GlaxoSmithKline Launches Alli® (orlistat 60 Mg)

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 23 Apr 2009 - 6:00 PDT

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GSK has announced that alli the first clinically proven over the counter weight loss aid is available in pharmacies across Europe.

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 introduce alli for adults with a BMI of 28 kg/m2 or more, in all 27 EU member countries.

Manfred Scheske, President GSK Consumer Healthcare Europe said, "alli offers adults a real opportunity for losing weight. alli has been well received by millions of people in the US and we are very excited about the number of people it could help across Europe achieve their goal to lose weight."

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

alli is a new category within weight loss management which is supported by a multi-million pound investment in pharmacy training, consumer marketing and a behavioural support programme in countries throughout Europe. It will be distributed exclusively through pharmacies.

Users can benefit from the online alli programme, which provides tools and support to help them follow a sensible diet and become more active, encouraging sustainable weight loss.

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

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 http://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.

The consumer healthcare business brings an added dynamic dimension to our company, with well known brands like Panadol, NiQuitin, Sensodyne and Aquafresh among 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.

References

1. alliSummary 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.

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 2008.

Source: GlaxoSmithKline

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