Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announce their new strategic partnership and licensing agreement to provide and distribute Neuraceq® from PharmaLogic’s radiopharmaceutical manufacturing site located near Denver, CO. The first doses were made available on August, 20th, 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 patients 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 partnering with PharmaLogic and offering Neuraceq® in Denver, Life Molecular Imaging is excited to expand access of Neuraceq® for the detection of beta-amyloid plaques in the brain. We believe this additional access benefits physicians and patients, as well as our pharma partners for routine clinical and research use. We are excited to collaborate with Pharmalogic today and look forward to more opportunities in the future. ” said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
Steve Chilinski, CEO of PharmaLogic:
“Expanding patient access to clinically-impactful radiopharmaceuticals is a core component of our mission. By partnering with Life Molecular Imaging in Denver, patients in the greater Rocky Mountain region will have even greater access to a new wave of disease targeting diagnostic radiopharmaceuticals.”
About Neuraceq (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-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 β-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 β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-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
