Milestone Ruling for Alzheimer's Disease Patients Announced

By Eisai And Pfizer, PRNE
Tuesday, October 5, 2010

LONDON, October 7, 2010 - 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today announced new draft guidance which represents a significant step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:

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 R&D 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


[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:
/digitalasset/dh_094052.pdf. Last accessed Sept 2010

[3] World Alzheimer Report 2010. Available at:
pdf. Last accessed Sept 2010

[4] Alzheimer's Research Trust -Dementia 2010. Available at: Last accessed Sept

[5] Alzheimer Society. Available at: 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: Last accessed Sept

(Due to the length of the URLs, it may be necessary to copy and paste
this hyperlinks into your Internet browser's URL address field. Remove the
space if one exists.)

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

will not be displayed