RestanzaTreatment for Pneumonia
Plans for NDA Submission for Cethromycin
Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin
CHICAGO, April 10, 2008 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for its novel once-a-day oral antibiotic, cethromycin, to treat mild-to-moderate community acquired pneumonia (CAP).
"We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal," said Dr. Michael T. Flavin, chief executive officer of Advanced Life Sciences. "In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner."
During the meeting, FDA officials agreed that the Company could submit the NDA for cethromycin to treat mild-to-moderate CAP based on the pivotal Phase 3 trial results previously reported. The FDA will review any submission the Company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.
Conference Call Details
The Company will host a conference call and live webcast today, Thursday, April 10, 2008, at 8:30 am (EDT). The focus of the call will be to discuss the planned NDA submission for the Company's novel once-a-day oral antibiotic, cethromycin, as a treatment for mild-to-moderate CAP.
The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website http://www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888-680-0894(domestic) or 617-213-4860(international). The passcode for the conference call is 31431743. A replay of the conference call will be available until April 17, 2008. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 33735345. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=PXKLGN4DD . Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at http://www.advancedlifesciences.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
CONTACT: Joe Camp of Advanced Life Sciences Holdings, Inc.,+1-630-754-4352, ; or Media, Melanie Nimrodi,+1-312-546-3508, , or Investors, Kathy Price,+1-213-486-6547, , both of Financial Relations Board, forAdvanced Life Sciences Holdings, Inc. firstname.lastname@example.org email@example.com firstname.lastname@example.org
Web site: http://www.advancedlifesciences.com/
Ticker Symbol: (NASDAQ-NMS:ADLS)
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Posted: April 2008
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- 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