NEW YORK, Sept. 7 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. 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.
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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.
Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO Forest Laboratories, Inc.
(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.
Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO Forest Laboratories, Inc.
