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implications,” he says. In the end, he adds, focusing on cancer—where side effects can be tolerated because of the gravity of the disease itself—made much more sense for the cash-starved biotech.
Mutations in the hedgehog signaling pathway have been implicated in 90 percent of BCC cases. Vismodegib inhibits hedgehog by targeting a protein with a similarly cute name: smoothened. The whole business of snagging smoothened to antagonize hedgehog has proven so promising that Genentech is working with the National Cancer Institute to determine whether manipulating the pathway might work in other types of cancer. Because of Curis’ relationship with Genentech, any expansion of the market could ultimately benefit Curis in the form of milestones and royalties, Passeri says.
Although the financial details of the Genentech alliance have not been spelled out in detail, Passeri says the FDA filing on vismodegib will trigger a “significant” milestone payment, as will the approval and any subsequent regulatory filings overseas. Royalties will be in the “mid to high single digits,” he says. Shareholders are optimistic: Curis’ stock has risen from $1.21 a share to $3.56 in the past year.
Passeri says the Genentech partnership has been essential to Curis’ development. “It has provided us much-needed capital, but more importantly, it gave us access to Genentech’s internal competencies,” he says. Curis’ scientists meet with Genentech’s scientists on a quarterly basis, and they trade phone calls in between. During the clinical trials, he says, Curis benefited from Genentech’s expertise in determining the best methods for collecting data.
After Roche acquired Genentech in 2009, the R&D process improved even more, Passeri says. “With Roche, we see a further formalizing of the clinical development process,” he says. And the European drug giant has supported Genentech’s efforts to explore the potential for manipulating the hedgehog pathway to treat other cancers.
Curis is now looking beyond hedgehog to build out its oncology pipeline. The company is currently in the early stages of testing a combination drug that inhibits three well-known cancer targets: HDAC, EGFR, and Her2. “It’s a chemical scaffold designed to inhibit multiple targets, so you get a more durable response,” Passeri says. “Our rationale is that cancer should be treated like HIV—you should hit it with one drug.”
Curis has 40 employees in Lexington, and it outsources some of its basic science work to 30 chemists in China. The company, which brought in $16 million in revenues last year, has yet to turn a profit, but Passeri is confident the royalties and milestones from vismodegib will be a strong lifeline. “This represents a substantive de-risking of the business model,” he says. “It will be a non-dilutive revenue source that will allow Curis to continue to build out its model.”
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