: CRIS), a drug development company focused on developing proprietary targeted medicines for cancer treatment and Debiopharm Group (Debiopharm), a group of companies with a focus on the development of prescription drugs that target unmet medical needs today announced that they have entered into a worldwide, exclusive license agreement for Curis’ Heat Shock Protein (Hsp90) technology, including CUDC-305, the company’s lead Hsp90 inhibitor candidate.
Under the terms of the agreement, Debiopharm will assume all future development responsibility and incur all future costs related to the licensed Hsp90 technology, including CUDC-305. Curis currently expects that Debiopharm will file an application with health authorities to begin Phase I clinical testing for CUDC-305 in Fall 2009. Curis will receive an up-front license fee and, pending approval of such application, Curis will receive additional near-term payments. Curis is further eligible to receive additional contingent payments assuming the successful achievement of specified clinical development and regulatory approval objectives as well as royalties on product sales, if any, on any products that are successfully commercialised by Debiopharm or its sublicensees.
“We are very pleased to have entered into this license agreement with Debiopharm. We have been highly impressed with the depth of Debiopharm’s development expertise and commitment to working with our team to create an optimum clinical development plan for our novel drug candidate, CUDC-305, which we believe may offer future benefit to cancer patients. This transaction is particularly important to Curis because the agreement provides non-dilutive capital that we expect will allow us to continue to seek to internally develop CUDC-101, our first-in-class HDAC/EGFR/Her2 inhibitor that is currently enrolling patients in a Phase I dose escalation trial, as well as our other promising preclinical multi-targeted development programs. We believe that the up-front license fee and near-term contingent payments will extend our cash runway well into 2011.”
-Dan Passeri, Curis President and Chief Executive Officer.
“We expect additional data during the second half of 2010 from our collaborator Genentech’s ongoing Phase II clinical trials of GDC-0449, a Hedgehog Pathway Inhibitor, in advanced basal cell carcinoma, metastatic colorectal cancer and advanced ovarian cancer. Positive results with GDC-0449 in any of these indications have the potential to be a significant value-creating event for Curis stockholders and could provide future milestone payments to further extend our cash runway and fund our further investment in our multi-targeted inhibitor programs, including CUDC-101.”
-Michael Gray, Curis’ Chief Operating and Chief Financial Officer.
“Debiopharm Group is very excited about this new opportunity. Curis has established its excellence in this type of targeted therapy, which has the potential of being effective in several cancer indications, alone or in combination with other drugs. The professionalism of the entire Curis team has made us very confident that the partnership would soon prove successful for the two parties and open the door to an outstanding cooperation to bring new and effective therapies to patients. ”
– Rolland-Yves Mauvernay, President and Founder of Debiopharm Group.
About Debiopharm Group
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales in excess of $2.6 billion in 2008.
For more information on Debiopharm Group, please visit: www.debiopharm.com
About Curis, Inc.
Curis is a drug development company that is committed to leveraging its innovative signalling pathway drug technologies to seek to create new medicines for cancer indications. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signalling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis’ website at www.curis.com
Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation the Company’s statements regarding: the expected timing and amount of payments to be received by Curis under the license agreement with Debiopharm and the expected benefits of the agreement; Debiopharm’s plans to seek approval for the commencement of a phase I clinical trial in Fall 2009; the estimated period in which Curis will have cash to meet its operating requirements and its assumptions about factors that may positively affect such period; expectations regarding the potential benefits of CUDC- 305; its ability to further progress its programs under development; and the expected receipt of clinical trial data from Genentech in the second half of 2010 and the expected shareholder and corporate benefits of any advancement of clinical trials of GDC-0449;. Forward-looking statements used in this press release may contain the words “believes”, “expects”, “anticipates”, “plans”, “seeks”, “estimates”, “will”, “may” 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 the actual results to be materially different from those indicated by such forward-looking statements including, among other things:
- Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its phase I clinical trial of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
- Genentech and Debiopharm may experience adverse results, delays and/or failures in their strategic alliance transactions with Curis. For example, Genentech may not be able to replicate in later trials any favourable outcomes from earlier trials of GDC-0449, and Debiopharm may not be able to successfully advance CUDC-305 into clinical trials as planned.
- Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
- Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
- Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
- Curis may experience unplanned cash requirements, and may not received additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis’ estimated operating expenses for 2009 and beyond.
- Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech and Debiopharm, and the risk that any such collaborators will not perform adequately.
- Curis also faces other risk factors identified in its Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Report for the Quarter ended June 30, 2009 and other filings that it periodically makes with the Securities and Exchange Commission.
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis’ 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.