LONDON, September 16, 2016 /PRNewswire/ --
Navidea's European Partner
SpePharm AG, an affiliate of Norgine B.V., will distribute
LYMPHOSEEK®
SpePharm AG's partner Navidea Biopharmaceuticals, Inc. (NYSE
MKT: 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 tumour in adult patients with breast cancer,
melanoma, or localised 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.
(Logo:
http://photos.prnewswire.com/prnh/20130829/633895-a )
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."
"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."
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 tumour site in patients with
solid tumours 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.
Access the full release on http://www.norgine.com
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Isabelle Jouin, T:
+44-(0)1895-453643
Charlotte Andrews, T:
+44-(0)1895-453607
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