- Lymphoseek® (technetium Tc 99m tilmanocept)
Injection Use for Sentinel Lymph Node detection also expanded to
include Breast Cancer and Melanoma -
- Expanded Lymphoseek indication increases the
addressable market with the potential to benefit up to 1.2 million
solid tumor patients in U.S. annually -
- Company to Host Conference Call on Wednesday,
October 15, 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 for lymphatic mapping in solid tumors
and adding Sentinel Lymph Node detection for breast cancer and
melanoma to the approved indications. Lymphoseek is now indicated
for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management
- Guiding Sentinel Lymph Node Biopsy
(SLNB) using a handheld gamma counter in patients with clinically
node negative squamous cell carcinoma (SCC) of the oral cavity,
breast cancer or melanoma.
The FDA also allowed expanded utilization of Lymphoseek with or
without scintigraphic imaging, known as lymphoscintigraphy, to
enable pre-operative imaging and mapping of lymph nodes to
facilitate node localization during surgical procedures. Lymphoseek
is the first and only FDA-approved radiopharmaceutical agent for
sentinel lymph node detection, is the only FDA-approved agent for
lymphatic mapping of solid tumors, and will be immediately
available using existing reimbursement codes for this expanded
population of cancer patients.
“Lymphoseek is the now the only agent approved by the FDA for
lymphatic mapping across solid tumors when used as a component of
surgical management. This significantly expands the potential
market for Lymphoseek and materially enhances the Company’s ability
to promote the use of Lymphoseek in solid tumor cancers where
assessment of lymphatic involvement is critical to properly staging
the disease, especially colorectal, gynecological, lung and
prostate cancers,” said Michael Goldberg, M.D., Interim Chief
Executive Officer. “We are highly encouraged by the expanded FDA
approval and believe that Lymphoseek now has the potential to
become a standard-of-care in lymphatic mapping and sentinel lymph
node biopsy for the staging and prognosis of upwards of 1.2 million
patients diagnosed with solid tumors annually in the U.S. We are
eager to discuss the new label with surgeons and oncologists whose
patients should benefit from the improved data resulting from
better utilization of lymphatic mapping and Sentinel Lymph Node
Biopsy procedures.”
“Based on our clinical experience in melanoma and head and neck
cancers, Lymphoseek appears to be an effective agent for
cancer staging to guide pre- and intra-operative patient management
and post-surgical treatment thereby avoiding unnecessary surgical
interventions, reducing surgical time and limiting potential
complications with associated morbidity,” commented Dr.
Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department
of Head and Neck Surgery, The University of Texas MD Anderson
Cancer Center. “The ability of Lymphoseek to accurately identify
sentinel lymph nodes in patients, demonstrated in clinical evidence
from more than 500 patients, may not only improve diagnostic
accuracy, but also enable more efficient and appropriate patient
care and provide us with greater precision during surgery to detect
lymph nodes with the highest likelihood of harboring tumor
metastases.”
“The success of lymphatic mapping and sentinel lymph node biopsy
is dependent upon a radiopharmaceutical’s ability to concentrate in
the lymph nodes most likely to contain cancer,” said H. William
Strauss, M.D., Attending Physician Emeritus, Molecular Imaging and
Therapy Service at Memorial Sloan-Kettering Cancer Center.
“Lymphoseek, with its specifically-designed ability to target
molecular markers in tumor-draining lymph nodes, has shown through
clinical studies in breast cancer, melanoma and certain head and
neck cancers, to possess a high degree of sensitivity and accuracy.
Based on the reliable performance of Lymphoseek as demonstrated in
these tumor-types, this approval opens up potential diagnostic
imaging opportunities broadly across all forms of solid
tumors.”
The expanded approval is supported by data from Navidea’s
combined analysis of Lymphoseek’s pivotal prospective Phase
3 data in melanoma, breast cancer, and certain head and neck
cancers from more than 500 subjects. An integrated analysis of data
from all three studies showed positive diagnostic performance of
Lymphoseek across the solid tumor types studied. The findings
indicate that Lymphoseek accurately identified lymph nodes for
assessment in the trial subjects, and is likely to be predictive of
overall node pathology status. 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%).
In the approval action letter, the FDA also outlined a
post-marketing requirement for initiation of a pediatric study in
solid tumor cancer with a target date for submission in 2018.
Conference Call Details
Navidea will host a conference call with the investment
community to discuss the sNDA scheduled for Wednesday, October 15,
2014 at 8:30 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: Wednesday, October 15, 2014 at 8:30 a.m. EDT Webcast
Link:
http://public.viavid.com/index.php?id=111146
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. 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 been recommended by CHMP for European approval
in sentinel lymph node detection for melanoma, breast cancer or
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.
Lymphoseek Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management.
- Guiding sentinel lymph node biopsy
using a handheld gamma counter in patients with clinically node
negative squamous cell carcinoma of the oral cavity, breast cancer
or melanoma.
Important Safety Information
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%).
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
CommunicationsorMediaContinuum Health CommunicationsTerri
Clevenger, 203-856-4326
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