DURATION-4 Study Results Released
SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., June 15 Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of exenatide once weekly, an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications. BYDUREON(TM) is the proposed brand name for exenatide once weekly in the United States.
This 26-week clinical study compared exenatide once weekly monotherapy to sitagliptin, pioglitazone or metformin, three oral type 2 diabetes medications commonly prescribed early in the treatment of type 2 diabetes. Study participants were not achieving adequate HbA1c control using diet and exercise, and were not on any diabetes medication when they entered the study. HbA1c is a measure of average blood sugar over three months. After 26 weeks of treatment, patients randomized to exenatide once weekly experienced a reduction in HbA1c of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for sitagliptin. Patients randomized to metformin experienced a reduction in HbA1c of 1.5 percentage points, and patients receiving pioglitazone experienced a reduction of 1.6 percentage points. Patients receiving exenatide once weekly, pioglitazone and metformin treatment achieved an average HbA1c of less than seven percent by study end.
Treatment with exenatide once weekly produced an average weight loss of 2.0 kilograms, which is statistically significantly greater than the average 0.77 kilograms patients lost with sitagliptin and the average 1.5 kilograms patients gained with pioglitazone. Patients receiving metformin experienced an average weight loss of 2.0 kilograms.
"The majority of patients in this study reached an HbA1c goal of less than seven percent," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "DURATION-4 continues to provide us with valuable insight into the potential role exenatide once weekly can play in helping physicians and patients manage type 2 diabetes."
More than 80 percent of patients in all treatment arms completed the study. There were no major hypoglycaemia events in any treatment group. The most frequently reported adverse events among exenatide once weekly users were nausea (withdrawal rate less than 1 percent) and diarrhea; metformin, diarrhea and headache; pioglitazone, upper respiratory tract infection, headache, hypertension and peripheral edema; and sitagliptin, upper respiratory tract infection and headache.
Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. Exenatide once weekly 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 in Europe since November 2006 and is used in approximately 60 countries worldwide to improve glycaemic control in adults with type 2 diabetes. Exenatide once weekly and exenatide belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
The 26-week, double-blind, randomized, four-arm parallel study enrolled 820 patients who were not achieving adequate HbA1c control on diet and exercise. Patients had an average type 2 diagnosis of two to three years. The patients were randomized as follows: exenatide once weekly (2 mg) (n=248); metformin (dose escalated up to 2,500 mg/day) (n=246); pioglitazone (dose escalated up to 45 mg/day) (n=163); and sitagliptin (100 mg/day) (n=163). The primary endpoint was reduction in HbA1c, while secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health and patient-reported outcomes.
It is estimated that by 2010, diabetes will affect 284.6 million adults worldwide and more than 55.4 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 high-income country, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation as well as one of the leading causes of death, largely because of a markedly increased risk of coronary heart disease and stroke (cardiovascular disease).(v) In the European region, estimates indicate that at least 106 billion USD will be spent on healthcare for diabetes in 2010, accounting for 28 percent of global expenditure.(vi)
About exenatide Injection
Exenatide was the first 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 Medisorb® technology for long-acting medications. Exenatide once weekly is not currently approved by any regulatory agencies.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients 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 and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility 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 once weekly may not be approved by the FDA or in the EU in a timely manner or at all; the companies' response to the complete response letter may not satisfy the FDA; the FDA may request additional information prior to approval; exenatide and/or the approval of exenatide once weekly and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical issues; clinical trials not being completed in a timely manner, not confirming previous results, not being predictive of real world use or not achieving the intended clinical endpoints; label expansion requests or NDA filings, such as the NDA filing for exenatide once weekly mentioned in this press release, not receiving regulatory approval; the commercial launch of exenatide once weekly being delayed; or manufacturing and supply issues. The potential for exenatide and/or exenatide once weekly 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 development and commercialization of pharmaceutical products including those inherent in the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. These and additional risks and uncertainties are described more fully in Amylin's, Lilly's and Alkermes' most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements.
BYDUREON(TM) and BYETTA® are trademarks of Amylin Pharmaceuticals, Inc., and Medisorb® is a registered trademark of Alkermes, Inc. All other marks are the marks of their respective owners.
(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/regional-overview. Accessed on June 9, 2010.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/europe. Accessed on June 9, 2010.
(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.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9, 2010.
(v) The International Diabetes Federation Diabetes Atlas. Available at http://www.diabetesatlas.org/content/what-is-diabetes. Accessed on June 9, 2010.
(vi) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/europe. Accessed on June 9, 2010.
(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.
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SOURCE Eli Lilly and Company
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