Welcome!

News Feed Item

Debiopharm Group™'s Innovative Antibiotic Debio 1450 - Developed From its Proprietary Platform Fabiotics - Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA

LAUSANNE, Switzerland, September 4, 2014 /PRNewswire/ --

Debiopharm Group(Debiopharm), a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, today announced that the US Food and Drug Administration (FDA) has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

QIDP designation will give Debio 1450 access to Priority Review, Fast Track and five additional years of market exclusivity in the United States. Fast Track status is intended to expedite drug development. Priority Review allows for an accelerated review of the marketing authorization, i.e. 6 months compared with the 10-month standard review.

These incentives were established as part of the GAIN Act - Generating Antibiotic Incentives Now -, passed by the US Congress in July 2012 to encourage pharmaceutical companies to develop new antimicrobials.

Debio 1450 (previously known as AFN-1720) is a highly potent oral/IV anti-infective agent that is specifically active against all Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA). Debio 1450 is currently in a dose-escalation Phase I study in healthy volunteers. It is one of the most advanced FabI inhibitors issued from the Debiopharm's antibiotic technology platform "Fabiotics". Debiopharm is very actively pursuing the development of new projects from this rich platform as seen in the recently launched Neisseria gonorrhoeae and enteric species programs.

"The threat of antibiotic resistance has become a reality", said Frederick Wittke, Medical Director Debiopharm International SA, "and there is a real need for targeted molecules that preserve indigenous gut microbiota and overcome resistance to broad-spectrum antibiotics". We are thrilled that the potential of Debio 1450 has been recognized with the FDA designation. It will clearly accelerate the development process and will give patients a quicker access to the drug" added Thierry Mauvernay, Delegate of the Board of Debiopharm Group. "We are very confident that our powerful platform Fabiotics will continue to provide highly valuable targeted anti-infectives in the future in order to alleviate problems of acquired resistance linked to broad-spectrum antibiotic usage".

About Debiopharm Group 

Debiopharm Group is a Swiss-based global biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses, develops and/or co-develops promising biological and small molecule drug candidates for global registration. The products are commercialized through
out-licensing to pharmaceutical partners to give access to the largest number of patients worldwide.

For more information about Debiopharm Group, please visit: http://www.debiopharm.com.

Debiopharm International SA Contact
Christelle Tur
Communication Coordinator
[email protected]
Tel: +41(0)21-321-01-11    

Additional Media Contacts

In London
Maitland
Brian Hudspith
[email protected]
Tel: +44(0)20-7379-5151

In New York
Russo Partners, LLC
Martina Schwarzkopf, Ph.D.
Account Executive
[email protected]
Tel: +1-212-845-4292

SOURCE Debiopharm Group

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
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, 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. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...