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Advanced Life Sciences Announces Third Quarter 2009 Financial Results
Date:11/10/2009

data in anthrax and plague and receiving orphan designation in tularemia and plague."

Dr. Flavin added: "As another indication of the government's interest in Restanza as a biodefense agent, the Company was invited to submit a full proposal in response to a Broad Agency Announcement (BAA) issued by the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services for the advanced development of Restanza as a broad spectrum countermeasure for biodefense. BARDA funding could significantly help to advance Restanza toward approval by the FDA as an important medical countermeasure, and toward consideration by the government for acquisition and stockpiling."

Operating Expense Analysis

  • Research and development expenses were $0.9 million for the three months ended September 30, 2009 compared to $11.2 million for the three months ended September 30, 2008. This difference was primarily due to the $10.0 million milestone expense incurred under our license agreement with Abbott in the third quarter of 2008.
  • Selling, general and administrative expenses totaled $2.2 million for the three months ended September 30, 2009 compared to $1.8 million for the same period in 2008.

Third Quarter Events

  • Reported results from a pivotal primate study in which Restanza demonstrated efficacy in treating anthrax infection;
  • Announced results showing Restanza's protective efficacy in a plague pivotal primate study;
  • Received FDA Orphan Drug Designation for Restanza in plague and tularemia;
  • Received complete response letter from FDA for Restanza in CAP.

Business Goals for 2009

  • Complete studies under the Department of Defense (DoD) contract and report data from pivotal primate study measuring Restanza's protective efficacy in tularemia;
  • Attend December 9th FDA Anti-Infective
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SOURCE Advanced Life Sciences Holdings, Inc.
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