Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (Navidea or the Company), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on November 23, 2018 the U.S. Food and Drug Administration (FDA) released a letter to the U.S. Patent and Trademark Office (USPTO) indicating that the USPTO is allowed to extend the patent duration of U.S. patent 6,409,990 for an additional 5 years or until May 12, 2025.
This patent claims Lymphoseek (technetium (Tc 99m) tilmanocept) and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.
I am pleased the FDA has taken positive action to extend the Lymphoseek patent until May 12, 2025, said Jed Latkin, CEO of Navidea. We are excited that this extension allows us to continue advancing the science as Navidea prepares for the many other indications for which Tilmanocept can be used.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept„¢ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navideas Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navideas strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Companys pipeline through global partnering and commercialization efforts.
For more information, please visit www.navidea.com.
This release and any oral statements made with respect to the information contained in this release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: any future actions by Platinum-Montaur; general economic and business conditions, both nationally and in our markets; our history of losses and uncertainty of future profitability; the final outcome of the CRG litigation in Texas and Ohio; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; our expectations and estimates concerning future financial performance, financing plans and the impact of competition; our ability to raise capital sufficient to fund our development and commercialization programs; our ability to implement our growth strategy; anticipated trends in our business; advances in technologies; our ability to comply with the NYSE American continued listing standards; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
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Navidea Biopharmaceuticals, Inc.
Jed Latkin, CEO, 614-973-7490
Joseph Green, 646-653-7030