San Diego-based Optimer Pharmaceuticals has spent more than $200 million and a dozen years of effort to get to the point where it can ask the FDA to clear its first product for sale on the U.S. market. And that’s the position Optimer finds itself in now.
Optimer (NASDAQ: OPTR) is announcing today that it has completed its new drug application filed with the FDA, which asks regulators to approve fidaxomicin as a new treatment for a dangerous bacterial infection known as Clostridium difficile, or “C.diff” for short. This particularly nasty bug causes awful diarrhea, the kind that can lead to severe dehydration, inflammation of the colon, hospitalization, and even death. The company is seeking a faster-than-usual six-month regulatory review, instead of the usual 10-month period, which the FDA sometimes provides for potentially lifesaving new therapies.
If the FDA clears this new therapy for sale, it would become Optimer’s first marketed product and the first new therapy for this dangerous hospital-based infection in about 25 years. C.diff, a hardy bug that lurks in hard-to-reach surfaces at hospitals and nursing homes, is estimated to kill between 15,000 and 30,000 people in the U.S. each year, many of them elderly. The disease, which is hard to diagnose properly, is currently treated with a common generic drug called metronidazole or an oral form of vancomycin (Vancocin) from Exton, PA-based Viropharma (NASDAQ: VPHM). Optimer’s application to the FDA is based on clinical trials that show it is about equal to vancomycin at killing the bug initially, but that its real advantage is in reducing the rate of recurrences, particularly in vulnerable subpopulations like the elderly, those taking other antibiotics, and in patients with weakened immune systems.
“When I was getting started at Pfizer, all the managers who joined when they were younger had a dream to bring to the market highly effective products that will benefit patients. That dream has stayed with me,” says Pedro Lichtinger, Optimer’s CEO. “When I retired from Pfizer, what I saw in Optimer was an opportunity to make a major advancement in medicine, that was at the same time cost-effective and would do a lot of good for thousands of patients.”
Partly because this disease doesn’t generate many scary headlines, Optimer tends to keep a pretty low profile. But the data to support its application looks like a pretty solid bet. It reached its primary goal in a pivotal clinical trial of about 600 patients in November 2008, and then confirmed … Next Page »