NEPTIS® synthesizer from ORA™ selected as a manufacturing platform for Eli Lilly’s AMYVID™

Philippeville, Belgium, June 8th 2013 / Optimized Radiochemical Applications (ORA™) today announced that its NEPTIS® plug synthesizer platform has been selected by Eli Lilly and Company as a disposable fluid-path radiosynthesizer used for the production of the radiopharmaceutical product, AMYVID™ (Florbetapir (18F)).

In April 2012, AMYVID™ became the first-and-only product of its kind to receive FDA approval as a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. In January 2013, AMYVID™ also received marketing authorization from the European Commission.

ORA has been manufacturing NEPTIS® plug synthesizers with a specific application (Virtual Synthesizer®) developed for AMYVID™ and has supplied them to Eli Lilly for the manufacture of florbetapir (18F) for clinical trial use at multiple sites in the United States (U.S.), Europe and Japan.

Vincent Tadino, Chief Technical Officer of ORA™ commented: “The decision made by Eli Lilly to select our NEPTIS® synthesizer demonstrates that we have made positive choices while developing the product, which match the need for reliable manufacturing under GMP conditions of advanced radiopharmaceuticals such as AMYVID™. The inclusion of the NEPTIS® synthesizer in the approved U.S. NDA and the European Union Marketing Authorization for AMYVID™ is a major milestone for our company.”

ORA™ is exhibiting at booth number #1500 at the Society for Nuclear Medicine (SNM) Annual Meeting 2013 from 8-12 June in Vancouver, Canada.

About NEPTIS®

NEPTIS® synthesizers, created for the production of PET radiopharmaceuticals, aim to address the various challenges of personalized medicine, a new and rapidly advancing field of healthcare. NEPTIS® synthesizers provide flexibility and freedom for researchers; provide developers with a robust tool for use from clinical trials to commercial production, and offer producers guaranteed performance. Additional information about NEPTIS® is available at www.neptis-vsa.com.

About Optimized Radiochemical Applications (ORA™)

ORA, an innovation-driven Belgian company founded in 2006, is developing an extensive range of PET synthesizers for existing and new radiopharmaceuticals and collaborates with major research institutions and pharmaceutical companies worldwide. Additional information about ORA is available at www.oradiochem.eu.

About Amyvid

Amyvid (Florbetapir (18F)) solution for injection is the first-and-only radioactive diagnostic agent approved for use in the United States and European Union for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. A negative Amyvid scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. A positive scan indicates moderate to frequent plaques, but does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia). Developed by Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, Amyvid is an adjunct to other diagnostic evaluations. Only a qualified physician can establish diagnosis of AD based on results of a comprehensive patient assessment.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaboration with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information is available at www.lilly.com.

For immediate release

Contact: Vincent Tadino
Phone: (0032) 71 61 40 53
Email: info@oradiochem.eu

 

©ORA Belgium, 2013. All rights reserved. PR1303
NEPTIS® is a trademark of ORA™