Navidea Biopharmaceuticals Announces Issuance of New U.S. Patent Covering Formulation for Neuroimaging Agent, NAV5001

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent covering the formulation of the Company’s radiolabeled dopamine transporter (DAT) receptor ligand, NAV5001, used with SPECT imaging for potential differential diagnosis of Parkinsonian Syndromes and Dementia with Lewy Bodies. The patent (8,574,545) is set to expire in 2031.

The new U.S. patent, “Labeled Iodinated Tropane Formulation,” extends the scope and longevity of the NAV5001 intellectual property (IP) portfolio. The high concentration formulation protected by this patent may afford greater commercial flexibility and manufacturing efficiency to optimize distribution. Navidea anticipates commencing the NAV5001 Phase 3 clinical program by year end. This new patent reinforces the Company’s NAV5001 platform alongside previously issued U.S. Patent 8,084,018, “Methods for Imaging Dopamine Transporter Level,” which covers the acquisition of Dopamine Transporter SPECT images soon after injection of NAV5001, a unique feature and competitive advantage for NAV5001. These patents were issued to Alseres Pharmaceuticals and have been licensed exclusively to Navidea.

About Navidea Biopharmaceuticals, Inc.
Navidea 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 RIGScan^TM , 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.

Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications

Source: Navidea Biopharmaceuticals, Inc.

Released November 14, 2013