Alzheimer's disease
 Around 600,000 people in the UK have dementia, of which some 55% have Alzheimer's disease
- These figures are likely to increase over time as the population ages
- Alzheimer's disease slowly attacks and eventually destroys the parts of the brain that store memory
- A person with Alzheimer's disease will find that their ability to remember, speak, think and make decisions gradually worsens as the illness takes hold
- They will eventually lose the ability to carry out normal daily activities such as dressing, eating and handling money
- Around 90% of patients experience 'behavioural disturbance', which is distressing for them, and equally upsetting and stressful for their carers
- Alzheimer's disease is incurable but acetylcholinesterase inhibitors have been shown to delay the progression of the disease and to improve the quality of life for both the patient and their carer(s)
- Our product REMINYL (with which we are involved with a joint venture with Janssen-Cilag) is one of these drugs
- REMINYL is a mild and well tolerated therapy with proven efficacy. It comprises a vital element in the treatment of Alzheimer's disease.
- As a result of our experience in treating Alzheimer's disease, we have a deep interest in various Government initiatives in this area including the Older Person's NSF and other NHS policies for delivering services for elderly people and especially those with dementia
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Reminyl and Alzheimer's Disease
- REMINYL is successful at slowing the progression of mild-moderate Alzheimer's and in helping to restore cognitive function in patients
- It has been shown to be effective for at least four years and across all the key domains of Alzheimer's disease
- Treatment of patients with Alzheimer's requires structured services and a high level of co-operation across primary and secondary care which is often missing in the NHS
- There is poor recognition of the disease both amongst patients themselves and amongst primary care clinicians
- This is compounded by a frequent failure of primary care to refer patients into secondary care even when the disease is recognised
- Waiting lists in secondary care can also be long
- These factors are concerning because early intervention gives patients their best chance of benefiting from the therapy
- It will also improve the likelihood that they are integrated into the various other local support services that may be available to help them deal with their condition
- There is also a significant positive impact on carers from delaying progression of the disease
- Delay in providing therapy leads to the opportunity to treat being lost for good, with concomitant effects on the patients and their family
- Many patients currently cannot access these treatments either because of local budgetary constraints or because of a lack of diagnostic memory clinics and other structures - often themselves caused by funding short-falls. There is also a shortage of medical staff in this area
- We would like to see an improvement in services to tackle waiting lists and to ensure that patients are treated quickly following diagnosis, also receiving drug therapy if they need it
- We would also like to see the greater involvement of primary care in diagnosing and treating patients with the disease, possibly initiating treatment in the period whilst a secondary consultation is awaited
Press Release
29/10/2002
First long-term study shows superiority of Reminyl(tm) over donepezil in patients with Alzheimer's Disease
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Osteoporosis
 Osteoporosis affects 1 in 3 women and 1 in 12 men over the age of 50[ 1]
- The cost of repairing the UK's 86,000 annual hip fractures is estimated at £1.7bn [2, 3]
- The burden of osteoporosis and osteoporotic fracture is expected to increase in coming years because of increased life expectancy [4]
- WHO has predicted that osteoporosis will reach epidemic proportions in developing countries if preventative measures not undertaken [5]
- Osteoporosis severely affects quality of life and results in increased mortality and morbidity [6, 7]
- There is up to 33% mortality rate in the first year of hip fracture [6]
- Osteoporosis is often very painful and seriously impairs the ability to conduct even routine daily activities such as cooking, shopping, housework and getting about
- Calcium and vitamin D deficiency increases the risk of osteoporosis and osteoporotic fracture. This is because:
- Calcium is the principal mineral of bone. It is generally agreed that adequate calcium insake is necessary to maintain bone strength [8]
- Vitamin D assists in the absorption of calcium
- Vitamin D helps to maintain neuromuscular function, which may help to prevent falls. [9, 10]
- Calcium and Vitamin D deficiency is particularly prevalent amongst the elderly [8]
- The institutionalised elderly would particularly benefit from being prescribed calcium and vitamin D not least because the rate of falls in institutions is nearly three times higher than in the community-dwelling elderly. [11] Current Government advice is that all ambulatory patients residing in residential homes should be prescribed calcium and vitamin D [11]
- As a result of Shire's experience with osteoporosis, Shire take a keen interest in supporting the implementation of policy initiatives in this area, including the Older Person's National Service Framework (NSF) and other NHS work to help deliver improved services for elderly people
- Standard Six of the NSF for Older People gives a clear commitment to tackling osteoporosis.
- "Where patients are identified as being at high risk of developing osteoporosis, investigations such as measurement of bone mineral density should be carried out in line with the Royal College of Physician's Guidelines on the prevention and treatment of osteoporosis"(NSF for Older People, 2001) [12]
- However, a lack of funding and co-ordinated effort means that less than ideal progress has been made in implementing Standard Six of the NSF for Older People
- Use of high dose supplements of vitamin D and calcium provide a means of clinically and cost effective fracture reduction in targeted populations. This would assist with the Government's aims of fracture reduction, but would be in keeping with the budgetary constraints of the NHS. [13, 14]
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Actinic Keratosis
- Actinic or solar keratoses (AK or SK) are skin lesions commonly found in fair skinned people and especially in the elderly
- They are caused by over exposure to ultraviolet (sun) light
- There are approximately 5.7m people suffering from SK lesions in the UK [1]
- Most lesions are benign but solar keratoses can progress to form malignancies and should be treated [2, 3]
- Up to 20% of SK lesions will develop into squamous cell carcinoma, a type of skin cancer [4]
- Skin cancer is the most common cancer in the UK. [5]
- There are various treatments for SK including the use of extremely cold liquids to freeze and destroy abnormal cells whilst preserving the surrounding healthy skin (cryotherapy)
- Cryotherapy is only suitable for single or limited numbers of lesions
- Amongst other effective treatments is a cream which destroys abnormal cells and causes severe skin inflammation during treatment
- Both of these and some of the other available treatment options can have unpleasant side effects
- Shire's treatment for SK is a product called SOLARAZE
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Hyperphosphataemia - a complication of kidney disease
Chronic kidney failure is complicated by hyperphosphataemia - high phosphate levels in the blood - caused by the inability of the kidneys (and dialysis) to filter out excess phosphate from food. Even with a low-phosphate diet as many as 80% of Europe's 225,000 and the United States' 269,000[1] dialysis patients develop hyperphosphataemia[2] and need treatment with a phosphate-binder.
