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©2000 Intelligent Systems |
Sharon Correia Aderis
Pharmaceuticals Announces Milestone Payment from
Fujisawa Healthcare, Inc. Results
of Phase II trial of DTI-0009 for treatment of
Atrial Fibrillation presented at American Heart
Association Meeting Hopkinton,
MA
- Mar
19, 2003
- Aderis
Pharmaceuticals announced the receipt of a $2
million milestone payment from its partner,
Fujisawa Healthcare, Inc (Fujisawa). This
milestone was released by Fujisawa in connection
with the final study report from a Phase II
study of DTI-0009, an adenosine A1 agonist,
being developed with Fujisawa to control heart
rate during atrial fibrillation. “We
are pleased to be working with Aderis on this
product candidate," said Hideo Fukumoto,
Chairman and CEO of Fujisawa Healthcare, Inc.
"As a next generation treatment for atrial
fibrillation, DTI-0009 plays an important role
in Fujisawa’s desire to deepen our presence in
the cardiovascular field. We are confident that
our continued partnership with Aderis will bring
us closer to achieving this goal. ” “This
milestone payment recognizes the continuing
progress in the development of this important
selective adenosine receptor agonist to treat
atrial fibrillation, a condition affecting
nearly 6 million worldwide,” said Peter Savas,
President, C.E.O. and Chairman of Aderis
Pharmaceuticals. “DTI–0009, unlike other
adenosine A1 agonists in development, is also
orally active and suitable for the treatment of
chronic atrial fibrillation. We believe
physicians will be able to treat patients both
acutely in the hospital and chronically at home
with this medication.” The
collaboration between Aderis Pharmaceuticals and
Fujisawa began in June 1999 when Fujisawa
licensed the US and Canadian rights to the
intravenous formulation of DTI-0009. Under terms
of the agreement, Fujisawa will pay for clinical
development and commercialization of DTI-0009,
additional clinical development milestone
payments, and royalty payments on sales of the
product. Aderis Pharmaceuticals has retained
worldwide rights to oral dosage forms of
DTI–0009 and the rights for the DTI–0009
intravenous product in markets outside North
America. Phase
II trial results were presented at the American
Heart Association’s Scientific Sessions in
November. This dose escalation study in the
electrophysiology laboratory demonstrated a dose
related slowing of conduction in the heart in
patients being studied that could translate to
slowing of an uncontrolled heart rate in atrial
fibrillation. Final results are pending from
three other Phase II trials in patients with
atrial fibrillation performed by Fujisawa
Healthcare and Aderis Pharmaceuticals. Background:
Atrial
fibrillation is an abnormal heart rhythm in the
top part of the heart, or atria, in which the
heart beats both rapidly and irregularly. While
a normally functioning heart beats at 60-80
beats/minute, a heart in atrial fibrillation
beats at 120-180 beats/minute. At this rate, the
heart cannot effectively contract enough to pump
blood to the rest of the body, causing symptoms
ranging from shortness of breath to heart
failure. According to the American Heart
Association, approximately 6 million people
worldwide experience atrial fibrillation. It is
the most common sustained arrhythmia and is a
major cause of stroke among the elderly. Adenosine
is a naturally occurring signal molecule that
acts at multiple adenosine receptor subtypes
(specialized proteins at the cell surface) to
modulate key cellular functions. In the heart,
adenosine acts at A1 receptors to slow
electrical conduction from the atria to the
ventricles (lower chambers of the heart). Using
its small molecule development expertise, Aderis
Pharmaceuticals specifically designed DTI–0009
to act selectively at the adenosine A1 receptor.
The slowing of conduction prompted by DTI-0009
is designed to slow abnormally high heart rate
response in patients without lowering blood
pressure, a common complication with current
treatments. Aderis
Pharmaceuticals is a private, biopharmaceutical
company engaged in small molecule drug
development to treat central nervous system,
cardiovascular and renal disorders. The Company
currently has four product candidates in six
clinical development programs. Aderis
Pharmaceuticals has a strategic alliance with
Schwarz Pharma AG, for the development of
rotigotine CDS, a proprietary dopamine agonist
formulated as a once-a-day, continuous delivery,
transdermal patch. Rotigotine is currently in
Phase III trials for Parkinson’s disease and
Phase II for the treatment of Restless Legs
Syndrome. The Company also has alliances with
Fujisawa Healthcare, Inc. and King
Pharmaceuticals. Aderis Pharmaceuticals’
product pipeline includes small molecule,
receptor agonists and antagonists for the
treatment of Parkinson’s disease, Restless
Legs Syndrome, atrial fibrillation, diabetic
foot ulcers, the diagnosis and prognosis of
coronary artery disease, and other
cardiovascular and renal indications. Founded in
1994, Aderis Pharmaceuticals is headquartered in
Hopkinton, Massachusetts and has research
facilities in Richmond, Virginia. Fujisawa
Healthcare, Inc., headquartered in Deerfield,
Illinois, develops, manufactures and markets
proprietary pharmaceutical products in the
United States and abroad. Fujisawa Healthcare,
Inc. is a subsidiary of Fujisawa Pharmaceutical
Co., Ltd., based in Osaka, Japan. Fujisawa
Pharmaceutical Co., Ltd., founded in 1894, is a
leading pharmaceutical manufacturer and is
actively developing its international operations
in North America, Europe and Asia. Additional
information on Fujisawa Healthcare, Inc. and its
products can be found on the company’s web
site at www.fujisawa.com. Certain
statements in this news release that are not
historical fact constitute “forward-looking
statements.” Such forward-looking statements
involve known and unknown risks, uncertainties
and other factors which may cause the actual
results of Aderis Pharmaceuticals to be
materially different from historical results or
from any results expressed or implied by such
forward-looking statements. Such statements
include, but are not limited to, any statements
relating to the Company’s development programs
and any other statements that are not historical
facts. Such statements involve risks and
uncertainties, including but not limited to,
those risks and uncertainties relating to
difficulties or delays in development, testing,
regulatory approval, production and marketing of
the Company’s drug candidates; unexpected
adverse side effects or inadequate therapeutic
efficacy of the Company’s drug candidates that
could slow or prevent product development or
commercialization; the uncertainty of patent
protection for the Company’s intellectual
property or trade secrets; and the Company’s
ability to obtain additional financing if
necessary. Such statements are based on
management’s current expectations, but actual
results may differ materially due to various
factors, some but not all of which may have been
mentioned above.
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