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FDA APPROVES ALLI (orlistat
60 mg capsules) OVER-THE-COUNTER AN INNOVATIVE
AND HONEST APPROACH TO WEIGHT LOSS Combines a Safe and
Effective Product With An Innovative Personalized Support
Program
Pittsburgh (February 7, 2007) - GlaxoSmithKline [NYSE:GSK]
Consumer Healthcare announces today that the U.S. Food
and Drug Administration (FDA) approved the weight-loss
product orlistat 60 mg capsules for over-the-counter
(OTC) use in the United States. GSK Consumer Healthcare
will market OTC orlistat under the brand name alli
(pronounced AL-eye). Approved for use by overweight
adults in conjunction with a reduced-calorie, low-fat
diet, alli helps people lose 50 percent more weight
than with diet alone. alli is the only FDA-approved
weight-loss product available to consumers without a
prescription, and it is the first clinically proven
over-the-counter product to be combined with a comprehensive
support program. alli is expected to be available in
stores nationwide by summer 2007. This approval marks
the start of an educational program that includes a
series of resources online at myalli.com.
GSK Consumer Healthcare selected alli as the brand
name because it conveys the concept of partnership with
consumers in their weight-loss efforts. Consumers spend
billions of dollars each year on fad diets, unproven
miracle pills, and potentially unsafe weight-loss supplements
that may not work. alli is the clinically proven option
to these hyped, quick-fix products that mislead overweight
adults away from weight-loss strategies that are backed
by medical science. With alli, consumers have access
to an individually tailored online action plan that
provides support and the necessary tools to help them
lose 50 percent more weight than with diet alone.
"The FDA approval of alli should prove a tremendous
benefit given the enormous impact of overweight and
obesity in the African American community," said
Dr. Valentine Burroughs, MD, MBA, who is the Chief Medical
Officer and Chairman of the Department of Medicine at
North General Hospital, located in Harlem, NY. "alli
is more than a pill, it's a program that emphasizes
the importance of following a reduced-fat diet, along
with exercise, as part of a total weight loss program.
I am eagerly awaiting the availability of alli as a
resource for my patients who are ready to change their
lives for the better."
Why alli is Different
Unlike other products on store shelves, alli is a proven
medicine with a comprehensive support program. To help
consumers get off to a successful start, the alli package
will include Welcome and Companion Guides, a Guide to
Healthy Eating, a Daily Journal, a Calorie and Fat Counter,
Quick Fact Cards, and free access to an individualized
online action plan at myalli.com.
"With alli, we're excited to offer a revolutionary
approach to weight loss," says Steven L. Burton,
Vice President, Weight Control, GlaxoSmithKline Consumer
Healthcare. "alli is more than a pill - it's a
comprehensive program that works in conjunction with
a sensible diet to increase weight loss. Because weight
loss doesn't happen overnight, we're starting to educate
consumers now about the importance of realistic expectations,
gradual weight loss and lifestyle changes. That's the
way to see results, and with alli, we know they can
do it."
Starting today, GSK Consumer Healthcare will gear up
production to have the product ready for shipment and
in stores by the summer. The company is using this period
to build awareness and understanding about the product
and its intended user - with the message - alli is not
for everyone. It's for the committed consumer who can
follow a reduced-calorie, low-fat diet. For this consumer,
alli will provide a unique, proven approach to weight
loss, offering straight talk, educational tools and
an online support program - myalli.com.
How to Use alli
alli, the only FDA-approved weight-loss medication soon
to be available without a prescription, is indicated
for weight loss in overweight adults18 years and older
when used along with a reduced-calorie, low-fat diet.
The recommended dose of alli is one 60 mg capsule three
times a day with meals containing fat.
Taken at meal-time, alli works by blocking about 25
percent of the fat in the food a person eats. Because
of the way it works, alli must be used in conjunction
with a reduced-calorie, low-fat diet containing about
15 grams of fat per meal. The guides and information
supplied in the alli package help the consumer to control
the amount of fat in their meals, and to follow an appealing,
reduced-calorie, low-fat diet. Consuming a meal with
too much fat, while taking alli, can result in bowel
changes such as having an urgent need to use the bathroom.
These changes, called treatment effects, generally occur
in the first weeks of treatment, are not harmful, and
can be managed by following the recommended diet with
about 15 grams of fat per meal. Users should take a
multivitamin once a day, at bedtime, because alli can
reduce the absorption of some vitamins.
Safety and Efficacy
alli (60 mg orlistat capsules) is safe and effective
when used as directed. As the most extensively studied
weight-loss medication on the market, the safety and
efficacy of orlistat is very well established. A higher
dose of orlistat has been marketed as the prescription
drug Xenical® (orlistat 120 mg capsules) in the
U.S. since 1999 and is supported by nine years of worldwide
use in 145 other countries. Orlistat experience in more
than 25 million patient treatments and more than 100
clinical studies with more than 30,000 patients is unprecedented.
One of these studies with Xenical is the four-year landmark
XENDOS trial conducted by Roche, its inventor and manufacturer.
This study is the longest study ever conducted for a
weight-loss medicine.
Xenical (orlistat 120 mg capsules) will remain available
by prescription for those who should be treated under
the care of a physician. Xenical will continue to be
manufactured and sold by Roche.
For more information on alli, go to myalli.com.
About Overweight and Obesity among African Americans
Currently, approximately 65 percent, or approximately
130 million, of U.S. adults are overweight or obese.
1 Studies have shown that African American and Hispanic
American women are particularly affected by overweight
and obesity. 2 Many obesity-related diseases including
diabetes, hypertension, cancer and heart disease are
found in higher rates among various members of racial-ethnic
minorities compared with whites. 3 Cultural factors
related to dietary choices, physical activity, and acceptance
of excess weight among African Americans and other racial-ethnic
groups, appear to play a role in interfering with weight
loss efforts. 4 Multiple studies have shown that a modest
reduction in weight improves health outcomes significantly
in overweight or obese patients. 5,6
About GlaxoSmithKline Consumer Healthcare
GSK Consumer Healthcare is one of the world's largest
over-the-counter consumer healthcare products companies.
Its more than 30 well-known brands include the leading
smoking cessation products, Nicorette®, NicoDerm®
CQ and Commit® as well as many medicine cabinet
staples, including Abreva®, Aquafresh®, Sensodyne,®
Tums® and Breathe Right®.
About GlaxoSmithKline
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 company
information visit: http://www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions
investors that any forward-looking statements or projections
made by the company, 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 the Group's operations are described
under 'Risk Factors' in the Operating and Financial
Review and Prospects in the company's Annual Report
2004.
# # #
Brian Jones
215) 751 3415
E-mail: Brian.L.Jones@gsk.com
Malesia Dunn
(412) 200 3544
E-mail: malesia.a.dunn@gsk.com
Patricia Seif
(215) 751 7709
E-mail: patricia.r.seif@gsk.com
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