GDC-0449 was discovered by Genentech, under the ongoing collaboration agreement between Genentech and Curis, and was jointly validated through a series of preclinical studies. Through this partnership, the duo are responsible for the clinical development and commercialization of GDC-0449.
The company says that it is entitled to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, and also royalties accrued from commercialization of GDC-0449 by Genentech and its sublicensees.
Curis said that 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. The enrollment of these studies was completed in the second and fourth quarters of 2009, respectively.
Genentech has notified that it anticipates to communicate results from the colorectal cancer study in the second half of this year. The molecule is also being evaluated in a Phase II clinical trial in advanced basal cell carcinoma, or BCC, which started in February 2009.
Dan Passeri, president and CEO of Curis, said: “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.
“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.”
Michael Gray, CFO of Curis, said: “Of the three tumor 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.”