FDA Gives Thumbs-Up to Skin Cancer Drug from Genentech and Curis

1/30/12Follow @arleneweintraub

South San Francisco-based Genentech said today that a cancer drug it developed with Curis (NASDAQ: CRIS), which is based in Lexington, MA, was approved by the FDA to treat basal cell carcinoma, a common form of skin cancer. The drug, called vismodegib (Erivedge), will be prescribed to patients with carcinomas that have spread to other parts of the body or that have returned after surgery or prior treatment. “These are patients who until now had no effective treatments,” says Genentech’s Jennifer Low, global development leader for vismodegib. “We’re really excited to be giving them new hope.”

Investors who made early bets on Curis are cashing in today. Shares of the company, which had nearly doubled in the last six months in anticipation of the approval, fell nearly 5 percent in morning trading to $4.94. This is the first approved product for Curis, which was founded in 2000, and the FDA nod sparks a $10 million milestone payment under the company’s agreement with Genentech, a unit of Swiss pharmaceutical giant Roche. Curis will also receive royalties on sales of the drug, which is a once-daily pill.

Vismodegib is also the first product approved in an emerging class of molecules that inhibit a target with a funny name: the hedgehog signaling pathway. The pathway, named after a mutant fruit fly in which it was discovered, is a network of proteins that cells use to send signals to each other. About 10 years ago, Genentech teamed up with Curis to explore whether inhibiting the pathway might offer a new way of treating skin cancer. “This approval validates the role hedgehog inhibition plays in metastatic and locally advanced basal cell carcinoma,” Low says.

In a late-stage trial, vismodegib shrank cancerous lesions in 43 percent of patients with locally advanced basal cell carcinoma and in 30 percent of patients whose disease had spread beyond the skin. Genentech says the drug will be available in one to two weeks.

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