Improvements in Systolic Blood Pressure and Triglycerides Also Observed
NEW ORLEANS, June 7 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc. (Nasdaq: ALKS) today announced long-term, interim results from the DURATION-1 study that showed sustained glucose control with weight loss, as well as improvements in systolic blood pressure and triglycerides, through two years of treatment with exenatide once weekly, an investigational therapy for type 2 diabetes. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans. A New Drug Application (NDA) for exenatide once weekly was recently submitted to the U.S. Food and Drug Administration.
In the controlled portion of the open-label study, patients received exenatide once weekly or BYETTA(R) (exenatide) injection for 30 weeks, followed by 74 weeks of treatment with exenatide once weekly for all patients during an open-ended assessment period. Significant reductions in HbA1c of 1.7 percent and fasting plasma glucose (FPG) of 2.22 mmol/L were maintained after two years of treatment. Sixty-five percent of patients achieved an HbA1c of 7 percent or less. HbA1c of less than 7 percent is the target for good glucose control as recommended by the ADA. Body weight was significantly reduced, with patients losing an average of 2.6 kilograms. Serum lipid profiles were significantly improved, and there was a significant reduction in systolic blood pressure (SBP).
"These two-year DURATION-1 data showed that maintenance of steady state concentrations of exenatide may result in sustained improvements in glycaemic control, with potential weight loss," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. "In DURATION-1, exenatide once weekly has been shown to provide superior glycaemic control, with weight loss, compared to exenatide. If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week."
Study Design and Findings
The study enrolled 295 patients, with nearly 75 percent completing the two years of treatment. Baseline characteristics for these patients were: HbA1c 8.2 +/- 1.0 percent, FPG 9.33 +/- 2.38 mmol/L, body weight 101.15 +/- 18.6 kilograms, BMI 34.8 +/- 4.8 kg/m(2), diabetes duration 7.1 +/- 5.3 years. Significant improvements in both HbA1c [-1.7 +/- 0.1 percent] and FPG [-2.22 +/- 0.16 mmol/L] were maintained after two years of treatment, body weight was significantly reduced [-2.63 +/- 0.54 kilograms], serum lipid profiles were significantly improved [total cholesterol -0.47 +/- 0.15 mmol/L; LDL cholesterol -0.25 +/- 0.12 mmol/L; triglycerides -15 +/- 3 percent], and there was a significant reduction in SBP [-3.0 +/- 1.0 mmHg for all participants and -9.4 +/- 1.5 mmHg for those with abnormal baselines].
About Diabetes
Diabetes affects an estimated 246 million adults worldwide and more than 53 million in Europe.(i, ii) Approximately 90 to 95 percent of those are affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta-cell to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(iii)
Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(iv) In virtually every developed society, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation, as well as death through its effects on cardiovascular disease (50 percent of people with diabetes die of cardiovascular disease).(v) The total cost of caring for people with diabetes in Europe is estimated between 28 billion and 53 billion Euros per year. (vi)
About Exenatide Injection
Exenatide is the first and only approved incretin mimetic, a class of drugs for the treatment of type 2 diabetes. Exenatide exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.(vii) Exenatide is approved in the European Union as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin and/or a sulfonylurea, two common oral diabetes medications. Since the U.S. market introduction in June 2005, more than one million patients worldwide have been treated with exenatide.
Important Safety Information for exenatide
In clinical studies, the most common side effects were hypoglycaemia (low blood sugar) when taken with a sulfonylurea, nausea (feeling sick), vomiting and diarrhea. For the full list of all side effects reported with exenatide, see the Package Leaflet. Exenatide should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.
About Amylin, Lilly and Alkermes
Amylin, Lilly, and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary technology for long-acting medications. Exenatide once weekly is not currently approved by any regulatory agencies.
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. 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.
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.
Lilly, a leading innovation-driven corporation is developing a growing portfolio of 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.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about Amylin, Lilly and Alkermes. 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 exenatide and the revenues generated from exenatide may be affected by competition; unexpected new data; technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; new drug applications and label expansion requests, not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for exenatide 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 the companies' most recently filed United States Securities and Exchange Commission documents including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. The companies undertake no duty to update these forward-looking statements.
P-LLY
(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed on June 5, 2009.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.eatlas.idf.org/index29fc.html. June 5, 2009.
(iii) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(iv) The International Diabetes Federation Diabetes Atlas. Available at http://www.eatlas.idf.org/index755a.html. Accessed on June 5, 2009.
(v)The International Diabetes Federation Diabetes Atlas. Available at http://www.eatlas.idf.org/index711b.html. Accessed on June 5, 2009.
(vi)The International Diabetes Federation, Diabetes Atlas, 2003 Second edition. Available at: http://www.idf.org/webdata/docs/background_info_EU.pdf.
Accessed June 5, 2009
(vii) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003; 88(7):3082-3089.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
(Logo: http://www.newscom.com/cgi-bin/prnh/20071031/CLW032LOGO )
(Logo: http://www.newscom.com/cgi-bin/prnh/20060610/AMYLINLOGO )
