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Ebixa, Extended Approval for Treatment of Moderate Alzheimer's Disease

COPENHAGEN, DENMARK -- October 17, 2005 -- At a meeting held on 10-13 October 2005, the European health authorities approved Ebixa (memantine) for the treatment of moderate Alzheimer's disease.

Ebixa(R) is already the leading drug for the treatment of severe stages of Alzheimer's disease. Following the extension of the indication for the treatment of moderate Alzheimer's disease -- an area that has so far been restricted to one class of drugs; the so-called acetylcholinesterase inhibitors (AchEI) -- Ebixa(R) is now the only approved drug for the treatment of moderate, moderately severe and severe Alzheimer's disease. The approval does not cover the very early mild stage of Alzheimer's disease.

"Alzheimer' disease is one of the most disabling, neurodegenerative disorders afflicting elderly people. The disease is severely disabling for the patient and involves major consequences for the relatives. Studies have shown that treatment with Ebixa(R) may limit the functional impairment and significantly reduce the need for assistance from nursing staff or relatives", says Anders Gersel Pedersen, head of Lundbeck's drug development.

Lundbeck markets Ebixa(R) in Europe and in a large number of markets in the rest of the world, including Canada, South America and Asia.

About Ebixa(R)
Ebixa(R) offers doctors a new treatment regime with a mode of action different from that of other products in the market, and Ebixa(R) is the first and so far only approved drug for the treatment of moderate, moderately severe and severe Alzheimer's disease. Ebixa(R) has excellent tolerability, and clinical studies have shown that the number of reported side-effects were comparable to placebo.

In meta-analyses from six international phase III placebo-controlled six-month studies, patients with moderate to severe Alzheimer's disease (MMSE total score at baseline below 20) showed statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains. Further analysis showed that twice as many memantine-treated patients showed a statistically significant benefit in preventing marked clinical worsening in all three domains as compared to placebo-treated patients.

The application was filed on 21 October 2004 and during the processing, the application was changed to exclusively comprise moderate Alzheimer's disease.

About Alzheimer's disease
Alzheimer's disease affects 5% of the population over the age of 65 and more than 20% of the over-85 age group. Today, about 60% of Alzheimer patients are correctly diagnosed, and of these patients about 80% are diagnosed with either moderate or severe Alzheimer's disease.

Alzheimer's disease is a neurodegenerative disease characterised by progressive cognitive impairment such as memory loss, reduced perception ability and language disruptions, eventually preventing the patient from taking care of himself. Anxiety, confusion and anger may occur in the late stages of the disease.


SOURCE: H. Lundbeck A/S

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