Curis, Inc, a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, announced that Chugai Pharmaceutical Co, Ltd has exercised its right of first refusal for the development and commercialization in Japan of GDC-0449, a Hedgehog pathway inhibitor, under an existing agreement with F. Hoffmann-La Roche, Ltd. GDC-0449 is being developed by Genentech, Inc., a wholly owned member of the Roche Group, under the 2003 collaboration agreement between Genentech and Curis.

"We are pleased that Chugai will lead the development and commercialization efforts for GDC-0449 in the Japan market. We believe that the combined development efforts of Genentech, Roche and Chugai will provide significant opportunities for the development of GDC-0449 in the majority of the significant global pharmaceutical markets," said Curis president and CEO Dan Passeri. "We continue to be extremely impressed with Genentech's progress in advancing GDC-0449 and we believe that Chugai's development and marketing expertise in Japan will further enhance Genentech's and Roche's ongoing development efforts of this first-in-class molecule."

GDC-0449 is currently being tested outside of Japan in phase-II clinical trials in first-line metastatic colorectal cancer and in advanced ovarian cancer. These studies completed enrolment in the second quarter of 2009 and the fourth quarter of 2009, respectively, and Genentech has indicated that it expects to report results from the colorectal cancer study in the second half of 2010. The molecule is also being evaluated in a pivotal phase-II clinical trial in advanced basal cell carcinoma, or BCC, which began in February 2009.

"Of the three tumour types being investigated in the ongoing GDC-0449 phase-II clinical studies, we believe that colorectal cancer and ovarian cancer have the potential to offer significant opportunities in Japan," said Michael Gray, Curis chief financial officer. "For example, it is estimated that there will be approximately 62,000 new cases of colorectal cancer and 6,000 newly diagnosed ovarian cancer patients in Japan in 2010."

Under the ongoing collaboration agreement between Genentech, a wholly owned member of the Roche Group, and Curis, GDC-0449 was discovered by Genentech and was jointly validated through a series of preclinical studies.

Curis is a drug development company that is committed to leveraging its innovative signalling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer.