Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the European Medicines Agency (EMA)
has provided updated Day 180 feedback and has elected to continue the assessment of the Marketing Authorization Application (MAA) for
(technetium 99m tilmanocept) Injection. The updated Day 180 feedback was limited to supplemental product specification data and the NEO3-06 Phase 3 study in Head and Neck Cancer, which was submitted later in the MAA review process at Day 120, leaving less time for evaluation of these new data. The MAA review clock will continue to be stopped at Day 180 to await Navidea’s responses to the updated EMA feedback. During this time, the MAA remains active and Navidea will continue its ongoing process of interacting with the EMA.
"With the Lymphoseek MAA remaining in the EMA’s assessment process, we will continue to work with the EMA to support a positive opinion as early as possible in 2014," stated Mark Pykett, VMD, PhD, Navidea CEO. “We view potentially gaining a positive opinion that would also include Head and Neck Cancer as advantageous. While we prepare our responses to the EMA’s updated Day 180 feedback, we will continue to implement our plans for European market development during 2014 which we believe will support material revenue generation from Europe beginning in 2015, as we have previously disclosed."
Expanding Global Efforts
Navidea’s activities in Europe are part of its expanding global strategy for Lymphoseek commercialization. The Company recently announced it has entered into a partnership agreement for Lymphoseek distribution in Canada; partnerships are in process for additional markets. Navidea has also commenced shipment of Lymphoseek to select medical centers in the Middle East. These market expansion activities build on the growth of Lymphoseek sales being seen in the United States, which continue the positive trends recently reported at the Company’s Analyst Science Day on December 5, 2013.
(technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with 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. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 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. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others. Lymphoseek was granted Fast Track designation in December 2013 for sentinel lymph node detection in patients with head and neck cancer.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to publicly available information, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013, with approximately 330,000 new cases of breast cancer, 69,000 new cases of melanoma and 95,000 new cases of head and neck/oral cancer diagnosed in Europe annually.