Navidea Biopharmaceuticals Announces Presentation of Meta-Analysis Results of Lymphoseek® and ACOSOG Radiolabeled Colloid in

  Navidea Biopharmaceuticals Announces Presentation of Meta-Analysis Results
  of Lymphoseek® and ACOSOG Radiolabeled Colloid in Head and Neck Cancer

    Lymphoseek Demonstrated Statistically Significant Efficacy and Overall
        Accuracy Performance in Identification of Sentinel Lymph Nodes

SNMMI 2013

Business Wire

DUBLIN, Ohio -- June 12, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced results
from a meta-analysis study of Lymphoseek^® (technetium Tc 99m tilmanocept)
Injection, a novel, receptor-targeted, small-molecule radiopharmaceutical. The
study compared Lymphoseek performance data from a pre-planned interim analysis
of its Phase 3 clinical trial (NEO3-06) versus published data from the ACOSOG
Z-0360 trial which was done using radiolabeled sulfur colloid. Results in this
study demonstrated that Lymphoseek identified sentinel lymph nodes (SLNs) in
subjects with squamous cell carcinoma of the head or neck (SCC) with a False
Negative Rate (FNR) of 2.56%, whereas sulfur colloid demonstrated an FNR of
10% (p=0.0006). Lymphoseek identified SLNs with an overall accuracy of 99%,
versus an overall accuracy of sulfur colloid of 97%. Dr. Francisco J.
Civantos, MD, FACS, University of Miami School of Medicine, Miami, Fla.,
presented the results in an oral presentation at the 2013 Annual Meeting of
the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Vancouver,
Canada.

“False negative rates and overall accuracy are key metrics used to define the
potential for performance of radiolabeled agents in lymphatic mapping and the
evaluation of nodal metastasis. We believe the fact that Lymphoseek achieved
statistically significant results, with a false negative rate of only 2.56%
and 99% overall accuracy, attests to the performance of the product in
identifying the appropriate tumor-draining lymph nodes,” said Frederick O.
Cope, PhD, Senior Vice President and Chief Scientific Officer at Navidea.

“The removal of minimal lymph tissue while obtaining appropriate information
as to whether cancer has spread is one of the key goals of sentinel lymph node
biopsy, because approximately 75% of head and neck cancer patients may have
pathology-negative lymph nodes and therefore do not require surgical removal
of the full regional lymph node chain, as is a typical practice currently,”
commented Dr. Civantos. “New receptor-targeted radiopharmaceuticals such as
technetium-labeled tilmanocept may facilitate the diagnostic evaluation of
these patients, to help spare them possible serious morbidity from full
regional lymph node dissections.”

“We are pleased that we could present results from this comparative
meta-analysis with Lymphoseek to the nuclear medicine physicians and industry
experts at SNMMI, as thousands of patients with head and neck cancer stand to
benefit from accurate diagnostic evaluation of their condition. The study uses
top-line results from our interim analysis of Lymphoseek in the NEO3-06 Phase
3 clinical trial in head and neck cancer, and those developed in a widely
regarded, independent, multi-center study,” said Mark Pykett, VMD, PhD, CEO of
Navidea. “Our NEO3-06 Phase 3 trial is an important clinical trial in
highlighting our belief that Lymphoseek may provide advances that could
benefit thousands of patients with head and neck cancer. Assessment of the
full data-set from the NEO3-06 trial continues, and we are working with the
FDA to evaluate the submission of a supplemental NDA that may potentially
augment the Lymphoseek label.”

About the Meta-analysis

The study used meta-analysis to examine two key parameters for assessing
performance of radiotracing agents in lymphatic mapping and the evaluation of
nodal metastasis in SCC: False Negative Rate (FNR), the percentage of patients
in whom the sentinel lymph node failed to correctly stage the patient; and
overall accuracy (AC), the degree of correctness. All patients in both studies
received sentinel lymph node biopsy and complete, elective dissection of head
and neck lymph nodes, and all nodes were evaluated for the presence of tumor.
Results for Lymphoseek indicated a FNR of 0.0256 (95% CI=0.001, 0.138; n=39);
p<0.0006 as compared to radiolabeled sulfur colloid; the FNR for radiolabeled
sulfur colloid was 0.10 (95% CI=0.027, 0.231; n=41). Overall accuracy for
Lymphoseek was 0.99 (n=82; P<0.0161 against radiolabeled sulfur colloid). The
overall accuracy for radiolabeled sulfur colloid was 0.97 (n=140).

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.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy
decisions and determines patient prognosis and risk of recurrence. According
to the American Cancer Society, approximately 232,000 new cases of breast
cancer, 77,000 new cases of melanoma and 67,000 new cases of head and
neck/oral cancer are expected to be diagnosed in the United States in 2013.

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 actively developing
four radiopharmaceutical agent platforms – Lymphoseek^®, NAV4694, NAV5001 and
RIGScan^TM – to help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making and, ultimately,
patient care. 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.

Contact:

Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Stern Investor Relations, Inc.
Beth DelGiacco, 212-362-1200
 
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