Navidea to Collaborate with Maimonides Medical Center on Clinical Trial Utilizing Lymphoseek® for Lymphatic Mapping in

  Navidea to Collaborate with Maimonides Medical Center on Clinical Trial
  Utilizing Lymphoseek® for Lymphatic Mapping in Colorectal Cancer

‒ Study will evaluate use of Lymphoseek to pinpoint lymph nodes most likely to
                               contain cancer ‒

Business Wire

DUBLIN, Ohio -- February 4, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced it has
entered into an agreement to collaborate with Maimonides Medical Center to
investigate the utility of Lymphoseek (technetium Tc 99m tilmanocept)
Injection in lymphatic mapping procedures for colorectal cancer. Dr. Danny
Sherwinter, surgeon and the Director of the Department of Minimally Invasive &
Bariatric Surgery at Maimonides Medical Center in Brooklyn, NY, will lead the
investigator-initiated clinical study. This open-label evaluation, expected to
start enrollment in early 2013, will be performed at Maimondes and will
include the assessment of lymph nodes from up to 40 colon cancer subjects.
According to the American Cancer Society, approximately 140,000 new cases of
colorectal cancer are expected to be diagnosed in the United States annually^1
while worldwide annual diagnosis is over 1.2 million.^2

"While colorectal surgeons have a strong interest in being able to more
accurately pinpoint lymph nodes most likely to contain cancer from among the
full draining bed of nodes removed during colorectal cancer resection, the
field has been awaiting the advent of a suitable lymphatic mapping agent,”
commented Dr. Sherwinter. “Although efforts are growing in the use of lymph
node mapping in colorectal cancer, the poor sensitivity of current agents and
techniques has hindered progress in the field. Due to its receptor-targeting
properties and strong performance in other malignancies such as breast and
melanoma, Lymphoseek holds promise to open new opportunities in the field of
lymphatic mapping in colorectal cancer."

Currently, the approach to lymph node assessment in colorectal cancer is to
remove the entire lymph node basin during colon resection surgery, resulting
in a large number of lymph nodes for pathology analysis. Interest in lymphatic
mapping in colorectal cancer is growing however broad application is impeded
by limitations in existing technology which have been associated with high
false negative rates.^3 With results from Phase III studies demonstrating its
rapid injection site clearance and retained localization to key predictive
lymph nodes, Lymphoseek has performance advantages that may be well suited to
lymphatic mapping in settings such as colorectal cancer in an effort to reduce
false negative rates and morbidity, and provide improved diagnostic accuracy.

"This study represents an important step forward in advancing Lymphoseek’s
medical and market potential in additional cancers where lymphatic mapping may
be very useful but in which effective technologies haven't been developed,”
said Mark Pykett, Navidea’s President and CEO. “Collaborations such as this,
with innovative investigators at leading medical institutions, are part of
Navidea's strategy to maximize the potential for Lymphoseek and help patients
who might benefit from more precise identification of key predictive lymph
nodes that harbor cancer."

About Lymphoseek^®

Lymphoseek^® (technetium Tc 99m tilmanocept) Injection is a novel,
receptor-targeted, small-molecule, investigational radiopharmaceutical used in
lymphatic mapping procedures that are performed to help stage cancers such as
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.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumor
metastases are identified and biopsied to determine if cancer has spread
beyond the primary tumor. Accurate staging of cancer is critical, as it guides
therapy decisions and determines patient prognosis and risk of recurrence.
According to the American Cancer Society, approximately 229,000 new cases of
breast cancer, 76,000 new cases of melanoma and 67,000 new cases of head and
neck cancers are expected to be diagnosed in the United States in 2012.

About Lymphatic Mapping

Lymphatic mapping is a procedure designed to guide lymph node dissection and
biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often
accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure
routinely performed pre-operatively to provide guidance on the location of
lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes
draining the area around a tumor are identified and biopsied to determine if
cancer has spread to the lymph nodes. These nodes, commonly referred to as
“Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant
cells. Lymphatic Mapping provides an accurate staging procedure that can help
ensure optimal surgical and therapeutic choices, including the avoidance of
the morbidity of a complete lymph node dissection for patients in whom the
Sentinel Lymph Nodes were found to be free of cancer.

About Navidea

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
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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.

^1 Cancer Statistics, 2013. CA Cancer J Clin, 2013;63:11–30

^2 Ferlay J et al; "GLOBOCAN 2008: Estimated Incidence, and Mortality and
Prevalence Worldwide in 2008." IARC CancerBase No. 10; Lyon, France:
International Agency for Research on Cancer; 2010; p1

^3 Tiffet O et al; “Combining radioisotopic and blue-dye technique does not
improve the false-negative rate in sentinel lymph node mapping for colorectal
cancer.” Dis Colon Rectum. 2007 Jul;50(7):962-70.

Contact:

Navidea Biopharmaceuticals, Inc.
Brent Larson, 614-822-2330
Sr. VP & CFO
 
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