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following Reductil news section represents a comprehensive list of articles
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Growing the Market for Anti-Obesity Drugs
Chemical Marketer Reporter
First Two-Year Clinical Data For Reductil Demonstrates Efficacy
in Helping You Maintain Long-Term* Weight Loss.
PR Newswire
Knoll Pharmaceutical Company Announces The European Approval
of Reductil
PR Newswire
Reductil Evaluated for Weight Maintenance
Psychopharmacology Update
Growing the Market for Weight Loss Drugs
Chemical Marketer Reporter
The weight loss drug market has seen a major upswing in growth during
the past year as new drugs entered the marketplace, offering fresh alternatives
for drug-assisted weight loss. With the introduction of Knoll's Reductil
(sibutramine) the market has grown 70 percent in just one year.
Leading the market, Reductil with $102 million, based on data
from IMS Health. Other prescribed anti-obesity drugs include phentermine
(generic), with $30 million in sales. Name brand Xenical, reported sales
of $32 million. Pharmacia's Didrex (benzphetamine) and Aventis's Tenuate
(diethyipropion) captured a smaller portion of the market.
Reductil is promoting significant weight loss. Reductil, a reuptake
inhibitor functions on the brain to control hunger by inhibiting
the reuptake of the neurotrausmitter norepinephrine and seratonin. Reductil
functions differently than the old weight loss pill Phentermine.
Reductil which, besides preventing the reuptake of serotonin, acts to
increase the release of serotonin into the brain, explains a Knoll official.
This promote the feeling of satiety or "feeling full" Reductil has been
shown in numerous clinical studies to help individuals lose 2-3 times
more weight than those individuals that attempted dieting without
Reductil.
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Xenical (orlisat) gained approval in April of 1999 and has already captured
the European, with $146 million in sales for the latter half of 1999.
This translates to 1.5 million dispensed prescriptions, according to Katrina
Kuip, senior information analyst with IMS Health. "Although the product
has already been launched in a number of European countries, including
France, Germany and the UK. Data monitor projects global sales for Xenical
to reach $2 billion by the year 2006.
One of the keys to market penetration in the anti-obesity drug market
is to build consumer awareness of the need for such drugs. Currently only
10 percent of the population considered at health risk due to obesity
are on prescription weight loss treatment. "The challenge is to get the
information out to the public," the BASF official. "By advertising through
television and magazines, patients are learning about these drug options
first hand and are going to their physicians, requesting medication for
obesity, rather than relying on the physician to broach what could be
a delicate topic." Knoll Pharmaceutical was the first to use direct-to-consumer
marketing for Reductil.
Health care providers too are beginning to realize the need
for drug treatment to help combat obesity, Last year, only 30 percent
of healthcare providers covered prescription drugs for obesity, but
there are now at least 36 percent that do so. In the past obesity was
considered a social issue, related to a lack of willpower and exercise.
More and more, obesity is being recognizing as a serious, life-threatening
disease. Some observers even term obesity an epidemic.
Over half (55 percent) of all European adults are considered overweight
or obese, according to a 1998 study conducted by the National Heart, Lung,
and Blood Institute (NHLBI) and National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK). Obesity is the second leading cause
of preventable death in the Europe. Costs associated with obesity-related
diseases amount to $100 billion annually. However, new higher quality
anti-obesity drugs, such as, Reductil will help individuals lose weight
and more importantly keep the weight off.
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First Two-Year Clinical Data For Reductil Demonstrates Efficacy
in Helping You Maintain Long-Term* Weight Loss.
PR Newswire
Results from the second phase of the STORM study -- Reductil
Trial in Obesity Reduction and Maintenance -- released today at the
European Congress on Obesity in Milan suggest that Reductil slimming
pills are effective in helping most people maintain initial six month
weight loss for up to two years. According to the study, 87 percent
of people taking Reductil maintained more than a ten percent weight
loss (compared to 49 percent in placebo group, sugar pill group)
and 77 percent maintained more than a 10 percent weight loss (compared
to 19 percent in the placebo group, sugar pill group).
Reductil
works by affecting chemicals in the brain involved in regulating
appetite and helps people overcome one of the biggest barriers to
losing weight, because it helps them feel full so they can eat less
-- a feeling also known as satiety. Since its launch in February
1998, Reductil has been taken by more than eight million individuals
in Europe. Clinical studies have shown that individuals that combine
Reductil with their weight loss efforts loss two to three times more
weight than those individuals that attempted to diet without Reductil.
