European Commission Approves Navidea's Sentinel Lymph Node Detection Agent Lymphoseek

Navidea Biopharmaceuticals, Inc. (NYSE MKT:

) has announced that the European Commission has granted marketing authorization for Lymphoseek® 250 micrograms kit for radiopharmaceutical preparation. Lymphoseek is now approved in the European Union (EU) for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. “This is yet another important milestone achieved by Navidea in our global commercialization of Lymphoseek and reaffirms our commitment to improving the lives of oncology patients worldwide,” said Navidea CEO, Rick Gonzalez. “We are excited that Lymphoseek is the first agent centrally approved in Europe for Sentinel Lymph Node (SLN) detection. It is differentiated in its ability to reliably and accurately locate SLNs to effectively stage cancer and inform post-surgical treatment. We look forward to making Lymphoseek available throughout Europe with initial launches into certain major markets planned for later in 2015. We will be sharing more details about our commercialization plans in the coming months.” “Lymphoseek can be a game changer in allowing more patients across Europe access to this technology which allows their cancer to be accurately staged without disfiguring and disabling surgery,” said John Buscombe, Physician in Nuclear Medicine, Addenbrooke's Hospital, Cambridge, UK. “The availability and convenience of a receptor-targeted imaging agent such as Lymphoseek, the first synthetic and biotargeted agent for use in sentinel node localization, provides both the required diagnostic accuracy and reliability that enables a surgeon planning sentinel node biopsy to be able to operate without the concerns raised with timing from imaging to surgery found with alternate methods.” The sentinel node detection label in Europe may now allow Lymphoseek to be used in approximately 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers diagnosed in Europe annually, respectively. Lymphoseek is approved in the U.S. for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.