Piramal Healthcare has signed an agreement to acquire the worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma, including rights to florbetaben, which is in the final stages of its Phase III clinical trials. Florbetaben is a PET tracer for the detection of beta-amyloid plaque deposition in the brain. Detection of beta-amyloid depositions is expected to result in earlier diagnosis and more specific treatment of Alzheimer’s disease.
First Phase III results will be presented April 25 at the American Academy of Neurology’s 64th annual meeting in New Orleans. The Phase III trial showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease, according to Mumbai, India-based Piramal. The visual assessment procedure proposed for routine clinical practice demonstrated 100 percent sensitivity and 92 percent specificity with excellent inter-reader agreement, the company said.
As per the agreement, Piramal will have the intellectual property (including patents, trademarks and know-how), worldwide development, marketing and distribution rights of the lead compound florbetaben, as well as other clinical and pre-clinical assets of Bayer’s molecular imaging business.
Piramal estimates that the new class of PET imaging agents for Alzheimer's has a global market potential of up to $1.5 billion and is setting up a dedicated global commercial team for florbetaben. Core members of Bayer’s research and development team working on the portfolio will be joining Piramal Imaging, which will carry forward the development of florbetaben and take it through regulatory approval processes worldwide. Piramal is planning to file for regulatory approvals in 2012.