Improved delivery capability of Neuraceq® to provide patients with better access to beta-amyloid PET
BOSTON, 20 August 2024 /PRNewswire/ — Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a premier contract development and manufacturing organization (CDMO) and provider of radiopharmaceutical solutions, announce their new strategic partnership and license agreement to supply and distribute Neuraceq® from PharmaLogic’s radiopharmaceutical manufacturing facility near Denver, Colorado. The first doses were made available on August 20.th2024.
Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Neuraceq® is used in routine clinical practice and is also a powerful imaging biomarker for the appropriate characterization of patients being assessed for treatment eligibility with newly approved anti-amyloid drugs or for enrollment in clinical trials to further support drug development for neurodegenerative diseases.
“Through the partnership with PharmaLogic and the offering from Neuraceq® In DenverLife Molecular Imaging is pleased to expand access to Neuraceq® for the detection of beta-amyloid plaques in the brain. We are convinced that this additional access will benefit physicians and patients as well as our pharmaceutical partners for routine clinical and research use. We are pleased with our collaboration with Pharmalogic today and look forward to further opportunities in the future,” said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
“Expanding patient access to clinically effective radiopharmaceuticals is a central part of our mission,” said Steve ChilinskiCEO of PharmaLogic. “Through the partnership with Life Molecular Imaging in DenverPatients in the greater Rocky Mountain region will have even better access to a new wave of disease-specific radiopharmaceuticals for diagnostics.”
To Neuraceq (Florbetaben 18F)
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Neuraceq® is a radioactive diagnostic agent indicated for positron emission tomography (PET) of the brain to estimate the density of β-amyloid neurite plaques 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 few to no neurite plaques and is not consistent with a neuropathological diagnosis of AD at the time the image was acquired; 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 neurite plaques; neuropathological studies have shown that this amount of amyloid neurite plaques is present in patients with AD, but it may also be present in patients with other types of neurological diseases as well as in older people with normal cognition. Neuraceq is an adjunct to other diagnostic tests.
Restrictions on use
- A positive Neuraceq® The scan does not allow the diagnosis of AD or other cognitive disorders.
- The safety and effectiveness of Neuraceq have not been established for:
- Predicting the development of dementia or other neurological diseases
- Monitoring responses to therapies.
Important safety information
Risk of image interpretation and other errors
Errors may occur in the Neuraceq estimate of the density of neuritic β-amyloid plaques in the brain during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in interpreting Neuraceq images has not been evaluated and may result in 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 cause image distortion. Neuraceq scan results indicate the presence of neuritic β-amyloid plaques in the brain only at the time of image acquisition, and a negative scan result does not preclude the development of neuritic β-amyloid plaques in the brain in the future.
Radiation risk
Neuraceq, like other radiopharmaceuticals, contributes to a patient’s 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 healthcare professionals from inadvertent radiation exposure.
Common side effects
The overall safety profile of Neuraceq is based on data from 1,090 Neuraceq administrations in 872 subjects. No serious adverse reactions were reported in association with Neuraceq administration. The most commonly observed adverse reactions in subjects receiving Neuraceq were injection site reactions, consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information visit: neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharmaceutical company dedicated to the development and delivery of novel, cutting-edge PET radiopharmaceuticals for imaging neurodegenerative and cardiovascular diseases. The company strives to be a leader in the field of molecular imaging. Our mission is to develop innovative PET products that improve the early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and a higher quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key area of modern medicine. LMI is a subsidiary of the Life Healthcare Group – an international, people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. For more information, visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global, people-centric, diversified healthcare company listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years of experience in the South African private healthcare sector and currently operates 64 healthcare facilities in South Africa. Services include acute hospital care, acute physical rehabilitation, acute mental health care, renal dialysis, oncology, diagnostic and molecular imaging, and health risk management services, including occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical company dedicated to the development and global commercialization of innovative molecular imaging agents for use in PET-CT diagnostics for the detection of specific diseases. Visit: https://www.lifehealthcare.co.za/ | https://life-mi.com/
For media inquiries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Phone: +1.484.735.2840 | [email protected]
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Source: Life Molecular Imaging
