Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, announced that today it held an update
meeting with the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) for the pending
Marketing Authorization Application (MAA) of Lymphoseek®
(technetium Tc 99m tilmanocept) Injection. Lymphoseek is a
lymphatic mapping agent designed to identify the lymph nodes that
drain from a primary tumor, which have the highest probability of
harboring cancer. As part of the MAA review process, Navidea
presented Oral Explanations to the CHMP relating to open questions
in the Lymphoseek MAA. At the conclusion of the meeting, the CHMP
informed Navidea that the Committee will continue with its review
of the MAA. Navidea believes the course of the review
continues to be supportive of its market development plans and
outlook for material revenue generation in Europe beginning in
2015, as previously disclosed.
Based on feedback received at the meeting, Navidea believes that
the CHMP has found the safety and efficacy data submitted in the
MAA for breast cancer and melanoma to be acceptable. The CHMP will
now focus its review on the remaining areas of product
specifications unique to the European application and on data from
the Phase 3 study in head and neck cancer. During this process,
the MAA remains active but the review clock will continue to
be stopped while Navidea works with the CHMP to address these
remaining areas.
"The European review of Lymphoseek continues to progress.
The Oral Explanation meeting was productive and provided an
opportunity for both Navidea and our technical experts to
discuss the Lymphoseek application with the CHMP. We achieved
our goals in this meeting of getting positive feedback on the
breast cancer and melanoma aspects of the filing and clarifying the
remaining areas of focus so the review can proceed in a timely
manner. We appreciate the CHMP's constructive input and
guidance,” stated Mark Pykett, VMD, PhD, Navidea CEO. “We will
continue our ongoing dialogue with the EMA to address
remaining areas and plan to provide further updates on this process
in the coming weeks.”
The Lymphoseek MAA is supported by a comprehensive, multi-trial
clinical program including two Phase 3 studies of Lymphoseek
(NEO3-05 and NEO3-09) performed in patients with either breast
cancer or melanoma and a third Phase 3 study (NEO3-06), in patients
with head and neck cancer, contributing to a safety database of
more than 550 patients. The MAA is based on the same pivotal
efficacy and safety data package provided in the U.S. New Drug
Application (NDA) and two supplemental NDA (sNDA) submissions. The
U.S. Food and Drug Administration (FDA) approved Lymphoseek in the
United States in 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. Lymphoseek was also granted Fast
Track designation and Priority Review for one of its sNDAs focused
on sentinel lymph node detection in patients with head and neck
cancer, with an upcoming Prescription Drug User Fee Act (PDUFA)
target date of June 16, 2014. The second sNDA has a PDUFA target
date of October 16, 2014.
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 (FDA) 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 and is
currently in review with the FDA.
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
Lymphoseek
Indication
Lymphoseek (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 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.
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 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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