Navidea Biopharma (NAVB) Receives Positive EMA CHMP Opinion on Lymphoseek for New Kit

September 16, 2016 8:16 AM EDT

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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB) has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for a new Lymphoseek® 50 microgram kit for radiopharmaceutical preparation. Lymphoseek is a medicinal product for diagnostic use only and 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 This new Lymphoseek “dose packaging” enables a single injection per patient and is appropriate for the radiopharmaceutical distribution model in Europe.

“This is an important milestone achieved by both Navidea and our partner SpePharm AG and was achieved through great collaboration by both companies,” said William J. Regan, Navidea Senior Vice President and Director Navidea UK, Ltd. “We are excited that Lymphoseek, with proven clinical benefits and performance characteristics which may improve the clinical outcomes of oncology patients, will shortly be available throughout Europe. The impact of this new dose packaging will also be important to Lymphoseek distribution as we register in markets throughout the rest of the world.”

Peter Stein, Chief Executive Officer, Norgine commented, “As a European specialist pharma company, Norgine is looking forward to making this specialist product available to patients in Europe. The EMA positive opinion on the Lymphoseek reduced mass dose vial will ensure that patients can have their cancer accurately staged with the minimum of potentially disfiguring and disabling surgical intervention.”

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.

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