IBA Molecular has entered into an agreement to manufacture and distribute Piramal's new diagnostic imaging agent, 18F-Florbetaben, in the US and Europe.
18F-Florbetaben, which is currently in development for use with positron emission tomography (PET), is designed for the detection of beta-amyloid plaque deposition in the brain, a pathological feature associated with Alzheimer’s disease and other neurologic conditions.
The visual assessment procedure of 18F-labeled PET tracer in pivotal Phase III study demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa=0.88).
IBA Molecular chief executive officer Renaud Dehareng said the company has seen data from the global phase III results of 18F-Florbetaben, and recognize the significant potential of the compound.
"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," Dehareng added.
"We are looking forward to joining forces with the Piramal team in their worldwide launch of the product."