Advanced Life Sciences Applies for FDA Orphan Drug Designation for ALS-886 to Treat Acute Lung Injury
CHICAGO , Nov. 18, 2010 /PRNewswire/ — Advanced Life Sciences Holdings, Inc. (OTCBB: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has applied to the U.S. Food and Drug Administration for orphan drug designation for ALS-886, a novel therapy to reduce and prevent tissue damage, for the treatment of Acute Respiratory Distress Syndrome (ARDS).
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.