Turns out that Optimer Pharmaceuticals won’t have to spend the holiday weekend on pins and needles. The San Diego-based biotech company got its wish today, as the FDA approved Optimer’s first new product for sale in the U.S.
The FDA cleared fidaxomicin (Dificid) as a new treatment for C. difficile, a hardy bacterial infection that hangs out in the nooks and crannies of hospitals, and causes diarrhea so severe it can be fatal. Optimer’s drug is designed to specifically kill this bug, while sparing most of the healthy bacteria in the gut. Optimer showed in clinical trials that its treatment cures patients about 90 percent of the time, offering a slight advantage over standard vancomycin. The trials, which followed patients for 30 days, showed that about half as many patients on the Optimer drug had a recurrence, when compared with those who got vancomycin.
Hard data on how many people are affected by “C.diff” is hard to obtain, partly because it’s hard to diagnose, and partly because hospitals don’t really like to advertise the fact that so many people get these dangerous infections in their buildings. Health officials estimate “C.diff” kills between 15,000 and 30,000 people in the U.S. each year, many of them elderly. One analyst who follows Optimer, Eun Yang of Jefferies & Co., has estimated the product could generate $158 million in sales in 2015.
The FDA issued a just-the-facts press release on its approval, just before knocking off for the holiday weekend. You can read the full prescribing information, which describes how the Optimer drug is superior to vancomycin.
“In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, in a statement. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea.”
Optimer hasn’t yet issued its own statement, and investors will surely want to comb carefully through the detailed prescribing information approved by the FDA, which doctors and insurers will rely on for guidance on how to use the drug. Optimer has said it plans to discuss the price of the product with investors next week.
