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NUTLEY, N.J., Dec. 2, 1996
Roche Laboratories today announced that it has filed a New
Drug Application
(NDA) with the U.S. Food and Drug Administration (FDA) and a New
Drug
Submission (NDS) to the Health Protection Branch (HPB) of Canada
to seek
approval to market Xenical(R) for patients who suffer from obesity.
Xenical, a
lipase inhibitor, is the first of an entirely new pharmaceutical
class of non-CNS,
non-systemic drug therapies for the treatment of obesity.
"This regulatory filing is the culmination of an intensive
effort on the part of
hundreds of Roche employees and physicians throughout the world,
all of whom
are working to improve the prognosis of patients who suffer from
this chronic,
relapsing medical disease affecting millions of Americans,"
said Patrick J.
Zenner, President and Chief Executive Officer. "We believe
that Xenical will bring
enormous value to the obesity community and we will continue to
seek regulatory
licensing throughout the world."
The multicenter, placebo-controlled Phase III clinical trials
involving nearly 5,000
obese patients studied the efficacy of Xenical when taken in conjunction
with a
mildly hypocaloric diet containing approximately one-third of
all calories from fat.
Xenical is the only treatment to date to have been evaluated in
two-year clinical
trials for weight loss, maintenance of lost weight, prevention
of weight regain and
improvement in co-morbidities including hypertension, dyslipidemia,
impaired
glucose tolerance and hyperinsulinemia compared to diet alone.
Xenical is an inhibitor of gastric and pancreatic lipases --
enzymes that play a
pivotal role in the absorption of dietary fat. Experts agree that
excess caloric
intake is a significant component in the development of obesity,
and for many
people, excess dietary fat is the largest component of this caloric
excess. The
action of Xenical against lipases blocks the absorption of approximately
30% of
the fat eaten in food, which provides an additional caloric deficit
for weight loss
and control. In clinical trials, no major adverse side effects
were noted. The most
common effects reported were non-systemic and were primarily gastrointestinal,
the majority of which were generally mild and temporary and frequently
seen
among patients who did not follow the appropriate diet regimen.
In the U.S., more than 70 million Americans are considered
to be overweight and
obese and are at high risk for hypertension, cardiovascular disease,
non-insulin
dependent diabetes, dyslipdemia, hyperinsulinemia and hypercholesterolemia.
As little as 5% reduction in patients' weight improves their health
outcomes
significantly.
Headquartered in Nutley, New Jersey, Hoffmann-LaRoche Inc.
is an affiliate of the
multinational group of companies headed by Roche Holding Ltd.
of Basel,
Switzerland. One of the world's leading research-intensive companies,
Roche has
discovered, developed and introduced numerous important prescription
pharmaceuticals.
The company's commitment to metabolic research and development
stems from
its recognition of obesity as a chronic disease needing long-term
therapy. In
addition to Xenical, Roche, is pursuing investigation of the OB
receptor and is
supporting gene therapy research through its collaboration with
the biotechnology
company, Millennium.
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