to get either the low dose of the Trius drug, 200 milligrams, once a day for seven days, or a 600 milligram dose of the Pfizer drug twice a day for 10 days, the FDA approved dosage, Stein says.
A second trial is expected to be structured so that patients start on an intravenous form of the Trius drug, and then switch over to an oral pill. That’s an important protocol, Stein says. Some patients in the hospital need an intravenous form because they are already on an IV in the hospital for some other reason, or they have difficulty swallowing, yet insurers want to see patients switched to a lower-cost treatment alternative quickly, Stein says.
Since cash is an issue for every biotech company still in the product development phase, I asked Stein how his balance sheet is holding up. Fortunately for him, not bad. The company last raised venture capital—$30 million—in March 2008, from Kleiner Perkins Caufield and Byers, FinTech Global Capital, Sofinnova Ventures, Versant Ventures, InterWest Partners, and Prism VentureWorks. Then the company got a $28 million contract from the National Institutes of Health for a biodefense program in October. That’s certainly not enough to run the kind of ambitious clinical trial program Trius has mapped out, but it gives Stein enough options that no one partner can really back him into a corner to accept lousy deal terms.
“We have cash into next year,” Stein says. “If need be, we can initiate the trials on our own.”
