Navidea Biopharmaceuticals Announces Completion of Additional Fundamental Clinical Trial for Radiopharmaceutical Agent, NAV4694,

  Navidea Biopharmaceuticals Announces Completion of Additional Fundamental
  Clinical Trial for Radiopharmaceutical Agent, NAV4694, in Alzheimer’s
  Disease

 - The Company also obtains rights to two additional β-amyloid imaging agents
                              from AstraZeneca -

Business Wire

DUBLIN, Ohio -- January 15, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced the
completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker
for visual detection and quantification of cerebral β-amyloid in diagnosing
Alzheimer’s disease (AD). The study was designed and conducted by Navidea’s
partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694
(NAV4694) on safety and the efficacy of Positron Emission Tomography (PET)
scanning in subjects with AD and in healthy volunteers (HVs). Evaluations were
completed on the effects of two mass doses of the radioligand on binding
parameters and overall image quality. These endpoints are typical and
important requirements of drug registration dossiers filed with regulatory
authorities for approval of diagnostic agents.

The completed trial was an open-label, non-randomized, multi-center, PET study
in a total of sixteen individuals (8 with mild to moderate AD and 8 elderly
HVs) each imaged on two PET systems at Karolinska Institutet sites in
Stockholm, Sweden.The study included elderly HVs to demonstrate that no
unexpected tracer mass effects of AZD4694 (NAV4694) in subjects with low or no
cerebral β-amyloid occur; to compare imaging parameters from healthy, non-AD
subjects with those from subjects with AD; and to extend the safety database.

“We are very pleased to have completed this study addressing some of the
fundamental requirements of diagnostic imaging agents seeking approval. We
continue to make exciting progress with NAV4694, which has demonstrated
important performance characteristics that we believe position it as a true
‘best-in-class’ second generation agent to aid in the diagnosis of Alzheimer’s
disease,” said Cornelia Reininger, MD, PhD, Navidea’s Chief Medical Officer.
“As previously reported in other Phase 2 studies, NAV4694 exhibits the
strengths of ^11C PIB, the benchmark amyloid imaging agent, but, as the agent
is radio-labeled with ^18F, has distribution characteristics that make it more
practical to use. The data from these studies suggest that NAV4694 shows
favorable sensitivity, specificity, rapid brain uptake yet decreased
white-matter uptake which affords improved image clarity.”

Dr. Reininger added, “We remain very enthusiastic about the potential of
NAV4694 to advance clinical capabilities in diagnostic and therapeutic
development for Alzheimer’s disease. Results from this study are expected to
be reported at the 2013 Annual Meeting of the Society of Nuclear Medicine and
Molecular Imaging. We look forward to initiation of the NAV4694 Phase 3 study
in 2013.”

Navidea is also announcing that it has expanded its relationship with
AstraZeneca and obtained rights to two additional β-amyloid imaging agents.
AZD2184 and AZD2995 expand Navidea’s intellectual property portfolio and are
positioned for research use to further establish its leadership within the AD
community in basic science research. AZD2184 and AZD2995 are ^11C Positron
Emission Tomography (PET) radioligand tracers discovered by AstraZeneca in
collaboration with Karolinska Institutet in Stockholm. AstraZeneca entered the
agreement to ensure that the compounds are available to KOLs and academic
centers. Both parties believe that these agents may serve as useful laboratory
tools to support additional investigation of Alzheimer’s disease. Financial
terms related to the granting of the additional rights were not disclosed as
they were not material.

About NAV4694

NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for
use in the imaging and evaluation of patients with signs or symptoms of
cognitive impairment such as AD. It binds to β-amyloid deposits in the brain
that can then be imaged in positron emission tomography (PET) scans. Amyloid
plaque pathology is a required feature of AD diagnosis and the presence of
amyloid pathology is a supportive feature for diagnosis of probable AD.
Patients who are negative for amyloid pathology do not have AD. AZD4694 was
licensed from AstraZeneca in December 2011.

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