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

COPENHAGEN, Denmark, January 18, 2011 /PRNewswire/ -- 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 disease.

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 disease.[2]

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 billion or USD 2.6 billion). For more information, please visit http://www.lundbeck.com.

References:

[1]. NICE guidance published at http://www.NICE.org.uk. Accessed January 2011

[2]. Ebixa(R), Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/document.aspx?documentId=10175 Accessed January 2011

[3]. Warner J, Butler R. Alzheimer's disease. Clinical Evidence 2000;3:419-425

[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, 2001