Both companies will now share US development costs and future net profits, if any, derived from sales in the US of a resultant therapeutic product candidate for the topical treatment of basal cell carcinoma, the most common form of all human cancers.
Curis plans to assist Genentech in filing an investigational new drug application (IND) with the FDA in order to initiate human clinical investigation of the product candidate.
In June 2003, Curis established a collaboration with Genentech for the continued development of a set of anticancer 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 US 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 IND by the FDA and the successful advancement of the 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.
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.