Of all the people I met last month on a whirlwind of meetings with San Diego biotech companies, none had more bounce in their step than the folks at Optimer Pharmaceuticals. This company passed a huge test last month that suggests it has created the first new drug in decades for a bacterial invader called Clostridium difficile, or C. Diff, which causes horrific, often fatal diarrhea.
Optimer (NASDAQ: OPTR) reached its goal in a trial of 600 patients, showing its drug was about equal to the standard antibiotic, vancomycin, at eradicating the infection, and was much better at preventing relapses. This caused its stock to double in a heartbeat. Of course, one trial of 600 patients is only part of the battle toward getting FDA approval to market the product. I got a rundown of what’s to come from Kevin Poulos, the company’s chief commercial officer, and Pamela Sears, the senior director of biology.
Before I even stirred the sugar into my coffee, Sears was bursting with enthusiasm about feedback she’s getting from doctors about the trial. “Everyone is really excited. They think it’s got potential to be a real breakthrough for the disease,” she says.
Much ink has been spilled about the emerging threat from MRSA bacterial infections in hospitals and nursing homes, but not so much about C.Diff. Data on this bug is hard to come by, likely because hospitals are reluctant to admit guilt. About 30 to 40 cases were reported per 100,000 people discharged from hospitals in 2001, and that figure tripled to about 100 cases per 100,000 discharges in 2005, according to data from the Centers for Disease Control and Prevention. The sales potential for a drug that fights C. Diff could be about $178 million in 2013, its third year on the market, according to Thomas Russo, an analyst with Robert W. Baird in Chicago.
Optimer’s findings still have to be published in more detail in a scientific paper, and physicians are surely going to comb through the company’s data carefully to see whether the drug is working across all subpopulations of patients, and against different strains of C. Diff, Sears said. The company also has to repeat the finding in one more identically-designed clinical trial of 600 patients that’s expected to produce results later in 2009. If Optimer gets positive results on that trial, it should have the data it needs to take an application to the FDA to market its first product.
This gives Optimer some time to lay the groundwork for how to make this drug into a commercial success, Poulos says. “Now the fun begins,” he says. … Next Page »
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