FRX Forest Road Acquisition Corp

New Data Highlight Positive Effect of Namenda(TM) on Brain Activity in Patients With Mild to Moderate Alzheimer's Disease SAN FRANCISCO, April 28 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today the results of a randomized, placebo- controlled, PET (positron emission tomography) imaging pilot study designed to measure the effect Namenda(TM) (memantine HCl) has on functional brain activity in patients with mild to moderate Alzheimer's disease. The results in this pilot study suggest that, compared to placebo-treated patients, treatment with Namenda may positively affect cerebral glucose metabolism in the brains of patients with mild to moderate Alzheimer's disease. The data presented yesterday at the American Academy of Neurology (AAN) Annual Meeting in San Francisco, California were from a subset of patients participating in a previously reported Phase III study evaluating the efficacy of Namenda as monotherapy in mild to moderate Alzheimer's disease. Researchers use PET to visualize and quantify a medication's effect on the brain of Alzheimer's patients over time. The Namenda PET study was conducted in conjunction with the Phase III, randomized, placebo-controlled study which showed that the use of Namenda produced statistically significant improvements in measures of cognition and global function compared to placebo. "By using the PET brain-imaging technique, we observed increased metabolic activity of Namenda in areas of a patient's brain associated with language and attention," said Steven G. Potkin, M.D., Professor in the Department of Psychiatry and Human Behavior at the University of California, Irvine, and lead investigator of the PET study presented at AAN. "While these data are from a small number of patients and need to be confirmed in larger scale studies, they indicate that Namenda may be able to reverse the cerebral metabolic decrease often associated with disease worsening in patients with mild to moderate Alzheimer's disease who do not receive treatment." Study Results In the randomized, double-blind, Phase III study, researchers at one center used PET to measure the regional cerebral glucose metabolism of patients with mild to moderate Alzheimer's disease taking 10 mg of Namenda twice a day compared to patients taking placebo. PET images were taken at the beginning of the study and 24 weeks later at the trial's close. The PET imaging study was completed at the University of California at Irvine and involved 10 patients evenly and randomly divided between the Namenda and placebo treatment arms. In the PET study, patients who received Namenda demonstrated a statistically significant increase in glucose metabolism in several regions of the brain associated with language and attention. In contrast, placebo- treated patients showed metabolic declines in several of these same regions. This pilot study was part of an overall Phase III trial of Namenda's effect in mild to moderate Alzheimer's disease which found that patients who received Namenda performed significantly better on co-primary outcome measures of cognition and global function compared to patients given placebo. During a period of six months, 403 patients with mild to moderate Alzheimer's disease at 42 U.S. centers were given a daily dosage of 10 mg twice a day. The two primary outcome measures were the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change -- Plus version (CIBIC-Plus). The ADAS-cog is a commonly used measure of cognitive function frequently used to evaluate mild to moderate Alzheimer's disease. It includes items which evaluate different types of cognitive functions like memory and language. As assessed by the ADAS-cog, patients receiving Namenda maintained cognitive abilities above baseline for the entire 24-week study. Patients receiving placebo exhibited a progressive decline during the study with the difference between the two treatment groups being statistically significant (p=0.003). The CIBIC-Plus is a global measure of a patient's overall status evaluating their cognition, behavior, and activities of daily living. The results of the study reveal that patients receiving Namenda had significantly better global status compared to those taking placebo as assessed by the CIBIC-Plus (p=0.004). Namenda was well tolerated. In the trial the most common adverse events reported with Namenda were agitation, fall, influenza-like symptoms and somnolence. Forest Laboratories plans to submit to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application for a mild to moderate Alzheimer's disease indication for Namenda in the second half of 2004. About PET Imaging PET is a non-invasive technology that can be used to measure metabolic, biochemical, and functional activity in living tissue. One of the most important functions of PET is its ability to model biological and physiological functions in the body by detecting and modeling regional concentrations of radioactivity in the brain using radioactively labeled tracers. PET provides detailed information about functional brain activity and estimates the brain's ability to utilize glucose, cerebral glucose metabolism, in whole sections and in regions of the brain. Previous PET studies have shown that progression of Alzheimer's disease is often associated with a decrease in cerebral glucose metabolism. About Namenda Namenda (memantine HCl) is the first in a new class of medications with a unique mechanism of action that focuses on the glutamate pathway, a new target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, Namenda was recently approved by the FDA based on the results of three placebo-controlled studies which demonstrated Namenda's efficacy as monotherapy, or when used in combination with the commonly prescribed drug, donepezil. Results from the two U.S. studies in moderate to severe Alzheimer's disease have been published in The New England Journal of Medicine and The Journal of the American Medical Association. About Forest Laboratories and Its Products Forest Laboratories' growing line of products includes: Namenda(TM), an N- methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Lexapro(TM), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Celexa(TM), an antidepressant; Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar(R)*, an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(TM), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment of asthma. *Benicar(R) is a registered trademark of Sankyo Pharma, Inc. Except for historical information contained herein, this release contains forward-looking statements that involve 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, 2003 and subsequent quarterly reports on Form 10-Q. Actual results may differ from those projected. DATASOURCE: Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice President - Investor Relations of Forest Laboratories, Inc., +1-212-224-6714,

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