NEW YORK, Oct. 25 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and its development partner for desmoteplase, PAION AG (Aachen,
Germany), today announced that the Steering Committee of the Phase IIB/III
stroke study, DIAS-2, has decided in agreement with the Companies to place
patient recruitment temporarily on hold until further data have been
analyzed. The DIAS-2 study is evaluating PAION's drug candidate
desmoteplase in patients with acute ischemic stroke.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The Steering Committee followed a recommendation by the independent
Data Monitoring Committee (DMC). The DMC had requested additional data in
order to facilitate the evaluation of a potential safety signal, which was
not specified further by the DMC. The DMC had notified the Steering
Committee in its statement that no conclusion on the safety or efficacy of
desmoteplase should be drawn based upon this recommendation. The requested
data has been processed and will be provided to the DMC within the next
day.
About Desmoteplase
Desmoteplase, the most specific plasminogen activator known today, is a
genetically engineered version of a clot-dissolving protein found in the
saliva of the vampire bat Desmodus rotundus. Currently in Phase III,
Desmoteplase has been successfully tested in two independent Phase II
studies for the treatment of acute ischaemic stroke between 3 and 9 hours
after onset of symptoms and has received fast-track designation from the
U.S. Food and Drug Administration.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated
for adults for the initial and maintenance treatment of major depressive
disorder and for generalized anxiety disorder; Namenda(R) (memantine HCl),
an N-methyl- D-aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar*
HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor
blocker and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
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 involve a number of risks
and uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Company's SEC
reports, including the Forest Laboratories, Inc.'s Annual Report on Form
10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for the
period ended June 30, 2006. and Replidyne, Inc.'s Prospectus on Form S-1
and on Form 10-Q for the period ended June 30, 2006.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
CONTACT:
Charles E. Triano, VP - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714,
Charles.Triano@FRX.com
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