Piramal Imaging SA and ISOLOGIC Innovative Radiopharmaceuticals today announce the companies have entered into a strategic partnership and licensing agreement to provide ISOLOGIC with exclusive rights to manufacture, market, and distribute Neuraceq (florbetaben F18 injection), a radiopharmaceutical tracer for positron emitting tomography (PET) imaging throughout Canada. The agreement will allow Piramal Imaging to gain access to the largest commercial network of cyclotrons for PET tracer production in the country.
Alzheimer’s disease, a condition that slowly destroys memory and cognitive abilities, currently affects more than 747,000 people in Canada according to the Canadian Institutes of Health Research. The total number of those affected is expected to surpass one million people in the country by 2031.1
“We are confident that our commitment to providing access to 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 at 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.”
The technical transfer of the manufacturing and quality control (QC) processes to ISOLOGIC has already been initiated and the company is currently exploring regulatory pathways and clinical trial applications in Canada to provide access to Neuraceq in ongoing and future clinical trials. ISOLOGIC intends to apply for a marketing authorization with Health Canada in the coming months.
“Piramal Imaging continues to expand the manufacturing and distribution network to bring Neuraceq into new markets,” said Friedrich Gause, Chief Operating Officer at Piramal Imaging. “The partnership with ISOLOGIC demonstrates our commitment to further expanding our global presence and increasing access to beta-amyloid PET scanning for imagers and referring physicians to advance the accuracy of clinical diagnosis in Alzheimer’s disease.”
Until today, an estimated 20-30% of patients with dementia have been misdiagnosed and often experienced extended diagnostic episodes before receiving a clinical diagnosis.2 A definitive diagnosis of Alzheimer’s disease could only be made after death based on autopsy findings of beta-amyloid plaques GLO/FBB/0515/0066 and neurofibrillary tangles in the brain. Today, a comprehensive clinical evaluation in combination with in-vivo biomarkers, such as beta-amyloid PET imaging, improves the diagnostic accuracy while the patient is still alive, allowing for optimal patient management and better outcomes.
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 betaamyloid 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 US package insert.
Important Safety Information
Neuraceq cannot be used to diagnose Alzheimer’s disease and it cannot predict a patient’s predisposition for beta-amyloid neuritic plaque 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.
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.
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 and 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 network of SPECT & PET radiopharmacies positions the company to service Group Purchase Organizations, regional health care systems, as well as stand-alone Independant Healthcare Facilities, and clinics and hospitals. 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.