Alitair Files Orphan Drug Designation to Treat Bronchiectasis with ALT-07
Orphan Drug Designation Could Provide Financial Incentives and Faster Regulatory Review
MORRISTOWN, New Jersey – May 7, 2013 – Alitair Pharmaceuticals, Inc. today announced that it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for ALT-07, an oral bronchodilator and anti-inflammatory compound, for use in the treatment of bronchiectasis, a respiratory disease that
is linked to progressive destruction of the lung and supportive tissues. Orphan drug designation is granted to treatments that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients per year. Orphan-designated drugs are eligible for incentives including a faster approval process and additional market exclusivity. Alitair holds the U.S. rights to ALT-07, which is approved in over ten countries outside the United States, for asthma and COPD treatment.
Alitair President and CEO William W. Howard said, "The availability of extensive human data with this compound should lead to a quick approval of an IND at FDA. Based on previous experience with compounds approved outside the United States, Alitair hopes to begin with a Phase II proof of concept study in Bronchiectasis after receiving the Orphan Designation."
"We believe that ALT-07 meets the criteria for orphan drug designation, in particular because there are no approved therapies specifically for bronchiectasis," Dr. Howard continued. "The wealth of data around ALT-07 also raises the credibility that ALT-07 is safe and will be effective for bronchiectasis."
About Alitair Pharmaceuticals:
Alitair Pharmaceuticals, Inc. is a clinical stage company that discovers, invents, and develops medicines for the treatment of respiratory illnesses. Alitair has out-licensed two prescription cough candidates that use its proprietary ion-exchange resin technology, REA™. Other product candidates are available for out-licensing. Additional information about Alitair is available on the Alitair website at www.alitair.com.
About Orphan Drug Status:
Orphan drug designations are granted by the FDA's Office of Orphan Products Development for treatments that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients per year. Receiving an orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.
Source: Alitair Pharmaceuticals, Inc.
Contact: Faith Pomeroy-Ward
Vice President, Corporate Development