Piramal Imaging SA (Piramal) and IBA Molecular 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 per cent sensitivity and 92 per cent 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.
“We are committed to creating a strong global pharma business based on intellectual property. 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. Piramal and IBA Molecular share a common vision and dedication towards fulfilling unmet medical needs and investing in superior discovery and research” said Ajay Piramal, Chairman, Piramal Group.
“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 have seen data from the global phase III results of 18F-Florbetaben, and recognize the significant potential of this compound. We are looking forward to joining forces with the Piramal team in their worldwide launch of the product,” said Renaud Dehareng, CEO of IBA Molecular.
Piramal recently acquired the intellectual property (including patents, trademarks and know-how), worldwide development, marketing and distribution rights of the lead compound 18F-Florbetaben as well as other clinical and pre-clinical assets of Bayer Healthcare’s molecular imaging business to form its imaging subsidiary, Piramal Imaging SA.
EH News Bureau