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Encouraging Phase III Study Results Show PET Imaging with Florbetaben Reliably Detects Beta-Amyloid in the Brain
Date:4/15/2012

MUMBAI, India, April 15, 2012 /PRNewswire/ -- Piramal Imaging SA ("Piramal"), a newly formed subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], announced positive first results from a Phase III study that 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. The study results will be featured as part of the Emerging Science Program on April 25th at the American Academy of Neurology's 64th Annual Meeting in New Orleans.

(Photo:  http://photos.prnewswire.com/prnh/20120415/NY87619 )

Historically, the only way to definitively diagnose Alzheimer's disease has been after death – at autopsy – through analysis and identification of beta-Amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).

Piramal 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. Florbetaben is the lead compound in the portfolio.

"This is not only an important milestone for florbetaben, but it also marks an important milestone for our company," says Dr. Swati A. Piramal, Director, Piramal Healthcare Limited, "The creation of Piramal Imaging allows us to pursue our mission to increase diagnostic accuracy of
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SOURCE Piramal Healthcare Limited
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