HOPKINTON, Mass., July 31, 2012 /PRNewswire/ -- Alseres
Pharmaceuticals, Inc. (OTC: ALSE) today announced that it has
entered into an agreement with Navidea Biopharmaceuticals, Inc.
(NYSE MKT: NAVB, "Navidea") to license, [123I]-E-IACFT
Injection (CFT), also called Altropane®, an Iodine-123 radiolabeled
imaging agent, being developed as an aid in the diagnosis of
Parkinson's disease and movement disorders.
"We are pleased to have completed this agreement with
Navidea. With its focus, dedication, and imaging expertise,
Navidea represents an ideal partner to complete the development and
commercialization of this promising agent that may help millions of
patients with movement disorders arrive at a more timely and
accurate diagnosis," said Peter G.
Savas, CEO of Alseres.
"The diagnostic dilemma in movement disorders remains a pressing
medical need that will continue to escalate as our world's
population ages," said Dr. Mark
Pykett, President and CEO of Navidea. "The addition of the
CFT program is consistent with our growth strategy to build our
precision radiopharmaceutical pipeline with later stage, high value
diagnostics aimed at important medical needs."
"We believe that CFT has the potential to be a best-in-class
imaging agent to improve diagnostic accuracy by differentiating
Parkinson's disease from non-degenerative movement disorders,
especially during the period soon after onset of symptoms," said
Dr. Thomas Tulip, Navidea' s EVP and
Chief Business Officer.
In January 2012, Alseres and
Navidea executed an Option Agreement pursuant to which Navidea paid
Alseres the non-refundable sum of $500,000 in exchange for the exclusive option to
license the CFT program, to conduct its final due diligence review
of the program and to prepare the paperwork necessary for the
execution of the license.
Under the terms of the license agreement, Alseres granted
Navidea an exclusive, worldwide sublicense to research, develop,
and commercialize CFT. In connection with the execution of
this agreement, Navidea will make a one-time sublicense execution
payment to Alseres equal to (i) One Hundred
Seventy-Five Thousand Dollars ($175,000) and (ii) issue Alseres 300,000 shares
of NAVB common stock.
The license agreement also provides for contingent milestone
payments of up to $2.9 million,
$2.5 million of which will
principally occur at the time of product registration or upon
commercial sales, and the issuance of up to an additional 1.15
million shares of Navidea stock, 950,000 shares of which are
issuable at the time of product registration or upon commercial
sales. In addition, the license terms anticipate royalties on
yearly net sales of the approved product which are consistent with
industry-standard terms and certain license extension fees, payable
in cash and shares of common stock, in the event certain milestones
are not met.
About [123I]-E-IACFT (CFT)
CFT is a patented, novel, small molecule radiopharmaceutical
used with single photon emission computed tomography (SPECT)
imaging to identify the status of specific regions in the brains of
patients suspected of having Parkinson's disease. The agent
binds to the dopamine transporter (DAT) on the cell surface of
dopaminergic neurons in the striatum and substantia nigra regions
of the brain. Loss of these neurons is a widely recognized
hallmark of Parkinson's disease.
CFT has been administered to more than 600 subjects in
multi-phase clinical trials to date. Results from these clinical
trials have demonstrated that CFT has high affinity for DAT and
rapid kinetics which enable the generation of clean diagnostic
images quickly, beginning within approximately 20 minutes after
injection. In addition to its potential use as an aid
in the differential diagnosis of Parkinson's disease and movement
disorders, CFT may also be useful in the diagnosis of Dementia with
Lewy Bodies (DLB), which after Alzheimer's disease, is one of the
most common forms of dementia.
About Parkinsonian Syndromes and Parkinson's Disease
Parkinsonian syndromes (PS) are neurodegenerative disorders that
affect a person's ability to control movement and other muscle
functions. Parkinson's Disease is the most common form of
Parkinsonian Syndromes believed to be caused by loss of dopamine
producing neurons in the brain and with first symptoms such as
tremor, rigidity, or slow movement. Other less common Parkinsonian
Syndromes include multiple system atrophy (MSA), Progressive
Supranuclear Palsy (PSP), and drug-induced Parkinsonism. According
to the Parkinson's Disease Foundation, approximately 60,000
Americans are diagnosed with Parkinson's disease each year, and
this number does not reflect the thousands of cases that go
undetected.i
Conference Call Access Information
The company will host a conference call to discuss this
transaction on, August 1, 2012, at
11:00 a.m. Eastern Daylight Time.
The call can be accessed by dialing 888-389-5988 (or
719-325-2452 for international participants). The participant
pass code for this conference call is 6427594. Please dial in
5 to 10 minutes prior to the scheduled start time.
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:
Alseres Pharmaceuticals, Inc. – Kenneth L. Rice Jr. EVP & CFO – (508)
497-2360
i Parkinson's Disease Foundation. Statistics on
Parkinson's: http://www.pdf.org/en/parkinson_statistics. Accessed
on July 27, 2012.
SOURCE Alseres Pharmaceuticals, Inc.
