SYMLIN Pen-Injector Devices Now Available
January 07 2008 - 8:35AM
PR Newswire (US)
SymlinPen Offers Convenient SYMLIN Administration for Enhanced
Glucose Control With Potential Weight Loss SAN DIEGO, Jan. 7
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) announced today the availability of the SymlinPen(TM)
120 and the SymlinPen(TM) 60 pen-injector devices for administering
SYMLIN(R) (pramlintide acetate) injection. These new pre-filled
pen-injector devices feature simple, fixed dosing to improve
mealtime glucose control. "SYMLIN offers enhanced blood glucose
control with potential weight loss for patients with diabetes using
mealtime insulin, enabling them to do more to manage their
diabetes," said Daniel M. Bradbury, President and CEO, Amylin
Pharmaceuticals. "The convenience of the new SymlinPen(TM) with
simple, fixed dosing will make it easier for these patients using
multiple daily injections to start and stay with SYMLIN."
SymlinPen(TM) 120 features fixed dosing to deliver 60 or 120
micrograms of SYMLIN per dose. SymlinPen(TM) 60 features fixed
dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
Both pen-injector devices can be conveniently stored at room
temperature not to exceed 86 degrees F (30 degrees C) after first
use. About SYMLIN SYMLIN is an injectable medicine used to control
blood sugar after meals in adults with type 2 or type 1 diabetes
who take mealtime insulin. SYMLIN is the first and only amylin
mimetic for use in patients with diabetes treated with mealtime
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
complex metabolic disease characterized by high blood glucose
levels resulting from a deficiency of both insulin and amylin
secretion. Diabetes represents a large and growing market in the
United States, affecting more than 20 million Americans and growing
at three times the rate of population growth. Approximately 4.2
million patients with diabetes use insulin. Diabetes is the sixth
leading cause of death in the United States. Poor control of blood
glucose may result in severe long-term complications such as
cardiovascular disease, blindness, kidney failure, nerve damage and
amputation. About Amylin Pharmaceuticals Amylin Pharmaceuticals,
Inc. 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. 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 1,900
employees nationwide. Further information on Amylin Pharmaceuticals
is available at http://www.amylin.com/. This press release contains
forward-looking statements about Amylin, which involve risks and
uncertainties. The Company's actual results could differ materially
from those discussed due to a number of risks and uncertainties,
including risks that SYMLIN and SymlinPen may be affected by
unexpected new data, technical issues, or manufacturing and supply
issues; risks that the results of clinical trials may not be
predictive of future results; and risks inherent in the drug
development and commercialization process. Commercial and
government reimbursement and pricing decisions and the pace of
market acceptance may also affect the potential for SYMLIN and
SymlinPen. These and additional risks and uncertainties are
described more fully in the Company's most recently filed SEC
documents, including its Form 10-Q. Amylin undertakes no duty to
update these forward-looking statements. Alert: Photo advisory
coming soon to accompany this release. DATASOURCE: Amylin
Pharmaceuticals, Inc. CONTACT: Alice Bahner Izzo, Executive
Director, Corporate Affairs of Amylin Pharmaceuticals, Inc.,
+1-858-642-7272 Web site: http://www.amylin.com/
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