FDA Approves Navidea’s Lymphoseek® (technetium Tc 99m tilmanocept) Injection for Use in Lymphatic Mapping

  FDA Approves Navidea’s Lymphoseek® (technetium Tc 99m tilmanocept) Injection
  for Use in Lymphatic Mapping

The first receptor-targeted radiopharmaceutical approved for lymphatic mapping
                    in breast cancer and melanoma patients

         Company to Host Conference Call at 4:00 p.m., March 13, 2013

Business Wire

DUBLIN, Ohio -- March 13, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced U.S.
Food and Drug Administration (FDA) approval of Lymphoseek^® (technetium Tc 99m
tilmanocept) Injection, a novel product indicated for use in lymphatic mapping
procedures to assist in the localization of lymph nodes draining a primary
tumor in patients with breast cancer or melanoma. Lymphoseek is a receptor
targeted radiopharmaceutical designed to identify these lymph nodes which have
the highest probability of harboring cancer and thereby assist physicians in
the staging of such patients.

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 lymph nodes 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 and 77,000 new cases of melanoma are expected to be
diagnosed in the United States in 2013.^1

“We recommend lymphatic node mapping and sentinel node biopsy for patients
with early stage breast cancer and in select cases of ductal carcinoma in
situ,” said Anne Wallace, M.D., Professor of Surgery, UC San Diego School of
Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center;
and Principal Investigator for breast cancer in the Lymphoseek Phase 3
clinical trials. “The ability to reliably identify multi-node
pathology-positive patients is important to optimize their post-surgery
management and to spare certain patients from unnecessary surgery and
potentially debilitating side effects. Products specifically designed to
address reliable lymph node uptake and retention can provide significant
clinical utility and help standardize the process of lymph node mapping.”

“Both the incidence rate and the death rate for melanoma continue to increase,
in the United States and in many other parts of the world," said Vernon K.
Sondak, M.D., Chair, Department of Cutaneous Oncology, Moffitt Cancer Center,
Tampa Fla., and Principal Investigator for melanoma in the Lymphoseek Phase
3clinical trials. "Most patients present with clinically localized disease,
but microscopic metastases to the regional lymph nodes are common and are the
major prognostic factor for these patients. Over the past 20 years, surgical
staging of the regional nodes with intraoperative lymphatic mapping and
sentinel node biopsy has emerged as the worldwide standard of care for
patients with clinically node-negative intermediate and thick melanomas, and
for selected patients with higher-risk thin primaries as well. New
technologies offer the promise of improvingintraoperative lymphatic mapping,
allowing procedures to be done more quickly and potentially lessening the risk
of misclassifying patients as node-negative when in fact their tumor has
already spread to the regional nodes.”

The approval of Lymphoseek is based on data from more than 540 subjects
receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332
patients with either breast cancer or melanoma, Lymphoseek, on average, was
present in 97% (range 94-100%) of resected, histology-confirmed lymph nodes.
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%).

“We believe today’s approval of Lymphoseek validates our ability to advance
the field of precision diagnostics,” said MarkJ.Pykett, V.M.D., Ph.D.,
President and CEO of Navidea. “Our vision is to improve diagnostic accuracy,
clinical decision-making and patient care. We are gratified that our
scientific achievements may benefit thousands of patients diagnosed with
breast cancer and melanoma each year. We look forward to continuing the
development of Lymphoseek into additional indications and to progressing our
oncology and neurology pipeline.”

Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by
Cardinal Health, Inc. As part of the distribution agreement, Cardinal Health’s
Nuclear Pharmacy Services business will be responsible for commercializing and
dispensing Lymphoseek to health care professionals who are involved in
lymphatic mapping. Navidea is also working to identify and partner with
distributors in other markets outside of the U.S. Navidea will play an ongoing
role in commercial activities through focused deployment of medical science
liaison and medical education activities. This is consistent with Navidea’s
overall strategy to remain involved in market-based activities with its
products while leveraging the extensive capabilities and infrastructure of
partners around the world.

Conference Call for Investors

Navidea Biopharmaceuticals will host a conference call for investors, today at
4:00 p.m. EDT to discuss FDA’s approval of Lymphoseek. Conference call dial-in
details will be announced this afternoon.

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 stage 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, in
patients with breast cancer or melanoma.

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.
Lymphoseek was approved for use by the FDA on March 13, 2013. According to the
American Cancer Society, approximately 232,000 new cases of breast cancer and
77,000 new cases of melanoma are expected to be diagnosed in the United States
in 2013.

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.

Indication and Important Safety Information About Lymphoseek

Indication

Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for
lymphatic mapping 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.

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harbor for forward-looking statements made by or on behalf of the Company.
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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 ACS Cancer Facts & Figures, 2013

Contact:

Investors:
Navidea Biopharmaceuticals, Inc.
Brent Larson, 614-822-2330
Sr. VP & CFO
or
Media:
Makovsky & Co.
Mark Marmur, 212-508-9670
 
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