Click here to close now.

Welcome!

News Feed Item

AAA Receives Orphan Drug Designation from FDA and EMA for Gallium-68 DOTATATE for Use in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors

SAINT-GENIS-POUILLY, France, March 4, 2014 /PRNewswire/ --

Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announced today that they have received orphan drug designation status for their radiopharmaceutical, Gallium-68 DOTATATE. The orphan drug designation has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use of Gallium-68 DOTATATE as a diagnostic agent for the management of Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs). The designation should foster rapid development of the agent for the benefit of GEP-NET patients in the U.S. and Europe.

Gallium-68 DOTATATE is a radiopharmaceutical used in PET/CT imaging of GEP-NETs. The product will be prepared using AAA's patented kit, which is reconstituted in hospital radiopharmacies without the use of a radiochemistry module, thus making the product available to all hospitals, even those who do not have a fully equipped GMP production radiopharmacy unit.

Existing data show that the Gallium-68-labeled PET radiopharmaceutical should represent a major improvement compared to the current standard. Available data indicates that Gallium-68 DOTATATE not only has greater sensitivity and specificity for tumor detection than the current standard, but it is also expected to significantly reduce radiation doses received by patients.

Stefano Buono, Chief Executive Officer of AAA, commented: "GEP-NETs constitute a life-threatening disease and effective patient management requires accurate diagnostic tools. The orphan drug designation of AAA's Gallium-68 DOTATATE will accelerate the development of this agent and hopefully allow it to be available to patients in the next few years."

"Receiving orphan drug designation for Gallium-68 DOTATATE is an important step in the overall approval process. It reinforces our position and interest in NETs, both on the diagnostic and treatment front. Strong literature evidence already exists about the efficacy of Gallium-68 DOTATATE, which we believe reduces our development risks for this product," added AAA's Chief Operating Officer Gérard Ber.

The EMA's orphan medicinal product designation is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. In addition to ten years of market exclusivity, the orphan drug designation also provides special incentives for sponsors including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.

Similarly, FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the U.S. This designation could provide AAA with seven years of marketing exclusivity for AAA's Gallium-68 DOTATATE as a diagnostic agent for the management of GEP-NETs if it receives first approval by the FDA. Prior to FDA approval, orphan designation by the FDA provides the opportunity to obtain grant funding to help finance costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA's application user fees.

About Gallium-68 DOTATATE kit

Gallium-68 DOTATATE or Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide is a diagnostic PET imaging agent currently under development. The pre-formulated GMP kit is used to prepare the final product, which is a ready-to-inject 68Ga-somatostatin analogue peptide solution.

Gallium-68 DOTATATE is a radiopharmaceutical agent used to help diagnose Gastro-Entero-Pancreatic Neuroendocrine cancers via PET/CT imaging. Existing data show that AAA's Ga-68-labeled GEP-NET PET radiopharmaceutical should represent a major improvement compared to the existing standard.

About Gastro-Entero-Pancreatic Neuroendocrine Tumors

Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs) are a rare group of tumors that start in the cells of the neuroendocrine system, a network of endocrine glands and cells throughout the body. GEP-NETs develop in the digestive system, usually starting in the stomach, bowel or pancreas and constitute a life-threatening disease.

About Molecular Nuclear Medicine (MNM)

Molecular Nuclear Medicine is a medical specialty which uses trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions and to treat various diseases, like cancer. The technique works by injecting into the patient's body targeted radiopharmaceuticals that accumulate in the organs or lesions that reveal specific biochemical processes.

Molecular Nuclear Diagnostics employ a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages.

PET (Positron Emission Tomography) is a MNM imaging technique used in diagnosis and biomedical research. In PET, a chemical compound labeled with a short-lived positron-emitting radionuclide of carbon, oxygen, nitrogen, or fluorine is injected into the body. The activity of such a radiopharmaceutical is quantitatively measured throughout the target organs. Data are analyzed and reconstructed by means of a computer to produce images of the organs being scanned.

About Advanced Accelerator Applications

Advanced Accelerator Applications (AAA) is a European pharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA's main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (Personalized Medicine). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 290 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2013 AAA is expecting to reach revenues of €56.6 million (+27% vs. 2012) and EBITDA of €14 million (+49% vs. 2012). For more information please visit: http://www.adacap.com

SOURCE Advanced Accelerator Applications

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
Containers are changing the security landscape for software development and deployment. As with any security solutions, security approaches that work for developers, operations personnel and security professionals is a requirement. In his session at DevOps Summit, Kevin Gilpin, CTO and Co-Founder of Conjur, will discuss various security considerations for container-based infrastructure and related DevOps workflows.
"We have a tagline - "Power in the API Economy." What that means is everything that is built in applications and connected applications is done through APIs," explained Roberto Medrano, Executive Vice President at Akana, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations migh...
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
"A lot of the enterprises that have been using our systems for many years are reaching out to the cloud - the public cloud, the private cloud and hybrid," stated Reuven Harrison, CTO and Co-Founder of Tufin, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies drivi...
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud envir...
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction. Th...
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
The last decade was about virtual machines, but the next one is about containers. Containers enable a service to run on any host at any time. Traditional tools are starting to show cracks because they were not designed for this level of application portability. Now is the time to look at new ways to deploy and manage applications at scale. In his session at @DevOpsSummit, Brian “Redbeard” Harrington, a principal architect at CoreOS, will examine how CoreOS helps teams run in production. Attende...
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York
SYS-CON Events announced today that Alert Logic, the leading provider of Security-as-a-Service solutions for the cloud, has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo® and DevOps Summit 2015 Silicon Valley, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Alert Logic provides Security-as-a-Service for on-premises, cloud, and hybrid IT infrastructures, delivering deep security insight and continuous protection for cust...