Piramal will acquire 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.
Florbetaben, which is in the final stages of its phase III clinical trials, is a PET tracer for the detection of beta-Amyloid plaque deposition in the brain, which is the pathological hallmark of disease in probable Alzheimer's disease patients. Detection of beta-Amyloid depositions is expected to result in earlier diagnosis and more specific treatment of Alzheimer's disease.
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. All study endpoints were met. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).
"This is the second acquisition of late-stage assets after our acquisition of assets of BioSyntech in 2011,” said Ajay Piramal, chairman, Piramal Group. “We plan to build a promising portfolio in the pharma space, including our newly acquired molecular imaging assets, which will help us create a global branded pharma 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 R&D 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.