With the addition of Jubilant’s Norcross Radiopharmacy to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain.
BOSTON (PRWEB) January 10, 2023
Life Molecular Imaging (LMI) and Jubilant Radiopharma announce today that both companies have entered into a strategic partnership and licensing agreement providing Jubilant Radiopharma with rights to manufacture and distribute Neuraceq® in the Southeast Region of United States.
Jubilant Radiopharma will manufacture Neuraceq® at their PET cyclotron facility which has an adjoining SPECT radiopharmacy in Norcross, GA. The first doses will be available from January 18th, 2023.
Neuraceq® is an approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline. It is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases.
“With the addition of Jubilant’s Norcross Radiopharmacy to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain. We are truly excited about this collaboration with Jubilant Radiopharma to make our approved beta-amyloid tracer Neuraceq® even more available to physicians and their patients and to our pharma partners for routine clinical and research use”, said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
“It is a great pleasure to have signed this important manufacturing and distribution agreement with Life Molecular Imaging” – declares Renato Leite, President at Jubilant Radiopharmacies. “Our strategic partnership with LMI will expand the availability of the innovative molecular imaging agent Neuraceq®, to patients in the Southeast contributing to the fight against Alzheimer’s disease and other causes of cognitive decline”.
About Neuraceq® (florbetaben 18F)
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.
A negative Neuraceq® scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.
Limitations of Use
· A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
· Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Neuraceq® images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
Administration of Neuraceq®, like other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection site reactions, consisting of erythema (1.7%), injection site irritation (1.1%), and pain (3.4%).
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization 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. Please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT, and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/
About Jubilant Radiopharma
Jubilant Radiopharma (Jubilant Draximage Inc.) is a subsidiary of Jubilant Pharma Limited. The Radiopharma business comprises development, manufacturing and commercializing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of Improving Lives Through Nuclear Medicine on a global scale through Radiopharmaceuticals business with cGMP complaint and ISO 13485 certified manufacturing facilities and distribution through the radiopharmacies business which is the second largest network in the US with 48 radiopharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals.
For media inquiries
Nick Karabatsos, Chief Commercial Officer, Life Molecular Imaging: mailto:firstname.lastname@example.org [email@example.com __title__ null]
Jonathan Pharr, Director of Marketing, Jubilant Radiopharma: mailto:Jonathan.Pharr@jubl.com [Jonathan.Pharr@jubl.com __title__ null]