First Reported Head-to-Head Study Showed Byetta (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia (sitagliptin) in Patients With Type 2 Diabetes

Patients Taking BYETTA Also Reduced Food Intake

ROME, September 09, 2008 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a randomized, double-blind, cross-over, four-week head-to-head study demonstrating that BYETTA(R) (exenatide) injection, a GLP-1 receptor agonist, provided significantly lower glucose levels in the post-meal setting when compared to Januvia(TM) (sitagliptin), a DPP-4 inhibitor. Additionally, patients treated with BYETTA reduced post-meal glucagon, showed more efficient use of their body's own insulin and decreased their food intake when compared to Januvia. This is the first reported head-to-head study directly comparing the therapeutic mechanisms of action (MOA) of BYETTA and Januvia. The findings were presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome, Italy. The study will also be published in the peer-reviewed journal, Current Medical Research and Opinion.

"There has been some confusion in the marketplace about the therapeutic differences between BYETTA and Januvia, and data from this first head-to-head study showed a clear difference in the MOAs and resultant short-term clinical effects between these two agents. BYETTA works directly on the GLP-1 receptor, whereas Januvia indirectly affects GLP-1 levels," said Ralph DeFronzo, M.D., professor of medicine and chief of the Diabetes Division at the Health Science Center in San Antonio and a clinical trial investigator on this study. "Patients on BYETTA experienced significantly lower post-meal glucose levels, improved measures of beta cell function and decreased food intake."

The primary endpoint of this four-week study compared the effect of BYETTA and Januvia on 2-hour post-meal glucose. Secondary endpoints included post-meal glucagon, insulin secretion rate, gastric emptying, and food intake. Patients were randomly assigned to treatment with either BYETTA (5 mcg twice daily for the first week followed by 10 mcg twice daily for the second week) or Januvia (100 mg once daily) for two weeks; patients were then switched to the alternate therapy for the remaining two weeks. At baseline and at the end of each two week treatment period, patients underwent a standard meal test and other evaluations to assess each drug's effects on various measures of post-meal glucose control, indicators of beta cell function and other parameters.

Study Findings

In response to a standard meal, patients (evaluable population, N=61) treated with BYETTA had significantly improved post-meal glucose levels two hours after the standard meal when compared to Januvia (133 mg/dL vs. 208 mg/dL at 2 hours respectively, baseline: 245 mg/dL; P<0.0001). Differences in post-meal glucose levels for the intent-to-treat (ITT) population (N=95) also showed significantly lower post-meal glucose levels with BYETTA compared to Januvia (166 mg/dL vs. 210 mg/dL respectively; P<0.0001). As patients were switched from Januvia to BYETTA after two weeks, the post-meal glucose was further improved (-76 mg/dL), while patients who switched from BYETTA to Januvia partially lost the post-meal glucose (+73 mg/dL) control achieved with BYETTA.

The study also showed that after two weeks of treatment both BYETTA and Januvia improved fasting plasma glucose (FPG) (-15 mg/dL and -19 mg/dL respectively, baseline: 178 mg/dL). BYETTA significantly improved an indicator of beta cell function, the insulinogenic index of insulin secretion compared to Januvia (ratio: 1.50 +/- 0.26, P=0.0239). BYETTA also reduced elevated post-meal glucagon (ratio AUC: 0.88 +/- 0.03, P=0.0011) to a greater extent than Januvia and slowed gastric emptying (ratio AUC: 0.56 +/- 0.05, P<0.0001). BYETTA reduced food intake compared to Januvia during buffet-style meals (-134 kcal vs. +130 kcal, P=0.0227), and patients treated with BYETTA experienced a greater reduction in post-meal triglyceride concentrations compared to Januvia (ratio AUC: 0.90 +/- 0.04, P=0.0118).

The most common adverse events for both BYETTA and Januvia were mild to moderate nausea (BYETTA: 34 percent vs. Januvia: 12 percent) and vomiting (BYETTA: 24 percent vs. Januvia: 3 percent). There were no major hypoglycemic events; a single event of minor hypoglycemia (moderate intensity) was reported in a patient treated with BYETTA.

Study Design and Population

The four-week study evaluated patients with type 2 diabetes who were on a stable regimen of metformin and had the following additional criteria: ages between 18 - 70 years; HbA1c: 7.0-11.0 percent, FPG<280 mg>

About BYETTA(R) (exenatide) injection

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.

About Diabetes

Diabetes affects more than 23 million in the United States and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)

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 the most common side effect 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.

About Amylin and Lilly

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 about Amylin Pharmaceuticals is available at www.amylin.com.

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products visit, www.lillydiabetes.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin's and Lilly's most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.

P-LLY

(i) The International Diabetes Federation Diabetes Atlas.

(ii) "All About Diabetes." American Diabetes Association.

(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 8, 2008.

(iv) Saydah SH, Fradkin J and Cowie CC. "Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes." JAMA: 291(3), January 21, 2004.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9

 

CONTACT: Alice Izzo of Amylin, +1-858-642-7272, or Cell, +1-858-232-9072,; or Kindra Strupp of Lilly, +1-317-277-5170, or Cell,+1-317-554-9577, alice.izzo@amylin.com kstrupp@lilly.com

Ticker Symbol: (NYSE:LLY),(NASDAQ-NMS:AMLN)

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Posted: September 2008

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