Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has submitted a Marketing Authorization Application (MAA) for its investigational radiopharmaceutical Lymphoseek ® (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping (ILM) agent, to the European Medicines Agency (EMA).
“The submission of the Lymphoseek MAA marks a significant milestone for Navidea as we continue our global development and commercialization efforts for Lymphoseek. It is also important to note that, as part of the normal MAA filing process, the EMA required good manufacturing practices (GMP) pre-submission inspections at the Lymphoseek contract manufacturing facilities. These inspections were recently successfully completed by independent auditors from the European Union (EU), thereby enabling our MAA filing,” commented Dr. Mark Pykett, President and CEO of Navidea. “We are encouraged by these positive pre-submission manufacturing audits which we believe bode well for Lymphoseek’s ultimate commercialization. We are prepared to support the ongoing EMA approval process and to continue our pre-commercialization activities as we confidently anticipate U.S. approval of Lymphoseek in the coming months.”
Navidea is seeking marketing approval for Lymphoseek in the EU for use in ILM, a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. The Lymphoseek MAA has proposed the use of the agent in general lymphatic mapping not restricted to any particular solid tumor type. According to the European Union’s FACT Public Health Programme Fighting Against Cancer, approximately 2.2 million new cases of solid tumor type cancers are expected to be diagnosed in the EU. i
Dr. Pykett added, “For patients and medical professionals, ILM is part of the standard of care in Europe for certain solid-tumor cancers, including breast cancer and melanoma and is actively being investigated in other cancer types such as head and neck cancer and prostate cancer. Lymphoseek is specifically designed to target key predictive lymph nodes through a receptor-based mechanism, which we believe may lead to enhanced diagnostic accuracy through rapid injection site clearance, stable target binding, lower false negative results, and better cancer staging of patients in ILM procedures while affording scheduling flexibility.”