News | April 16, 2014

Navidea Provides Update on European Marketing Authorization Application for Lymphoseek

April 16, 2014 — Navidea Biopharmaceuticals Inc. held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the pending Marketing Authorization Application (MAA) of Lymphoseek (technetium Tc 99m tilmanocept) Injection. Lymphoseek is a lymphatic mapping agent designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. As part of the MAA review process, Navidea presented Oral Explanations to the CHMP relating to open questions in the Lymphoseek MAA. At the conclusion of the meeting, the CHMP informed Navidea that the committee would continue with its review of the MAA. Navidea believes the course of the review continues to be supportive of its market development plans and outlook for material revenue generation in Europe beginning in 2015, as previously disclosed.

Based on feedback received at the meeting, Navidea believes that the CHMP has found the safety and efficacy data submitted in the MAA for breast cancer and melanoma to be acceptable. The CHMP will now focus its review on the remaining areas of product specifications unique to the European application and on data from the Phase 3 study in head and neck cancer. During this process, the MAA remains active but the review clock will continue to be stopped while Navidea works with the CHMP to address these remaining areas.

The Lymphoseek MAA is supported by a comprehensive, multi-trial clinical program including two Phase 3 studies of Lymphoseek (NEO3-05 and NEO3-09) performed in patients with either breast cancer or melanoma and a third Phase 3 study (NEO3-06), in patients with head and neck cancer, contributing to a safety database of more than 550 patients. The MAA is based on the same pivotal efficacy and safety data package provided in the U.S. New Drug Application (NDA) and two supplemental NDA (sNDA) submissions. The U.S. Food and Drug Administration (FDA) approved Lymphoseek in the United States in 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek was also granted Fast Track designation and Priority Review for one of its sNDAs focused on sentinel lymph node detection in patients with head and neck cancer, with an upcoming Prescription Drug User Fee Act (PDUFA) target date of June 16, 2014. The second sNDA has a PDUFA target date of Oct.16, 2014.

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