Welcome!

Microsoft Cloud Authors: David Bermingham, Dana Gardner, Yung Chou, Jayaram Krishnaswamy, Pat Romanski

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.

@ThingsExpo Stories
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Silver Spring Networks, Inc. (NYSE: SSNI) extended its Internet of Things technology platform with performance enhancements to Gen5 – its fifth generation critical infrastructure networking platform. Already delivering nearly 23 million devices on five continents as one of the leading networking providers in the market, Silver Spring announced it is doubling the maximum speed of its Gen5 network to up to 2.4 Mbps, increasing computational performance by 10x, supporting simultaneous mesh communic...
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
The Quantified Economy represents the total global addressable market (TAM) for IoT that, according to a recent IDC report, will grow to an unprecedented $1.3 trillion by 2019. With this the third wave of the Internet-global proliferation of connected devices, appliances and sensors is poised to take off in 2016. In his session at @ThingsExpo, David McLauchlan, CEO and co-founder of Buddy Platform, will discuss how the ability to access and analyze the massive volume of streaming data from mil...
WebSocket is effectively a persistent and fat pipe that is compatible with a standard web infrastructure; a "TCP for the Web." If you think of WebSocket in this light, there are other more hugely interesting applications of WebSocket than just simply sending data to a browser. In his session at 18th Cloud Expo, Frank Greco, Director of Technology for Kaazing Corporation, will compare other modern web connectivity methods such as HTTP/2, HTTP Streaming, Server-Sent Events and new W3C event APIs ...
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...