LONDON, October 7, 2010 /PRNewswire/ -- The National Institute for Health and Clinical Excellence (NICE) has today announced new draft guidance which represents a significant step towards ensuring patients with Alzheimer's disease in England and Wales receive treatment for their condition, from the early stages of disease.

New draft NICE guidance released today recommends that acetylcholinesterase inhibitors, including Aricept(R) (donepezil), should be made available to patients in England and Wales as options for managing mild to moderate disease.[1]* This is a significant change to an earlier 2006 NICE ruling which restricted access to these medicines for patients with moderate disease only.

This provisional decision by NICE is an important milestone for the thousands of Alzheimer's patients currently unable to receive treatment for their condition. Early diagnosis and access to medication is critical to help reduce both the short and long-term impact of this devastating condition on patients, families and carers. says Professor Roy Jones from The Research Institute for the Care of Older People (RICE) Centre, Royal United Hospital, Bath, UK

Today's announcement is expected to be widely welcomed as it supports the Department of Health's National Dementia Strategy (NDS).[2] The NDS encourages the active management of Alzheimer's disease from its earlier stages to minimise the burden of the condition on patients, their carers and society. In addition, the need for greater access to dementia-specific treatments is in line with the recent Alzheimer's Disease International report which calls for governments to make dementia a higher health priority, to help tackle the huge burden of the disease.[3]

Nick Burgin, Managing Director UK, Eisai Limited (the manufacturer of Aricept(R)) said: We are delighted by NICE's decision to again recommend Alzheimer's treatments such as Aricept(R) in the early stages of the disease. This was the right decision for patients in 2000 when these medicines were originally reviewed by NICE and it is the right decision today. While we welcome this decision, it will always remain a huge disappointment that NICE changed their original guidance in 2006, thereby preventing patients with early stage Alzheimer's disease from benefiting from early treatment. After a five year battle, today's recommendation will once again allow patients to get the treatment they need, when they need it most.

The draft NICE recommendations on Alzheimer's disease treatment will now go into consultation, with final guidance expected in early 2011.

*Additional information on the draft NICE guidance1

Appraisal Committee's preliminary recommendations

1.1 The three acetylcholinesterase (AChE) inhibitors (donepezil, galantamine and rivastigmine) are recommended as options for managing mild to moderate Alzheimer's disease (as per their license indications), under all of the following conditions:

- Only specialists in the care of patients with dementia should initiate treatment. - Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional and behavioural symptoms - Patients who continue on the drug should be reviewed at least every six months using cognitive, global, functional and behavioural assessment. - If prescribing an AChE inhibitor, treatment should normally be started with a drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started). However, an alternative AChE inhibitor could be prescribed if it is considered appropriate when taking into account adverse event profile, expectations around adherence, medical comorbidity, possibility of drug interactions and dosing profiles 1.2 Memantine is recommended within its licensed indication 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

For the full guidance, please visit: http://guidance.nice.org.uk/Type/TA/Published

About Alzheimer's disease

Currently, there are around 820,000 people living with Alzheimer's and other dementias in the UK,[4] including an estimated 575,000 sufferers in England and 37,000 in Wales.[5] Alzheimer's disease is the most common form of dementia, affecting 62% of dementia patients in the UK.5 This irreversible, progressive brain disorder gradually destroys memory, reasoning and thinking skills, and may eventually leave patients unable to carry out even the simplest tasks.[6] Alzheimer's disease has impacts in many ways including physical, mental, nursing, medical and social impacts.1 Despite its burden, Alzheimer's remains a relatively overlooked disease. Just 2.5% of the government's medical research budget is devoted to dementia; in contrast a quarter is allocated to cancer research.[7]

About Eisai

Eisai is one of the worlds leading research-based pharmaceutical companies that has defined its corporate mission as giving first thought to patients and their families and to increasing the benefits health care provides, which we call human health care (hhc).

Eisai concentrates its research activities in three key areas: - Integrative Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression - Integrative Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea - Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ more than 11,000 people worldwide.

About Pfizer: Working Together for a Healthier World(TM)

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

In the UK, Pfizer has its European RD headquarters at Sandwich and its UK business headquarters in Surrey, and is the major supplier of medicines to the NHS. To learn more about our commitments, please visit us at http://www.pfizer.co.uk.

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[1] National Institute for Health and Clinical Excellence. Appraisal consultation document - donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (review of NICE technology appraisal guidance 111). September 2010

[2] NHS National Dementia Strategy. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/docu... /digitalasset/dh_094052.pdf. Last accessed Sept 2010

[3] World Alzheimer Report 2010. Available at: http://www.alz.co.uk/research/files/WorldAlzheimerReport2010ExecutiveSum.... pdf. Last accessed Sept 2010

[4] Alzheimer's Research Trust -Dementia 2010. Available at: http://www.dementia2010.org/reports/Dementia2010Full.pdf. Last accessed Sept 2010

[5] Alzheimer Society. Available at: http://alzheimers.org.uk Last accessed Sept 2010

[6] National Institute on Aging (NIA). Alzheimer's Disease Factsheet. NIH Publication No 08-6423. Reprinted February 2010

[7] Alzheimer's Research Trust. Available at: http://www.alzheimers-research.org.uk/info/statistics/ Last accessed Sept 2010

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SOURCE: Eisai and Pfizer

CONTACT: For further information contact: Leah Peyton / Benjamyn Tan,Tonic Life Communications, +44(0)7788-191-434 / +44(0)20-7798-9923,Leah.peyton@toniclc.com / Benjamyn.tan@toniclc.com; Eisai Europe Ltd,Cressida Robson, +44(0)845-676-5318; Pfizer Press Office, +44(0)845-3008033