Summary of ADVANCED LIFE SCIENCES HOLDINGS, INC.

Item 8.01 Other Events.

On July 31, 2009, Advanced Life Sciences announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Restanza™(cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). In its letter, the FDA indicated that they cannot approve the application for Restanza in its current form and that, to gain approval, additional clinical data is required to demonstrate efficacy. Advanced Life Sciences submitted the NDA in September 2008 based on the results of 53 clinical studies including pivotal Phase 3 studies in CAP and a safety database of over 5,000 patients.

On June 2, 2009, the FDA Anti-Infective Drugs Advisory Committee (AIDAC) reviewed the Restanza NDA. The AIDAC voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, but voted that Restanza did not demonstrate efficacy in the treatment of CAP. The AIDAC's negative vote on the drug candidate's efficacy followed a discussion that the Restanza NDA included data on patients with mild-to-moderate disease and that the new draft guidance for developing treatments for CAP, released by the FDA in March 2009, requires the enrollment of moderate-to-severe CAP patients for approval in the mild-to-moderate CAP indication. Advanced Life Sciences' pivotal Phase 3 program included in the NDA was designed and conducted under prior FDA guidance and before the new draft guidance was released.

Advanced Life Sciences intends to comply with the FDA's recommendations and continue to pursue approval of Restanza in CAP. The Company believes that an additional clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. Advanced Life Sciences is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information. The Company intends to meet with and work closely with the FDA to design and establish a protocol under a Special Protocol Assessment. Advanced Life Sciences is currently developing and evaluating the scope of the additional Phase 3 trial and, following input from the FDA, will be able to provide an estimate of the cost and timing of the additional Phase 3 trial.

A copy of the press release dated July 31, 2009 announcing the Company's receipt of a complete response letter from the FDA regarding its NDA for Restanza is attached hereto as Exhibit 99.1.