GlaxoSmithKline Consumer Healthcare is spending $150 million to roll out its much-anticipated over-the-counter weight-loss drug, Alli, next week, with a far-reaching campaign that tries to persuade people to alter their diet and exercise regimes in addition to swallowing the non-prescription capsule three times a day.
Alli is the only federally approved weight-loss medication available over-the-counter.
"If you want to lose weight, you have to make changes in the way you eat and your lifestyle," said Steve Burton, vice president of weight control for GSK Consumer Healthcare, which is headquartered in Moon.
To that end, consumers who plop down about $60 for an Alli starter pak will receive 90 capsules -- a one-month supply -- as well as menu planners, calorie guides and information about accessing on-line help to achieve and maintain their weight loss goals.
Alli is scheduled to hit some store shelves as early as Wednesday but GSK officials don't expect full nationwide availability until next Friday. It will be sold in drugstores, supermarket pharmacies and discount chains.
In 2004, GSK paid Switzerland's Roche Holdings Inc. $100 million for the rights to sell its weight-loss drug, orlistat, over the counter and in February received approval to do so from the Food and Drug Administration. Orlistat is sold in prescription form under the name Xenical. The drug helps users lose weight by reducing by about 25 percent the amount of fat the body absorbs.
Because Alli is the only FDA-approved weight loss drug available without a prescription and has an estimated market of 5 million to 6 million customers annually, GSK is treating the launch with an "unprecedented" marketing strategy, said Mr. Burton.
To generate interest in Alli before next week's official launch, GSK has published a paperback book, "Are You Losing It?" written by a physician, a chef and weight management experts. The book retails for $5.99 and will be on sale where Alli is sold. Proceeds will be donated to programs that target childhood obesity. .....
A 30-second TV commercial already has been running on network and cable stations to alert viewers about the product Web site, myalli.com; and a 60-second TV ad will air later this month after the product is available in stores. Though GSK is touting Alli as safe and effective, criticism has surfaced about its side effects and whether teens looking for quick weight-loss methods might abuse the product because they can obtain it without a prescription.
Yesterday, a consumer coalition, Prescription Access Litigation, criticized GSK for making the drug available over the counter because of its side effects, which the group said include diarrhea, oily stools and flatulence.
GSK has acknowledged that Alli can produce what it calls "treatment effects" such as loose or more frequent stools and gas with discharge. The book, "Are You Losing It?" advises users to start using the product when they have time away from the office or perhaps to bring a change of clothes to work. The effects are manageable, said Mr. Burton.
Because Alli works by removing 25 percent of fat from calories consumed, high-fat meals can cause more undigested fat to pass through the body and result in gas and other side effects.
Clinical studies showed about 50 percent of users never experienced such effects, he said. As for concerns about teenagers abusing Alli, Mr. Burton said product labels will state the product is intended for overweight people ages 18 and over.
