Oscient Pharmaceuticals Obtains Special Protocol Assessment from FDA for Ramoplanin; SPA details pivotal Phase III program of Ramoplanin for the treatment of CDAD
08:30 EST Wednesday, December 21, 2005
WALTHAM, Mass. (Business Wire) -- Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) and the U.S. Food and Drug Administration (FDA) have agreed to a Special Protocol Assessment (SPA) for the continued clinical development of Ramoplanin for the potential treatment of Clostridium difficile-associated disease (CDAD). By reaching consensus on the SPA, the Company has received guidance on the specific components of the Phase III program that, if completed successfully, would support regulatory approval for the indication.
"Securing agreement with the FDA on an SPA is an integral step in advancing our clinical development program for Ramoplanin," stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. "As the incidence and severity of CDAD cases has increased recently, the need for novel approaches for treating the condition has also risen. We hope to further demonstrate Ramoplanin's potential through this pivotal Phase III program."
According to the agreement reached with the FDA, Oscient will conduct two concurrent, pivotal Phase III trials. The two non-inferiority studies will enroll, in each trial, approximately 490 patients diagnosed with CDAD, from centers in the United States, Canada and other parts of the world. Each patient will be randomly assigned to one of two treatment arms, in a double-blind, placebo-controlled regimen: Ramoplanin 200 mg twice daily or vancomycin 125 mg four times daily for ten days. The primary endpoint will be the response rate at end of therapy.
"We will communicate details on the initiation and duration of the trials following additional discussions with Pfizer, our partner for Ramoplanin," Mr. Rauscher added.
About C. difficile-Associated Disease
C. difficile is a spore-forming bacterium known to cause diarrhea and colitis. In the past, C. difficile-associated disease has been mainly a concern in patients who have had recent antibiotic therapy and/or are hospitalized. In recent years, the incidence and severity of CDAD has increased and anecdotal cases are being reported where no antibiotic therapy or exposure to hospitals has occurred. Currently, it is estimated that 400,000-500,000 cases of CDAD occur each year in the U.S. The disease generates an estimated $1.1 billion in hospital health care costs annually in the U.S., and can prolong hospital stays by one to three days. Presently, vancomycin and metronidazole are used to treat CDAD, although only vancomycin is FDA-approved for such use. |
