Improved Glucose Control and Reduced Weight without Increased Incidence of
Hypoglycemia
CHICAGO, June 23 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) announced today study results showing SYMLIN(R) (pramlintide
acetate) injection used in conjunction with basal insulin improved glucose
control and reduced weight without increased hypoglycemia in patients with
type 2 diabetes inadequately controlled with insulin glargine and oral
agents. These findings were detailed in four poster presentations at the
American Diabetes Association's 67th Annual Scientific Sessions (ADA) in
Chicago.
"We are encouraged by the results from this study investigating the use
of SYMLIN with an established regimen of basal, or long-acting, insulin,"
said Matthew C. Riddle, M.D., Professor of Medicine, Oregon Health &
Science University. "Improved glucose control often is accompanied by
weight-gain or increased hypoglycemia, but with this approach, neither of
these problems occurred while glucose control improved."
This 16-week, randomized, double-blind, placebo-controlled, multicenter
study evaluated the safety and efficacy of using SYMLIN as an adjunct to
basal insulin glargine in patients with type 2 diabetes. The study
demonstrated reductions in a set of pre-defined diabetes treatment goals
including A1C, post-meal glucose, weight, and incidence of severe
hypoglycemia. One in four SYMLIN patients achieved these goals (a composite
endpoint) compared to less than one in ten patients on basal insulin
without SYMLIN. A1C is a test that measures average blood sugar levels over
approximately three months. Overall rates of hypoglycemia were similar
between groups and SYMLIN patients reported mild nausea, consistent with
previous studies.
Additional analysis of data from this study demonstrated that weight
loss also was associated with a significant reduction in C-reactive protein
levels, a marker for increased risk for cardiovascular disease.
Results from this study formed the basis of a supplemental New Drug
Application submitted in the fourth quarter of 2006.
About SYMLIN
SYMLIN is an antihyperglycemic drug for use in patients with diabetes
treated with insulin. SYMLIN is a synthetic analog of human amylin, a
naturally occurring hormone that is made in the beta cells of the pancreas,
the same cells that make insulin. In patients with type 2 diabetes who use
insulin, and in patients with type 1 diabetes, those cells in the pancreas
are either damaged or destroyed, resulting in reduced secretion of both
insulin and amylin after meals. The use of SYMLIN contributes to glucose
control after meals.
Healthcare professionals and people with diabetes may obtain more
information, including the complete prescribing information and the
medication guide, at http://www.SYMLIN.com.
Important Safety Information
SYMLIN is not intended for all patients with diabetes. SYMLIN is used
with insulin and has been associated with an increased risk of
insulin-induced severe hypoglycemia, particularly in patients with type 1
diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is
seen within three hours following a SYMLIN injection. If severe
hypoglycemia occurs while operating a motor vehicle, heavy machinery, or
while engaging in other high- risk activities, serious injuries may occur.
Appropriate patient selection, careful patient instruction, and insulin
dose adjustments are critical elements for reducing this risk. This
information is highlighted in a boxed warning in the SYMLIN prescribing
information for healthcare professionals and in a medication guide for
patients, which will be distributed by pharmacists.
Other adverse events commonly observed with SYMLIN when co-administered
with insulin were mostly gastrointestinal in nature, including nausea,
which was the most frequently reported. The incidence of nausea was higher
at the beginning of SYMLIN treatment and decreased with time in most
patients. The incidence and severity of nausea are reduced when SYMLIN is
gradually increased to the recommended doses.
About Diabetes
Diabetes is a large and growing market in the United States, affecting
over 20 million Americans and growing at three times the rate of population
growth. Approximately 4.5 million patients with diabetes use insulin.
Diabetes is the sixth leading cause of death in the United States.
Diabetes is a complex metabolic disease manifesting with a defect in
the beta cells in the pancreas, resulting in a deficiency of both insulin
and amylin secretion. Poor control of blood sugar may result in severe
long-term complications such as kidney failure, nerve damage, blindness,
amputation and cardiovascular disease.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first- in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate)
injection and BYETTA(R) (exenatide) injection. Amylin's research and
development activities leverage the company's expertise in metabolism to
develop potential therapies to treat diabetes and obesity. Amylin is
located in San Diego, California with over 1,700 employees nationwide. For
more information about Amylin visit http://www.amylin.com.
This press release contains forward-looking statements about Amylin,
which involve risks and uncertainties. Amylin's actual results could differ
materially from those discussed herein due to a number of risks and
uncertainties, including risks that BYETTA or SYMLIN may be affected by
unexpected new data, technical issues, or manufacturing and supply issues;
risks that the results of pre-clinical studies or clinical trials may not
be predictive of future results; risks that our clinical trials will not
start or be completed when planned; risks that the FDA may not approve
Amylin's regulatory submissions; and risks inherent in the drug development
and commercialization process. These and additional risks and uncertainties
are described more fully in Amylin's recently filed Form 10-Q. Amylin
disclaims any obligation to update these forward-looking statements.
Poster Presentation - Abstract Number: 0536-P
Poster Presentation - Abstract Number: 0538-P
Poster Presentation - Abstract Number: 0541-P
Poster Presentation - Abstract Number: 0552-P
SOURCE Amylin Pharmaceuticals, Inc.
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Related links:
http://www.amylin.com
CONTACT:
Alice Bahner Izzo of Amylin, +1-858-642-7272,
cell, +1-858-232-9072; or Heather Pierce of MS&L,
+1-415-293-2803, cell, +1-415-845-5720, for Amylin
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