SAN DIEGO, June 2 CA-Amylin-Pharma-ADA
SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) today announced that the company will present new data for its
FDA-approved diabetes drugs, BYETTA(R) (exenatide) injection and SYMLIN(R)
(pramlintide acetate) injection, and its pipeline diabetes and obesity drug
candidates at the American Diabetes Association's 68th Annual Scientific
Sessions (ADA) being held in San Francisco, CA from June 6 to 10. The company
will also host an investor presentation on Sunday, June 8, at 7:45 PM PT
(10:45 PM ET) that will be available by webcast. ADA is one of the largest
scientific meetings for endocrinologists and other health care professionals
involved in diabetes research and the delivery of diabetes care.
Amylin will be introducing data through over 20 posters and eight oral
presentations at the meeting. The data will demonstrate significant progress
in key research and clinical programs that include studies of BYETTA, SYMLIN,
and Amylin's early and late-stage pipeline candidates. Additional information
will be presented during two symposia focused on the multi-hormonal approach
to the treatment of diabetes and obesity, and the role of incretin-based
therapies in type 2 diabetes.
"We are excited to demonstrate advancement in our diabetes and obesity
pipeline programs at this year's ADA, particularly with updated data related
to the once-weekly formulation of exenatide and the combination therapy
program for obesity," said Daniel M. Bradbury, President and Chief Executive
Officer, Amylin Pharmaceuticals, Inc. "At Amylin, we continually strive toward
our mission of Challenging Science and Changing Lives. By challenging science
we question conventional thinking, and open the door for truly innovative
approaches for developing novel, life-changing therapies. This unique
approach, paired with our deep expertise in peptide hormones and broad
experience in diabetes markets, has allowed us to continue developing
important medicines with life-changing therapeutic potential for patients."
KEY AMYLIN ABSTRACTS BEING PRESENTED AT ADA
Diabetes
1. Oral Late Breaker: "Exenatide Once Weekly Elicits Sustained Glycemic
Control and Weight Loss Over 52 Weeks" will be presented by John B.
Buse, M.D., Ph.D., on Monday, June 9 at 5:50 PM PT (8:50 PM ET).
2. Oral: "Exenatide Once Weekly Results in Significantly Greater
Improvements in Glycemic Control Compared to Exenatide Twice Daily in
Patients with Type 2 Diabetes" will be presented by Daniel Drucker,
M.D. on Saturday, June 7 at 9:00 AM PT (12:00 PM ET).
3. Poster: "Exenatide Monotherapy Improves Glycemic Control and is Well
Tolerated Over 24 Weeks in Drug-Naive Patients with Type 2 Diabetes"
will be presented by Robert Brodows, M.D. during a poster session on
Sunday, June 8 from 12:00 - 2:00 PM PT (3:00 - 5:00 PM ET).
4. Oral Late Breaker: "Pramlintide or Mealtime Insulin Added to Basal
Insulin Treatment in Patients with Type 2 Diabetes" will be presented
by Matthew Riddle, M.D. on Monday, June 9 at 4:30 PM PT (7:30 PM ET).
Obesity
1. Poster: "Enhanced Weight Loss Following Pramlintide/Metreleptin
Combination Treatment in Obese Subjects: Clinical Evidence for
Restoration of Leptin Responsiveness by Amylin Agonism" will be
presented by Christian Weyer, M.D. during a poster session on Monday,
June 9 from 12:00 - 2:00 PM PT (3:00 - 5:00 PM ET).
2. Oral: "Enhanced Weight Loss Following Co-Administration of Pramlintide
with Sibutramine or Phentermine in Obese Subjects" will be presented
by Louis Aronne, M.D. on Saturday, June 7 at 5:00 PM PT (8:00 PM ET).
3. Oral: "Triple Peptide Administration of Amylin, Leptin and PYY (3-36)
in Diet-Induced Obese Rats: Magnitude and Mechanism of Weight Loss"
will be presented by James Trevaskis, M.D. on Sunday, June 8 at
3:15 PM PT (6:15 PM ET).
