News | April 16, 2012

Piramal to Acquire Worldwide Molecular Imaging Portfolio of Bayer

April 16, 2012 — Piramal Healthcare Ltd. has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG 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 April 25, 2012, at the American Academy of Neurology's 64th Annual Meeting in New Orleans.

Florbetaben is a positron emission tomography (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 (AD) patients. Detection of beta-amyloid depositions is expected to result in earlier diagnosis and more specific treatment of AD.

The Phase III trial showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy, thus showing value as a potential tool to aid in the diagnosis and assessment of AD. All study endpoints were met. The visual assessment procedure proposed for routine clinical practice demonstrated 100 percent sensitivity and 92 percent 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, where we have recently received the European CE mark approval for an innovative bio-orthopedic 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," said Ajay Piramal, chairman of Piramal Group.

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 AD 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.

Historically, the only way to definitively diagnose AD has been after death at autopsy, through analysis and identification of beta-amyloid in brain tissue. The Phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to postmortem analysis of brain tissue.

"This is not only an important milestone for florbetaben, but it also marks an important milestone for our company," said Swati A. Piramal, director, Piramal Healthcare Ltd. "The creation of Piramal Imaging allows us to pursue our mission to increase diagnostic accuracy of serious medical conditions for improved patient outcomes."

The trial is the first to overlay MRI (magnetic resonance imaging) and PET data to accurately match florbetaben gray matter uptake with disease in six defined regions of the brain. This was done to confirm that florbetaben binds to beta-amyloid on both a regional (brain sections) and subject (whole brain) level. This combination provides considerably more data points than any other beta-amyloid tracer trial to date. Based on a region-by-region comparison, florbetaben detected beta-amyloid with a sensitivity of 77 percent and a specificity of 94 percent with substantial inter-reader agreement (kappa = 0.66), significantly exceeding the pre-specified threshold, confirming the study hypotheses.

For more information: www.piramalhealthcare.com

Related Content

Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
Axumin PET Agent Added to NCCN Guidelines for Suspected Recurrent Prostate Cancer
News | PET Imaging | February 21, 2018
Blue Earth Diagnostics announced that Axumin (fluciclovine F 18) injection has been added to the National Comprehensive...
A Tc99m SPECT cardiac exam showing myocardial perfusion in the heart.

Technetium-99m is primarily used for the detection of cancer and to assess perfusion defects in the heart caused by heart attacks or other conditions.

Feature | Radiopharmaceuticals and Tracers | February 08, 2018 | Dave Fornell
February 8, 2018 — The U.S.
PSMA PET-CT Clearly Differentiates Prostate Cancer from Benign Tissue

68Ga-PSMA PET/CT images showing multifocal PCA in peripheral zone with GS of 5 1 5 5 10. (A and C) Axial PET images. (B and D) Fused PET/CT images. SUVmax of lesion in B was 84.3 and that of lesion in D was 5.7. IRS was 3, and 80% of cells were stained. Credit: Senior author V Prasad, Charité Universitätsmedizin Berlin, Berlin, Germany.

News | PET-CT | February 05, 2018
February 5, 2018 — Using nuclear medicine...
PET Tracer Measures Damage From Multiple Sclerosis in Mouse Models
News | PET Imaging | January 24, 2018
January 24, 2018 — The loss or damage of myelin, a cellular sheath that surrounds and insulates nerves, is the hallma
Novel PET Tracer Clearly Identifies and Tracks Bacterial Lung Infection

Representative PET/CT images of 18F-FDS and 18F-FDG in inflamed mice. Mice were inoculated with dead K. pneumoniae (10^8 CFU/mL). Imaging was performed for days 1, 2, 3 and 4 using 18F-FDG and 18F-FDS. CT images showed clear inflammation on day 2 and day 3 with corresponding high 18F-FDG uptake on PET. No significant uptake of 18F-FDS was detected for any of those 4 days. Credit: J Li et al., University of Louisville School of Medicine, Louisville, Ky.

News | PET-CT | January 22, 2018
January 22, 2018 — Researchers at the University of Louisville, Kentucky, have demonstrated that a new...
PET Tracer Gauges Effectiveness of Promising Alzheimer's Treatment

Longitudinal PET imaging with 18F-AV45. PET imaging shows the average 18F-AV45 uptake per animal group at 8 and 13 months of age. A significant interaction of genotype treatment was observed in the cortex (p = 0.0248), hippocampus (p = 0.0071) and thalamus (p = 0.0084), indicating reduced [18F]-AV45 uptake in BACE1 inhibited transgenic mice. Credit: MICA, University of Antwerp, Belgium.

News | Radiopharmaceuticals and Tracers | December 28, 2017
In the December featured basic science article in The Journal of Nuclear Medicine, Belgian researchers report on the...
Michael J. Fox Foundation and Tau Consortium Developing PET Tracers for Neurodegenerative Disease
News | Radiopharmaceuticals and Tracers | October 27, 2017
The Michael J. Fox Foundation for Parkinson's Research (MJFF) and the Tau Consortium announced a funding partnership to...
Overlay Init