News Feature | April 29, 2014

Edmond Pharma's Bronchiectasis Drug Receives Orphan Status

By Estel Grace Masangkay

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Edmond Pharma announced that Erdosteine, its most recent molecule developed in the class of mucus active drugs, has received Orphan Drug Designation from the U.S. Food and Drug Administration Office of Orphan Products Development (OOPD) for the treatment of bronchiectasis.

The company said Erdosteine addresses a crucial unmet medical need in the U.S., especially considering there is currently no approved drug therapy for the treatment of bronchiectasis in the U.S. The drug also holds the potential to be a large financial contributor to Edmond Pharma.

Roberto Teruzzi, CEO of Edmond Pharma and Corvette Group S.p.A. (holding company of the group), said, “We are very excited to have achieved, together with our U.S. partner Alitair Pharmaceuticals, the orphan drug status for Erdosteine. The market potential of this new therapy in the United States is considerable, more than 1 billion dollars, and corresponds to a need of essential drug therapies, not completely satisfied. As a matter of fact there are no other drugs approved by the FDA for the treatment of bronchiectasis, a condition which has a heavy impact on the quality of life of the people affected.”

Bronchiectasis is a debilitating condition characterized by irreversible dilation of the bronchial tree where the lungs produce excessive amounts of mucus. This leads to obstruction of the airways resulting in bacteria proliferation and recurrent infections. Bronchiectasis also causes other serious health problems such as dyspnea and heart diseases.

Erdosteine is a thiol that was discovered Edmond Pharma’s Research and Development laboratories in Italy. Erdosteine is effective in the treatment of respiratory diseases such as Acute Bronchitis (AB), Chronic Bronchitis (CB), and Chronic Obstructive Pulmonary Disease (COPD) thanks to its muco-modulatory, anti-bacterial, anti-inflammatory and anti-oxidant activities. The drug is already marketed in more than 40 countries worldwide for the treatment of a range of respiratory diseases from acute bronchitis to COPD.