Xenical available from pharmacists

News Release (for general release)

Xenical available from pharmacists

Auckland, March 10 2005 – Weight loss medication Xenical® (orlistat) is now available direct from a pharmacist for the first time in New Zealand. Xenical has been re-classified to a pharmacist only medicine meaning pharmacists can sell Xenical to appropriate people with an initial body mass index (BMI) of 30 or above without a doctors prescription.

New Zealand’s Medicines Classification Committee recommended approval of Roche’s application to reclassify Xenical from a Prescription Medicine to a Pharmacist Only Medicine for weight control. This brings New Zealand in line with Australia, which was the first country in the world to re-classify Xenical in May last year. Consultations for Xenical must be conducted on a face-to-face basis and all sales and customer details are recorded.

Professor Jim Mann, Professor in Human Nutrition and Medicine at the University of Otago, welcomes the change in access to a treatment that can compliment dietary changes and regular exercise, the cornerstone of treatment for obesity. “For New Zealanders who are significantly overweight or obese, particularly those with health problems associated with obesity, it may be necessary to offer an approach which can complement lifestyle changes. The availability of Xenical provides such individuals with a clinically proven addition to the dietary changes and regular exercise essential to long term weight control.”

The College of Pharmacists has welcomed the access change and says pharmacists are well prepared after almost 900 pharmacists completed its weight-management training course. “Pharmacists are well placed to help tackle New Zealand’s alarming rise in obesity as they are often the first port of call for people looking for a weight loss solution,” said Richard Townley, General Manager of the New Zealand College of Pharmacists. "Pharmacists are very enthusiastic about the opportunity to manage the sale of Xenical and a large number have completed our accredited training programme to encourage effective weight management counselling and the best outcomes for people struggling to lose weight.”

Xenical customers can enrol on the Xenical Support Programme, which provides ongoing support and follow-up by New Zealand registered dietitians. The support programme gives dietary advice to help people identify hidden fats in their diet and encourages them to increase physical activity. A previous study of Xenical Support Programme participants showed they lost an average of 8 kilograms in a 3-month period1.

Roche Products (New Zealand) Ltd Sales and Marketing Director Stuart Knight says the company is delighted Xenical is now more accessible for those most in need. “Xenical has had widespread use as a prescription medicine and has helped thousands of New Zealanders achieve their weight loss goals since it first became available over six years ago. Roche has worked closely with the pharmacy profession which has created a practical dispensing protocol that will ensure Xenical continues to be recommended responsibly and appropriately.”

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Prepared for Roche Products by Communication By Design. For more information please contact:

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated health groups in the fields of pharmaceuticals and diagnostics. Roche’s products and services address prevention, diagnosis and treatment of disease, enhancing well-being and quality of life. Roche employs over 60 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

Reference:

1. Xenical (orlistat) Persistance Survey June 2002 – November 2004. Response analysis Xenical Support Programme, Roche Products (New Zealand) Limited. *Based on 754 patients surveyed participating in the Xenical Support Programme June 2002 –November 2004.

Xenical® (orlistat 120mg capsules) is a Pharmacist Only Medicine used to assist with losing weight, maintaining a certain weight and preventing weight regain in adults with an initial body mass index (BMI) of 30 or more. Xenical should be used in conjunction with a low fat, calorie controlled diet and other lifestyle modifications such as exercise.

Most common unwanted side effects are related to the digestive system such as abdominal pain/discomfort, wind, fatty/oily stools, rectal pain and discomfort and urgent need to go to the toilet.

If you are pregnant or breastfeeding discuss this with your pharmacist or doctor prior to starting treatment. Do not give Xenical to children. Xenical must not be taken by patients with a low uptake of essential nutrients or problems with bile flow.

Ask your pharmacist if Xenical is right for you. Always read the label and use strictly as directed. If you have side effects consult your pharmacist. For further information visit www.xenical.co.nz, www.medsafe.govt.nz or see your doctor or pharmacist. TAPS#NA9398

Pharmaceuticals Roche Products (New Zealand) Limited, PO Box 12-492, Penrose, Auckland.

Weight Management Backgrounder

Weighty facts
 One in two New Zealanders are overweight or obese1
 One in five New Zealand adults are obese1
 Obesity levels in the New Zealand adult population increased from 11% in 1989 to 17% in 1997 to 20% in 2003 and are projected to increase to 29% by 20111–3
 Excess weight contributed to 3,154 deaths (11% of all deaths) in 19974
 90 percent of all people with type 2 diabetes are overweight or obese3
 Excess weight is associated with an increased risk of type 2 diabetes, heart disease, high blood pressure and some cancers3
 Weight loss of around 10% helps to improve blood sugar control, lower cholesterol levels, and reduce blood pressure5,6

Xenical facts
 Over 30,000 people have taken Xenical in over 100 clinical studies7
 New Zealand was one of the first countries in the world to launch Xenical in 1998
 Used by over 19 million people worldwide8
 Used by over 50,000 New Zealanders since its launch in 19989
 Average weight loss of 8kg in 3 months10*
 68% more effective than diet alone11
* Based on 754 patients surveyed participating in the Xenical Support Programme June 2002 –November 2004.

