- Additional Supplemental New Drug
Application (sNDA) for Lymphoseek focuses on more flexible and
expanded utilization practices -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, announced today that the U.S. Food and Drug
Administration (FDA) has accepted for review an additional
Supplemental New Drug Application (sNDA) for the proposed expanded
label for Lymphoseek® (technetium 99m tilmanocept) Injection to
support broader and more flexible use in imaging and lymphatic
mapping procedures, including lymphoscintigraphy and other
optimization capabilities. Under the Prescription Drug User Fee Act
(PDUFA), the FDA has set a target review date for the second
Lymphoseek sNDA of October 16, 2014.
The two Lymphoseek sNDAs now accepted are derived from a single,
data-rich application submitted to FDA in December 2013. In
assessing the application, FDA chose to separate the filing in two
based on the proposed labeling extensions requested and the scope
of information provided. This second sNDA application is aimed at
expanding the Lymphoseek label to support more flexible utilization
practices for Lymphoseek in lymphatic mapping and
lymphoscintigraphy imaging. The first sNDA, aimed at Lymphoseek’s
use as a sentinel lymph node detection agent in patients with head
and neck cancer, received FDA Fast Track designation and was
accepted for Priority Review, as previously announced, with a PDUFA
date target of June 16, 2014. Lymphoseek is currently approved for
use in lymphatic mapping procedures performed to aid in the
diagnostic evaluation of lymph nodes draining a primary tumor in
patients with breast cancer and melanoma.
“The FDA’s decision to review an additional sNDA to further
expand Lymphoseek’s labeling underscores our belief that the agent
can make a critical difference for patients as part of their
overall diagnosis and treatment,” commented Cornelia Reininger, MD,
PhD, Navidea’s Senior Vice President and Chief Medical Officer.
“Additionally, the FDA’s decision to grant Priority Review for our
first Lymphoseek sNDA focused on sentinel lymph node (SLN)
detection in patients with head and neck cancer supports
recognition that Lymphoseek-guided SLN detection in this disease
can have a significant impact on morbidity. Label expansion for
these sNDAs, if approved, may allow for broader cancer-type use,
enable more consistent and standardized lymphatic mapping and
lymphoscintigraphy analysis, and address important areas of unmet
medical need.”
The second Lymphoseek sNDA seeks to expand product claims to
enable broader and more flexible utilization of the agent in
routine practice, including lymphoscintigraphy imaging and flexible
timing of Lymphoseek administration allowing for a 2-day protocol.
Data submitted in support of these parameters were derived from
Navidea’s series of prospective, well-controlled Phase 3 studies in
patients with breast cancer, head and neck cancer, and melanoma.
These study results demonstrated the ability of Lymphoseek to
detect lymph nodes in same-day or subsequent-day surgery following
injection, as well as being used in lymph node imaging, or
lymphoscintigraphy.
About Lymphoseek®Lymphoseek® (technetium Tc 99m
tilmanocept) Injection is a novel, receptor-targeted,
small-molecule radiopharmaceutical used in lymphatic mapping
procedures that are performed to help in the diagnostic evaluation
of potential cancer spread for patients with breast cancer and
melanoma. Lymphoseek is designed to identify the lymph nodes that
drain from a primary tumor, which have the highest probability of
harboring cancer. Lymphoseek was approved by the U.S. Food and Drug
Administration in March, 2013 for use in lymphatic mapping to
assist in the localization of lymph nodes draining a primary tumor
in patients with breast cancer or melanoma. The Company anticipates
continuing development of Lymphoseek into other solid tumor areas
that may include head and neck cancers, prostate cancer, thyroid
cancer, lung/bronchus cancers, colorectal cancer and others.
Lymphoseek was granted Fast Track and Priority Review designation
for its sNDA for sentinel lymph node detection in patients with
head and neck cancer.
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 69,500 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 137,000 new cases of head and neck/oral cancer
diagnosed in Europe annually.
U.S. Indication and Important Safety Information About
LymphoseekIndicationLymphoseek (technetium Tc 99m
tilmanocept) Injection is a lymphatic mapping agent indicated for
use with a hand-held gamma counter to assist in the localization of
lymph nodes draining a primary tumor site in patients with breast
cancer or melanoma.
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.
The most common adverse reactions are 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 NAV4694, NAV5001, Manocept™ 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 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, Executive VP & CFO,
614-822-2330orSharon Correia, Associate Director, Corporate
Communications, 978-655-2686
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