- Navidea’s European Partner SpePharm AG, an
affiliate of Norgine B.V., will distribute Lymphoseek®
-
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 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.
About Lymphoseek®
Lymphoseek (technetium Tc 99m tilmanocept) injection is the
first and only FDA- and EMA-approved receptor-targeted lymphatic
mapping agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by FDA for use in solid tumor cancers where
lymphatic mapping is a component of surgical management and for
guiding sentinel lymph node biopsy in patients with clinically node
negative breast cancer, melanoma or squamous cell carcinoma of the
oral cavity. Lymphoseek also received EMA European approval in
imaging and intraoperative detection of sentinel lymph nodes
draining a primary tumor in patients with melanoma, breast cancer
or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results
guide therapy decisions and determine patient prognosis and risk of
recurrence. Overall in the U.S., solid tumor cancers may represent
up to 1.2 million cases per year. The sentinel node label in the
U.S. and Europe may address approximately 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed annually.
EU Lymphoseek® Indication
Radiolabelled Lymphoseek is indicated 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.
External imaging and intraoperative evaluation may be performed
using a gamma detection device.
Important Safety Information about Lymphoseek®
for EU patients
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers.
In clinical trials, no patients experienced serious adverse
reactions and the most common adverse reactions were injection site
irritation and/or pain (<1%).
Prescribing information and more information about Lymphoseek
for EU patients is available on the EMA website.
For full prescribing information and more information about
Lymphoseek for U.S. patients, please visit: www.lymphoseek.com.
About Norgine
Norgine is a European specialist pharmaceutical company that has
been established for over 100 years. In 2015, Norgine’s total
revenue was EUR 320 million and the company employs over 1,000
people.
Norgine provides expertise and ‘know how’ in Europe to develop,
manufacture and market products that offer real value to healthcare
professionals, payers and patients. Norgine’s approach and
infrastructure is integrated and focused upon ensuring that Norgine
wins partnership opportunities for growth.
Norgine is headquartered in the Netherlands and its global
operations are based in Amsterdam and in Harefield, UK. Norgine
owns a R&D site in Hengoed, Wales and two manufacturing sites,
one in Hengoed, Wales and one in Dreux, France.
For more information, please visit www.norgine.com.
In 2012, Norgine established a complementary business Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the U.S. For more
information, please visit www.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of
companies.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision immunodiagnostic agents and
immunotherapeutics. Navidea is developing multiple
precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment and, ultimately, patient care.
Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved
by the FDA in March 2013 and in Europe in November 2014. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. Navidea’s strategy is to deliver superior
growth and shareholder return by bringing to market novel products
and advancing the Company’s pipeline through global partnering and
commercialization efforts. For more information, please visit
www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, our
ability to repay our debt, the outcome of the CRG litigation,
reliance on third party manufacturers, accumulated deficit, future
capital needs, uncertainty of capital funding, dependence on
limited product line and distribution channels, competition,
limited marketing and manufacturing experience, risks of
development of new products, regulatory risks and other risks
detailed in the Company’s most recent Annual Report on Form 10-K
and other Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any
forward-looking statements.
Source: Navidea Biopharmaceuticals, Inc.
_____________________________________
References
1 European Medicines Agency LYMPHOSEEK approval 2014.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002085/human_med_001827.jsp&mid=WC0b01ac058001d124.
Accessed 13 September 2016.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160916005378/en/
Navidea BiopharmaceuticalsInvestors
& MediaSharon Correia,
978-655-2686Senior Director, Corporate CommunicationsorNavidea UK Ltd.30 Upper High StreetThame 0X9
3EZUnited KingdomNavideaUKLtd@navidea.comorNorgine Media:Isabelle Jouin, +44 (0)1895
453643Charlotte Andrews, +44 (0)1895 453607Follow us @norgine
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