Warner-Lambert to Begin Diabetes Prevention Study with Rezulin
PR Wire, November 20, 1998, 8:15 a.m. ET
President and Chief Operating Officer, Lodewijk J.R. de Vink, today said that
the company will initiate a long-term study to investigate the potential of
ReZulin (troglitazone) to delay or prevent the progression of impaired glucose
tolerance (IGT), a state of insulin resistance that precedes type 2 diabetes.
Speaking at an investor health care conference, de Vink said, "We are pleased
the U.S. Food and Drug Administration (FDA) has agreed to our proceeding with
this important study, recognizing that ReZulin can be investigated in this
otherwise healthy population."
The five-year "Diabetes Prevention Study with Troglitazone" will examine
the effects of troglitazone in a study of 1,000 patients with IGT. It will
involve more than 100 sites and is expected to begin in the first quarter of
1999.
IGT is strongly associated with insulin resistance and is recognized as an
important precursor to type 2 diabetes. Because ReZulin acts to reduce
insulin resistance, this study will assess whether early treatment with
ReZulin can prevent the progression of IGT to type 2 diabetes. The study will
also examine the potential effects of ReZulin on cardiovascular parameters
such as blood pressure and lipid levels.
Mr. de Vink explained that ReZulin offers promise to millions of people
suffering from type 2 diabetes. ReZulin, the first drug in a new class,
treats insulin resistance, an underlying cause of type 2 diabetes. ReZulin
was approved in January 1997 for the treatment of type 2 diabetes in people
not controlled on insulin. It gained additional indications for use as
monotherapy and in conjunction with sulfonylureas six months later.
In June 1998, the National Institutes of Health (NIH) discontinued the
troglitazone treatment arm of the Diabetes Prevention Program (DPP) based on
concerns relating to one patient in the study. At that time, the company
committed to continuing an investigation into the potential of ReZulin to
prevent type 2 diabetes. "We are very pleased by the FDA's decision to accept
this protocol," explained de Vink.
Diabetes is the sixth leading cause of disease-related death in the United
States, accounting for 18% of all deaths in people 25 years of age and older.
Diabetes is the leading cause of kidney failure, new cases of blindness and
amputations in adults. Cardiovascular disease is 2 to 4 times more common in
diabetes patients, and their risk for stroke is 2.5 times higher than normal.
ReZulin may be used concomitantly with a sulfonylurea or insulin to
improve glycemic control. ReZulin, as monotherapy, is indicated as an adjunct
to diet and exercise to lower blood glucose in patients with type 2 diabetes.
ReZulin should not be used as monotherapy in patients previously well
controlled on sulfonylurea therapy. For patients inadequately controlled with
a sulfonylurea alone, ReZulin should be added to, not substituted for, the
sulfonylurea.
Management of type 2 diabetes should also include diet control, weight
loss, and exercise. ReZulin should not be used in type 1 diabetes or for the
treatment of diabetic ketoacidosis.
In clinical studies, ReZulin was well tolerated. The incidence of
withdrawals during clinical trials was similar for patients treated with
placebo or ReZulin (4 percent). The most common adverse events included
infection (22 percent placebo vs. 18 percent ReZulin), headache (11 percent
placebo vs. 11 percent ReZulin), and pain (14 percent placebo vs. 10 percent
ReZulin). In rare cases, ReZulin has been associated with serious liver
problems which are usually reversible. In very rare cases, these have
resulted in liver failure leading to death or liver transplant. Serious liver
events have occurred after both short and long term troglitazone treatment.
Therefore, ReZulin patients should be monitored regularly for liver function.
Serum transaminase levels should be checked at the start of therapy, monthly
for the first eight months of therapy, every two months for the remainder of
the first year of ReZulin therapy, and periodically thereafter.
In premenopausal anovulatory patients with insulin resistance, ReZulin
treatment may result in resumption of ovulation. These patients may be at
risk for pregnancy. ReZulin should not be used during pregnancy unless the
potential benefit justifies the potential risk to the fetus.
ReZulin has not been tested in patients with New York Heart Association
(NYHA) Class III and IV cardiac status; therefore, ReZulin is not indicated in
these patients unless the expected benefit is believed to outweigh the
potential risk. ReZulin is available in 200, 300 and 400 mg. tablets.
Earnings Outlook Remains On Track
While speaking at the conference, de Vink also reaffirmed the company's
earlier forecast that "based on current planning assumptions, we believe 1998
diluted earnings per share of $1.48 are achievable. This represents an
increase of more than 40 percent compared to the prior year.
"Looking ahead to 1999," he continued, "and again based on current
planning assumptions, we anticipate an increase in diluted earnings per share
of 30 percent."
ReZulin was discovered by Sankyo Company, Ltd., of Japan and co-developed
in the U.S. by Parke-Davis and the Sankyo U.S.A. Corporation. Parke-Davis
co-promotes ReZulin in the U.S. with Sankyo/Parke-Davis, a joint venture that
was announced in September 1996.
Parke-Davis is a division of Warner-Lambert, a worldwide company devoted
to discovering, developing, manufacturing, and marketing quality
pharmaceutical, consumer health care, and confectionery products. It employs
more than 40,000 people worldwide.
Statements made in this press release that state "we believe," or
otherwise state the company's predictions for the future are forward-looking
statements. Actual results might differ materially from those projected in
the forward-looking statements. Additional information concerning factors that
could cause actual results to materially differ from those in the
forward-looking statements is contained in the company's annual report on Form
10-K for the year ended December 31, 1997 filed with the U.S. Securities and
Exchange Commission. For a copy of this filing, please contact one of the
individuals listed below.
SOURCE Warner -Lambert Company
-0- 11/20/98
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