Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Roche has submitted a Marketing Authorization Application (MAA) for vismodegib (GDC-0449, RG3616) to the European Medicines Agency (EMA). The MAA is currently under review for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Vismodegib is a first-in-class, investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway and is being developed by Roche and Genentech, under a collaboration agreement between Curis and Genentech, a member of the Roche Group. Curis earned a $6 million milestone payment from Genentech as a result of the MAA submission to the EMA. If vismodegib receives Marketing Authorization by the EMA , Curis will also be entitled to receive an additional milestone payment as well as royalties on any future sales. "We continue to be extremely pleased with Roche and Genentech’s efforts in progressing vismodegib towards commercialization. Vismodegib is now under review for approval in both the United States and Europe, with an FDA PDUFA action date of March 8, 2012, in the U.S.," said Dan Passeri, Curis President and Chief Executive Officer. "Vismodegib represents a potential advance for patients suffering from this serious and debilitating form of BCC, for whom no current therapeutic alternatives are available. We continue to remain hopeful that this important treatment for advanced BCC will be approved in these territories." The application is based on clinical data from ERIVANCE BCC/SHH4476g, a pivotal Phase II study of vismodegib in patients with advanced BCC. The results were presented at the Seventh European Association of Dermato-Oncology (EADO) Congress in July 2011 as well as at the European Multidisciplinary Cancer Congress (EMCC) in September 2011. About Basal Cell Carcinoma BCC is the most common cancer in Europe and the United States. The disease is generally considered curable when the cancer is restricted to a small area of the skin. However, in a small group of people, if the disease is left untreated or does not respond to treatment, the cancer may advance further into the skin, bones or other tissues, or spread to other parts of the body. In such rare cases, the disease can become difficult to treat and life-threatening. There are no approved therapies to treat advanced basal cell carcinoma.
About Vismodegib and the Hedgehog PathwayVismodegib is designed to selectively inhibit signaling in the Hedgehog pathway by targeting a protein called Smoothened. The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults. However, mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer. Abnormal signaling in the Hedgehog pathway is implicated in the more than 90 percent of BCC cases. Genentech is also evaluating vismodegib in a Phase II trial in patients with operable forms of BCC, which opened for patient enrollment in October 2010. Furthermore, vismodegib is being evaluated by third-party investigators in a number of other cancers and in people with BCC who have Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing BCC. For more information, visit http://www.clinicaltrials.gov. About the Curis-Genentech Collaboration Under the ongoing collaboration agreement between Genentech, a wholly owned member of the Roche Group, and Curis, vismodegib (GDC-0449, RG3616) was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies. Pursuant to this collaboration, Genentech and Roche are responsible for global clinical development, and Genentech (U.S.), Roche (Ex-U.S. excluding Japan and Korea) and Chugai Pharmaceuticals (Japan and Korea) are responsible for commercialization of vismodegib. Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties assuming successful commercialization of vismodegib by Genentech and its sublicensees, which include Roche and Chugai. 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. Curis is building upon its previous experiences in targeting signaling pathways, including the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. 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 statements regarding: the expected timing for FDA’s review of the NDA for vismodegib; and the potential for vismodegib to have a clinical benefit in treating advanced BCC patients. 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 including, among other things:
- Although the FDA has indicated that it expects to complete its review of the NDA on or before March 8, 2012, the FDA may not complete its activities within this time frame.
- The EMA and/or FDA could impose additional unanticipated requirements, including additional clinical trials, to gain approval of vismodegib in advanced BCC, and any failure to satisfy the FDA's additional requirements could significantly delay, or preclude outright, approval of vismodegib.
- The EMA and/or FDA may not be satisfied with the results of anticipated pre-approval inspections of Genentech’s and Roche’s manufacturing facilities and the facilities of third party laboratories and manufacturers of active pharmaceutical ingredients (APIs) and other materials used in the manufacture of vismodegib, and, as a result, Genentech and Roche may be unable to gain approval of vismodegib, if at all, within the time frame indicated above.
- Genentech and Roche may not ultimately demonstrate to the satisfaction of the EMA and/or FDA the safety and efficacy profile of vismodegib in the treatment of advanced BCC, in which case vismodegib will not be approved for sales and marketing for the treatment of such indication.
- Even if vismodegib receives marketing authorization, the EMA and/or FDA may impose limitations on the approved indications for use or the conditions to approval, or impose requirements for post-marketing testing and surveillance to monitor the safety and efficacy of the product. Moreover, vismodegib’s benefit/risk profile may not be widely accepted by the medical community or third party payors for the treatment of advanced BCC.
- Curis also faces other important risks relating to the successful development and commercialization of vismodegib, and with respect to its business, operations, financial condition and future prospects generally, that are discussed in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 and other filings that it periodically makes with the Securities and Exchange Commission.