Who is Xenical for?
Xenical is for adults with an initial body mass index (BMI) of 30 or more.12 BMI is a simple index for weight that is commonly used to classify underweight, overweight and obesity in adults. People with a BMI of 30 or more carry excess fat and may have an increased risk for heart disease, diabetes, high blood pressure, gall bladder disease and some cancers.3

How does Xenical work?
Xenical prevents the absorption of one third of the fat eaten in a meal. Xenical interferes with the activity of enzymes in the gut that break down dietary fat before it is absorbed into the body. When Xenical is taken with a meal one third of the fat eaten in the meal passes through the gut undigested. This leads to a reduction in calories stored as fatty tissue or used for energy. Existing fat stores are used instead resulting in weight loss. Xenical is usually taken as one 120mg capsule three times a day with each main meal (breakfast, lunch, dinner).13

How does Xenical compare to dieting?
Xenical is 68% more effective than diet alone.11 Xenical works best in conjunction with a well-balanced low-fat diet and regular exercise.13 Xenical works in tandem with the diet blocking absorption of one third of the fat consumed.13 As with any weight control programme, over-consumption of fat and calories may counteract any weight loss effect.13

Side effects of Xenical
Xenical can cause changes in bowel habits due to the undigested fat passing through the body.13 If high fat foods are eaten while taking Xenical side effects such as abdominal pain/discomfort, flatulence, fatty/oily stools, rectal pain and discomfort and an urgent need to go to the toilet may be experienced.13 These side effects can be avoided by commitment to a low fat diet.14

Weight Management Programme
Everyone on Xenical has access to individualised support via the Xenical Support Programme which is run by New Zealand registered dietitians. The programme helps people learn to recognise the hidden fats in their diet and encourages them to increase their physical activity. These skills help people maintain a healthy weight so they no longer require the extra assistance from Xenical.

Pharmacist suitability to sell Xenical
Pharmacists have been dispensing Xenical in New Zealand since 1998 in response to a doctor’s prescription. While the MCC has been considering the re-classification of Xenical, almost 900 pharmacists have attended weight management training courses developed by the College of Pharmacists to ensure Xenical is sold appropriately. In addition it has been agreed Xenical can only be sold following a face-to-face consultation so pharmacists will have the opportunity to screen customers more closely.

How much does Xenical cost?
As a prescription medicine the average price paid for Xenical is $165 per month15 While this is unlikely to change greatly as a Pharmacist Only Medicine, prices may vary from pharmacy to pharmacy. The Xenical Support Programme is a service provided at no additional cost for people taking Xenical.

Additional information
Additional information is also available on the Xenical (www.xenical.co.nz) and Medsafe (www.medsafe.govt.nz) websites.

References
1. Ministry of Health. A Snapshot of Health: Provisional results of the 2002/03 New Zealand Health Survey. December 2003.
2. Ministry of Health. NZ Food: NZ People. Key Results of the 1997 National Nutrition Survey. August 1999.
3. Ministry of Health. Food and Nutrition Guidelines for Healthy Adults. October 2003.
4. Ministry of Health and the University of Auckland. Nutrition and the Burden of Disease: New Zealand 1997–2011. August 2003.
5. Hollander P et al. Role of Orlistat in the Treatment of Obese People with Type 2 Diabetes. Diabetes Care 1998; 21(8):1288-1294
6. Zavoral J. Treatment with orlistat reduces cardiovascular risk in obese people. Journal of Hypertension 1998, 16; 2013-2017
7. Electronic Communications. 16 June 2004. Roche Basle. Roche Products (New Zealand) Limited.
8. Periodic Safety Update Report on Orlistat (Xenical®). 1 February 2003 – 31 January 2004. No. 1013727.
9. Xenical New Zealand Sales. Roche Internal Data.
10. Xenical (orlistat) Persistence Survey June 2002 – November 2004. Response analysis Xenical Support Programme, Roche Products (New Zealand) Limited. *Based on 754 patients surveyed participating in the Xenical Support Programme June 2002 –November 2004.
11. Sjostrom L et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet 1998; 352(9123):167-172.
12. Xenical (orlistat) Data Sheet. Roche Products (New Zealand) Limited. 19 January 2005.
13. Xenical (orlistat) Consumer Medical Information. Roche Products (New Zealand) Limited. 31 May 2004 .
14. Marks S. The role of orlistat in weight management. Australian Family Physician 2001; 30(4): 335-338.
15. Xenical® Support Programme Persistence Survey Results November 2003 – April 2004. Roche Products (New Zealand) Ltd.
Xenical® (orlistat 120mg capsules) is a Pharmacist Only Medicine used to assist with losing weight, maintaining a certain weight and preventing weight regain in adults with an initial body mass index (BMI) of 30 or more. Xenical should be used in conjunction with a low fat, calorie controlled diet and other lifestyle modifications such as exercise.

Most common unwanted side effects are related to the digestive system such as abdominal pain/discomfort, wind, fatty/oily stools, rectal pain and discomfort and urgent need to go to the toilet.

If you are pregnant or breastfeeding discuss this with your pharmacist or doctor prior to starting treatment. Do not give Xenical to children. Xenical must not be taken by patients with a low uptake of essential nutrients or problems with bile flow.

Ask your pharmacist if Xenical is right for you. Always read the label and use strictly as directed. If you have side effects consult your pharmacist. For further information visit www.xenical.co.nz, www.medsafe.govt.nz or see your doctor or pharmacist. TAPS#NA9398

Pharmaceuticals Roche Products (New Zealand) Limited, PO Box 12-492, Penrose, Auckland.

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