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Navidea Biopharmaceuticals Highlights New Data For NAV4694 PET β-Amyloid Imaging Agent Presented At AAIC 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that researchers at McGill Center for Studies in Aging, Douglas Research Institute and Montreal Neurological Institute presented results of a post-mortem brain tissue study using Navidea’s investigational Fluorine-18 labeled β-amyloid imaging agent, NAV4694, during the Alzheimer's Association International Conference (AAIC) in Boston, MA. The study comparing performance characteristics of NAV4694 to the gold-standard imaging agent, 11C-labeled Pittsburgh Compound-B (PiB), in control and AD brain tissue concluded that although the molecules share structural similarity, NAV4694 better differentiated amyloid deposition associated with AD in post-mortem brains than PiB. 1

“Our research indicates that NAV4694 shows strong performance characteristics as an amyloid imaging agent for AD research and clinical use,” said Pedro Rosa-Neto MD, PhD, Assistant Professor of Neurology, Neurosurgery and Psychiatry at McGill University, Quebec, Canada. “This study indicated that unlike PiB, the benchmark PET amyloid agent, NAV4694 was capable of differentiating controls from AD in all brain regions and also exhibited a wider dynamic range and fewer false negatives as compared to gold-standard pathology.”

“We are very pleased that the McGill research team has shared these data with our colleagues and the scientific community at AAIC,” said Connie Reininger, MD, PhD, Navidea’s Senior Vice President and Chief Medical Officer. “We remain committed to providing physicians and patients an improved diagnostic agent that can aid in the differential diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia. These results further support the recently announced AIBL decision to utilize NAV4694 in place of PiB in their comprehensive research initiative in AD and Mild Cognitive Impairment.”

1 The study entitled, “[18F]NAV4694 shows higher binding and wider dynamic range compared to [11C]PIB in Alzheimer’s disease post-mortem tissue” was presented as a poster by E. Zimmer et al on Tuesday, July 16, 2013 at Alzheimer's Association International Conference (AAIC). The study included analysis of 25 Control (age=74.6+/-11.7) and 13 AD (age=75.3+/-8.6) human post-mortem brain samples containing the prefrontal cortex, hippocampus, posterior cingulate cortex, inferior parietal cortex and striatum regions.

About NAV4694

NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate intended for use in Positron Emission Tomography (PET) imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). NAV4694 binds to β-amyloid deposits in the brain that can then be imaged in scans. β-amyloid plaque pathology is widely used in the diagnosis of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. Navidea has an ongoing NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for NAV4694 in AD.

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