Alitair Receives Orphan Drug Designation for Erdosteine® in Bronchiectasis
Alitair to Seek U.S. Approval for Erdosteine, Already Approved in 50 Countries
January 07, 2014 06:11 AM Eastern Standard Time
MORRISTOWN, N.J.--(BUSINESS WIRE)--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.
Bronchiectasis is a condition in which the lungs produce excessive amounts of mucus. Cystic fibrosis is the best known disease that causes bronchiectasis. In bronchiectasis, the mucus builds up in the airways, allowing bacteria to grow, which leads to recurring infections. Each infection causes more damage to the airways, impairing the airways' ability to move air in and out of the lungs. Bronchiectasis can lead to serious health problems including respiratory failure, atelectasis, heart failure, and death.
Erdosteine is a thiol derivative developed for the treatment of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis, bronchiectasis, and other respiratory diseases. Erdosteine modulates mucus production and viscosity and increases mucociliary transport, thereby improving expectoration. It also exhibits inhibitory activity against the effects of free radicals. Clinical studies in patients with chronic obstructive lung disease have demonstrated the efficacy and tolerability of Erdosteine. Erdosteine is associated with a low incidence of adverse events, most of which are gastrointestinal and generally mild.
About Alitair Pharmaceuticals:
Alitair Pharmaceuticals, Inc., develops medicines for the treatment of respiratory illnesses. Alitair has exclusively licensed the rights to market Erdosteine in the U.S. from Edmond Pharma Srl. For more information about Alitair, visit the Alitair website at www.alitair.com.
Alitair Pharmaceuticals, Inc.
Faith Pomeroy-Ward, 505-780-5472
VP, Corporate Development