On September 22, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) reported it will receive payments totaling $1 million from two recently achieved Lymphoseek commercial milestones under its distribution agreements with U.S. partner Cardinal Health, Inc. (Cardinal) and European partner SpePharm AG, an affiliate of Norgine B.V. (Norgine) (Press release, Navidea Biopharmaceuticals, SEP 22, 2016, View Source;p=RssLanding&cat=news&id=2205270 [SID:SID1234515279]). Navidea will collect a $500,000 milestone payment from Cardinal based on the sale of a 100,000th patient dose of Lymphoseek (technetium Tc 99m tilmanocept) injection since launch. The Company will also receive a $500,000 payment from Norgine resulting from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion for the Lymphoseek 50 microgram kit for radiopharmaceutical preparation, a reduced-mass, single-dose vial appropriate for the radiopharmaceutical distribution model in Europe.
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"We are pleased with the meaningful progress that Navidea and its partners have made in our commercial distribution efforts in both the U.S. and Europe," said Jed Latkin, interim Chief Operating Officer and Chief Financial Officer. "These milestones reflect the growing acceptance of Lymphoseek in the U.S. for improving the outcomes in patients with melanoma, breast and oral cavity cancers and signal the expected European launch of Lymphoseek in Q42016."
Lymphoseek is approved in the U.S. by the U.S. Food and Drug Administration (FDA) 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. Lymphoseek is indicated in the EU for 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.1