Release number: 73
Release date: 22-07-2002
Release time: 12:00
Data on Ebixa®, presented at the Alzheimer’s Association 8th International Conference on Alzheimer’s Disease and Related Disorders held in Stockholm July 20-25 demonstrated several potential benefits. Ebixa showed sustained clinical efficacy over a period of 1 year, reduced caregiver burden and reduced costs to society, demonstrated good tolerability in patients in concurrent treatment with cholinesterase inhibitors, and showed neuroprotective effects in pre-clinical studies.

Results from a 6-month placebo-controlled trial indicated that treatment with Ebixa® reduces the time and costs associated with caring for patients with moderate to severe Alzheimer's Disease (AD). Compared to placebo, treatment with Ebixa® was associated with a reduction of more than 50 hours per month in caregiver time. In addition, the number of patients institutionalised due to their disease was lower in the Ebixa® treated group.

In an oral presentation to be delivered at the conference, Professor Barry Reisberg, M.D., Department of Psychiatry, New York University School of Medicine, will present data supporting a sustained efficacy of Ebixa® over a treatment period of 52 weeks. Moreover, in the 24 week open label extension phase the former placebo patients who switched to Ebixa® showed improvement in cognitive, functional and global domains compared to the projected rate of decline. Ebixa® was well tolerated throughout the study.

New results from a post marketing surveillance study in Germany show that memantine was well tolerated in combined treatment with cholinesterase inhibitors in patients with AD and vascular dementia.

Results from three pre-clinical studies, presented at the meeting, support a neuroprotective potential for Ebixa®.  Scientists tested clinically relevant doses of Ebixa in various experimental models for neuroprotective effects.  In a rat model, Ebixa® prevented cell death associated with glutamate neurotoxicity. The neurotransmitter glutamate plays an integral role in neural pathways associated with learning and memory, and the excitotoxicity produced by excessive amounts of glutamate is hypothesized to contribute to the nerve cell death observed in Alzheimer’s Disease. In another rat model exploring Ebixa's effect on the neurotoxicity of beta-amyloid, Ebixa® exerted a protective effect against the loss of nerve cells. It is believed that the formation of beta-amyloid containing plaques in the brain and progressive nerve cell death are primary causes of the cognitive and functional deterioration of Alzheimer’s Disease. Furthermore, in rat brain cell cultures with experimentally induced disturbance in the tau phosphorylation,  Ebixa® restored the balance. Abnormal hyperphosphorylation of tau and the associated neurofibrillary degeneration is a consistent finding in AD.

Ebixa® is the first in a new class of drugs - the NMDA glutamate antagonists - for the treatment of Alzheimer’s disease, demonstrating clinically significant efficacy in patients with moderately severe to severe Alzheimer’s disease. Ebixa® is expected to fulfil unmet needs within this group of patients  - for whom no approved treatment has been available until now.

Alzheimer’s Disease affects approximately 5 percent of the population over 65 years of age and more than 20 percent in the age group above 85 years. Currently less than 50 percent of the people suffering from Alzheimer's disease are correctly diagnosed and of these, only 10-30 percent receive appropriate treatment. There are considerable variations in diagnosis rate and treatment between countries.

Alzheimer’s Disease is a neurodegenerative disease characterised by progressive cognitive impairment, such as failing memory, reduced perception and language derangement, which ultimately leads to patients not being able to look after themselves. In later stages of the disease, mental disturbances such as anxiety, confusion and anger, appear.

Lundbeck has licensed Ebixa® from Merz Pharmaceuticals, a German research-based pharmaceutical company. Lundbeck has acquired exclusive rights to a number of European countries as well as Canada, Australia and South Africa. Under a co-marketing agreement with Merz, Lundbeck has acquired semi-exclusive rights to the rest of the world, exclusive of USA and Japan.

The content of this release will have no influence on the Lundbeck Group’s result for the Lundbeck Group’s result for 2002. The company still expects an increase in turnover of approx. 20% compared to 2001, while the operating profit still is expected to increase by 20% compared to 2001.

For further information please contact Hans Henrik Munch-Jensen, CFO, tel +45 36 30 15 11, ext. 2660 or Steen Juul Jensen, Director of Corporate Communication & Investor Relations, tel +45 36 30 13 11, ext. 3006.

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H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2001, the Company’s revenue was DKK 7.7 billion and the number of employees approx. 4,000.

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Copenhagen Valby

Phone +45 3630 1311
Fax +45 3630 1940

information@lundbeck.com