Curis to Co-Develop Cancer Drug with Genentech in the United States
Tuesday February 1, 8:31 am ET
Agreement provides for sharing of development costs and future profits on a potential therapeutic to treat basal cell carcinoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 1, 2005-- Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company, today announced that it has elected to exercise a co-development option with its collaborative partner, Genentech, Inc. (NYSE: DNA - News), and will now share in U.S. development costs and future net profits, if any, derived from sales in the U.S. of a therapeutic product candidate for the topical treatment of basal cell carcinoma. Basal cell carcinoma, a skin cancer, is the most common form of all human cancers with approximately 800,000 to 1,000,000 new cases every year in the U.S.
Daniel Passeri, Curis' President and Chief Executive Officer, commented, "Our election to exercise the co-development option represents another step forward in the implementation of our business model that specifies a diversified development approach for our broad product portfolio. We believe that co-development may provide a means of managing the risk of clinical development while at the same time allowing us to retain greater upside potential on certain promising programs. We have a high degree of confidence in our collaborative partner, Genentech, and in the science that underlies the basal cell carcinoma product candidate."
Curis plans to assist Genentech in filing an Investigational New Drug application with the Food and Drug Administration in order to initiate human clinical investigation of the basal cell carcinoma product candidate. In June 2003, Curis established a collaboration with Genentech for the continued development of a set of anti-cancer technologies based on inhibition of the Hedgehog signaling pathway, including small molecule Hedgehog pathway inhibitors. Under the terms of the collaboration, Curis retained a co-development option to share in development costs and future net profits, specifically for one of the small molecule Hedgehog pathway inhibitors. This co-development right applies solely to the U.S. marketplace and includes applications for basal cell carcinoma and any additional indications for which this product candidate may be developed.
Curis expects that by exercising this co-development and equal cost-sharing option it will incur approximately $20 million in development expenses through Phase II clinical trials, a portion of which will be booked in the first quarter of 2005. Assuming the acceptance of the Investigational New Drug application by the Food and Drug Administration and the successful advancement of the basal cell carcinoma product candidate through Phase I and Phase II clinical trials, the Company expects that the Phase II clinical trial will be completed in mid-2007. Curis expects to incur additional costs to complete Phase III clinical trials and complete the regulatory approval process, assuming that the parties successfully complete Phase II clinical trials. In exchange for this investment, Curis has increased its downstream revenue potential, through its right to a commensurate share in U.S. net profits, if any. In addition to the U.S. market, Curis will receive milestones if specific development objectives are achieved and a royalty on any international sales of the topical Hedgehog antagonist.
To date, preclinical evidence indicates that inhibition of the Hedgehog pathway in basal cell carcinoma results in the selective and specific death of the tumor cells while conferring no harm to adjacent normal cells. .. |
