SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN) announced today that the U.S. Food and Drug
Administration (FDA) has approved 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.
"SymlinPen 120 and SymlinPen 60 offer patients improved convenience and
accuracy," said Daniel M. Bradbury, President and CEO, Amylin
Pharmaceuticals. "For people with diabetes using mealtime insulin, the
addition of SYMLIN can enhance glucose control with the potential for
weight loss."
SymlinPen(TM) 60 features fixed dosing to deliver 15, 30, 45, or 60
micrograms per dose. SymlinPen(TM) 120 features fixed dosing to deliver 60
or 120 micrograms 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. The pens are expected to be available to patients by December
2007.
"Not Approvable" Letter Received for SYMLIN Use with Basal Insulin
Alone
Amylin also announced today that the FDA has issued a "Not Approvable"
letter for SYMLIN use with basal insulin (without mealtime insulin) in
patients with type 2 diabetes who have not achieved desired glucose
control. SYMLIN is currently approved in the U.S. for patients with type 2
or type 1 diabetes who use mealtime insulin and need improved glucose
control.
"SYMLIN remains an important therapeutic option for people with
diabetes who use mealtime insulin therapy," Bradbury added. "We will
initiate discussions with the FDA to clarify their response for its use
with basal insulin alone."
About SYMLIN
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, Inc.
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, 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 1,800 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.
SOURCE Amylin Pharmaceuticals, Inc.
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Related links:
http://www.amylin.com/
CONTACT:
Alice Bahner Izzo, Executive Director,
Corporate Affairs of Amylin Pharmaceuticals, Inc.,
+1-858-642-7272
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