CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc., announced today that its licensee Debiopharm S.A. (“Debiopharm”) has received approval from France’s regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.
“We believe that Debio 0932 may have broad potential in a number of cancer indications based on its multiple mechanisms of action and client proteins, and its remarkable pharmacological properties, and we are pleased that the second compound generated from Curis’ proprietary targeted cancer platform has advanced into the clinic,” said Dan Passeri, Curis’ President and Chief Executive. “The acceptance by the French regulatory authorities of Debiopharm’s CTA package is an important milestone in the development of this innovative cancer treatment and a testimony to Debiopharm’s regulatory expertise and commitment to Debio 0932.”
“We are excited that Debio 0932 has reached this important milestone and that the clinical studies will start. Debiopharm is committed to the development of this compound and we believe that Debio 0932 can address a major unmet medical need and become an important tool available for the treatment of cancer,” said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group™.
Debiopharm plans to open a Phase I clinical trial evaluating the safety of Debio 0932 during the first quarter of 2010. The study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of multiple doses of Debio 0932 in patients suffering from advanced solid tumors or lymphoma.
Based on Curis’ research to date, the company believes that Debio 0932 may provide key benefits over Hsp90 inhibitors currently in clinical testing. Curis has evaluated the potency, safety, efficacy and pharmacological properties of Debio 0932 in multiple animal models, where it exhibits high oral bioavailability and selective retention in tumors, crosses the blood brain barrier and displays potent antitumor activity in several animal models when given alone or in combination with standard-of-care agents, while robustly inhibiting multiple signaling pathways, including PI3K/AKT and RAF/MEK/ERK.
“The $8 million milestone payment provides us with significant additional non-dilutive capital to continue our development of our first-in-class, network-targeted EGFR, Her2 and HDAC inhibitor CUDC-101 and other preclinical network-targeted agents, including an HDAC and Pi3K inhibitor, which we expect to advance as a development candidate in 2010,” said Mike Gray, Curis’ Chief Financial Officer. “Curis currently has adequate cash to fund its operations well into the first half of 2012, not including any additional potential future milestone payments from our collaborations with Genentech and Debiopharm.”
About the 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. The group in-licenses and co-develops promising biological and small molecule drug candidates having reached clinical development phases I, II or III. It develops its products for global registration and maximum commercial potential. 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 five 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 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 the Company’s statements regarding: its belief that it will receive the $8 million payment that Debiopharm is contractually obligated to pay for the achievement of this development objective, its belief that Debio 0932 may have broad potential in a number of cancer indications as well as provide key benefits when compared to existing Hsp90 inhibitors that are currently in development. 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 respective development programs under collaboration with Curis. For example, Genentech may not be able to replicate in later trials any favorable outcomes from earlier trials of GDC-0449, and Debiopharm may not be able to successfully advance Debio 0932 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 September 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.
Contact:
Curis, Inc. Michael P. Gray, 617-503-6632 Chief Financial and Chief Operating Officer mgray@curis.com
