CHICAGO, April 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that it held its Annual Meeting of Shareholders yesterday at its Woodridge headquarters.
At the meeting, the shareholders elected Drs. Terry W. Osborn, Israel Rubinstein and Theron E. Odlaug to the Company's Board of Directors each for a term of three years and ratified the appointment of Deloitte & Touche LLP as the Company's independent registered public accounting firm for fiscal year 2009. The shareholders also approved an amendment to the Company's articles of incorporation to increase the number of authorized shares from 65,000,000 to 125,000,000 including an increase in the number of authorized shares of common stock from 60,000,000 to 120,000,000.
In addition, the Company announced that the Anti-Infective Drugs Advisory Committee meeting has been confirmed for June 2, 2009, from 8 a.m. and 5 p.m. EDT. At the meeting, the Committee will discuss new drug application (NDA) 22-398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia (CAP). The meeting, which will be open to the public, will be held at the Hilton Washington DC/Silver Spring at 8727 Colesville Rd. in Silver Springs, MD.
"We are eagerly preparing for this upcoming Advisory Committee meeting and we are looking forward to the opportunity to present not only the clinical safety and efficacy of our drug, but also the medical need for a product like cethromycin," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences.
In November 2008, the FDA filed the Company's NDA for cethromycin and established a target Prescription Drug User Fee Act (PDUFA) action date for the cethromycin NDA of July 31, 2009. Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria, certain Gram-negative bacteria and atypical organisms associated with respiratory tract infections. In in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated as a broad spectrum biodefense countermeasure to combat agents of bioterror including anthrax, tularemia, plague and melioidosis. The FDA has designated cethromycin 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 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, respiratory diseases and biodefense. For more information, please visit us on the web at 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. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
|SOURCE Advanced Life Sciences Holdings, Inc.|
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