- Following European Commission authorization,
Lymphoseek (technetium Tc 99m tilmanocept) Injection will be the
first approved Sentinel Lymph Node detection agent in the EU -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) has announced
that that the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has adopted a positive
opinion recommending the granting of marketing authorization for
Lymphoseek® 250 micrograms kit for radiopharmaceutical preparation
(tilmanocept) in the European Union (EU). The recommendation is for
Lymphoseek use in imaging and intraoperative detection of sentinel
lymph nodes draining a primary tumor in adult patients with breast
cancer, melanoma, or head and neck oral cavity squamous cell
carcinoma.
The CHMP's positive recommendation will be reviewed by the
European Commission, which has the authority to approve medicinal
products for use in the 28 countries of the European Union and
generally follows the recommendations of the CHMP. Navidea expects
the European Commission to issue its final decision on the
marketing authorization for Lymphoseek later this year.
"This positive CHMP opinion moves Lymphoseek closer to becoming
the first and only sentinel lymph node detection agent approved in
all 28 member countries of European Union,” said Michael Goldberg,
M.D., Interim CEO of Navidea. "We believe Lymphoseek is
differentiated in its ability to reliably and accurately locate
sentinel lymph nodes draining a tumor, to help more effectively
stage cancer and inform post-surgical treatment, and to decrease
patient morbidity. We are increasingly excited by the global
opportunity for Lymphoseek as we build upon our approval in the
U.S. and prepare to make the product available next year to
physicians in Europe looking to provide the best care for their
patients.”
“Current medical practices for head and neck cancers call for
removal of large numbers of lymph nodes, lymph node dissection,
even in patients without proven lymph node metastasis,” said
Professor Remco de Bree, M.D., Ph.D., Department of
Otolaryngology-Head and Neck Surgery, VU University Medical Center,
Amsterdam, The Netherlands. “Using the common practice of elective
treatment of the neck, large numbers of patients undergo
unnecessary extensive surgical procedures, which are associated
with the risk of decreased shoulder function, decreased quality of
life and increased costs. The practice of Sentinel Lymph Node
Biopsy (SLNB) may offer a less invasive and equally predictive
alternative for patient staging and directing adequate treatment of
the neck. We welcome the addition of Lymphoseek in Europe as an
approved sentinel lymph node detection agent with the potential to
offer surgeons the ability to reliably and accurately guide SLNB
procedures.”
The opinion of the CHMP was based on positive and consistent
results from Lymphoseek’s three pivotal prospective Phase 3 studies
in melanoma, breast cancer, and certain head and neck cancers and
included associated analysis of the combined data from more than
500 subjects. All three studies showed positive diagnostic
performance of Lymphoseek across the solid tumor types studied. To
date, no clinically significant drug-related adverse reactions have
been reported. Lymphoseek has no contraindications and the most
common adverse reactions were injection site irritation and/or pain
(<1%).
Lymphoseek is approved in the U.S. by the U.S. Food and Drug
Administration (FDA) for use in lymphatic mapping to assist in the
detection of tumor-draining lymph nodes in patients with breast
cancer or melanoma and for use in guiding sentinel lymph node
biopsy in certain oral cancer patients. Lymphoseek is also the
subject of a supplemental New Drug Application (sNDA) currently
under review by the FDA, related to broader and more flexible
utilization in lymphatic mapping procedures.
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 with breast cancer, melanoma and head and neck cancer
patients with oral cavity carcinoma. 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 lymphatic mapping to assist in the localization of
lymph nodes draining a primary tumor in patients with breast cancer
or melanoma and for use in guiding sentinel lymph node biopsy in
head and neck cancer patients with squamous cell carcinoma of the
oral cavity. The Company anticipates continuing development of
Lymphoseek into other solid tumor areas.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. According to publicly available information,
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 are
expected to be diagnosed in the United States in 2014, 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.
Lymphoseek Indication and Important Safety Information in the
United StatesLymphoseek (technetium Tc 99m tilmanocept)
Injection is indicated, using a hand-held gamma counter, for:
- Lymphatic mapping to assist in the
localization of lymph nodes draining a primary tumor site in
patients with breast cancer or melanoma;
- Guiding sentinel lymph node biopsy, in
patients with clinically node negative squamous cell carcinoma
(SCC) of the oral cavity.
Important Safety InformationIn 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%).
Full Lymphoseek Prescribing Information Can Be Found at:
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. 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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