>>WALTHAM, Mass.--(BUSINESS WIRE)--Jan. 20, 2006--Oscient Pharmaceuticals (Nasdaq: OSCI - News)
- Company to continue dialogue with FDA regarding the ABS claim -
- Management to host conference call today at 8:30 AM ET -
The U.S. Food and Drug Administration (FDA) has accepted for filing Oscient Pharmaceuticals' (Nasdaq: OSCI - News) supplemental New Drug Application (sNDA) seeking marketing approval for the use of FACTIVE® (gemifloxacin mesylate) tablets (320 mg once-daily) for the five-day treatment of mild to moderate community-acquired pneumonia (CAP). The FDA has refused to accept the sNDA filing for the five-day treatment of acute bacterial sinusitis (ABS).
The FDA has granted a standard ten-month review period for the five-day CAP sNDA and is expected to act on the filing by the end of September 2006. The acceptance of the CAP sNDA filing does not assure approval. FACTIVE is currently approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic bronchitis (AECB) and the seven-day treatment of mild to moderate CAP.
In its refusal to accept the sNDA filing for ABS, the FDA indicated that FACTIVE did not exhibit an acceptable risk versus benefit profile for the ABS indication. In addition, the FDA expressed the opinion that demonstrating an acceptable risk versus benefit profile for FACTIVE in ABS was not feasible, given the FDA's view of the potential risk of rash in those patients.
"We are pleased with the Agency's decision to file our sNDA for the five-day treatment of CAP, but disappointed by its decision not to file our sNDA for the five-day treatment of ABS," stated Steven Rauscher, President and CEO. "We have worked diligently with the FDA to compile an application that included supplemental clinical data and post-marketing safety reports, as well as a commitment to conduct additional post-approval surveillance, in order to assemble a submission that we believed would support approval of FACTIVE for ABS. We will continue to pursue short course indications and will discuss with the FDA potential paths that would allow us to file for the ABS indication."
Conference Call & Webcast Information
A conference call will be held today at 8:30 AM ET with Steven Rauscher, President and CEO, and other members of Oscient's management team. Participants can access the call by dialing 1-888-634-4009. International participants are asked to dial 1-706-634-2285. The call will also be available via webcast on the Company's website at www.oscient.com. A replay will be available two hours after the conclusion of the call until January 27, 2006. Domestic participants can access the replay by dialing 1-800-642-1687, while international participants are asked to dial 1-706-645-9291. The conference ID number for the replay is 4613389. A replay of the webcast will also be available on the Company's website.<<
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Bummer about the ABS no-go. That would have been good upside. Stock is down slightly pre-market.
Cheers, Tuck |
