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Ebixa (Memantine) Promising Treatment for Alzheimer's Disease: Presented at AD/PD 2005

SORRENTO, ITALY -- March 14, 2005 -- Lundbeck announced today results from two independent studies demonstrating the efficacy and tolerability of Ebixa in the treatment of Alzheimer's disease (AD) patients at the 7th International Conference on Alzheimer's and Parkinson's Disease (AD/PD 2005) in Sorrento, Italy.

The placebo controlled study results demonstrated that in moderate to severe Alzheimer's patients for whom treatment was switched either abruptly or gradually from donepezil to Ebixa, the switch was found to be well tolerated with the majority of patients maintained or improved in their global performance. The results from an open label naturalistic study showed that Ebixa treatment led to clinical improvements in Alzheimer's disease patients.

"Previous data has indicated potential withdrawal reactions to the interruption of acetylcholinesterase inhibitor treatment in Alzheimer's patients, characterised by global patient deterioration." said Anders Gersel Pedersen, head of drug development at Lundbeck. "These results show that Alzheimer's patients, who were switched either abruptly or gradually to Ebixa treatment from donepezil, did not experience tolerability problems and that the majority of these patients stabilised or improved with Ebixa treatment. In addition, the open label study further supports Ebixa's efficacy and favourable tolerability, as previously reported in randomised clinical studies."

Study 1: Switching to memantine in AD

Results from a double-blind, placebo controlled study in forty six patients with moderate to severe Alzheimer's disease (mean MMSE < 14) conducted in Scandinavia, showed that switching from the acetylcholinesterase inhibitor donepezil to memantine is well tolerated. Patients who appeared to be no longer benefiting from donepezil treatment, were randomised to either a placebo group, with their current donepezil 10 mg therapy discontinued abruptly, or a gradual down-titration group, with their current donepezil therapy discontinued in a stepwise programme, down-titrating donepezil from 10 mg to 5 mg for two weeks before discontinuing. At the same time, memantine was up-titrated to 20mg/day over a three-week period for both patient groups. The adverse events reported in either group were considered mild to moderate by the investigator and there were no clinically relevant differences in tolerability between the abrupt and stepwise switching schedules respectively.

In addition, switching from donepezil to memantine appeared to maintain or improve patients' global performance, with 74% of the patients either stabilising or improving as measured by Clinician's Global Impression of Change (CGI-C) after being switched to memantine.


Study 2: Efficacy and tolerability of memantine in a naturalistic setting

Open label data from a large naturalistic study in 1,845 Alzheimer's disease patients in Germany were also presented at the AD/PD conference today. Alzheimer's disease patients were treated for six months with memantine (20mg/day). Cognitive function assessment as measured by the Mini Mental State Examination (MMSE), and other measures such as the Nurses' Observation Scale for Geriatric Patients (NOSGER measure of behaviour and function), the Explorations Modul Demenz (EMD measure of cognition, function and insight) and a rating of global efficacy by the clinician were recorded at baseline and at six months.

After six months of open label treatment with memantine, patients' cognitive function was statistically significantly improved by a mean of 2.5 MMSE points (p<0.0001) compared to baseline. The additional assessment measures also supported the positive memantine treatment effects. The tolerability of memantine was found to be very good or good in 93% of the patients. These positive results in a naturalistic setting from an open label study, further support memantine's efficacy and tolerability demonstrated in previous randomized, placebo controlled Alzheimer's disease studies.

About Ebixa (Memantine)
Memantine is a moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist that is unique among Alzheimer's disease treatments since it targets the neurotransmitter glutamate, a chemical messenger in the brain that is involved in normal memory and learning processes. Memantine works by blocking the effect of abnormal glutamate levels in AD, leading to symptomatic benefits in cognition, behavior, activities of daily living, and overall performance for patients.

Lundbeck markets memantine under the trade name, EbixaŽ, in a number of markets worldwide including Europe for the treatment of moderately severe to severe Alzheimer's disease. Forest Laboratories markets memantine as NamendaŽ in the US for the treatment of moderate to severe Alzheimer's disease. Memantine is marketed under license from Merz Pharmaceuticals, Germany, who also market memantine in a number of markets under the trade name Axura. Memantine is currently under evaluation by the EU regulatory authorities for the mild to moderate stages of Alzheimer's disease and is also under review by the US regulatory authorities for the mild stages of Alzheimer's disease.


SOURCE: H. Lundbeck A/S

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