Approval Sets the Stage for Revenue
Generation through Targeted Launches in Europe
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) 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.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-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 the U.S. Food and Drug Administration
(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 has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines 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 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
annually.
EU Lymphoseek® Indication and Important Safety
Information
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 will be available at:
http://ec.europa.eu/health/documents/community-register/index_en.htm
For full prescribing information and more information about
Lymphoseek for U.S. patients, please visit: www.lymphoseek.com
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is developing multiple precision diagnostic
products and platforms including Manocept™, NAV4694, NAV5001, and
NAV1800 (RIGScan™), to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making 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 by the EMA in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and advancing
the Company’s pipeline through selective acquisitions, 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, 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.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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