Amylin Pharmaceuticals To Present Data On BYDUREON™, BYETTA® And SYMLIN® At The American Diabetes Association 2012 Meeting

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that it will present data for BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly diabetes treatment, as well as first-in-class diabetes drugs BYETTA ® (exenatide) injection and SYMLIN ® (pramlintide acetate) injection at the 72 nd Scientific Sessions of the American Diabetes Association (ADA), June 8-12, 2012, in Philadelphia. The Company will also host an investor presentation and webcast on Sunday, June 10 at 7:30 p.m. ET/4:30 p.m. PT.

Amylin will highlight data from 13 abstracts, offering new insights into the clinical utility of BYDUREON, BYETTA and SYMLIN, as well as continued research into the exenatide pipeline. BYETTA will be featured at this year’s Joint ADA/The Lancet Symposium, and additional information on the use of long-acting GLP-1 receptor agonist therapy to improve efficacy, adherence and weight in patients with type 2 diabetes will be presented during a corporate symposium.

“Multiple presentations at this year’s meeting demonstrate the durability of effect and long-term safety and tolerability of BYDUREON and BYETTA, as well as provide important insights into the effect of SYMLIN on glucose targets,” said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. “For 25 years, Amylin has been an innovator in diabetes treatment. These studies further demonstrate our commitment to expanding physician and patient choices for improving diabetes management and the lives of the millions of people living with this chronic disease.”

Joint ADA/The Lancet SymposiumJoint ADA/The Lancet Symposium: “Exenatide Twice a Day Versus Glimepiride for Prevention of Glycemic Deterioration in Patients with Type 2 Diabetes with Metformin Failure (EUREXA) – An Open-Label Randomized Controlled Trial” will be presented by Guntram Schernthaner, M.D., on Saturday, June 9 at 8:30 a.m. ET.

Featured Symposium“Long-Acting GLP-1 Receptor Agonist Therapy – Improving Efficacy, Adherence, and Weight in Type 2 Diabetes.” This medical education symposium will provide healthcare professionals information about GLP-1 based therapies as an important option in the treatment of type 2 diabetes, restoring the diminished incretin effect and potentially addressing the decline in beta cell function characteristic of type 2 diabetes. The event will be chaired by John Buse, M.D., with medical and scientific presentations by Ralph DeFronzo, M.D., and David D’Alessio, M.D., on Sunday, June 10 at 5:30 a.m. ET. This symposium is supported by an educational grant from Amylin.

Investor PresentationAmylin will also conduct a webcast on Sunday, June 10 at 7:30 p.m. ET/4:30 p.m. PT for the investment community that will include ADA conference highlights. The presentation will be webcast live through the “Investors” section of Amylin’s corporate website at www.amylin.com, and a recording will be made available on the website following the event. To access the live webcast, please log on to Amylin's website approximately 15 minutes prior to the presentation to register, download and install any necessary audio software.

Key Amylin Abstracts at ADA
     

1.
    Late Breaking Poster: “Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir: Randomized, Open-Label Clinical Trial of Efficacy and Safety in Patients with Type 2 Diabetes Inadequately Controlled With Metformin ± Sulphonylureas” will be presented by Melanie Davies, M.D., during a poster session on Sunday, June 10 from 12 – 2 p.m. ET.

2.
Poster: “Pharmacokinetics and Pharmacodynamics of a New Exenatide Formulation, Exenatide Suspension” will be presented by Leigh MacConell, Ph.D., during a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

3.
Poster: “Exenatide Once Weekly Resulted in Sustained Improvement in Glycemic Control with Weight Loss through 4 Years” will be presented by Leigh MacConell, Ph.D., during a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

4.
Poster: “Two-Year Use of Exenatide Once Weekly in Type 2 Diabetes Mellitus (T2DM) Patients Taking Thiazolidinedione” will be presented by Michael Trautmann, M.D., during a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

5.
Poster: “Exenatide Once Weekly was Associated with Improved Glycemic Control Regardless of Baseline Body Weight” will be presented by Richard Pencek, Ph.D., during a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

6.
Poster: “Improved Diabetes Treatment Satisfaction and Weight-Related Quality of Life for Asian Patients Treated with Exenatide Once Weekly Versus Twice Daily” will be presented by Marilyn Boardman, Ph.D., during a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

7.

Poster and Guided Audio Poster Tour: “Anti-diabetic Effects of Exenatide and Dapagliflozin in Diabetic Mice” will be presented by Krystyna Tatarkiewicz, Ph.D., at a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET and at a Guided Audio Poster Tour on Monday, June 11 from 12 – 1 p.m. ET.

