SmithKline Diabetes Drug Appears Safe, Effective, Study Shows
Bloomberg News
June 14, 1998, 4:02 p.m. PT
SmithKline Diabetes Drug Appears Safe, Effective, Study Shows
Chicago, June 14 (Bloomberg) -- SmithKline Beecham Plc's
experimental oral diabetes drug significantly lowered levels of
blood sugar in patients and was free of serious side effects that
have dogged a similar drug on the market, a new study found.
The study, released in Chicago at the annual meeting of the
American Diabetes Association, could boost the prospects of what
analysts say is one of the London-based drugmaker's most
promising new drugs in development.
Merrill Lynch & Co. forecasts the drug, called Avandia,
could generate $1.8 billion in sales by 2005 if it proves
effective and safer than troglitazone, a drug invented by Sankyo
Co. and licensed to Warner-Lambert Co. in the U.S. and Glaxo
Wellcome Plc in Europe.
''I think there's no question that it will be used
frequently'' if its promise of greater safety holds true, said
Barry Goldstein, a researcher on the SmithKline-sponsored study
and head of the division of endocrinology, diabetes and metabolic
diseases at Jefferson Medical College in Philadelphia.
SmithKline's Avandia is about 100 times as potent as
troglitazone, Goldstein added, meaning doctors can prescribe less
of it and lower the risk of potential side effects. In addition,
Avandia works in a slightly different way, which also appears to
lessen side effects compared to troglitazone, he said.
Both troglitazone, marketed by Warner-Lambert as Rezulin,
and Avandia are members of a new class of oral treatments for so-
called type 2 diabetes, the most common form of the chronic
disorder characterized by the body's inability to properly
regulate blood sugar levels. Type 2 diabetics make up the
majority of the estimated 16 million Americans who suffer from
diabetes.
Serious Complications
While Rezulin is one of Morris Plains, New Jersey-based
Warner-Lambert's strongest selling new drugs, reports of serious
liver complications, including deaths, prompted the company to
twice strengthen its warning label to patients. It advised
doctors to closely monitor patients on the drug, which generated
$420 million in sales last year.
London-based Glaxo halted sales of its version of the drug
last year in the U.K. after at least five people died, although
the company has said it plans to reintroduce the drug with a
stronger label and monitoring requirements.
The Avandia study, which included 493 patients and took
place over 26 weeks, found that the drug ''produces clinically
and statistically significant lowering of blood sugar in type 2
diabetes patients,'' SmithKline said in a statement.
It said there have been no serious reported side effects,
such as jaundice and liver failure, in patients taking the drug
in any of its clinical trials. The drug, for which SmithKline
expects to seek approval next year, has been tested on nearly
5,500 people to date.
Avandia, also known as rosiglitazone, ''appeared to be free
of clinically significant side effects,'' SmithKline said. The
most common side effects were respiratory infections and
headache, the company said.
Patients were routinely monitored for blood enzyme levels
that may indicate liver damage, similar to what is recommended
for Rezulin, the company said.
Japan's Takeda Chemical Industries is also developing a new
drug, known as pioglitazone, in the same class as the Warner-
Lambert and SmithKline drugs. If approved, Indianapolis-based Eli
Lilly & Co. will sell Takeda's drug in the U.S.
The interest by drug manufacturers is a mark of the promise
of this group of drugs, which work by enhancing the body's
sensitivity to insulin, Goldstein said. Insulin, a naturally
occurring hormone, helps the body regulate levels of blood sugar.
''This class is very exciting,'' Goldstein said. The drugs
''are really targeted toward what we believe is the cause of Type
2 diabetes.''
--Dane Hamilton in the London newsroom (44-171) 330-7727 and |
