FDA GRANTS ORPHAN DRUG STATUS TO ANTHRAX TREATMENT

Advanced Life Sciences has announced that the FDA granted orphan drug designation to cethromycin for the prophylactic treatment of exposure to inhalation anthrax.

The Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, according to the company. Orphan drug designation provides companies with financial and regulatory benefits such as eligibility for a special seven-year period of market exclusivity on approval, potential tax credits for research, potential grant funding for R&D, reduced filing fees and assistance with clinical trial protocol review.

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

Cethromycin is a second-generation ketolide antibiotic in development for the treatment of respiratory tract infections. Cethromycin has been tested in more than 4,400 human subjects and is currently in Phase III trials for the treatment of mild-to-moderate community acquired pneumonia. Cethromycin has also been demonstrated to have significant in vitro activity against more than 30 anthrax strains. It is currently being tested in primates to determine its potential efficacy for the prophylactic treatment of exposure to inhalation anthrax.