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.