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
"Codigm is based on the cloud and we are here to explore marketing opportunities in America. Our mission is to make an ecosystem of the SW environment that anyone can understand, learn, teach, and develop the SW on the cloud," explained Sung Tae Ryu, CEO of Codigm, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"We're developing a software that is based on the cloud environment and we are providing those services to corporations and the general public," explained Seungmin Kim, CEO/CTO of SM Systems Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"We're focused on how to get some of the attributes that you would expect from an Amazon, Azure, Google, and doing that on-prem. We believe today that you can actually get those types of things done with certain architectures available in the market today," explained Steve Conner, VP of Sales at Cloudistics, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, introduced two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a multip...
"CA has been doing a lot of things in the area of DevOps. Now we have a complete set of tool sets in order to enable customers to go all the way from planning to development to testing down to release into the operations," explained Aruna Ravichandran, Vice President of Global Marketing and Strategy at CA Technologies, in this SYS-CON.tv interview at DevOps Summit at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
"The reason Tier 1 companies are coming to us is we're able to narrow the gap where custom applications need to be built. They provide a lot of services, like IBM has Watson, and they provide a lot of hardware but how do you bring it all together? Bringing it all together they have to build custom applications and that's the niche that we are able to help them with," explained Peter Jung, Product Leader at Pulzze Systems Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2,...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, discussed how by using ne...
"We work around really protecting the confidentiality of information, and by doing so we've developed implementations of encryption through a patented process that is known as superencipherment," explained Richard Blech, CEO of Secure Channels Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.