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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.

NEURACEQ (florbetaben F 18 injection), for intravenous use Initial U.S. Approval: 2014

INDICATIONS AND USAGE --------------------------

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.

PET Pharm Biotech Co. Ltd and Piramal Imaging SA of Germany have entered into a strategic partnership and licensing agreement with exclusive rights for PET Pharm Biotech to manufacture, market, and distribute NeuraCeq (florbetaben F18 injection), throughout Taiwan. NeuraCeq has been approved in the USEU , South Korea and Japan… and PET Pharm Biotech is currently applying for a marketing authorization with the Taiwanese FDA.

Piramal Imaging continues to expand its manufacturing and distribution network to bring NeuraCeq into new markets and the partnership with PET Pharm Biotech increases access to beta-amyloid PET scanning for imagers and referring physicians to advance the accuracy of clinical diagnosis in Alzheimer’s disease.