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Advanced Life Sciences' Restanza Shows 100% Survival in Tularemia Pivotal Animal Study
Date:12/16/2009

e the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the "Animal Efficacy Rule" is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product's approval was based on efficacy studies conducted in animals alone.

The non-human primates used in the study referenced above were used to help understand tularemia disease mechanisms and to assess novel approaches for the prophylactic treatment of inhaled tularemia in lieu of human efficacy testing pursuant to FDA's "Animal Efficacy Rule" (21 C.F.R. Section 314.600-650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.

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. For more information, please visit us on the web at www.advancedlifesciences.com

Any statements contained in this presentation 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 th
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SOURCE Advanced Life Sciences Holdings, Inc.
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