8.
Poster: “Pramlintide-Induced Shift Towards Euglycemia Based on SMBG Profiles in T2DM” will be presented by Kathrin Herrmann, Ph.D., at a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.

A full list of all Amylin abstracts being presented at ADA is available at http://scientificsessions.diabetes.org.

Amylin will post insights from the conference on its corporate blog, “Building Blocks” at www.amylinbuildingblocks.com. The blog will feature perspectives from Amylin leadership and global experts on key issues facing the diabetes community, and the latest innovations that could shape the future of diabetes care.

About BYDUREON™ (exenatide extended-release for injectable suspension)BYDUREON is the first and only once-weekly medicine to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. It is a once-weekly formulation of exenatide, the active ingredient in BYETTA ® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Using Alkermes plc’s proprietary technology for long-acting medications, the biodegradable microspheres in each dose of BYDUREON provide a controlled release of exenatide throughout the week. BYDUREON was approved in the U.S. in January 2012 and in Europe in June 2011.

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.

BYDUREON and BYETTA both contain the same active ingredient, exenatide, and therefore should not be used together. BYDUREON is not insulin and should not be taken instead of insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems. See important safety information below. Additional information about BYDUREON is available at www.BYDUREON.com.

Important Safety Information for BYDUREON™ (exenatide extended-release for injectable suspension)

In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some tumors were cancers. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. BYDUREON should not be used if there is a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2.

Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation of BYDUREON.

The risk of getting low blood sugar is higher if BYDUREON is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of sulfonylurea may need to be lowered while BYDUREON is used. BYDUREON should not be used in people who have or had severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYDUREON, which may lead to worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYDUREON. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.

The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.

These are not all the side effects from use of BYDUREON. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For additional important safety information about BYDUREON, please see the full Prescribing Information ( www.BYDUREON.com/pi ) and patient Medication Guide ( www.BYDUREON.com/mg ).

About BYETTA ® (exenatide) InjectionBYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone 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 an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. It can also be used with metformin, a sulfonylurea, a thiazolidinedione or Lantus ® (insulin glargine), which is a long-acting insulin.

BYETTA is not insulin and should not be taken instead of insulin. BYETTA should not be taken with short- and/or rapid-acting insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered for these patients.

BYETTA provides sustained A1C control with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. See important safety information below. Additional information about BYETTA is available at www.BYETTA.com.

Important Safety Information for BYETTA ® (exenatide) Injection

Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA.

The risk of getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of sulfonylurea or insulin may need to be lowered while BYETTA is used. BYETTA should not be used in people who have severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all 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 additional important safety information about BYETTA, please see the full Prescribing Information ( www.BYETTA.com/pi ) and patient Medication Guide ( www.BYETTA.com/mg ).

About SYMLIN ® (pramlintide acetate) InjectionTaken at mealtime, SYMLIN is the first and only amylin mimetic for use in patients with diabetes treated with mealtime insulin. SYMLIN is a synthetic analogue 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, beta cells in the pancreas that make both insulin and amylin are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. Amylin deficiency can make it harder to control glucose levels after meals; therefore, using SYMLIN can help patients to spend more time in their normal glycemic range.

The SymlinPen ® (pramlintide acetate) pen-injector is an easy way for patients to use SYMLIN and offers convenient pre-filled SYMLIN administration with simple, dial-up dosing to improve mealtime glucose control. The SymlinPen ® 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. The SymlinPen ® 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.

For additional important safety information about SYMLIN, please see the full Prescribing Information ( http://documents.symlin.com/SYMLIN_PI.pdf ) and patient Medication Guide ( http://documents.symlin.com/SYMLIN_Medication_Guide.pdf ).

Important Safety Information for SYMLIN (pramlintide acetate) InjectionSYMLIN 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.

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 adverse event. 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 Amylin PharmaceuticalsAmylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin is committed to delivering novel therapies that transform the way diabetes and related metabolic disorders are treated. Amylin is headquartered in San Diego, Calif. and has a commercial manufacturing facility in Ohio. More information about Amylin Pharmaceuticals is available at 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 herein due to a number of risks and uncertainties, including risks that BYETTA, SYMLIN or BYDUREON may be affected by competition, unexpected new data, technical or safety issues, or manufacturing and supply issues; risks that our clinical trials may not start when planned, confirm previous results, achieve intended clinical end-points and/or be predictive of real world use; risks that our preclinical studies may not be predictive; risks that our product candidates may not receive regulatory approval; 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.

BYETTA, SYMLIN and SymlinPen are registered trademarks and BYDUREON is a trademark of Amylin Pharmaceuticals, Inc. All other marks are the marks of their respective owners.

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