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Improved supply capabilities of Neuraceq^® to provide better patient access to beta-amyloid PET

BOSTON, April 5, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq^® out of SOFIE's radiopharmaceutical manufacturing site located in Cleveland, Ohio. The first doses have been made available on April 4, 2024.

Neuraceq^® is an FDA-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. Neuraceq^® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases.

"By adding Cleveland to our distribution network, Life Molecular Imaging is thrilled to provide additional availability of Neuraceq^®, an important imaging tool for the detection of beta-amyloid plaques in the brain. Our continued collaboration with SOFIE provides greater availability of our approved beta-amyloid tracer Neuraceq^®. We believe this additional access to Neuraceq^® benefits physicians and patients, as well as our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI.

Brian Schumer, PharmD, SOFIE COO states, "We are excited to bring Neuraceq^® availability to another SOFIE network site. The continued growth and advancement in Alzheimer's disease diagnosis and treatment is very promising for patients and their families. SOFIE is committed to the further expansion and availability of LMI's Neuraceq^® PET diagnostic tracer throughout our national PET manufacturing and dispensing network." 

About Neuraceq (florbetaben 18F)

Indication

Neuraceq^® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate ?-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 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:
  • Predicting development of dementia or other neurologic conditions
  • Monitoring responses to therapies.

Important Safety Information

Risk for Image Interpretation and Other Errors

Errors may occur in the Neuraceq estimation of brain neuritic ?-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic ?-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic ?-amyloid plaques in the future.

Radiation Risk

Neuraceq, similar to 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. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Common Adverse Reactions

The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).

For more information please visit: neuraceq.com

About Life Molecular Imaging (LMI)

Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field.  Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, 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 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/ 

For media queries

Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging

Tel: +1.484.735.2840 |  b.hahn@life-mi.com 

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SOURCE Life Molecular Imaging