Forest Laboratories, Inc. to Continue Clinical Development of Neramexane Based on New Clinical Trial Results

NEW YORK, July 14 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today that a recently completed placebo-controlled proof of concept study of neramexane in the treatment of moderate to severe Alzheimer's disease showed sufficient clinical activity, safety, and tolerability to continue development of the compound.

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"We are pleased with the results of this study," said Ivan Gergel, M.D., Senior Vice President -- Scientific Affairs and President of the Forest Research Institute. "Even though recruitment of patients into this study was stopped early due to slow patient enrollment, the neramexane treatment group actually achieved statistical significance on scales assessing activities of daily living and exhibited strong trends in favor of neramexane on measures of cognition."

The 24-week trial was a double-blind, randomized, placebo-controlled trial conducted at 47 U.S. study sites, evaluating 198 patients out of an originally planned 400 patients who were suffering from moderate-to-severe Alzheimer's disease and who were not receiving any other treatments for their dementia. The primary outcome assessments were the Alzheimer's Disease Cooperative Study Inventory -- Activities of Daily Living (ADCS-ADL19) scale, a measure of daily function, and the Severe Impairment Battery (SIB), a measure of cognition. At endpoint, patients on neramexane showed statistically significant improvement versus placebo-treated patients on the ADCS-ADL19 (p<0.02). While the difference on the SIB was not significant at week 24, data from assessments at week 12 showed a significant difference in favor of neramexane (p<0.05) with a strong trend in favor of neramexane at week 18 (p<0.07) as well. The adverse event profile of neramexane in this study was comparable to placebo.

About Neramexane

Neramexane is being developed jointly by Forest and its licensor, Merz Pharmaceuticals, a German-based specialty pharmaceutical company dedicated to research and development in the fields of neurology and psychiatry.

Neramexane and Namenda (memantine HCl) belong to a new class of drugs for Alzheimer's disease called NMDA (N-methyl-D-aspartate) receptor antagonists. While neramexane's mechanism of action is similar to that of Namenda, neramexane is a distinct chemical entity. Neramexane is a low to moderate-affinity, uncompetitive NMDA-receptor antagonist believed to selectively block the excitotoxic effects associated with abnormal transmission of glutamate (a neurotransmitter that performs an integral role in the neural pathways associated with learning and memory, which is believed to play a role in Alzheimer's disease). While neramexane appears to protect neurons from the damaging effects resulting from abnormal glutamatergic activity, there is currently no clinical evidence that neramexane prevents or slows neurodegeneration in patients with Alzheimer's disease.

About Alzheimer's Disease

Alzheimer's is a progressive disease of the brain and it is the most common type of dementia. The term dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. Published reports project that by 2050 more than 16 million people in the United States will have Alzheimer's disease. Currently, all Alzheimer's medications approved in the United States other than Namenda belong to a class of agents called acetylcholinesterase inhibitors, which are indicated for patients with mild to moderate symptoms of the disease.

About Forest Laboratories and Its Products

Forest Laboratories' growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; 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 indicated for the treatment of hypertension; Benicar* HCT(R) (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 in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.

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 Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2005.

* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.