Navidea Awarded an Additional NIH SBIR Grant for NAV4694 Beta-Amyloid Imaging Agent for Study in Mild Cognitive Impairment

  Navidea Awarded an Additional NIH SBIR Grant for NAV4694 Beta-Amyloid
  Imaging Agent for Study in Mild Cognitive Impairment

Business Wire

DUBLIN, Ohio -- September 4, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announcedthe
awardof a Small Business Innovation Research (SBIR) grant from theNational
Institute on Aging(NIA)of theNational Institutes of Health (NIH) in
connection withthe development of the Company's NAV4694 beta-amyloid imaging
agent. This grant, which follows the recent SBIR award for the Company’s Phase
3 study with NAV4694, will partially support the Phase 2b clinical study which
is evaluating NAV4694 as a diagnostic imaging agent that may aid physicians in
identifying those individuals with MCI who are at greatest risk of progressing
to Alzheimer’s disease (AD). The SBIR grant has the potential to provideup
to$2.3 million in support,if fully funded, through the conclusion
oftheclinicalstudy. Fundingforthe approved first stage of thegrant
($152,000) isintendedtoprovide support for initiationactivities of
theclinical trial program.Funding ofthesecond stage of the grantis
contingent upon meeting specific aimsrelated tothe first stage ofthegrant
such as clinical site contracting, investigator training and institutional
review board approvals. Navidea announced the initiation of the Phase 2b trial
in March 2013.

“There is a great clinical need to develop better methods to identify
individuals who are at high risk of developing dementia caused by AD before
their symptoms become severe. Beta-amyloid plaque, which is indicative of AD,
begins to appear in the brains of AD patients many years before they develop
dementia,” said Cornelia Reininger, MD, PhD, Navidea Senior Vice President and
Chief Medical Officer. “The outcome of this trial may enable earlier and
accurate differentiation of MCI subjects who are at risk of developing AD from
those who are not, before the disease has advanced to the stage of impairing
daily activities. If diagnosed at an earlier stage, the avenues for disorder
management and therapeutic intervention could be improved considerably.”

"We very much appreciatetheadditional supportoftheNIHas weconductthis
valuable clinical trial aimed at evaluating a patient population in whom
dementia is just emerging," saidFrederick Cope, PhD, FACN,NavideaSenior
Vice President and Chief Scientific Officer.“Earlier and more effective
diagnosis of cognitive impairment and dementia is clearly a priority of the
federal government’s initiative to address important medical unmet needs in
these areas. We believe the strong biochemical performance elements embodied
in NAV4694 such as high amyloid binding and low white matter uptake for
clearer images may differentiate NAV4694 in the effort to assist in earlier
differential diagnoses in patients with disorders such as MCI.”

NAV4-04 is a Phase 2b, open-label, multi-center, non-randomized, PET imaging
study to assess the safety and efficacy of NAV4694 in subjects diagnosed with
MCI to investigate whether NAV4694 PET scan findings have the ability to
distinguish subjects with MCI who progress to AD from those who do not. In
conjunction with neuro-cognitive testing examinations, subjects are planned to
receive three injections of the investigational, diagnostic agent during a 36
month period: at baseline, 18 months and 36 months. The study will determine
the specificity of NAV4694 PET imaging to identify the portion of all MCI
patients that are at high risk of developing AD dementia and will estimate the
rate of progression of the MCI patients with beta-amyloid deposits to AD
dementia. Information on the protocol and enrolling sites for this study
(NAV4-04) can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT01812213?term=Navidea&rank=4.

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 beta-amyloid deposits in the brain that can
then be imaged in scans. Beta-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 Mild Cognitive Impairment

Mild cognitive impairment (MCI) is a condition in which people have memory or
other thinking problems greater than normal for their age and education.^1
People with mild cognitive impairment are at increased risk of progressing to
dementia due to Alzheimer's disease (AD) or other causes. New therapies are on
the horizon that offer the potential to modify the trajectory of AD. To be
most effective, these new therapies will most likely need to be administered
early in the progression of a patient’s illness when their cognitive symptoms
are least severe. Patients with MCI and the underlying pathology associated
with AD would be candidates for treatment with these new AD therapies, while
MCI patients with other pathologies would not. Imaging studies that can
visualize beta-amyloid deposits in the brains of living patients will become a
key component of the diagnostic protocol that identifies these patients which
will enable the most effective use of these new therapies.

About Alzheimer’s

Alzheimer’s disease (AD) is a progressive and fatal neurodegenerative disease
which affects a person’s memory and ability to learn, reason, communicate and
carry out daily activities. Increasing age is the greatest risk factor for AD
and there is no prevention or cure. The World Health Organization estimates
that AD affects over 24 million people worldwide. Currently in the U.S. alone,
there are over 5 million AD patients with estimates that by 2050, as many as
14 million Americans could have the disease according to the Alzheimer’s
Association. Among the brain changes believed to contribute to the development
of AD are the accumulation of the protein beta-amyloid outside nerve cells
(neurons) in the brain and the accumulation of the protein tau inside neurons.
Approximately 75 to 100 experimental technologies aimed at diagnosing, slowing
or stopping the progression of AD are now in human clinical trials.

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^® (technetium 99m
tilmanocept) Injection, 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
first commercial agent, Lymphoseek, ^ was approved by the FDA in March 2013.
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.

     National Institute on Aging: About Alzheimer's Disease: Mild Cognitive
^1  Impairment,
     http://www.nia.nih.gov/alzheimers/topics/mild-cognitive-impairment.
     Accessed August 28, 2013.

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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