BASINGSTOKE, England, May 26 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) is disappointed that NICE (National Institute for Health and Clinical Excellence) has issued its Final Appraisal Determination (FAD) and made no changes to its draft guidance issued in March 2006 on drug treatments for Alzheimer's disease (AD). The FAD confirms that patients newly diagnosed with mild AD should not have access to drug treatments on the NHS.[1]
"We fundamentally disagree with the decision that acetylcholinesterase inhibitors, such as Reminyl(R) and Reminyl XL(R), should not be made available for those newly diagnosed with mild AD,"[2] says John Freeman, Managing Director of Shire Pharmaceuticals UK commercial operation.
With Reminyl and Reminyl XL having been proven as clinically effective for mild and moderate AD, and licensed for these conditions, it is hard to reconcile this recommendation from NICE with the recently issued Scottish Intercollegiate Guidelines Network (SIGN's) report.[3] SIGN recommends the use of cholinesterase inhibitors for the treatment of people at all stages of Alzheimer's disease.
This guidance will have a potentially devastating impact on the lives of people in the earlier stages of AD. "
Dr Ian Howe, Medical Director of Shire Pharmaceuticals in the UK, explains: "Withdrawing drug treatments on the NHS for people diagnosed with mild AD is a grave error as clinical trials demonstrate that mild AD patients benefit significantly with measurable improvements in cognition and the ability to continue to participate in activities of daily living (ADL).[4]
There is also evidence in clinical practice that patients initiated on treatment earlier have a cumulative advantage in that the progression of their disease is slowed, which means they remain stable for longer. Some patients retain treatment benefits for years.[5]
With the right support, care and treatment those with mild and moderate AD can enjoy a better quality of life for longer, buying valuable time for families before the disease progresses."
Clinicians have declared they will find it hard to implement this guidance in practice, since the drug treatments are all licensed for the treatment of mild to moderate AD. In a survey conducted by the Faculty of Old Age Psychiatry, two thirds of Old Age Psychiatrists stated that they would feel unable to withhold treatment with cholinesterase inhibitors from someone with AD who met the licensing requirements.[6]
"The degree of severity of AD is currently measured using the Mini-Mental State Evaluation (MMSE), a screening tool which clinicians state is not the best means for identifying who may benefit from cholinesterase inhibitors," explains Dr Ian Howe.
Restricting access to the anticholinesterase drugs to people with an MMSE score of between 10 and 20 will discourage early diagnosis and counteract the positive work in recent years to encourage people to seek help earlier. Early detection of dementia allows individuals faster access to appropriate agencies and support networks, which can reduce the distress that patients and their carers' experience."[7]
John Freeman adds: "Shire Pharmaceuticals is considering all options following the issue of this FAD, including the option to appeal. Shire will continue to press for newly diagnosed mild AD patients to receive these drugs on the NHS
in England & Wales and challenge the inequality of care that will be generated by this NICE recommendation.
NICE's recommendation will result in those diagnosed with mild AD missing out on effective treatment - a treatment that costs less than GBP2.50 a day."
Shire markets the acetylcholinesterase inhibitor Reminyl(R) and Reminyl XL (galantamine)[8] in the UK. It is licensed for the treatment of mild and moderate dementia of the Alzheimer's type.
SHIRE PLC
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forwarding-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire plc's results could be materially affected. The risks and uncertainties include, but are not limited to: risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire plc's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM (I2S) (Hunter syndrome) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc's ability to benefit from the acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the US Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.
[1] Log onto www.nice.org.uk to view the FAD.
[2] The Mini-Mental State Evaluation (MMSE) score (range 0-30) assesses mild AD as 26-21, moderate AD 20-10 and severe AD below 10.
[3] Log onto www.sign.ac.uk to view the report - Management of People with Dementia.
[4] Shire Pharmaceuticals/Johnson& Johnson: submission to NICE 21 October 2005.
[5] Dartigues JF et al. Long-term effects of galantamine on cognitive function in Alzheimer's disease:
a large-scale international retrospective study. Poster presented at the European Federation of Neurological Sciences meeting; Athens, Greece, September 2005.
[6] Log onto www.rcpsych.ac.uk for a report on the results of the survey of members of the Faculty of Old Age Psychiatry of the Royal College of Psychiatrists into the NICE Guidance on cholinesterase inhibitors.
[7] Levin E, Sinclair L and Gorbach P, Families, Confusion and Old Age, 1989, Gower: Aldershot.
[8] Shire markets Reminyl and Reminyl XL in the UK and Ireland. Janssen Pharmaceutica NV markets Reminyl under licence from Shire in the rest of the world.
