FDA News

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

(March 14, 2007)--Advanced Life Sciences Holdings 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."

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