Advanced Life Sciences Announces Cethromycin Granted FDA Orphan Drug Designation For Anthrax

Advanced Life
Sciences Holdings, Inc. (Nasdaq: ADLS) today announced that the United
States Food and Drug Administration (FDA) has granted Orphan Drug
Designation to cethromycin for the prophylactic treatment of patients
exposed to inhalation anthrax.


The FDA's U.S. Orphan Drug Act is intended to assist and encourage
companies to develop safe and effective therapies for the treatment of rare
diseases and disorders. Orphan Drug designation is awarded to compounds
that offer potential therapeutic value in the treatment of rare diseases,
defined as those affecting fewer than 200,000 Americans. This designation
provides companies with financial and regulatory benefits such as
eligibility for a special seven-year period of market exclusivity upon
approval for the compound and indication with orphan designation, potential
tax credits for research, potential grant funding for research and
development, reduced filing fees for marketing applications, and assistance
with clinical trial protocol review.



Michael T. Flavin, Ph.D., chairman and chief executive officer of
Advanced Life Sciences, commented on the notice of designation saying that
"We are very pleased to receive this Orphan Drug designation and we believe
that it represents the achievement of another important milestone in the
development of cethromycin. This designation will benefit us as we continue
to build the cethromycin safety and efficacy database and will ultimately
help position cethromycin as a potentially important antibiotic for the
U.S. Government's Strategic National Stockpile."



Advanced Life Sciences has established collaborations with U.S. Army
Medical Research Institute of Infectious Diseases (USAMRIID) and the NIH's
National Institute of Allergy and Infectious Disease (NIAID) for the
research and development of cethromycin against anthrax and other
biowarfare agents.



About Cethromycin



Advanced Life Sciences' most advanced product candidate, cethromycin,
is a second generation ketolide antibiotic in Phase III clinical
development for the treatment of respiratory tract infections. Cethromycin
has been tested in over 4,400 human subjects and is currently in Pivotal
Phase III trials for the treatment of mild-to-moderate community acquired
pneumonia (CAP). Cethromycin has also been demonstrated to have significant
in vitro activity against over 30 anthrax (Bacillus anthracis) strains. It
is currently being tested in non- human primates to determine its potential
efficacy for the prophylactic treatment of patients exposed to inhalation
anthrax.



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 inflammation. Visit us on the
web at advancedlifesciences.



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 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.


Advanced Life Sciences Holdings, Inc.

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