Advanced Life Sciences Holdings, Inc. Announces Cethromycin Granted FDA Orphan Drug Designation for Anthrax
Published: Mar 14, 2007
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.
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 http://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 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.
CONTACT: Investor Relations, Edward P. Flavin of Advanced Life SciencesHoldings, Inc., +1-630-754-4325
Web site: http://www.advancedlifesciences.com/