Piramal Imaging SA and ISOLOGIC Innovative Radiopharmaceuticals Announce Commercial Approval of NeuraCeq™ by Health Canada
MONTREAL, Feb. 28, 2017 /CNW Telbec/ - Piramal Imaging SA and ISOLOGIC Innovative Radiopharmaceuticals today announce that Health Canada has issued a Notice of Compliance (NOC) to ISOLOGIC Innovative Radiopharmaceuticals for NeuraCeq (florbetaben F18 injection). ISOLOGIC has received marketing authorization from Health Canada for the commercial production and market supply of NeuraCeq in Canada. NeuraCeq is the first diagnostic radiotracer to support the early diagnosis of Alzheimer's disease (AD) that is commercially available in the country. NeuraCeq availability in Canada was previously limited to investigational medicine purposes.
"The commercial availability of NeuraCeq will provide physicians throughout Canada a non-invasive method to more confidently and accurately assess complex and atypical cases of cognitively impaired patients for early diagnosis of Alzheimer's disease," said Doctor Jean-Paul Soucy, Medical Director of PET imaging at the Montreal Neurological Institute. "In the absence of an approved disease modifying treatment, advancing our ability to make an early and accurate AD diagnosis is critically important to providing optimal symptomatic treatment and non-pharmacological measures to manage disease progression and quality of life in these patients."
NeuraCeq has previously received approval from the FDA and several countries in EU and Asia, and is a diagnostic radiotracer that when used in combination with positron emission tomography (PET) imaging, can identify beta-amyloid plaques in the human brain, which are known as an important biomarker for Alzheimer's disease.
"We are confident that our commitment to providing access to this new diagnostic beta-amyloid radiotracers in Canada will have a significant impact on the management of patients suspected of having Alzheimer's disease," said André Gagnon, President and CEO of ISOLOGIC. "In the context of evidence-based medicine, the introduction of NeuraCeq in the marketplace will offer a new clinical evaluation method for patients, physicians and caregivers alike in the diagnosis and management of Alzheimer's disease. It could potentially help identify more efficacious interventions to help prevent, halt or slow down this terrible disease."
"We are very pleased to bring this very important diagnostic imaging tool to new markets like Canada," said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. "Piramal Imaging is proud to have chosen ISOLOGIC as a partner allowing us to continue our strategic endeavours to provide this important solution to Canadian patients."
About Neuraceq (florbetaben F18 injection)
This medicinal product is for diagnostic use only.
NeuraCeq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. NeuraCeq should be used in conjunction with a clinical evaluation. A negative scan indicates sparse or no neuritic plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, please refer to the full product monograph.
Important Safety Information
NeuraCeq cannot be used to diagnose Alzheimer's disease and it cannot predict a patient's predisposition for beta-amyloid neuritic plaques development in the future. NeuraCeq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben F18 injection. Following training, image-reading errors (including false positive or false negative interpretation of NeuraCeq images) may still occur. Additional interpretation errors may occur due to image noise, brain atrophy with a thinned cortical ribbon, or image blurs.
Administration of NeuraCeq, as with other radiopharmaceuticals, results in a low amount of ionizing radiation exposure. Safety precautions should be taken to ensure healthcare providers and patients do not receive unintentional radiation exposure from NeuraCeq.
Most Common Adverse Events
The most common side effects observed in clinical trials were injection site reaction and injection site pain.
About Piramal Imaging SA
Piramal Imaging SA, a division of Piramal Enterprises Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life threatening diseases, leading to better therapeutic outcomes and improved quality of life. For more information please go to www.piramal.com/imaging.
About ISOLOGIC Innovative Radiopharmaceuticals
ISOLOGIC Innovative Radiopharmaceuticals (ISOLOGIC) is a Canadian radiopharmaceutical company dedicated to nuclear medicine and the science of radiopharmaceutical production. ISOLOGIC's commitment to these fields includes cyclotron centers, SPECT and PET radiopharmaceutical manufacturing facilities throughout Canada. Utilizing significant experience, expertise to provide its customers and patients with reliable, safe and high quality radiopharmaceutical products and services. ISOLOGIC's open formulary of radiopharmaceutical drugs and medical devices provides the flexibility of choice, providing its customers with access to all radiopharmaceuticals, having Health Canada market authorization.