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Erdosteine Received Orphan Drug Status by the FDA

MILAN, April 28, 2014 /PRNewswire/ --

Edmond Pharma is now looking for licensing partnership in Europe 

The Food and Drug Administration (FDA) has recently granted the Orphan Drug Status to Erdosteine​​, molecule discovered and developed by the R&D division of the Italian pharmaceutical company Edmond Pharma. The Orphan drug status refers to the new indication for the treatment of bronchiectasis, a rare disease for which no drug therapies are currently approved in the U.S. 

The molecule answers to an important unmet therapeutic need and it could reach remarkable performances. Indeed the potential for this treatment in the U.S. exceed 1 billion dollars. 

Today Erdosteine is marketed in over 40 countries worldwide for the treatment of various respiratory diseases, ranging from acute bronchitis to COPD. With a strong presence in Asia, Latin America and Estern Europe, today Edmond Pharma is looking for commercial licensing partnership in order to expand its presence in Europe.  

Milan, xxApril 2014 - Erdosteine, the most recent molecule developed in the class of mucus active drugs, discovered and developed by Edmond Pharma's research laboratories, has received the Orphan Drug Designation for the treatment of bronchiectasis by the FDA Office of Orphan Products Development (OOPD). The American regulatory Agency grants this status to drugs that can treat diseases affecting fewer than 200.000 patients in United States.

Already marketed in over 40 countries worldwide, for the treatment of acute and chronic bronchitis together with COPD, Erdosteine has started its registration process in U.S.

Considering the promising results for this new indication, Edmond Pharma is investing on further developments of the molecule and aims to build new partnership in Germany and France.

"We are very excited to have achieved, together with our U.S. partner Alitair Pharmaceuticals, the orphan drug status for Erdosteine​​®" says Roberto Teruzzi, CEO of Edmond Pharma and Corvette Group S.p.A. (holding company of the group). "This result represents a key milestone in our worldwide expansion. With our partners we extensively cover Asia, Middle East, Latin America and Eastern Europe and we are interested in newstrategicalliances for GermanyandFrance. 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".

Erdosteine​​ is now being used in studies targeted on bronchiectasis, conducted in the United States as part of the clinical development plan aimed to obtain the final marketing authorization of the product as orphan drug.

About Bronchiectasis 

Bronchiectasis is a condition characterized by irreversible dilation of the bronchial tree where the lungs produce an excessive quantity of mucus, which causes an obstruction of the airways resulting in proliferation of bacteria and recurrent infections. Impairing the airways' ability to move air in and out of the lungs, the disease can cause other serious health problems, such as dyspnea, atelectasis, and heart diseases, resulting in some cases even fatal. Today there are no therapies approved by the Food and Drug Administration to treat bronchiectasis.

About Erdosteine 

Erdosteine is a thiol, discovered in Italy in the Research and Development laboratories of Edmond Pharma, which, thanks to its muco-modulatory, anti-bacterial, anti-inflammatory and anti-oxidant activities, is particularly effective in the treatment of respiratory diseases, such as Acute Bronchitis (AB), Chronic Bronchitis (CB) and Chronic Obstructive Pulmonary Disease (COPD). It modulates mucus production and viscosity and increases the motility of the mucociliary transport, improving expectoration. Its clinical efficacy, combined with an excellent safety profile, is proved by more than 3.000 patients treated in 60 clinical trials and by over ten year experience in clinical practice worldwide. Several studies on CB and COPD are currently ongoing in Europe, involving approximately 600 patients from 10 different countries.  

About Edmond Pharma Srl 

Edmond Pharma operates in three main business areas: production of active ingredients (APIs), finished pharmaceutical products and Erdosteine. Most of the APIs production is for export. Thanks to Erdosteine, Edmond Pharma is strongly involved in research and development in the respiratory field, it enters targeted partnership with leading pharmaceutical companies operating in this therapeutic area.

The company is controlled by Corvette Pharmaceutical Services Group SpA, parent company which provides high added value services to the pharmaceutical industry.

Additional information is available on the websites:



For further information: 

Edmond Pharma S.r.l.
Contact: Pierfrancesco Manzo
Erdosteine Sales and Business Development Director
+39-(0)2-95-00-46-283 | [email protected]

Press office

Contact: Marco Giorgetti, Antonella Martucci,
+39-(0)2-20-24-13-57 | [email protected]; [email protected]

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