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Bayer HealthCare Presents Florbetaben Phase II Study Results at World Congress of Neurology
Date:10/30/2009

meaning that about 80 percent of the subjects with probable Alzheimer's disease had florbetaben scans indicating the presence of cerebral beta-Amyloid plaques. This is consistent with the results of studies where the clinical diagnosis of Alzheimer's disease was compared with the definitive post-mortem histopathological diagnosis. Additional data analysis is still ongoing in this study.

There were twenty-nine treatment-emergent AEs, the most-frequent of which were injection site changes, were reported in 24 subjects (16 percent), 10 of whom were patients with probable Alzheimer's disease and 14 of whom were healthy volunteers. In two patients with probable Alzheimer's disease and three healthy volunteers, the AEs were deemed to be related to florbetaben, and included fatigue, "feeling hot", increased blood pressure, hematoma and "shaking of both hands." All adverse events (AEs) in the trial were resolved during the study period.

"Alzheimer's disease can be devastating for its victims and their families, and represents a large and growing cost burden for society," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "At Bayer HealthCare Pharmaceuticals, we are pleased that these encouraging results from our phase II studies suggest the potential of florbetaben PET imaging as a valuable tool for the detection of the hallmark indicator associated with Alzheimer's disease."

About Florbetaben

Florbetaben is an in-licensed 18F-labeled PET tracer currently being investigated for imaging of cerebral beta-Amyloid plaques, which are one of the pathological hallmarks of Alzheimer's disease. It is a leading candidate in Bayer's efforts to build a strong pipeline of PET tracers in neuroimaging, oncology, and cardiovascular disease. Additional Phase II and pivotal Phase III global studies are under preparation to validate the potential shown by florbetaben in thi
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SOURCE Bayer HealthCare Pharmaceuticals
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