Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that collaborators from the Department of Nuclear Medicine at University Hospital of Leipzig plan presentations highlighting Navidea’s PET imaging agent, NAV4694, at the German Society of Nuclear Medicine Annual Congress in Hannover, Germany, March 26-29, 2014. NAV4694 is an investigational Fluorine-18 labeled beta-amyloid imaging agent currently being evaluated in late stage clinical trials for use as an aid in differential diagnosis and to monitor progression of Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and other forms of neurodegenerative dementia. On March 27, Osama Sabri, MD, PhD, Professor of Nuclear Medicine, Chairman and Director of the Department of Nuclear Medicine of the University of Leipzig, Germany, and President of the SNMMI Brain Imaging Council is presenting the plenary Wolfgang Becker Memorial Lecture entitled “Modern Nuclear Medical Diagnostic Methods in Dementia” in which NAV4694 images and results will be highlighted. “As the dementia field strives for earlier evaluation and treatment of cognitive impairment, it is of increasing importance to have diagnostic agents that can accurately assess patient status. Through our collaborative work with Navidea, we have been impressed with the clarity of patient diagnostic images using NAV4694 allowing easy interpretation and differentiation into amyloid-positive or amyloid-negative categories,” said Dr. Sabri. “I and my colleagues are pleased to present this information to the European nuclear medicine community.” “We are delighted that our collaborators at the Leipzig University have shared these data with the medical community at the German Society of Nuclear Medicine. These results add to our conviction that NAV4694, with its inherent performance characteristics, may afford new opportunities to advance the early diagnosis of cognitive decline, including MCI,” said Cornelia Reininger, MD, PhD, Navidea’s Senior Vice President and Chief Medical Officer. “We remain committed to providing physicians and patients an improved PET-diagnostic agent that can aid in the differential diagnosis of Alzheimer's disease and other forms of neurodegenerative dementia.”
Also on March 27, during the Dementia session, Dr. Henryk Barthel, MD, PhD, Assistant Medical Director Neuro-PET and PET-MRI, Department of Nuclear Medicine, University Hospital Leipzig is presenting “ β-Amyloid PET Tracer 18F-NAV4694: White Matter Influence on Detectability of Brain Amyloid,” which concludes that evaluation of NAV4694 PET scans and MRI data from 20 patients (10 AD, 10 age-matched HV) showed lower white matter uptake of NAV4694 compared with other 18F amyloid radiotracers, meaning that white matter contribution to measurements is less and may provide better sensitivity for detecting within-subject changes.About NAV4694NAV4694 is an investigational 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 a Phase 2b study underway in MCI and a Phase 3 program in AD underway. About Navidea BiopharmaceuticalsNavidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is developing multiple precision diagnostic products and platforms, including NAV4694, NAV5001, Manocept™ and NAV1800 (RIGScan™), to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and, ultimately, patient care. Lymphoseek® (technetium 99m tilmanocept) Injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and advancing the Company’s pipeline through selective acquisitions, global partnering and commercialization efforts. For more information, please visit www.navidea.com. The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.