Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking sales and marketing approval for vismodegib (GDC-0449, RG3616) to treat people with advanced basal cell carcinoma (BCC), which includes metastatic and locally advanced BCC for whom surgery is inappropriate.

Vismodegib is a first-in-class investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90 percent of BCC cases. Curis is eligible to receive an $8 million milestone payment from Genentech upon FDA acceptance of this submission. If the drug receives FDA approval, then Curis will also be entitled to receive an additional milestone payment as well as royalties on any future sales.

"We continue to be impressed by Genentech's development efforts with respect to this molecule and are pleased that, following its successful completion of a pivotal study in advanced BCC, the vismodegib program has advanced to a U.S. NDA submission," said Dan Passeri, Curis President and Chief Executive Officer. "We believe that vismodegib is an excellent example of a targeted cancer drug that has been developed based on an understanding of the underlying molecular biology that drives the disease. We believe that this molecule has the potential to provide an important treatment option for patients with advanced BCC."

Curis expects that the FDA will notify Genentech whether its NDA submission has been accepted for filing within 60 days of submission. Assuming the FDA accepts the NDA submission, the agency will communicate a PDUFA date to Genentech.

Roche has also indicated that the timing of a European regulatory submission is subject to its ongoing discussions with the European Medicines Agency (EMA). Curis is entitled to receive an additional milestone payment should such submission be made by Roche and subsequently accepted by EMA, as well a milestone payment and royalties on future sales should vismodegib be approved by EMA.