- It is important to control serum phosphate levels in ESRD patients in order to reduce the risk of:
- Secondary hyperparathyroidism
- Renal osteodystrophy
- Metastatic calcifications
- Development of cardiovascular disease
- Nearly 50% of all deaths in dialysis patients are attributable to cardiovascular disease[4]
- Hyperphosphataemia is an independent risk factor for mortality[3]
- Control of elevated serum phosphate levels is therefore essential in reducing the considerable morbidity and mortality associated with hyperphosphataemia[5,6]
Current approaches to controlling hyperphosphataemia have limited success
- Dialysis on its own is unable to efficiently prevent the build up of phosphate[1]
- Most patients with hyperphosphataemia are managed by a combination of dietary restrictions and phosphate-binding agents[2]
- High prevalence of hyperphosphataemia suggests that many dialysis patients do not have adequately controlled serum phosphate levels despite the use of phosphate-binding agents[2,3]
- Phosphate-binding agents currently used to treat hyperphosphataemia include:
- Calcium-based agents
- Aluminium-based agents
- Polymer-based agent
- Currently available phosphate-binding agents have serious therapeutic shortfalls including:
- Development or exacerbation of hypercalcaemia and metastatic calcification (calcium-based agents)[4]
- Osteomalacia and neurological disorders (aluminium-based agents)[5,6]
- Acidosis and high pill count (sevelamer hydrochloride)[7]
- Therefore, there is a pressing need for more effective and better tolerated non-calcium, non-aluminium phosphate-binding agents
Shire Pharmaceuticals received approval in October 2004 from the U.S. Food and Drug Administration for Fosrenol (lanthanum carbonate), a binding agent for use in end-stage renal disease (ESRD) patients. Also, earlier in the year March 2004 regulatory authorities in Sweden granted marketing authorization for FOSRENOL. As Sweden is the reference member state in the European Union Mutual Recognition Procedure for FOSRENOL, this approval was the first step in securing marketing approval throughout Europe. The company has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd. Shire has an exclusive worldwide license to develop, manufacture, use and sell Lanthanum carbonate under patents owned by AnorMED Inc.
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Osteoporosis references
1. National Osteoporosis Society website (www.nos.org.uk)
2. Dolan P and Torgerson DJ. Osteoporosis Int 1998; 8: 611-617
3. Torgerson D. Personal Communication
4. Tobacco Free Initiative - http://www.tobacco.who.int/
5. World Health Organisation Press Release (WHO/58) October 1999
6. Keene GS et al. BMJ 1993; 307: 1248-1250
7. Cooper Melton MJ III. In Marcus R, Feldman D, Kelsey J eds Osteoporosis. San Diego Academic Press Inc 1996: 419-34
8. Dept of Health. Nutrition and Bone Health, TSO, 1998
9. Biscoff HA et al. J Bone Min Res 2003; 18: 343-51
10. Pfeifer M et al. J Bone Min Res 2000; 15: 1113-1118
11. NHS Modernisation Agency
12. National Service Framework for Older People, March 2001
13. Bandolier No. 37, March 1997
14. Royal College of Physicians. Osteoporosis: Clinical Guidelines for Prevention and Treatment, 1999, 2000
AK references
1. Can't find refer to Client
2. Wolf JE et al. Int J Dermatol 2001; 40: 709-713
3. Glogau RG. JAAD 2000; 42: 23-4
4. Montgomery H, Doerffel J. Arch f Dermat u Syphil (Berlin) 1932;166: 286-97
5. Cancer Research UK. Sunfacts 2002.
Hyperphosphataemia refrences
1. U.S. Renal Data System. USRDS 2002 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2002, page 44.
2. Numbers of patients on dialysis broadly equates to patients with end stage kidney disease. Source: Market Research, Insight International, Dec 01/Jan 02
3. Block GA, et al. Am J Kidney Dis 1998; 31:607-617
4. Block GA & Port FK. A J Kidney Dis 2000; 35:1226-1237
5. Hsu CH. Am J Kidney Dis 1997; 29:641-649
6. Forman MB, et al. Chest 1984; 85:367-371
More Hyperphosphataemia refrences
1. Hsu CH. Am J Kidney Dis 1997; 29:641-649
2. Block GA, et al. Am J Kidney Dis 1998; 31:607-617
3. Block GA & Port FK. A J Kidney Dis 2000; 35:1226-1237
4. Sperschneider H, et al. Nephrol Dial Transplant 1993; 8:530-534
5. Smith AJ, et al. Am J Nephrol 1986; 6:275-283
6. Armstrong RA, et al. Dementia 1996; 7:1-9
7. Renagel® summery of product charesteristics 2001
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