Navidea Biopharmaceuticals Submits Lymphoseek Marketing Authorization Application to European Medicines Agency
DUBLIN, Ohio--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."
About the Lymphoseek MAA Submission
The Marketing Authorization Application submission is supported by a comprehensive clinical program including the results from two Phase 3 studies of Lymphoseek, NEO3-05 and NEO3-09, performed in patients with either breast cancer or melanoma. The primary endpoint for both the NEO3-05 and NEO3-09 studies was the concordance (or the rate of agreement) on a lymph node count basis of Lymphoseek with vital blue dye. In both of the Phase 3 studies (NEO3-05, NEO3-09), the concordance of Lymphoseek to vital blue dye was highly statistically significant (p<0.0001).ii Lymphoseek met all primary and secondary endpoints across both studies. In addition, a meta-analysis and pooled-data comparison of results from Navidea's prospective Phase 3 clinical trials of Lymphoseek in patients with breast cancer and melanoma to European colloidal products was included in the MAA filing. The analysis evaluated the performance of Lymphoseek to a meta-analysis of historical, published data for 99m-Tc-labeled colloidal agents considered part of the standard of care in Europe. iii
In more than 500 subjects receiving Lymphoseek to date, including those studied as a part of the NEO3-05 and NEO3-09 studies, no drug-related serious adverse events or clinically significant drug-related adverse events have been reported.
U.S. regulatory status
Navidea is also seeking marketing approval of Lymphoseek in the United States. The U.S. Food and Drug Administration (FDA) has assigned the Lymphoseek New Drug Application (NDA) a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2013.
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancers such as breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 229,000 new cases of breast cancer and 76,000 new cases of melanoma are expected to be diagnosed in the United States in 2012.
About Lymphatic Mapping
Lymphatic mapping is a procedure designed to guide lymph node dissection and biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide guidance on the location of lymph nodes to be biopsied. ILM is a surgical 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. These nodes, commonly referred to as "Sentinel Lymph Nodes," are removed and analyzed for the presence of malignant cells. Lymphatic Mapping provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is actively developing four radiopharmaceutical agent platforms – Lymphoseek®, NAV4694, NAV5001 and RIGScanTM – to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and, ultimately, patient care. 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.
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