Optimer Seeks Quick Green Light From FDA for Antibiotic Against Deadly Bug

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the results with another 535-patient study that generated results in February. The most recent trial found that 91.7 percent of patients on the Optimer drug were considered clinically cured, compared with 90.6 percent on standard vancomycin. About 12.8 percent of patients on the Optimer drug had a recurrence, compared with 25.3 percent in the control group. The new drug was considered well-tolerated, Optimer has said.

What’s interesting about this drug scientifically is that it’s tailored to deal with one of the big public health problems in the U.S. today—antibiotic resistence. The Optimer drug is what’s known as a “narrow spectrum” antibiotic, meaning that it is specifically designed to kill C.diff bacteria, and not wipe out all kinds of other bacteria in the body. Many public health officials want physicians to have access to “broad spectrum” antibiotics that can kill nasty infections even when a doctor doesn’t have a diagnosis nailed down, but overuse of those potent weapons has contributed to the rise of multi-drug resistant bacteria that really freak out docs. So if a doctor really knows that he or she is dealing with a case of C.diff, then it would stand to reason that a “narrow spectrum” antibiotic like Optimer’s would be the best choice for limiting collateral damage.

The challenge at Optimer will be in raising awareness among physicians about its drug, and in encouraging them to adopt a new standard of care, Lichtinger says. The company is asking the FDA to clear its product to treat and prevent all cases of C.diff infection, and it will seek out specific language to show its advantages in preventing recurrences among the most vulnerable populations, Lichtinger says. Doctors currently think about which treatment to choose based on whether the infection is classified as mild, moderate, or severe. Optimer’s hope is to encourage doctors to think differently, and to prescribe based on a patient’s likelihood of suffering a costly and more difficult recurrence, he says.

Pricing will be a key factor in how well this drug gets adopted by the medical establishment. The current standard of care is metronidazole, a cheap generic. Optimer’s drug will certainly be priced much higher than that, and will be priced at a premium to the brand-name competitor from Viropharma, Lichtinger says. He wouldn’t be more specific on price, saying the company is still studying the market, although he said it will be priced in line with the value it delivers to the healthcare system.

Optimer doesn’t have a partner, and it plans to initially try to tackle this market alone, with its own U.S. sales force, Lichtinger says. It’s manageable for a small company, given that C.diff tends to be concentrated in hospitals, with about three-fourths of cases coming from about 1,000 hospitals and clinics, he says.

While Optimer hasn’t yet said what it plans to charge for fidaxomicin, analysts are already penciling out the market potential. Eun Yang, an analyst with Jefferies & Co, estimates the drug will cost $1,500 per treatment, which could create a U.S. market worth $410 million to $440 million a year. She projects about $150 million in U.S. sales of the new drug in 2015, according to note to clients published on Nov. 18.

“Given fidaxomicin’s superior efficacy (vs. Vancocin), we see low regulatory risks and our modest sales projections as achievable,” Yang wrote.

While there’s obviously a ton of work to do with the FDA, and insurers, Lichtinger was clearly in a pretty good mood when we spoke yesterday. He joined the company back in May, after a long career at Pfizer, where he ended up as president of the company’s primary care business. His experience is in commercialization, exactly the phase of the game that Optimer is just now about to enter.

“It’s a great moment for our company,” Lichtinger says.

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