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Advanced Life Sciences Announces Restanza(TM) Granted FDA Orphan Drug Designation for Plague and Tularemia
Date:9/15/2009

r the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.

"We believe that Restanza is a major advance in biodefense preparedness against lethal pathogens, given its novel mechanism of action, demonstrated broad spectrum of activity against multiple bioterror agents and favorable safety profile," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Pathogens such as anthrax, plague and tularemia represent extreme public health threats of potentially epidemic proportion as they are highly infectious and fatal diseases particularly if aerosolized, they can be deployed and spread quickly especially in densely populated areas. We look forward to continuing to work with the US government on the development of this promising new antibiotic and to meeting with the FDA to determine the regulatory pathway to approval for Restanza in the biodefense indications."

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.

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense. The FDA has designated Restanza as an orphan drug for the post-exposure pr
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SOURCE Advanced Life Sciences Holdings, Inc.
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