Indian drugmaker Piramal Healthcare has agreed to buy a research and development portfolio from Bayer AG, the company said, in a deal that gives Piramal rights to florbetaben, a possible Alzheimer treatment.
Florbetaben, which is in the final stages of clinical trials, works by detecting symptoms in probable sufferers of Alzheimer’s, and is expected to allow earlier detection and specific treatment of the disease, Piramal said in a statement.
Florbetaben is racing with similar Alzheimer’s imaging agents from global pharmaceutical companies such as Eli Lilly and Co, Pfizer Inc and General Electric Co to enter a global market estimated at anywhere from $1 billion to $5 billion.
Piramal will acquire intellectual property, worldwide development, marketing and distribution rights of florbetaben and other clinical and pre-clinical assets of Bayer’s molecular imaging business in the deal. Financial aspects of the deal were not available.
“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,” Ajay Piramal, chairman of the Piramal Group, was quoted as saying.
PET imaging of amyloid-β has recently emerged as a valuable biomarker to support the in vivo diagnosis of Alzheimer’s disease (AD). So far, however, no tracer is available suitable for general clinical routine application. Florbetaben is a promising 18F-labeled amyloid-β-targeted PET tracer currently in Phase 2/3 clinical development. This review provides an overview on the current knowledge and future research activities on florbetaben. Recently, the first worldwide multi-center trial to test the diagnostic performance of amyloid-β PET in AD was conducted with this tracer. From this trial, a sensitivity and specificity of 80 and 91% in the discrimination between patients with probable AD and age-matched healthy controls was reported. Ongoing florbetaben PET trials deal with correlating the in vivo PET signal to post mortem histopathology evaluation, and with investigating the value of the tracer to predict progression to AD at the stage of mild cognitive impairment. The preclinical and clinical data currently available verify florbetaben as a safe and efficacious PET tracer suitable for detection of amyloid-β deposition in the brain. The results of the ongoing trials will contribute to current knowledge on the characteristics of florbetaben, and will help to determine the future potential of florbetaben PET imaging as a visual adjunct to supplement the routine clinical “AD diagnostic toolbox”.
Barthel H, Sabri O.