NEW YORK, Aug 29, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest
Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug
Administration (FDA) has approved new labeling for Lexapro(TM) (escitalopram
oxalate) as maintenance treatment for patients with major depressive disorder.
Lexapro, a selective serotonin reuptake inhibitor (SSRI), is the single-isomer
of Celexa(TM) (citalopram HBr).
The long-term efficacy of Lexapro was demonstrated in a placebo-controlled
relapse trial. Patients receiving Lexapro experienced a significantly longer
time to relapse compared to those receiving placebo. Relapse in depression is
defined as the return of the symptoms of depression within four to six months of
achieving initial success with antidepressant treatment. Lexapro was approved by
the FDA on August 14, 2002 for the treatment of major depressive disorder.
"We are pleased that the FDA has granted Lexapro this additional indication
shortly after its approval of Lexapro for the treatment of major depressive
disorder," said Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories. "Relapse is one of the greatest concerns following successful
treatment of depression. The use of Lexapro as maintenance therapy may help
people who suffer from depression lead more productive lives."
About Depression
Each year, nearly 19 million adult Americans suffer from a depressive illness.
One of every 4 women and 1 in 10 men can expect to be diagnosed with depression
during their lifetime. Depression costs the United States an estimated $44
billion each year. The World Health Organization predicts depression will become
the leading cause of disability by the year 2020.
About Lexapro: An Isomer of Celexa
Lexapro is the product of a relatively new approach that involves the removal of
one of two enantiomers from Celexa to create a single-enantiomer drug. Celexa is
a racemic mixture of two mirror-image halves called the S- and R-enantiomers.
With Lexapro, the R-enantiomer (that does not contribute to Celexa's
antidepressant activity) has been removed, leaving only the therapeutically
active S-enantiomer. For more information on Lexapro, visit
http://www.lexapro.com.
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H.
Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
About Forest Laboratories and Its Products
Forest Laboratories develops, manufactures, and sells ethical pharmaceutical
products that are used for the treatment of a wide range of illnesses. Forest's
growing line of products includes: Lexapro(TM), indicated as initial as well as
maintenance treatment of major depressive disorder; Celexa(TM), indicated for
the treatment of depression; Tiazac(R), a once-daily diltiazem, which is
indicated for the treatment of angina and hypertension; and Aerobid(R) an
inhaled steroid indicated for the treatment of asthma. The Company has also
entered into a co-promotion agreement with Sankyo of Japan for the marketing of
Benicar(TM)* for the treatment of hypertension.
Except for historical information contained herein, this release contains
"forward-looking statements" within the meaning of the Private Securities
Litigation 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, 2002 and Quarterly Report on Form
10-Q for the period ended June 30, 2002. Actual results may differ materially
from those projected.