Neoprobe Corporation (NYSE Amex: NEOP) today announced that it has
in-licensed the worldwide exclusive rights from AstraZeneca to the
late-stage radiopharmaceutical imaging candidate, AZD4694, for aiding
the diagnosis of Alzheimer’s disease (AD).
AZD4694 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 Beta-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.
Clinical studies in more than 70 patients suggest that AZD4694 has the
ability to image patients quickly and safely with high sensitivity.
Importantly, AZD4694 exhibits low background and white matter uptake,
thereby providing clear images of Beta-amyloid deposits. Neoprobe
intends to initiate a Phase III clinical program in early 2013, while
simultaneously building the requisite safety and training database.
Patents and patent applications filed around the world related to
AZD4694 are effective until 2028.
“To gain the recognition of AstraZeneca through a rigorous licensing
process and secure such a promising late-stage imaging asset is a strong
endorsement of our development capability and focus,” commented
Neoprobe’s Executive Vice President and Chief Business Officer, Thomas
Tulip, Ph.D. “We believe AZD4694 has a compelling global commercial
outlook and should beneficially facilitate development of more effective
disease-modifying therapies for Alzheimer´s disease. This potentially
powerful second-generation agent with apparent best-in-class properties
has demonstrated strong performance attributes. We believe AZD4694
imaging may be quite useful as an adjunct measure in the diagnosis of
this large, growing disease and may allow patients to seek earlier, and
therefore potentially more effective, treatment options.”
“The discovery and development of new treatments for Alzheimer’s disease
is a top priority for AstraZeneca. This alliance couples Neoprobe’s
expertise in diagnostic imaging with our own expertise in the discovery
and development of innovative medicines, and will further expand our
ability to evaluate new treatments for Alzheimer’s disease in the
future,” said Christer Köhler, Vice President and Head of CNS & Pain
Innovative Medicines at AstraZeneca.
“New Alzheimer’s disease imaging agents are potentially powerful tools
in aiding the diagnosis of AD and evaluation of new drugs aiming to
modify amyloid plaque levels and possibly alter disease progression.
Having worked in the development of first-generation agents, early data
suggests that AZD4694 may have imaging performance and convenience
attributes making it a best-in-class prospect for accurate and earlier
disease definition,” said Dr. Kenneth Marek, Chief Executive Officer and
Co-Founder of Molecular NeuroImaging (MNI). MNI is a world leader in
neuroscience and radiopharmaceutical imaging for the diagnosis and
monitoring of neurological and neuropsychiatric disorders. MNI will be a
key collaborator with Neoprobe in the clinical development of AZD4694.
Financial terms of the in-licensing agreement include an upfront payment
of $5 million to AstraZeneca and a series of contingent milestone
payments including up to $6.5 million in potential payments based on the
achievement of clinical development and regulatory filing milestones and
up to additional $11 million due following the receipt of regulatory
approvals and the initiation of commercial sales. In addition, Neoprobe
will pay AstraZeneca royalties on net sales of the approved product.
AstraZeneca retains the right to use AZD4694 in clinical trials to
support development of potential treatments for Alzheimer’s disease.
“Licensing this important asset is consistent with the growth strategy
to build out our precision radiopharmaceutical pipeline and transform
Neoprobe into a leader in the development and commercialization of
targeted diagnostic agents,” stated Dr. Mark Pykett, Neoprobe’s
President and CEO. “We are encouraged to have secured a high-quality,
late-stage asset from a world-class partner for a large and growing
disease in a patient community with significant unmet medical need. We
are pleased to have structured an agreement for an asset that we believe
will return substantial value to our shareholders and where a
significant part of the future compensation is based on the product’s
approval and ultimately product sales. We look forward to collaborating
with AstraZeneca on the progress of this agent and assisting them in the
development of their Alzheimer’s disease therapeutics.”
Neoprobe’s President and CEO, Dr. Mark Pykett, Executive Vice President
and CBO, Dr. Thomas Tulip, and Senior Vice President and CFO, Brent
Larson, will discuss the license transaction during a conference call
with the investment community scheduled for tomorrow morning, December
13, 2011 at 8:30 AM EST. The conference call can be accessed as follows:
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Dec. 13, 2011
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Available until:
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Dec. 27, 2011
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8:30 AM ET
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(877) 660-6853
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International Dial in # :
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(201) 612-7415
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(877) 407-8033
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International Dial in #:
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286
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384608
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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 Alzheimer’s disease affects
over 24,000,000 people worldwide. Currently in the U.S. alone, there are
over 5 million Alzheimer’s patients with estimates that by 2050, as many
as 16 million Americans could have the disease according to the
Alzheimer’s Association. Among the brain changes believed to
contribute to the development of Alzheimer’s 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 therapies aimed at diagnosing,
slowing or stopping the progression of Alzheimer’s are now in human
clinical trials.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialisation
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
About Neoprobe
Neoprobe Corporation (NYSE Amex: NEOP) is a biopharmaceutical company
focused on the development and commercialization of precision
diagnostics and radiopharmaceutical agents. Neoprobe is actively
developing three radiopharmaceutical agent platforms – Lymphoseek®,
AZD4694 and RIGScanTM CR – to help identify the sites and
pathways of undetected disease and enable better diagnostic accuracy,
clinical decision-making and ultimately patient care. Neoprobe’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.neoprobe.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.
