Amylin Pharmaceuticals Announces FDA Approval of SYMLIN(R) for Insulin-Using Type 2 and Type 1 Diabetes
March 16 2005 - 4:59PM
PR Newswire (US)
Amylin Pharmaceuticals Announces FDA Approval of SYMLIN(R) for
Insulin-Using Type 2 and Type 1 Diabetes For Use With Insulin to
Improve Glucose Control SAN DIEGO, March 16 /PRNewswire-FirstCall/
-- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) today announced that
the U.S. Food and Drug Administration (FDA) has approved SYMLIN(R)
(pramlintide acetate) injection to be used in conjunction with
insulin to treat diabetes. SYMLIN is to be used at mealtime in
patients with type 2 or type 1 diabetes who have failed to achieve
desired glucose control despite optimal insulin therapy. SYMLIN
will be commercially available in approximately 90 days. "The
approval of SYMLIN, a first-in-class therapy, is a major milestone
for Amylin Pharmaceuticals. It is the result of 18 years of
research in diabetes," said Ginger L. Graham, President and CEO of
Amylin Pharmaceuticals, Inc. "This extensive development program
has resulted in prescribing information for SYMLIN that we believe
is an excellent tool to introduce SYMLIN to the diabetes
community." Clinical studies demonstrate that SYMLIN, a
self-administered injection given prior to meals, helps patients
achieve lower blood glucose (sugar) after meals, leading to less
fluctuation during the day, and better long-term glucose control
(A1C) compared to patients taking insulin alone. In these studies,
patients used less mealtime insulin and also had a reduction in
body weight compared to patients taking insulin alone. SYMLIN was
studied in over 5300 individuals in the clinical program that led
to approval. "SYMLIN provides a new option for many patients who,
despite their best efforts with insulin therapy, continue to
struggle to achieve their glucose control targets. These patients
often experience weight gain and continued high blood sugar after
meals," said Robert E. Ratner, MD, an investigator for SYMLIN
clinical studies, Vice President for Scientific Affairs, MedStar
Research Institute and Professor of Medicine at the Georgetown
University Medical School. "The science behind SYMLIN has improved
our understanding of the physiology of diabetes and has provided a
welcome new tool for insulin users." 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. Amylin will provide educational
programs for physicians, diabetes care teams, and patients to help
ensure appropriate administration and patient selection. In
addition, the company plans to conduct a small pediatric study and
a two-year open-label study to evaluate SYMLIN use in clinical
practice and assess the effectiveness of its education programs.
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/. About Diabetes Diabetes is a large and
growing market in the United States, affecting over 18 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.
Webcast Announcement Amylin Pharmaceuticals will webcast a
conference call to discuss the SYMLIN approval and
commercialization plans on Thursday, March 17, 2005 at 8:30 a.m. ET
(5:30 a.m. PT). Ginger L. Graham, President and Chief Executive
Officer of Amylin Pharmaceuticals, will lead the call. The call
will be webcast live through Amylin's corporate website, and a
recording will be made available following the close of the call.
To access the webcast, please log on to http://www.amylin.com/
approximately fifteen minutes prior to the call to register,
download and install any necessary audio software. A recording will
be available by phone for 24 hours beginning approximately one hour
after the close of the call and can be accessed at 888-286-8010
(domestic) or 617-801-6888 (international), passcode 17581369.
About Amylin Pharmaceuticals Amylin Pharmaceuticals is a
biopharmaceutical company committed to improving lives through the
discovery, development and commercialization of innovative
medicines. The company's first product, SYMLIN(R) (pramlintide
acetate) injection is an antihyperglycemic drug for use in patients
with diabetes treated with insulin. The company's second compound,
exenatide, is under review at the FDA for improved glucose control
for people with type 2 diabetes. Further information on Amylin and
its pipeline in metabolism is available at http://www.amylin.com/.
Safe Harbor/Forward Looking Statements This press release contains
forward-looking statements about Amylin. The company's actual
results could differ materially from those discussed in this press
release due to a number of risks and uncertainties, including that
SYMLIN may not prove to be an important new therapeutic option,
SYMLIN may not be commercially available in 90 days, SYMLIN may be
affected by unexpected new data or technical issues, or that
exenatide may not be approved by the FDA or that approval, if any,
may be withheld, delayed and/or limited. The potential for SYMLIN
may also be affected by reimbursement and pricing decisions, the
pace of market acceptance, and any issues related to manufacturing
and supply. These and additional risks and uncertainties are
described more fully in the Company's recently filed Form 10-K
under the heading "Risks Related to Our Business". Amylin
undertakes no duty to update these forward-looking statements.
DATASOURCE: Amylin Pharmaceuticals CONTACT: investors, Alice
Bahner, Executive Director, Investor Relations, ext. 7272, or
media, Eric Shearin, Sr. Manager, Corporate Communications, ext.
7177, both of Amylin Pharmaceuticals, Inc., +1-858-552-2200 Web
site: http://www.symlin.com/ Web site: http://www.amylin.com/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jul 2023 to Jul 2024