Submitted to FDA for Stand-Alone Therapy in Q1 2008
SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced additional results from a study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone and were treated with either monotherapy (stand-alone) BYETTA(R) (exenatide) injection taken twice daily or placebo. Study findings showed that patients treated with monotherapy exenatide showed statistically significant improvement in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.
In this 24-week randomized, double-blind, placebo-controlled, parallel study of 232 drug-naive patients (N=77 exenatide 5 mcg, N=78 exenatide 10 mcg, N=77 placebo) with type 2 diabetes who were treated with 5 mcg and 10 mcg of exenatide as a monotherapy reduced their A1C (a measure of average blood sugar over three months) by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C of 7.9 and 7.8 percent, respectively. In the 5 mcg arm, 86 percent of study participants completed the study and in the 10 mcg arm, 87 percent completed the study. Sixty percent of the 5 mcg evaluable study participants and 61 percent of the 10 mcg evaluable study participants achieved or maintained an A1C of less than or equal to 7 percent at study end, a common target for good glucose control.
"Healthcare professionals and their patients with type 2 diabetes need a variety of treatment options to successfully manage the disease," said Jim Malone, M.D., Global Medical Director, Eli Lilly and Company. "These data are robust and show the important glucose lowering properties of BYETTA taken as monotherapy. If approved, this indication would give physicians the option to prescribe exenatide as a stand-alone treatment, which may allow for increased patient access to BYETTA."
This study was conducted following receipt of an approvable letter for a monotherapy indication from the FDA in 2005. In addition to the clinical studies included in the 2005 submission package, data from this study address requests by the FDA as a result of that approvable letter.
Treatment with exenatide also resulted in a statistically significant lowering of fasting glucose concentrations for EXE 5 mcg (-17.5+/-4 mg/dL) and EXE 10 mcg (-18.7+/-4 mg/dL) at endpoint compared with placebo (-5.2+/-4 mg/dL). A statistically significant weight loss was also noted of -6.1 pounds (EXE 5 mcg) and -6.8 pounds (EXE 10 mcg) compared with -3.2 pounds for placebo. In an oral glucose tolerance test conducted in a subset of patients (N=104), two hour serum glucose excursion decreased for EXE 5 mcg (-18.4+/-14 mg/dL) and EXE 10 mcg (-55.1+/-13 mg/dL), while this measure increased (+4.5+/-14 mg/dL) in patients treated with placebo.
In addition, fasting serum lipid profiles, including total cholesterol and high- and low-density lipoprotein, remained unchanged and blood pressure levels improved. Systolic blood pressure decreased from baseline to endpoint by -3.7+/-1.2 mm Hg in the 5 mcg exenatide group (P=0.037; vs placebo) and also -3.7+/-1.2 mm Hg in the 10 mcg exenatide group (P=0.037; vs placebo), compared with -0.3+/-1.2 mm Hg for placebo (means +/- SEM). Diastolic blood pressure decreased from baseline to endpoint by -0.8+/-0.7 mm Hg in the 5 mcg exenatide group (P=0.619; vs placebo) and -2.3+/-0.7 mm Hg in the 10 mcg exenatide group (P=0.046; vs placebo), compared with -0.3+/-0.7 mm Hg for placebo (means +/- SEM).
There was an incidence of reported nausea in both the 5 mcg and 10 mcg arms of 3 and 13 percent, respectively, which is a lower incidence than what was observed in previous studies, where exenatide has been used in combination with other diabetes therapies. There were no instances of severe hypoglycemia. The overall incidence of hypoglycemia was similar to that seen in studies where exenatide was used in conjunction with metformin only.
The 24-week, randomized study included 232 patients with type 2 diabetes who were not achieving adequate glucose control using diet and exercise without previous use of antidiabetes agents. Study participants were randomized to receive subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg exenatide twice daily without taking any oral antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg injections for the first four weeks, and increased to 10 mcg injections for the final 20 weeks.
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. For full prescribing information, visit http://www.BYETTA.com.
Diabetes affects more than 21 million in the United States and an estimated 246 million adults worldwide.(1,2) 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.(3)
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.(4) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(5) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(6,7)
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.
For full prescribing information, visit http://www.BYETTA.com.
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 http://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, http://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 http://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; technical issue; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests, including the FDA submission referred to in this press release, 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 and Lilly's most recently filed SEC 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.
(1) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A . Accessed June 2, 2008.
(2) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 6, 2008.
(3) "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 6, 2008.
(4) 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.
(5) 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.
(6) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
(7) 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
|SOURCE Eli Lilly and Company|
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