FDA Advisory Committee Provides Clear Path Forward For Development of Amyloid Imaging...

FDA Advisory Committee Provides Clear Path Forward For Development of Amyloid Imaging Agents For Alzheimer's Disease

-Avid Radiopharmaceuticals Applauds FDA and Advisory Committee for
Advancing the Field of Molecular Imaging-
SILVER SPRING, Md.--(Business Wire)--
Avid Radiopharmaceuticals today announced that the U.S. Food and
Drug Administration (FDA) Peripheral and CNS Advisory Committee
provided strong support for development of amyloid imaging agents to
test for the presence or absence of Alzheimer's disease pathology in
people with symptoms of cognitive impairment. Avid's Phase II amyloid
imaging compound, (18)F-AV-45 (AV-45) is well positioned to rapidly
enter late stage development based on the FDA Advisory Committee
recommendations.

"Today was a pivotal day for the entire Alzheimer's community, and
a perfect example of the FDA and industry working together to
successfully tackle a major public health challenge," said Daniel
Skovronsky, M.D., Ph.D., CEO and President of Avid. "This was a
significant and positive milestone for Avid and we are very pleased
with the feedback received. We look forward to continuing to work
closely with the FDA to move our Phase III clinical program forward."

"Rapid development of these agents is essential to catalyze trials
for new therapies that may halt or even prevent Alzheimer's disease,"
said Michael Weiner, M.D. Professor of Radiology at the VA Medical
Center, University of California San Francisco and the Principal
Investigator of the Alzheimer's Disease Neuroimaging Initiative
(ADNI). "Prior to this meeting, there were two major unanswered
questions that could have impeded the further development of amyloid
imaging. The FDA Advisory Committee today tackled both the issues of
defining the clinical utility and of selecting the appropriate
reference standard, thereby addressing these major obstacles to late
stage development of amyloid imaging."

Avid's AV-45 was the first amyloid imaging compound to enter
multi-center Phase II clinical studies in the United States and has
now been studied in over 250 people, ranging from cognitively normal
individuals to those with Alzheimer's disease. Avid is currently
conducting clinical trials at over 25 research centers across the
United States and anticipates initiating Phase III trials in early
2009. For more details please visit www.clinicaltrials.gov.

About Avid Radiopharmaceuticals Inc.

Based in Philadelphia, PA, Avid Radiopharmaceuticals Inc. is a
leader in the development of products with the potential for earlier
and more effective detection, diagnosis and monitoring of brain
disorders. The company is a pioneer in the development of molecular
imaging agents for Alzheimer's disease that could lead to earlier
diagnosis and better evaluation of drugs designed to prevent or
reverse amyloid plaque build-up in the brain. Avid is currently
enrolling patients in clinical studies of (18)F-PET agents for imaging
amyloid plaques in Alzheimer's disease and for imaging the vesicular
monoamine transporter (VMAT2) in diseases such as Parkinson's disease
(PD), Dementia with Lewy Bodies (DLB) and Diabetes Mellitus (DM). More
information about Avid is available at www.avidrp.com.

Avid Radiopharmaceuticals, Inc.
Alan P. Carpenter, Ph.D., J.D.
Vice President, Business Development and Legal Affairs
215-966-6208
or
Sam Brown Corporate Communications
Mike Beyer, 773-463-4211
beyer@sambrown.com

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