A full list of all Amylin abstracts being presented at ADA is available
at: http://scientificsessions.diabetes.org.
FEATURED SYMPOSIA
1. "Multi-Hormonal Treatment Approaches and the Diabetes-Obesity
Continuum." Building upon the success of last year's symposium, this
medical education symposium will help healthcare providers understand
the potential of multi-hormonal treatment approaches for diabetes and
obesity. The event will be chaired by Carol Hatch Wysham, M.D., FACP,
FACE on Saturday, June 7 at 6:00 AM PT (9:00 AM ET). This symposium is
supported by an unrestricted educational grant from Amylin
Pharmaceuticals.
2. "Transformation of the Type 2 Diabetes Algorithm: The Incretin
Effect." This medical education symposium will help healthcare
providers understand the role of incretin-based therapies in relation
to type 2 diabetes. The event will be chaired by Ralph DeFronzo, M.D.
on Sunday, June 8 at 6:00 AM PT (9:00 AM ET). This symposium is
supported by an unrestricted educational grant from Amylin
Pharmaceuticals and Eli Lilly and Company.
INVESTOR PRESENTATION
Amylin will also conduct a webcast for investors to review the information
presented at ADA on Sunday, June 8 at 7:45 PM PT (10:45 PM ET). The live
presentation will be webcast, and a recording will be made available following
the event. The webcast and recording will be accessible through Amylin's
corporate Web site, located at http://www.amylin.com. To access the live
webcast, please log on to Amylin's site approximately 15 minutes prior to the
presentation to register and download any necessary audio software.
About SYMLIN
Taken at mealtime, 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.
SymlinPen(R) (pramlintide acetate) pen-injector devices offer convenient
pre-filled SYMLIN administration with simple, fixed dosing to improve mealtime
glucose control. SymlinPen(R) 120 features fixed dosing to deliver 60 or 120
micrograms of SYMLIN per dose. SymlinPen(R) 60 features fixed dosing to
deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
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 for SYMLIN
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 BYETTA
BYETTA is the first and only FDA-approved incretin mimetic for the
treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the
human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood
sugar after food intake through multiple effects that work in concert on the
stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by
people with type 2 diabetes who are unsuccessful at controlling their blood
sugar levels. BYETTA is an add-on therapy for people currently using
metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained
A1C control, low incidence of hypoglycemia when used with metformin or a
thiazolidinedione, and progressive weight loss. BYETTA was approved in April
2005 and has been used by approximately one million patients since its
introduction. For full prescribing information, visit http://www.BYETTA.com.
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione.
BYETTA is not a substitute for insulin in patients whose diabetes requires
insulin treatment. BYETTA is not recommended for use in patients with severe
problems digesting food or those who have severe disease of the stomach or
kidney.
When BYETTA is used with a medicine that contains a sulfonylurea,
hypoglycemia (low blood sugar) is a possible side effect. To reduce this
possibility, the dose of sulfonylurea medicine may need to be reduced while
using BYETTA. Other common side effects with BYETTA include nausea, vomiting,
diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is
most common when first starting BYETTA, but decreases over time in most
patients.
If patients experience the following severe and persistent symptoms (alone
or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should
talk to their healthcare provider because these symptoms could be signs of
serious medical conditions. BYETTA may reduce appetite, the amount of food
eaten, and body weight. No changes in dose are needed for these side effects.
These are not all of the side effects from use of BYETTA. A healthcare
provider should be consulted about any side effect that is bothersome or does
not go away.
For full prescribing information, visit http://www.BYETTA.com.
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
headquartered in San Diego, California with over 2,000 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 that our clinical trials may not start when planned and/or confirm
previous results; our preclinical studies may not be predictive; our product
candidates may not receive regulatory approval; and inherent scientific,
regulatory and other risks in the drug development and commercialization
process. 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.
