U.S. Food and Drug Administration approved over-the-counter version of the company's orlistat prescription diet medicine. It will be one of the largest launches GSK has ever undertaken, probably one of the largest over-the-counter launches ever.
London-based Glaxo is selling the medicine without a prescription to help offset slowing revenue from its top-selling asthma drug Advair. An estimated 140 million adults in the U.S. were overweight or obese in 2004. The figures are based on body-mass index, which is calculated using a person's height and weight.
Glaxo is also preparing 250 pages of educational materials to accompany the starter pack, a Web site, 200,000 copies of a diet plan and 800,000 copies of a book to help dieters combine the pill with weight-loss programs. People who take alli while improving their diets and exercise regimens can lose 50 percent more weight.
The company is aiming the product at committed dieters who will help sustain sales rather than fad dieters who will buy alli and then drop it.
Orlistst costs about $270 for a one-month supply of 120- milligram pills and has been on the market for eight years. It brought in $90 million in the U.S. last year. The drug acts by blocking fat absorption in the stomach and intestines and doesn't affect the heart or brain.
Glaxo markets the prescription version, known as Xenical, in the U.S. through an agreement.
Glaxo plans to seek permission by the end of this year to sell the product without a prescription in Europe. About 40 percent of Europeans are overweight and 15 percent are obese.
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