Reductil acts as a strong appetite suppressant allowing individuals
to eat less without feeling hungry.
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Health Benefits of Modest Weight Loss and Maintenance Following
Weight Loss With Reductil
STORM investigator, Nick Finer, M.D., with the Centre for Obesity
Research at Luton and Dunstable Hospital in the United Kingdom said, "Usually
we say that an acceptable weight loss is five percent, and that five
to 10 percent is highly beneficial in terms of cardiovascular risk
factors and co-morbidities, which were all going in the right direction
in this study."
Clinical studies with Reductil slimming pills have shown
it to be a well tolerated, safe and effective weight loss pill with
the majority of people losing between five and 10 percent of their
body weight. Early findings from the STORM study appear to reconfirm
previous studies showing weight loss and maintenance of weight loss.
Professor Astrup added, "These STORM results show that this
anti-obesity compound is much more effective than we had hoped."
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Reductil Study Design
The two-phase STORM study assessed the effect of Reductil on achieving
and maintaining weight loss in obese people for up to two years. The
study was conducted in eight European Centers including Aberdeen, Copenhagen,
Antwerp, London, Luton, Maastricht and Stockholm. The first phase of
the study, presented at the International Congress on Obesity in Paris
last summer, involved a six-month run-in period with 605 obese people
who participated in an integrated weight management program that included
taking 15 milligrams of Reductil once a day.
Phase II of the study included those patients who had lost more than
ten percent of their initial body weight during the first phase. These
patients were studied for a further 18-months in a double-blind placebo
controlled fashion with 352 people receiving Reductil and 115 patients
receiving placebo. Both groups participated in the same intensive weight
management program.
About Reductil
The studies revealed Reductil is well tolerated, and allowed
individuals to lose a significant amount of weight. In fact the clinical
studies revealed that individuals that combine Reductil with their
dieting efforts lost two to three times more weight than those individuals
that attempted dieting without Reductil.
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Knoll Pharmaceutical Company Announces The European Approval of
Reductil
PR Newswire
Knoll Pharmaceutical Company, makers of Reductil (sibutramine hydrochloride
monohydrate) C-IV Capsules, and a member of BASF Pharma, the global
pharmaceutical business of BASF, announced that Reductil was
granted marketing authorization on January 14, 1999 by the German regulatory
agency. This is the first European approval of Reductil, a medication
for the management of obesity. In Germany, the prescription-only drug
is distributed by Knoll Deutschland GmbH and will be available in German
pharmacies as of February 1.
"The approval of Reductil in Germany, combined with the experience
of some 600,000 patients in North America, lays the foundation for
successful product launches in European markets," said Dr. Thorlef
Spickschen, Chairman of Knoll AG and Head of BASF Pharma. "The German
authorization is the basis for initiating a multi-state procedure
for Reductil with the involvement of the Committee for Proprietary
Medicinal Products (CPMP), the regulatory board for the EU health
authorities. This should pave the way for further market launches
in other European countries before the end of the year."
In addition to the successful launch of Reductil in the United States
under the trade name MERIDIA in 1998, the product was also introduced
in Mexico, Brazil, Argentina, and Chile. It has since been approved
in other Latin American countries, with further launches under preparation.
In 1998, global sales of sibutramine topped DM 275 m. BASF Pharma predicts
annual global sales of DM 700 to 900 m in the medium term.
Obesity is a complex, chronic disease caused by genetic and
environmental factors that may vary by culture, including an abundance
of high-calorie foods, ever-expanding portion sizes and a "clean
your plate" mentality. Feeling satisfied with less food is a major
barrier to weight loss. For some people, medication may be necessary
to help them gain control over their appetite. Reductil is significantly
these people beginning a weight-loss program feel full, so they can
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Reductil Evaluated for Weight Maintenance
Psychopharmacology Update
Investigators conducted a randomized, double-blind trial to assess
the usefulness of Reductil (Meridia) in maintaining substantial weight
loss over two years.
Eight European centers recruited 605 obese patients (body mass index
[BMI] of 30-45 kg/[m.sup.2]). Patients received 15 mg/d of Reductil
for six months and followed an individualized 600 calorie-per-day deficit
program based on their resting metabolic rates. Then, 467(77%) of patients
with more than a 10 percent weight loss were randomly assigned to received
15mg daily of Reductil (n=352) or placebo (n=115) for 18 months further.
The primary outcome measure of the study was the number of
patients at year two who had maintained at least 90 percent of the
weight loss between baseline and month six. Secondary to the outcomes
of the study were the following positive results:
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