Alitair Pharmaceuticals, Inc., today announced that the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA) has granted orphan drug designation for its drug candidate, Erdosteine®, for the treatment of bronchiectasis. Erdosteine is a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties.
Alitair President and CEO William Howard said, “We are excited to have been granted orphan drug status for Erdosteine, which is currently approved for the treatment of COPD and Chronic Bronchitis in 50 countries outside of the U.S. Because we currently have an open IND for Erdosteine for a different indication, we will be able to go directly into the clinic once we have a pre-IND meeting with FDA. This fast track to the clinic will save many years of development time and millions of dollars in development costs. The need for this new treatment is great, because there are currently no FDA-approved treatments for bronchiectasis. Based on our market research for Erdosteine, we believe the market potential for this treatment exceeds $1 billion.”
Orphan drug designation is granted by the FDA OOPD to drug therapies intended to treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides tax incentives to offset development costs, an exemption from FDA user fees, and the potential for a seven-year period of market exclusivity in the U.S. after product approval. Orphan drugs often command premium pricing and have smaller marketing costs than conventional drugs, making them attractive targets for development.