NEW YORK, July 25 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today that the United States Food and Drug Administration (FDA) has issued a non-approvable letter in response to its supplemental New Drug Application (sNDA) to expand the indication of Namenda (memantine HCl) to include treatment of mild Alzheimer's disease. Namenda was approved by the FDA for the treatment of moderate to severe Alzheimer's disease in October 2003.
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The FDA accepted the sNDA for review in November 2004. Upon completing its review, the FDA acknowledged that it had informed Forest that a single positive study in patients with mild to moderate Alzheimer's disease would be adequate to support extending Namenda's claim to include mild patients. The FDA further acknowledged that the six-month, U.S., mild to moderate study which reached statistical significance at the required primary endpoints was such a study. Nevertheless the FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies of Namenda in patients with mild to moderate Alzheimer's disease -- a study of Namenda monotherapy conducted by H. Lundbeck in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. Forest plans to meet with the FDA to further discuss the non-approvable letter. The Company also indicated that the non- approvable status of Namenda for mild Alzheimer's disease would not impact its current earnings per share guidance of $2.30 for the fiscal year ending March 31, 2006.
Namenda is currently approved for the treatment of moderate to severe Alzheimer's disease. "Namenda offers a well tolerated and effective treatment option to the millions of Americans suffering with moderate or severe Alzheimer's disease," said Ivan Gergel, M.D., Senior Vice President of Scientific Affairs at Forest Laboratories and President of Forest Research Institute. "As the only approved treatment option for patients who have progressed beyond the moderate stage of disease, and as a first-line therapy that can be used alone or in combination with other approved treatments, Namenda plays a very important role in the Alzheimer's disease treatment paradigm."
About Alzheimer's Disease
Alzheimer's is a progressive disease of the brain and the most common type of dementia. 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, and are indicated only for patients with mild to moderate symptoms of the disease. Namenda can be used alone or in combination with an acetylcholinesterase inhibitor for moderate- and severe-stage patients.
Namenda (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, the FDA approved Namenda in October 2003 based on three studies of Namenda used alone or in combination with another Alzheimer's disease drug.
Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda vs placebo (greater than or equal to 5% and higher than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, dosage should be reduced.
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 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, 2005. Actual results may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma Inc.; Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Forest Laboratories markets Namenda(R)(memantine HCl) in the United States under license from Merz Pharma GmbH & Co. of Germany. Lundbeck, under license from Merz, markets memantine as Ebixa(R), and Merz markets memantine as Axura(R) and as Akatinol(R), each in a number of markets worldwide. Ebixa, Axura, and Akatinol are registered trademarks of Merz Pharma GmbH & Co.
Forest Laboratories, Inc.