SYMLIN(R) Used in Conjunction with Basal Insulin in Patients with Type 2 Diabetes
June 23 2007 - 12:00PM
PR Newswire (US)
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 DATASOURCE:
Amylin Pharmaceuticals, Inc. 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 Web
site: http://www.amylin.com/
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