RestanzaTreatment for Pneumonia
Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)
CHICAGO, June 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. announced today that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).
"We believe in Restanza's potential and remain committed to its development. We were particularly encouraged by the supportive comments of several members of the committee relative to their positive review of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the company pursue further development," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "As we have throughout the review process we will continue to work closely with the FDA as they complete their assessment of the Restanza new drug application (NDA)."
Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP. The FDA has established a Prescription Drugs User Fee Act (PDUFA) date of July 31, 2009 for the Restanza NDA.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 8:30 a.m. Eastern Time on Wednesday, June 3, 2009 to discuss the outcome of the AIDAC Review.
The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 866.713.8567 (domestic) or 617.597.5326 (international). The passcode for the conference call is 15573457. A replay of the conference call will be available until July 10, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 27483036. Investors are advised to dial into the call at least ten minutes prior to the call to register.
Restanza is a novel, once-a-day, oral antibiotic that is under review for approval by the FDA for the treatment of CAP. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin-, macrolide-, and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CAP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.
About Community Acquired Pneumonia (CAP)
About Advanced Life Sciences
Posted: June 2009
- Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza (Cethromycin) in Community Acquired Pneumonia - August 6, 2009
- Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin) - May 29, 2009
- Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee - February 27, 2009
- Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia - December 3, 2008
- Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia - October 1, 2008
- Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin - April 10, 2008