April 7, 2010 - A new imaging agent, used in brain positron emission tomography (PET) imaging of ?-amyloid in patients with suspected Alzheimer’s disease (AD) or mild cognitive impairment (MCI), is being evaluated for use in the United States and the European Union.
Avid Radiopharmaceuticals Inc. (Avid) and PETNET Solutions Inc. (PETNET), a wholly-owned subsidiary of Siemens Medical Solutions USA, shipped the first dose shipped from a PETNET Solutions manufacturing facility as part of its collaboration with Avid on Florbetapir F 18 (Florbetapir). The molecular imaging agent is used for PET imaging of ?-amyloid deposits in the brain, a key pathological component of Alzheimer’s disease.
PETNET manufactures Florbetapir at multiple facilities in the United States are expanding production capabilities to support the clinical development of Florbetapir.
Avid’s Florbetapir was the first ?-amyloid imaging compound to enter multi-center, IND clinical studies in the United States, and has now been studied in more than a dozen trials in subjects ranging from cognitively normal individuals to those with Alzheimer’s dementia. A pivotal Phase III registration study which was initiated early last year in the United States is nearing completion, and the compound is currently in additional clinical studies in the European Union, South America, Australia and Asia.