On the heels of a favorable FDA advisory panel vote on its experimental antibiotic, San Diego-based Optimer Pharmaceuticals (NASDAQ:OPTR) says today that Cubist Pharmaceuticals (NASDAQ:CBST) has agreed to help sell the drug in the U.S.
The deal calls for Lexington, MA-based Cubist to co-promote the Optimer antibiotic, fidxomicin (Dificid), for two years; the drug is under review at FDA as a potential treatment for C. difficile infections. Optimer, which is now in the process of building a sales force, has agreed to pay Cubist quarterly fees that amount to $15 million per year as well as $17.5 million in additional fees to Cubist if certain sale levels are reached during the term the deal, according to the companies.
For Cubist, this deal could give its existing U.S. sales force another product to market in addition to the company’s antibiotic daptomycin (Cubicin), which is approved for treating certain infections caused by such bugs as the notorious Methicillin-resistant Staphylococcus aureus (MRSA). Still, Optimer’s antibiotic has to pass muster with the FDA, which is expected to say by May 30 whether the drug can be marketed in the U.S. An FDA advisory panel unanimously endorsed the safety and effectiveness of the antibiotic yesterday, but the group voted 7-6 against Optimer on whether the drug reduces recurrence of “C. diff” infections. My colleague Luke Timmerman spoke to Optimer CEO Pedro Lichtinger after the FDA panel votes yesterday about the company’s plans to discuss how best to explain the benefits of the drug to doctors.
In today’s announcement about the Cubist deal, Lichtinger explained how the collaboration benefits his company as it prepares for the marketing of what could be its first approved product in the U.S.
“Cubist has a proven track record and well established relations with all stakeholders involved in the antibiotics space. We believe this collaboration will maximize the impact of and de-risk Dificid’s U.S. commercial launch, assuming approval,” said Lichtinger, in a statement. “We also believe this collaboration with Cubist will allow us to accelerate formulary adoption, expand our market reach and penetration to up to 2,000 hospitals, comprising over 90% of U.S. hospital [C. difficile infection] cases, and commit resources to long-term care facilities that comprise approximately one-third of all CDI cases. In addition, this provides the opportunity to capture the undiagnosed CDI market segment which some estimate to be as many as three million cases per year.”
Optimer says that there are an estimated 700,000 cases of “C. diff” infection in the U.S. annually. The bugs infect the inner lining of the colon and cause inflammation, diarrhea, and, in the worst of cases, death. Optimer’s drug has a novel mechanism to selectively kill “C. diff” and reduce impacts on healthy bacteria.
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