Navidea’s Commercial Partner, Norgine B.V., Launches LYMPHOSEEK® in Europe

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea”), a company
focused on the development and commercialization of precision
immunodiagnostic agents and immunotherapeutics, today announced that its
European commercial partner, SpePharm AG, an affiliate of Norgine, B.V.,
launched LYMPHOSEEK® (technetium TC 99m tilmanocept), originally
developed by Navidea, in Denmark, the Netherlands and the UK.

Navidea entered into an exclusive sublicense agreement with SpePharm, in
exchange Navidea received an upfront payment, milestone payments and
will receive royalties on all European net sales. The territory covered
by the agreement includes all 28 member states of the European Economic
Union.

LYMPHOSEEK® is specifically designed to target, bind to and be retained
in sentinel lymph nodes, the first lymph node (or group of nodes) to
which cancer cells are most likely to spread from a primary tumour.
LYMPHOSEEK® has a false negative rate of 2.6% in T1-T4cN0 oral squamous
cell carcinoma (OSCC). It detected sentinel lymph nodes in 98% of
patients with Tis, Tx or T1-T4cN0 breast cancer and T1-T4cN0 melanoma.

Michael Goldberg, M.D., President and Chief Executive Officer of
Navidea, stated, “The commercial launch of tilmanocept is an important
revenue provider for Navidea through royalties that boost our ability to
progress our Manocept™ platform further not only in diagnostic utility
but also advancing therapeutics development. I applaud Norgine in
launching tilmanocept’s successful commercialization in three European
countries. We also look forward to bringing additional value to our
shareholders, and to patients, as Norgine strategizes expanding its
commercial launch into the remaining European Union countries.”

Europe represents a major growth opportunity and medical need due to
LYMPHOSEEK®’s ability to identify lymphatic drainage from tumors in the
floor of the mouth (underneath the tongue). Currently up to 70-80% of
patients with early oral cancer receive elective neck dissection
surgery, an expensive procedure which could be avoided by using sentinel
lymph node biopsy (SLNB) for staging. In major European markets, 76,917
new cases of head and neck cancer diagnosed in 2014. The European
nuclear medicine/radiopharmaceuticals market is expected to reach $1.62
billion by 2020 from $1.09 billion in 2015, growing at a CAGR of 8.2%
from 2015 to 2020.

About LYMPHOSEEK^®

LYMPHOSEEK^® 50 microgram kit for radiopharmaceutical
preparation is approved in Europe for imaging and intraoperative
detection of sentinel lymph nodes draining a primary tumor in adult
patients with breast cancer, melanoma, or localized squamous cell
carcinoma of the oral cavity.² External imaging and
intraoperative evaluation may be performed using a gamma detection
device.² LYMPHOSEEK^® is designed for the precise
identification of lymph nodes that drain from a primary tumor, which
have the highest probability of harboring cancer.

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%).

Please see full Prescribing
Information on www.lymphoseek.com
for more information.

About Sentinel lymph node biopsy

Sentinel lymph node biopsy (SLNB) is a diagnostic procedure which
involves surgical removal of the first lymph node or group of nodes (the
sentinel node) which drain directly from the primary cancer site. It is
a surgical procedure which requires an overnight stay in hospital and
usually has no significant morbidity attached to it.

About Norgine B.V.

Norgine is a leading European specialist pharmaceutical company with a
direct commercial presence in all major European markets. In 2016,
Norgine’s total revenue was EUR 368 million. Norgine employs over 1,000
people across its commercial, development and manufacturing operations
and manages all aspects of product development, production, marketing,
sale and supply. Norgine specialises in gastroenterology, hepatology,
cancer and supportive care.

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in
Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux,
France.

About Navidea Biopharmaceuticals

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of precision
immunodiagnostic agents and immunotherapeutics. Navidea is developing
multiple precision-targeted products based on its ManoceptTM platform to
enhance patient care by identifying the sites and pathways of disease
and enable better diagnostic accuracy, clinical decision-making, and
targeted treatment. Navidea’s Manocept platform is predicated on the
ability to specifically target the CD206 mannose receptor expressed on
activated macrophages. The Manocept platform serves as the molecular
backbone of Tc 99m tilmanocept, the first product developed and
commercialized by Navidea based on the platform. The development
activities of the Manocept immunotherapeutic platform are being
conducted by Navidea in conjunction with its subsidiary, Macrophage
Therapeutics, Inc. Navidea’s strategy is to deliver superior growth and
shareholder return by bringing to market novel products and advancing
the Company’s pipeline through global partnering and commercialization
efforts.

For more information, please visit www.navidea.com.

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