Forest Laboratories Announces Adoption of On-line Registry for Clinical Studies; Attorney General Agrees to Close Inquiry
September 07 2004 - 6:41PM
PR Newswire (US)
Forest Laboratories Announces Adoption of On-line Registry for
Clinical Studies; Attorney General Agrees to Close Inquiry NEW
YORK, Sept. 7 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE:FRX) today announced that it will establish a publicly
available, on-line Clinical Trial Registry containing summaries of
key Forest-sponsored clinical studies completed since January 1,
2000 for drugs which Forest currently markets. The creation of the
Clinical Trial Registry is also part of an agreement reached today
with the New York State Attorney General. As a result of Forest's
adoption of the Clinical Trial Registry, the Attorney General has
agreed to end his inquiry of Forest's clinical study disclosure
practices. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) Howard
Solomon, Chairman and Chief Executive Officer of Forest, stated:
"We recognize that there is great interest in the widespread
availability of clinical study results. We at Forest are pleased to
respond by creating a Clinical Trial Registry that would provide
extensive information about our study results to the medical
community. Forest's mission is to develop and distribute effective
and safe drugs that improve the quality of life of the people who
take them, and if there is a desire in the medical community for
additional information on clinical studies, Forest wants to provide
it. We also are gratified that the Attorney General has agreed to
end his inquiry in recognition of the Clinical Trial Registry we
are announcing today." The Clinical Trial Registry The Clinical
Trial Registry announced today will contain the following
information: Ongoing Studies Forest's Clinical Trial Registry will
include a listing of Forest-sponsored ongoing phase III and phase
IV clinical studies for all Forest drugs. In particular, when
Forest initiates a Phase III or Phase IV clinical study, the
number, title, start date and key objectives will be posted to the
Clinical Trial Registry. Completed Studies For all phase III and
phase IV Forest-sponsored studies relating to currently-marketed
Forest products completed since January 1, 2000, Forest will by
December 31, 2005 post summaries of the results of these studies on
the Clinical Trial Registry. This will include summaries of
clinical study reports for clinical studies of the use of Celexa
and Lexapro by pediatric patients. These summaries will include
results for the protocol-defined efficacy and safety outcomes, as
well as a description of the trial design and methodology. For all
phase III studies relating to Forest products completed after
today, Forest will post summaries of the results on the Clinical
Trial Registry upon the commercial introduction of the product in
the United States. For phase IV trials conducted for the approved
indications completed after today, Forest will post summaries of
the results within a year of study completion. For studies
submitted to scientific peer-reviewed journals whose policies do
not permit disclosure of study results prior to publication in
these journals, the clinical study summary will be posted at the
time of publication. Also, Forest will post a summary on the
Clinical Trial Registry of: (a) those Forest-sponsored phase I and
phase II studies completed after January 1, 2000 for products which
Forest currently markets which provide additional important
information for physicians and the care of patients; and (b) those
Forest-sponsored studies completed prior to January 1, 2000 for
products which Forest currently actively promotes which provide
additional important information for physicians and the care of
patients. About Forest Laboratories and Its Products Forest
Laboratories' growing line of products includes: Namenda(R)
(memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist
indicated for the treatment of moderate to severe Alzheimer's
disease; Lexapro(R) (escitalopram oxalate), an SSRI antidepressant
indicated for the initial and maintenance treatment of major
depressive disorder and for generalized anxiety disorder; Celexa(R)
(citalopram HBr), an antidepressant; Benicar(R) * (olmesartan
medoxomil), an angiotensin receptor blocker indicated for the
treatment of hypertension; Benicar HCT(TM) (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 when used in combination with psychosocial
support; Aerobid(R) (flunisolide), an inhaled steroid indicated for
the treatment of asthma; and Tiazac(R) (diltiazem HCl), a
once-daily diltiazem, indicated for the treatment of angina and
hypertension. *Benicar(R) is a registered trademark of Sankyo
Pharma, Inc. 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 period ended June 30, 2004. Actual results may differ
materially from those projected.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Web site: http://www.frx.com/
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