GlaxoSmithKline receives European Commission approval to market alli® (orlistat 60mg)

Issued: Wednesday 21 January 2009, London UK

A decision made by the European Commission today opens access to a treatment that could help people who are overweight and obese.  GlaxoSmithKline (GSK) has received a non-prescription licence for alli (orlistat 60mg); the first time the European Commission has approved a non-prescription product for weight loss. The centrally approved marketing authorisation means GSK can now introduce alli for adults with a BMI of 28 kg/m² or more, in all 27 EU member countries. Plans are underway to launch alli in the coming months.

Manfred Scheske, President GSK Consumer Healthcare Europe said: “alli, in the US, has successfully helped millions of users lose weight gradually and steadily, and adopt a healthy lifestyle. We are very excited about the opportunity to create similar success in Europe and we will be launching alli in pharmacies throughout Europe soon.”  

Clinical trials show that alli, when used in conjunction with a reduced calorie, lower-fat diet, can help people lose 50 per cent more weight than by dieting alone.¹ So for every two kilos (pounds) lost by dieting alone, alli could help them lose one more. It works by stopping some of the fat you eat being absorbed into the body and turning into extra kilos (pounds).²

Leading European obesity expert, Professor Stephan Jacob from the Cardio-Metabolic Institute, Germany, added: “Research has shown that consumers are spending millions of Euros each year on fad diets, unproven ‘miracle pills’ and potentially unsafe weight-loss supplements, often without any scientific evidence to back them up. By making a licensed non-prescription product available, consumers will have the option of a proven therapy which can support them with their struggle against weight loss. For many, losing weight can become the catalyst to improvements in their overall health and self-esteem.”

alli is a trade mark of the GlaxoSmithKline group of companies.

Notes to editors

How to use alli

alli, is indicated for weight loss in  adults, with a BMI 28 kg/m² or more, when used along with a reduced calorie, lower-fat diet. The recommended dose of alli is one 60 mg capsule three times a day with meals containing the recommended amount of fat.

About alli

• A summary of product characteristics is available at www.emea.europa.eu
• The active ingredient in alli is orlistat 60 mg
• Orlistat 60 mg acts locally within the digestive system to prevent fat absorption, so there is minimal absorption of the active ingredient in the bloodstream²
• Orlistat 120 mg has been available as a prescription treatment for 10 years
• The safety and efficacy profile of orlistat is well documented and has been established through data from more than 100 clinical studies³
• GlaxoSmithKline completed an agreement with Roche (who market prescription orlistat 120 mg) in February 2007 that allows the company to seek regulatory approval for orlistat 60 mg as the first licensed non-prescription weight loss product in Europe
• The centrally approved marketing authorisation covers all 27 EU member countries, plus Norway
• alli (orlistat 60 mg) was launched in the US in June 2007 as the only Food and Drug Administration (FDA) approved weight loss aid available without prescription

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

The consumer healthcare business brings an added dynamic dimension to our company, with well known brands like Panadol, NiQuitin, Sensodyne and Aquafreshamong others but, as with all our products, the driving force behind our consumer healthcare business is science. With four dedicated consumer healthcare R&D centres and consumer healthcare regulatory affairs, the business takes scientific innovation as seriously as marketing excellence and offers leading-edge capability in both. GSK recently launched alli,the first FDA-approved OTC product for weight loss in the US, and is committed to tackling the public health burden of obesity globally.

For company information, please visit www.gsk.com.

References

1.        alli Summary of Product Characteristics (SPC)

2.        Anderson J. Orlistat for the management of overweight individuals and obesity: a review of potential for the 60-mg, over-the-counter dosage. Expert Opin Pharmacother. 2007;8 (11):1733-1742.

3.        Jacob S, Togerson J. Orlistat treatment beneficial in both primary care and tertiary settings. obesity reviews. 2005;6(s1):166.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.