Navidea Offers Update on Clinical Development Plan for Diagnostic Use of Lymphoseek IV in RA

Navidea Biopharmaceuticals, Inc. (NYSE MKT:

) announced today that based on its very recent meeting with the U.S. Food and Drug Administration (FDA), the Company will begin the clinical trial development process for its intravenous (IV) injection protocols for use of Lymphoseek® (technetium Tc 99m tilmanocept) injection in rheumatoid arthritis (RA) and other disease states. Lymphoseek is Navidea's first commercial product from its Manocept™ platform. "Our efforts to continue to unlock the significant value of the Manocept platform are well underway as we seek to expand Lymphoseek's label so it can be used as an immunodiagnostic for additional diseases," said Rick Gonzalez, President and CEO of Navidea. "This collaborative meeting with FDA has enabled us to continue to advance the regulatory process and begin to implement our clinical program in rheumatoid arthritis, an indication that has an addressable market that is substantially larger than the current Lymphoseek indications. We look forward to reporting our progress throughout the year." Over the past year Navidea conducted a series of meetings and communications with the FDA to gain clarity on a path to extend the current Lymphoseek IND to support IV administration of Lymphoseek. In parallel the Company initiated its clinical development efforts and has already completed six required non-clinical animal studies for this new route of administration, submitted the summary results in a briefing package to the FDA, and secured NIH grants in RA and Kaposi's Sarcoma, worth up to $3.8 million to support further development through Phase 2 studies. Based upon the feedback from the latest meeting, Navidea expects to submit an IND amendment to the FDA that will allow initiation of Phase 1/2 IV studies of Lymphoseek. The addition of this new route of administration would enable further development of Lymphoseek in broader immunodiagnostic disease applications including rheumatoid arthritis. The timing is expected to be consistent with Navidea's previously disclosed development plans to initiate a multi-center Phase 1/2 registrational trial employing IV-administration to evaluate Lymphoseek for the primary diagnosis of rheumatoid arthritis and to aid in the differential diagnosis of rheumatoid arthritis from other types of inflammatory arthritis during the second half of 2016. In addition, we expect to begin the Phase 1 pilot trial evaluating subcutaneous injection of Lymphoseek in active RA subjects in the second quarter of 2016.