NICE Recommends Ebixa(R) (Memantine) in Alzheimer's Disease

By H. Lundbeck As, PRNE
Monday, January 17, 2011

COPENHAGEN, Denmark, January 18, 2011 - Lundbeck welcomes the news that patients in England and Wales with
moderate or severe Alzheimer's, within specific conditions, will qualify for
treatment with Ebixa(R) under the Final Appraisal Determination (FAD) from
the National Institute for Health and Clinical Excellence (NICE)[1]. The
company urges the rapid implementation of this Technology Appraisal guidance
with allocation of the mandatory funding to ensure eligible patients will be
given access without delay.

Dr David Wilkinson, consultant in Old Age Psychiatry at the Memory
Assessment and Research Centre in Southampton commented: "This decision from
NICE is very welcome news as memantine, with its different mode of action
from the other available treatments, offers new hope for patients, carers and
doctors dealing with Alzheimer's disease - one of the most distressing
diseases we have to face."

Karin Jexner Hamberg , Vice President Medical Affairs & Clinical
Development Centres at Lundbeck said: "We are delighted that this review has
broadened the scope for patient access to Ebixa(R) in England and Wales. We
hope this guidance will quickly provide improved access to treatment for
Alzheimer's patients when their physicians deem it appropriate."This guidance
brings England and Wales into line with the majority of other European
countries where Ebixa(R) is already available to patients with Alzheimer's

Previously in England and Wales, only patients with moderate disease had
access to Alzheimer's treatment. This new guidance also permits the broader
use of AChEIs to include mild to moderate Alzheimer's disease - effectively
now giving all Alzheimer's patients in England and Wales access to treatment.

Notes to Editors:

The NICE Final Appraisal Determination (2011)

Donepezil, galantamine, rivastigmine and memantine for the treatment of
Alzheimer's disease (review of NICE technology appraisal 111) provides the
following guidance for the National Health Service in England and Wales for
Ebixa(R) (memantine)1:

"Memantine is recommended as an option for managing Alzheimer's disease
for people with:

    - moderate Alzheimer's disease who are intolerant of or have a
      contraindication to AChE inhibitors or
    - severe Alzheimer's disease.

Treatment should be under the conditions specified in 1.3."

About Ebixa

Ebixa(R) (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
modulating the effect of abnormal glutamate levels in Alzheimer's disease,
leading to symptomatic benefits in cognition, behaviour, activities of daily
living and overall clinical symptom performance for patients. It is well
tolerated with a side-effect profile similar to placebo and a low potential
for drug-drug interactions.

Ebixa(R) is licensed for the treatment of moderate to severe Alzheimer's

Memantine was developed by Merz and licensed to Forest for the U.S. and
Lundbeck for selected European and international markets. Memantine is
marketed under the brands Axura(R) and Akatinol(R) by Merz, Namenda(R) by
Forest and Ebixa(R) by Lundbeck.

About Alzheimer's disease

Alzheimer's disease is a progressive neurodegenerative disease. One in
every 20 people over the age of 65 has Alzheimer's disease, the most common
form of dementia.[3] Approximately 24 million people suffer from dementia
worldwide and this rate is due to increase to 80 million by 2040.[4]
Symptoms include memory deterioration, difficulty with language and the
ability to communicate (cognition), inability to perform previously routine
tasks (functional decline) and personality and mood changes (behaviour).[5]

The three key stages of Alzheimer's disease are referred to as mild,
moderate and severe. People with mild Alzheimer's can usually live alone and
function fairly well. As a result they may not even be aware that they have
Alzheimer's disease and may not have been correctly diagnosed. By the
moderate stage, the symptoms are more pronounced and Alzheimer's sufferers
have greater difficulty coping without some supervision. In more severe
Alzheimer's, the advanced stages of the disease, patients generally can no
longer care for themselves.

About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international
pharmaceutical company highly committed to improving the quality of life for
people suffering from central nervous system (CNS) disorders. For this
purpose, Lundbeck is engaged in the research and development, production,
marketing and sale of pharmaceuticals across the world. The company's
products are targeted at disorders such as depression and anxiety,
schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and
Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark.
Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one
of the world's leading pharmaceutical companies working with CNS disorders.
In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8
or USD 2.6 billion). For more information, please visit


[1]. NICE guidance published at Accessed January

[2]. Ebixa(R), Summary of Product Characteristics. Available at: Accessed
January 2011

[3]. Warner J, Butler R. Alzheimer's disease. Clinical Evidence

[4]. Ferri CP et al. Global prevalence of dementia: a Delphi consensus
study. Lancet 2005;366(9503):2112-7

[5]. Lovestone and Gauthier. Management of Dementia. Martin Dunitz Ltd,

Media contact: Rachel Terry, Burson-Marsteller London: Rachel.Terry at, +44(0)20-7300-6352

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