Welcome!

News Feed Item

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:

http://www.edmondpharma.com

http://www.erdosteine.net

For further information: 


Edmond Pharma S.r.l.
http://www.edmondpharma.it
http://www.erdosteine.net
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]


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Leading companies, from the Global Fortune 500 to the smallest companies, are adopting hybrid cloud as the path to business advantage. Hybrid cloud depends on cloud services and on-premises infrastructure working in unison. Successful implementations require new levels of data mobility, enabled by an automated and seamless flow across on-premises and cloud resources. In his general session at 21st Cloud Expo, Greg Tevis, an IBM Storage Software Technical Strategist and Customer Solution Architec...
The need for greater agility and scalability necessitated the digital transformation in the form of following equation: monolithic to microservices to serverless architecture (FaaS). To keep up with the cut-throat competition, the organisations need to update their technology stack to make software development their differentiating factor. Thus microservices architecture emerged as a potential method to provide development teams with greater flexibility and other advantages, such as the abili...
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...