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Navidea Biopharmaceuticals’ NAV4694 β-Amyloid Imaging Agent to Be Used in Alzheimer’s Disease Studies by Australian



  Navidea Biopharmaceuticals’ NAV4694 β-Amyloid Imaging Agent to Be Used in
  Alzheimer’s Disease Studies by Australian Imaging, Biomarker & Lifestyle
  Flagship Study of Ageing (AIBL)

 Leading Neurodegenerative Disease and Imaging Research Consortium to Convert
   to NAV4694 from “Gold Standard” ^11C-labeled Pittsburgh Compound-B (PiB)

Business Wire

DUBLIN, Ohio -- July 16, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced that the
Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL)
plans to switch to using Navidea’s Fluorine-18 labeled β-amyloid imaging
candidate, NAV4694, from ^11C-labeled Pittsburgh Compound-B (PiB) for its
comprehensive research initiative in Alzheimer’s disease and Mild Cognitive
Impairment. Dr. Christopher C. Rowe, MD FRACP, Director of the Department of
Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia,
announced the changeover to NAV4694 at the World Wide Alzheimer's Disease
Neuroimaging Initiative meeting in Boston, MA.

AIBL, a globally renowned, multi-disciplinary effort to investigate factors
impacting the development of Alzheimer’s disease across Australia, has
previously employed the widely-recognized PiB compound in its research. PiB is
the PET imaging agent prototype for β-amyloid detection, and remains an
accepted benchmark standard for studies investigating Alzheimer’s disease and
differential diagnoses of dementia. Recently published results from a
head-to-head study funded by AstraZeneca that directly compared PiB to NAV4694
demonstrated that NAV4694 displayed imaging characteristics nearly identical
to those of PiB.^1

“Recent updates to appropriate use criteria allow for earlier diagnosis and
therapeutic intervention in the diagnosis of probable Alzheimer’s disease, and
we believe β-amyloid PET imaging will play an increasingly important role for
clinicians investigating this disease,” said Dr. Rowe, lead author on the
head-to-head study. “As the accepted benchmark β-amyloid imaging agent, PiB
has an excellent performance profile, but issues around timing, logistics and
costs make its routine use challenging. A β-amyloid imaging agent that is
accessible and affordable and that can be reliably interpreted in a variety of
clinical settings would be most pragmatic. Our studies with NAV4694 show that
it mirrors the performance of PiB, and that we can therefore confidently make
this changeover and begin using NAV4694 in our research.”

“The team at AIBL is recognized as a world leader in neurodegenerative disease
and imaging diagnostics, and we are honored that they have selected NAV4694 as
a β-amyloid standard for their research,” said Thomas H. Tulip, PhD, President
and Chief Business Officer of Navidea. “We are pleased to support AIBL’s work
in advancing research and knowledge about the development and diagnosis of
Alzheimer’s disease, with the mutual goal of providing physicians with an
improved diagnostic tool having outstanding performance characteristics that
can aid in the diagnosis of Alzheimer's disease and other forms of
neurodegenerative dementia.”

About NAV4694

NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate
intended for use in Positron Emission Tomography (PET) imaging and evaluation
of patients with signs or symptoms of cognitive impairment such as Alzheimer’s
disease (AD). NAV4694 binds to β-amyloid deposits in the brain that can then
be imaged in scans. β-amyloid plaque pathology is widely used in the diagnosis
of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may
enable earlier identification of AD and improve monitoring of disease
progression and interpretation of brain scan images. Navidea has an ongoing
NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for
NAV4694 in AD.

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.

^1 Rowe CC, Pejoska S, Mulligan R, et al. Head-to-Head Comparison of ^11C-PiB
and ^18F-AZD4694 (NAV4694) for β-Amyloid Imaging in Aging and Dementia. J Nucl
Med. 2013; 54:880-886.

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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