Navidea Awarded NIH SBIR Grant for NAV4694 Beta-Amyloid Imaging Agent Phase 3 Clinical Program Aimed at Alzheimer's Disease

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the award of a Small Business Innovation Research (SBIR) grant from the National Institute On Aging (NIA) of the National Institutes of Health (NIH) in connection with the Company's Phase 3 clinical program for its NAV4694 beta-amyloid imaging agent as an aid in the differential diagnosis of Alzheimer's disease. The SBIR grant has the potential to provide up to $1.8 million in support, if fully funded, through the conclusion of the Phase 3 clinical study. Funding for the approved first stage of the grant ($259,000) is intended to provide support for initiation activities of the Phase 3 clinical program. Funding of the second stage of the grant is contingent upon meeting specific aims related to the first stage of the grant such as institutional review board approval of the Phase 3 protocol, clinical site contracting and investigator training. Navidea announced the initiation of the Phase 3 program in June 2013.

"We are pleased that the NIH has recognized the potential value for NAV4694 which we believe can play an important role in clinical practice allowing for earlier diagnosis and therapeutic intervention in cases of dementia," said Frederick Cope, PhD, FACN, Navidea Senior Vice President and Chief Scientific Officer. "We expect this trial will further highlight several of the key features of NAV4694 such as high amyloid binding/sensitivity, low white matter uptake, strong signal-to-noise ratios and clear, unambiguous images. We believe that earlier and more effective diagnosis is directly in line with the federal government's aim to address the impact of this devastating disease. We very much appreciate the support of the NIH as we conduct this pivotal Phase 3 clinical trial."

"The pivotal Phase 3 study is designed to provide a direct comparison of NAV4694 patient images collected during life with postmortem histopathology findings. The results from this study may lead to improved differential diagnosis and patient management," said Cornelia Reininger, MD, PhD, Navidea Senior Vice President and Chief Medical Officer. "NAV4694 is a great example of a precision diagnostic agent with the potential to help physicians overcome the frequent challenges of diagnostic uncertainty and provide millions of patients with more accurate diagnoses."

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 beta-amyloid deposits in the brain that can then be imaged in scans. Beta-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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