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.
Earlier in his career, Poulos led commercialization efforts for other novel antibiotics, like Pfizer’s linezolid (Zyvox), among others. He says the experience has taught him to think about getting the word out at conferences of infectious disease specialists, and gastroenterologists. The company is thinking about forming a partnership with a pharmaceutical company that can help it commercialize the drug overseas. It also has to think about price, and how to respond to people who might balk at paying more than they would for a generic option. Then there’s the art of picking a catchy name for a compound tentatively slugged with the boring code name of OPT-80.
The competition, as Poulos sees it, is mostly from metranidozole, a generic drug that costs about $5 a day, but isn’t well-tolerated by patients and leads to a high risk of recurrence. Another option is a brand-name oral vancomycin marketed by Exton, PA-based Viropharma (NASDAQ: VPHM) as Vancocin, which costs about $800 for a 10-day course of treatment. Companies usually don’t set the price of their product until right before it’s being introduced, but Poulos says “we’ll price ours closer to vancomycin.”
There is a looming threat that a generic version of vancomycin will enter the market, but the current branded version has low sales volume, and generic companies make their money on high-volume products like cholesterol-lowering meds, Poulos says. He is anticipating a generic will come along, and his counterattack will be something along these lines: Optimer’s drug already beat vancomycin on effectiveness in a head-to-head clinical trial.
Right now, Poulos says he envisions building a sales force of about 100 reps to pitch the product to hospitals with the highest rates of C. Diff infections. The model for how to do this in a low-cost fashion is Lexington, MA-based Cubist Pharmaceuticals, which generates $400 million a year in sales from its daptomycin (Cubicin) antibiotic with a sales force of about 175, Poulos says.
I had to ask about large-scale manufacturing too, because this is often a bugaboo that biotech companies don’t spend much time thinking about. Optimer get this work done by an outside contractor in India, which performs a fermentation process in bacteria. It’s an efficient, low-cost method that’s similar to how vancomycin is made, Sears says.
I get the impression that pricing, and persuading hospitals to shell out bigger bucks for this drug, is the point that worries Optimer the most. The company is planning to do health economics studies that will try to cushion the sticker shock, by explaining that hospitals will save a bundle over the long term with lower costs from complications with the other drugs and hospitalization.
Poulos also acknowledges there’s going to be a challenge in being a little company, with no track record selling to hospitals, suddenly trying to drum up demand to treat a disease that hasn’t gotten attention from big marketing machines like Pfizer and Merck. The diagnostic tests for C. Diff also have a tendency to turn up “false negatives,” meaning they overlook it, Sears says. “It’s undertreated, underdiagnosed, and underreported,” Poulos says.
It sounds like Optimer team has its work cut out over the next couple years. If they’re successful, they will have raised awareness of C. Diff is a serious problem and that something can be done about it.
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