07 Aug 2012, BioSpectrum Bureau , BioSpectrum
Singapore: IBA Molecular and Piramal Imaging entered an agreement whereby IBA will manufacture and distribute 18F-Florbetaben, Piramal's new diagnostic imaging agent, in the European and US markets. The agent, which is called 18F- Florbetaben, is a radiopharmaceutical that is currently in development for use with positron emission tomography (PET). The agent is used for the detection of beta-amyloid plaque deposition in the brain, a pathological feature associated with Alzheimer's disease and other neurologic conditions.
Recent results from phase III studies 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 percent sensitivity and 92 percent 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.
Mr Ajay Piramal, chairman, Piramal Group, said that, "18F-Florbetaben is our lead compound in the molecular imaging business, and we are confident that it has the potential to increase clinicians' accuracy and confidence. IBA Molecular and Piramal share a common vision and dedication towards fulfilling unmet medical needs and investing in superior discovery and research."
Mr Renaud Dehareng, CEO, IBA Molecular, "IBA Molecular is deeply committed to the future of nuclear medicine, and the 18F-Florbetaben distribution agreement with Piramal will allow us to provide, upon its approval, one of the most anticipated compounds in nuclear medicine to our network of customers. We are looking forward to joining forces with the Piramal team in their worldwide launch of the product."