To Confirm Expanded 9-Hour Treatment Window Seen in Two Phase II Studies
NEW YORK, Feb 09, 2005 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) today announced the initiation of a phase IIb/III study of
desmoteplase, an investigational novel plasminogen activator, or blood clot
buster, for the treatment of acute ischemic stroke, a condition affecting over
600,000 patients annually in the U.S.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The DIAS2 (Desmoteplase in Acute Ischemic Stroke) study will be a multi-
center, multinational, randomized, parallel-design dose-ranging study of more
than 150 patients to confirm the results of earlier Phase II studies that
demonstrated the potential of desmoteplase to treat acute ischemic stroke
patients up to nine hours after the onset of stroke symptoms, three times
longer than the currently available treatment allows. Because most stroke
patients arrive at the hospital outside the accepted three hour treatment
window, the majority of patients are not eligible for the currently available
treatment. Lengthening that window may expand the number of patients who
could benefit from treatment.
"Preserving brain function and restoring quality of life in patients after
acute ischemic stroke is the goal of effective stroke treatment," says Anthony
Furlan, MD, Medical Director, Cleveland Clinic Foundation and primary
investigator of the DIAS2 and DEDAS (Dose Escalation study of Desmoteplase in
Acute Ischemic Stroke) studies. "The consistent results from two completed
studies of desmoteplase in patients with acute stroke strongly support moving
forward to further assess this potential breakthrough treatment in a large-
scale worldwide trial."
Results of Desmoteplase Confirmed in Second Phase II Study
Results from the recently completed DEDAS study, presented for the first
time on February 4, 2005, as a late-breaker presentation at the 30th
International Stroke Conference in New Orleans, Louisiana, showed trends
indicating that desmoteplase administered intravenously in the time window up
to nine hours after the onset of stroke symptoms:
* Improved blood flow in the damaged area of the brain in patients
treated with 125µg/kg of desmoteplase.
* Improved clinical outcome after 90 days compared to placebo.
The DEDAS study was a multi-center, placebo-controlled, double-blind,
randomized, dose-escalation Phase II trial conducted in 38 patients across 17
hospitals in the U.S. and three hospitals in Europe. This study showed
similar results to the earlier DIAS (Desmoteplase in Acute Ischemic Stroke)
trial, which was published in Stroke in January 2005 and presented at the 29th
International Stroke Conference in February 2004. The former DIAS study used
a similar protocol to DEDAS, with 104 patients across 25 hospitals in Europe,
Australia and Asia. In both these studies, patients with the potential to
benefit from reperfusion therapy were selected using MRI methods to determine
whether they had salvageable tissue and were then administered intravenous
(IV) desmoteplase or placebo in the time window up to nine hours after the
onset of stroke symptoms. Both of these studies were pilot in nature and were
not sized to show statistical differences.
About Desmoteplase
Desmoteplase, first in a new class of plasminogen activators, is a
genetically engineered version of a clot-busting agent found in the saliva of
the vampire bat, Desmodus rotundus. It possesses high fibrin selectivity,
potentially allowing it to dissolve a clot locally without adversely affecting
the blood coagulation system, possibly reducing the risk of intracranial
bleeding (a common risk when administering blood clot-dissolvers) as compared
to other less fibrin-specific plasminogen activators.
Desmoteplase has received fast-track review designation from the U.S. Food
and Drug Administration (FDA) for the treatment of acute ischemic stroke
beyond the three-hour time window. Desmoteplase was licensed to Forest by
PAION GmbH on June 30, 2004. Under the agreement, Forest will be responsible
for regulatory and sales and marketing activities in the U.S. and Canada, and
will have development and marketing rights to other indications of the product
in these territories. PAION retains commercial rights in Europe, Japan, and
the rest of the world.
About Stroke
Stroke is the third leading cause of death in the United States and
Europe, behind heart disease and cancer. According to the American Heart
Association, over 600,000 people in the U.S. fall victim to an ischemic stroke
each year, which comprises approximately 88 percent of all strokes. The
treatment of acute stroke and its serious long-term disabilities currently
present an extensive unmet need.
Ischemic stroke occurs when a blood vessel supplying the brain with oxygen
and nutrients is obstructed by a blood clot. The blockage or rupture of the
vessel results in a lack of blood flow to part of the brain. Deprived of
oxygen, nerve cells in the affected region die within minutes or hours after
the event resulting in loss of function of the part of the body they control.
Ischemic stroke requires emergency treatment to rapidly dissolve or remove the
blood clots in the brain, but many people delay getting treatment.
The only drug currently approved for the treatment of acute ischemic
stroke, tPA (Activase(R)), must be administered within three hours after onset
of stroke symptoms, thus limiting the potential patient population who can
safely benefit from the rapid dissolution of the blood clot and the
reperfusion of blood supply to the affected area of the brain. The majority of
stroke patients arrive at the hospital outside that treatment window. At
present, only eleven percent of ischemic stroke patients are eligible for the
treatment and fewer than four percent actually receive it.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Celexa(R) (citalopram HBr), an antidepressant for adults;
Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar HCT(R) (olmesartan
medoxomil/hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product indicated for the second-line treatment of hypertension;
Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated
for the maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation in combination with
psychosocial support; Combunox(TM) (Oxycodone HCl and Ibuprofen) an opioid and
NSAID combination indicated for the short-term management of acute, moderate
to severe pain expected to be available in the U.S. in early 2005.
About PAION
PAION, a biopharmaceutical company based in Aachen, Germany, aims to
become a leading provider of innovative drugs for the treatment of stroke and
other thrombotic diseases. In addition to Desmoteplase, the company is
developing the neuroprotective drug Enecadin for stroke, and the anti-
thrombotic Solulin. With a core competence in advancing purchased or in-
licensed drug candidates through the clinical development and regulatory
approval process, PAION believes it is well-equipped to achieve this goal.
The company today employs approximately 60 people and has raised 51 million
euro in four financing rounds since its founding in 2000. More information is
available at http://www.paion.de.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including risk factors listed from
time to time in the Company's SEC reports, including the Company's Annual
Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q
for the periods ended June 30, 2004, and September 30, 2004. Actual results
may differ materially from those projected.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc., Campral(R)
is a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany. Activase(R) is a registered trademark of
Genentech, Inc.
SOURCE Forest Laboratories, Inc.
Charles E. Triano, Vice President, Investor Relations of Forest Laboratories,
+1-212-224-6714, charles.triano@frx.com
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