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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 28 June 2005\line \line {\b Xenical 
gains European approval for use in young people} \line \line Only weight loss 
medication whose benefits have been studied in adolescents\line \line Roche announced 
today that its leading weight loss medicine Xenical (orlistat) has received European approval to include 
clinical, safety and efficacy data in the label on the use in obese adolescents aged 12 years or over. 
The label change has been approved following the results of a major study that shows Xenical to be highly 
effective in helping obese young people to lose weight. As a result of this change, physicians may now 
consider Xenical as an effective option in the management of obesity in adolescents. \line \line In 
Europe in the last few years there has been a significant increase in obesity in children and adolescents, 
with as many as one in four affected in some regions. Obese children tend to become obese adults, and 
they carry a high risk of acute and chronic diseases, leading to reduced life expectancy. Treatment 
and prevention of childhood obesity has been identified as a healthcare priority in Europe. \line \line \u8220?This 
is a further example of Roche's continuing commitment to tackling the growing epidemic of obesity. By 
studying the use of Xenical in obese adolescents aged 12 and over, we have now shown that the drug can 
benefit young people as much as adults. Xenical is now the only weight loss treatment in the US and 
EU that provides guidance from clinical trials in its label on use in this population,\u8221? said William 
M. Burns, CEO Roche Pharma.\line \line The label change is based on data from a 
large study (recently published in JAMA{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} ) 
in which 539 obese adolescent patients received either 120 mg Xenical or placebo three times daily, 
alongside a reduced-calorie diet and exercise for 1 year. Weight loss was tracked using changes in the 
adolescents\u8217? Body Mass Index (BMI), a measure that takes into account not only the changes in body weight 
but also the changes in height which occur in growing adolescents. \line \line Study 
results were consistent with those seen in adults and showed at the end of treatment:\line \u8226? 
Adolescents treated with Xenical had a significantly reduced BMI (decrease of 0.55 kg/m2 compared to 
an increase of 0.31 kg/m2 in the placebo group).\line \u8226? Almost twice as many adolescents treated 
with Xenical reduced by \u8805?5% their BMI (26.5% vs 15.7%) and their body weight (19% vs 11.7%)\line \u8226? 
Adolescents treated with Xenical had a greater decrease in body fat (2.4kg vs 0.4kg)\line \u8226? 
Waist circumference decreased significantly in Xenical recipients, but increased in placebo recipients 
(\u8211?1.33 cm vs +0.12 cm). \line \u8226? Adolescents who responded to treatment (\u8805?5% weight loss at 
12 weeks) had a reduction in body weight of 7.6 kg and a BMI decrease of 3.7 kg/m2.\line \u8226? 
Treatment was well tolerated, with adverse events generally similar to those observed in adults. \line \line These 
data, from the largest and longest study of a weight loss medication in adolescents, add to the extensive 
evidence base including safety, and clinical experience gained with Xenical since it was first marketed 
in 1998. \line \line \u8220?Access to pharmacotherapy such as orlistat to complement diet 
and exercise will be important for physicians and patients trying to combat the growing trend of adolescent 
obesity. It means that the medical profession will have a new weapon to help adolescents lose weight, 
and stop them progressing to become overweight adults with the associated health complications\u8221? commented 
lead investigator Professor Prof. Jean-Pierre Chanoine, Endocrinology and Diabetes Unit, British Columbia 
Children's Hospital, Vancouver, Canada.\line \line {\b About Xenical} \line Xenical 
is the number one prescription weight loss medication, approved for use in adults in over 50 countries 
worldwide. Xenical has a unique mode of action, it works locally in the gut to prevent dietary fat absorption 
by around 30 percent and effectively promotes weight loss. It is the most extensively studied pharmacological 
weight management treatment to date, with over 30,000 overweight or obese patients participating in 
clinical trials with Xenical, including the 4 year landmark XENDOS study. It is an effective therapy 
that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical was 
approved in December 2003 for use in adolescents 12 years and above in the US. \line \line {\b About 
Roche} \line Headquartered in Basel, Switzerland, Roche is one of the world\u8217?s leading 
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of 
innovative products and services for the early detection, prevention, diagnosis and treatment of disease, 
the Group contributes on a broad range of fronts to improving people\u8217?s health and quality of life. Roche 
is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and 
a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss 
francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, 
including majority ownership interests in Genentech and Chugai.\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line {\b Additional 
information} \line - Roche Health Kiosk, Overweight (http://www.health-kiosk.ch/start_uebg.htm)\line - 
Managing your weight (http://www.roche-obesity.net)\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 \line Reference:\line 1. 
Chanoine J-P, Hampl S, Jensen C, Boldrin M, Hauptman, J. Effect of orlistat on weight and body composition 
in obese adolescents: A randomized controlled trial. JAMA. 2005; 293:2873 - 2883 \par}\par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}