– Lymphoseek is first and only FDA-approved
sentinel lymph node biopsy agent for use in head and neck cancer
patients with oral cavity carcinoma –
– Lymphoseek now available for multiple patient
populations using existing reimbursement codes –
– Company to Host Conference Call on Monday,
June 16, 2014, 8:30 a.m. EDT –
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced that the U.S. Food and Drug
Administration (FDA) has approved the Supplemental New Drug
Application (sNDA) for the expanded use of Lymphoseek® (technetium
Tc 99m tilmanocept) Injection indicated for guiding sentinel lymph
node (SLN) biopsy in head and neck cancer patients with squamous
cell carcinoma of the oral cavity. Lymphoseek becomes the
first and only FDA-approved radiopharmaceutical application for
sentinel lymph node detection and was first approved in March 2013
for lymphatic mapping in breast cancer and melanoma patients.
“In the current standard of care for certain head and neck
tumors, such as oral cavity cancers, as many as 30 or more lymph
nodes may be removed during a surgical procedure. While sentinel
lymph node mapping may be an effective alternative to elective neck
dissection, adoption of this approach has been slow in the U.S.
because of the lack of an FDA-approved agent with favorable
characteristics for use in the head and neck region,” said Stephen
Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head
and Neck Surgery, The University of Texas MD Anderson Cancer
Center. “This underscores the urgent need Lymphoseek may be able to
address in improving the precision of SLN mapping and decreasing
nodal excision to an average of only four lymph nodes. As a result,
Lymphoseek offers the potential to more effectively stage certain
cancers, direct post-surgical treatment and decrease patient
morbidity.”
“Our community eagerly welcomes a diagnostic aid such as
Lymphoseek that may allow for a less invasive surgical procedure
for patients with oral, head, and neck cancers,” said Nancy
Leupold, Founder & President of Support for People with Oral,
Head, and Neck Cancer. “According to the National Cancer Institute,
oral, head, and neck cancers account for approximately three
percent of all malignancies in the United States, however,
post-procedural side effects are more severe than with many other
types of cancer. Significant changes in a patient's facial and neck
appearance may be present. In addition, a patient may have
difficulty with chewing, swallowing, smelling, tasting, speaking
and hearing in addition to dental problems.”
“With this approval, Lymphoseek is now the only FDA-approved
diagnostic agent with a label for guiding sentinel lymph node
biopsy procedures and will be immediately available with the
existing reimbursement codes for this expanded population of cancer
patients,” said Michael Goldberg M.D., Navidea Interim Chief
Executive Officer. “Navidea intends to continue its investment in
Lymphoseek to further expand its use in other types of cancer,
where current alternatives are neither efficient nor effective. We
believe Lymphoseek can play a critical role in the staging and
treatment of cancer, with potential for additional procedural cost
savings.”
The expanded approval is supported by data from Navidea’s
NEO3-06 prospective Phase 3 study that showed with statistical
significance the ability of Lymphoseek to correctly identify
patients with pathology-positive lymph nodes compared with multiple
level lymph node dissection and pathology assessment, which is the
current “gold standard.” The findings indicate that Lymphoseek
accurately identified SLNs in the trial subjects for assessment,
and is likely to be predictive of overall node pathology status.
Moreover, multiple level nodal dissections of patients in the trial
with cancer-positive lymph nodes led to an average removal of 38
lymph nodes per patient, whereas Lymphoseek on average would have
led to the removal of approximately 4 lymph nodes, representing a
substantial reduction in potential morbidity for patients with head
and neck cancer undergoing sentinel lymph node biopsy.
The FDA granted the Lymphoseek application Fast Track
Designation in December 2013 and Priority Review in February 2014.
Fast Track Designation and FDA Priority Review are awarded to drug
applications to expedite review of drug candidates intended to
treat serious or life-threatening conditions, that demonstrate the
potential to address unmet medical needs and may offer a
significant improvement in treatment over existing options. Navidea
has an additional sNDA under review at the FDA to further expand
the Lymphoseek label. This second sNDA focuses on more flexible and
extended utilization practices, and has been assigned a PDUFA date
set for October 16, 2014.
Conference Call DetailsNavidea will host a conference
call with the investment community to discuss the sNDA scheduled
for Monday, June 16, 2014 at 08:30 a.m. EDT. Investors and the
public are invited to access the live webcast through the link
below. Participants who would like to ask questions during the
question and answer session following the presentation must
participate by telephone also. Participants are encouraged to
log-in and/or dial-in fifteen minutes before the conference call
begins. The webcast replay is expected to be available on our
investor website, http://ir.navidea.com, approximately two to four
hours after the live event.
Event: Navidea Biopharmaceuticals sNDA Approval Call
Date/Time: Monday, June 16, 2014 at 08:30 a.m. EDT Webcast Link:
http://public.viavid.com/index.php?id=109550
Dial-in Number – US: 1-877-407-0789 Dial in Number – Int’l:
1-201-689-8562 Replay
A webcast replay will be available on the
Investor Relations section of our website at
http://ir.navidea.com.
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
InformationLymphoseek (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 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 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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