Piramal Healthcare Limited, one of India’s largest healthcare companies, has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG (Bayer) through its newly created subsidiary – Piramal Imaging SA.
The portfolio includes rights to florbetaben, which is in the final stages of its phase III clinical trials. First phase III results will be presented on April 25, at the American Academy of Neurology’s 64th Annual Meeting in New Orleans.
Florbetaben 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 specifictreatment 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 per cent sensitivity and 92 per cent specificity with excellent inter-reader agreement (kappa = 0.88).
Commenting on the transaction, Ajay Piramal, chairman of Piramal Group, said,“This is the second acquisition of late stage assets after our acquisition of assets of BioSyntech in 2011, where we have recently received the European CE mark approval for an innovative bio-orthopaedic product for cartilage repair, BST-CarGel, which enables the company to commercialize BST-CarGel in all of the countries in the European Union. 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.”
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.
Florbetaben is an 18F-labelled PET tracer that specifically binds to deposition of beta- Amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer's disease. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches. A phase II study showed that patients with clinical diagnosis of Alzheimer's disease could be differentiated from age-matched healthy volunteers on the basis of florbetaben uptake pattern in the brain. The results of the phase II study were presented at the International Conference on Alzheimer's diseases (ICAD) in Vienna, Austria in July 2009 and published in the Lancet Neurology in April 2011.
Alzheimer's disease is a devastating neuro-degenerative disease and the most common cause of dementia. Most cases of Alzheimer's disease affect people over the age of 60. It is a progressive disease that can lead to premature death. At present there is no cure for Alzheimer's disease, but treatments for symptoms, combined with the right services and support, can make life better for the millions of people living with Alzheimer's.