Alitair Pharmaceuticals and Edmond Pharma Announce Erdosteine® Licensing Agreement
Alitair to Seek U.S. Approval for Erdosteine, Already Approved in 43 Countries
MORRISTOWN, New Jersey and MILAN – September 25, 2013 – Alitair Pharmaceuticals, Inc., and Edmond Pharma S.r.l. today announced that they have entered into a definitive agreement for Alitair Pharmaceuticals to license Erdosteine, a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties, from Edmond Pharma for development as an orphan drug in the United States and Canada. Financial terms of
the agreement were not disclosed.
Alitair President and CEO William Howard said, "We are delighted to have licensed Erdosteine from Edmond Pharma. Erdosteine is currently approved in 30 countries for the treatment of chronic bronchitis and chronic obstructive pulmonary disorder, or COPD, and it is approved in 4 countries to treat bronchiectasis. We will seek an orphan drug designation for Erdosteine to treat bronchiectasis in the United States, which affects approximately 130,000 people."
"Erdosteine further strengthens our respiratory pipeline and is our second licensed orphan drug candidate," continued Howard. "Erdosteine is the perfect follow-on to our recently licensed next generation xanthine orphan drug candidate, ALT-07, as we believe Erdosteine can be used concomitantly with ALT-07 to treat both CF- and non-CF bronchiectasis."
Roberto Teruzzi, CEO of Edmond Pharma S.r.l. holding company, Corvette, and President and CEO of Edmond Pharma, stated, "We at Edmond Pharma are very excited to have licensed Erdosteine to Alitair. Erdosteine was discovered years ago in our R&D labs in Italy and is now successfully distributed in several markets. Erdosteine is a very safe and effective drug with a unique pharmacological profile. We are very confident that, thanks to the cooperation with our partner Alitair, Erdosteine will play an important role in treating bronchiectasis patients in the United States."
About Alitair Pharmaceuticals:
Alitair Pharmaceuticals, Inc., 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™), and other product candidates are available for out-licensing. Additional information about Alitair is available on the Alitair website at www.alitair.com.
About Edmond Pharma S.r.l.:
Edmond Pharma S.r.l. operates in three distinct business areas: active pharmaceutical ingredient (API) supply, finished products, and Erdosteine. The majority of Edmond’s API business is devoted to export. Edmond Pharma manufactures oral solid finished products which are sold worldwide, and the company discovered and developed Erdosteine as a new chemical entity (NCE). Today, Erdosteine is registered in 43 countries worldwide for the treatment of respiratory diseases, including COPD. Find out more at www.edmondpharma.com and www.erdosteine.net.
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., and Edmond Pharma S.r.l.
For more information, please contact Faith Pomeroy-Ward, Alitair Pharmaceuticals, 505-780-5472,
, or Pierfrancesco Manzo, Edmond Pharma S.r.l, +39 02.95.00.46.283,