NEW YORK, Feb. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Replidyne, Inc. announced today that they have terminated
their collaboration agreement for the development of faropenem medoxomil, a
novel oral, community antibiotic.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The agreement was announced in February 2006. In October 2006 the U.S.
Food and Drug Administration (FDA) issued a non-approvable letter for four
adult indications: acute bacterial sinusitis (ABS), community-acquired
pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and
uncomplicated skin and skin structure infections (SSSI). There are no
payments by Forest associated with the termination.
Howard Solomon, Chairman and Chief Executive Officer of Forest, stated:
"Forest believes the FDA's non-approvable letter clearly raises regulatory
uncertainty. We have carefully reviewed all the existing data and the FDA's
pronouncements and have determined that we should not continue further
development of the faropenem program."
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 Companies'
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
periods ended June 30, 2006 and September 30, 2006.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Charles E. Triano, Vice President - Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714,
charles.triano@frx.com
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