Date: 2012-08-06
Type of information: Production agreement
Compound: 18F-Florbetaben
Company: IBA Molecular (Belgium) Piramal (India)
Therapeutic area: Neurodegenerative diseases
Type agreement: manufacturing
production
distribution
Action mechanism: 18F-Florbetaben is an 18F-labeled PET tracer currently under development that has proven to specifically bind to deposition of beta-amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer\'s disease and other neurologic conditions. As the aggregation of the beta-amyloid protein in the brain is also a key target for new therapeutic treatments under development, 18F-Florbetaben might also be able to support the development of these new treatment approaches. A Phase II study showed that patients with clinical diagnosis of Alzheimer´s disease could be differentiated from age-matched healthy volunteers on the basis of 18F-Florbetaben uptake pattern in the brain. Results from a global Phase 3 trial indicate that PET imaging with 18F-Florbetaben reliably detects beta-amyloid deposition in the brain. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).
Disease: Alzheimer\'s disease
Details: IBA Molecular and Piramal Imaging SA have announced an agreement whereby IBA Molecular will manufacture and distribute 18F-Florbetaben, Piramal’s new diagnostic imaging agent, in the European and US markets. 18F Florbetaben is a radiopharmaceutical currently in development for use with positron emission tomography (PET) for the detection of beta-Amyloid plaque deposition in the brain, a pathological feature associated with Alzheimer’s disease and other neurologic conditions. Recently announced results from Phase III studies (presented at the American Academy of Neurology’s 64th Annual Meeting) indicate that PET imaging with 18F-Florbetaben reliably detects beta-amyloid in the brain with great accuracy and may have potential as an aid in the diagnosis and assessment of Alzheimer’s disease. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa=0.88). This pivotal trial was the first to overlay MRI and PET data to accurately match Florbetaben gray matter uptake with disease in six defined regions of the brain. This was done to confirm that Florbetaben binds to beta-Amyloid on both a regional (brain sections) and subject (whole brain) level. This combination provided considerably more data points than any other beta-Amyloid tracer trial to date.
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