SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food andDrug Administration (FDA) recently indicated that the ongoing extension of theDURATION-1 study is appropriate to use as the basis for demonstratingcomparability between intermediate-scale clinical trial material made inAlkermes' manufacturing facility, and commercial-scale drug product made atAmylin's manufacturing facility.
"Following feedback from FDA, we now have an appropriate pathway todemonstrate manufacturing comparability of exenatide once weekly. This is avery important step for the submission of exenatide once weekly," said OrvilleG. Kolterman, M.D., senior vice president, research and development at AmylinPharmaceuticals. "We remain confident that our NDA submission is on track tobe completed by the end of the first half of 2009."
Final acceptance of the comparability data is dependent upon DURATION-1study extension results that are expected in early 2009.
DURATION Program Update
The overall DURATION clinical program, designed to demonstrate superiorityof exenatide once weekly as compared to other medications in the treatment oftype 2 diabetes, remains on track. The companies recently initiatedDURATION-4, the fourth planned DURATION study. The DURATION-4 study examinesexenatide once weekly as a monotherapy treatment compared to either metformin,a thiazolidinedione (TZD) or a dipeptidyl peptidase-4 (DPP-4) inhibitor. Thedouble-blind study is expected to include approximately 800 patients andcomplete in 2010.
"We are confident that the strategy of the DURATION program will yieldpowerful data to support a strong launch for exenatide once weekly," saidJames Malone, M.D., global exenatide medical director, Eli Lilly and Company."We believe the program will demonstrate the value of exenatide once weekly tophysicians, patients and payers."
DURATION-3 completed enrollment in the fourth quarter. This approximately450 patient, open-label, superiority study compares exenatide once weekly withinsulin glargine on a background of oral agent therapy. Results are expectedin the third quarter of 2009.
DURATION-2 completed enrollment in the third quarter of 2008. This 500patient, double-blind, superiority study compares exenatide once weekly withTZD and a DPP-4 inhibitor on a background of metformin therapy. Results areexpected in the second quarter of 2009.
DURATION is an acronym for the overall exenatide once weekly clinicalprogram. It stands for "Diabetes therapy Utilization: Researching changes inA1C, weight and other factors Through Intervention with exenatide ONceweekly."
Exenatide once weekly uses a proprietary technology for long-actingmedications developed by Alkermes. The technology encapsulates activemedication into polymer-based microspheres that are injected into the bodywhere they degrade slowly, gradually releasing the drug in a controlled mannerto provide continuous therapeutic exenatide levels in plasma.
Diabetes affects more than 23 million in the United States and anestimated 246 million adults worldwide.(i, ii) Approximately 90-95 percent ofthose affected have type 2 diabetes. Diabetes is the fifth leading cause ofdeath by disease in the United States and costs approximately $132 billion peryear in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's NationalHealth and Nutrition Examination Survey, approximately 60 percent of peoplewith diabetes do not achieve their target blood sugar levels with theircurrent treatment regimen.(iv) In addition, 85 percent of type 2 diabetespatients are overweight and 55 percent are considered obese.(v) Data supportthat weight loss (even a modest amount) supports patients in their efforts toachieve and sustain glycemic control. (vi, vii)
About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved incretin mimetic for thetreatment of type 2 diabetes. BYETTA exhibits many of the same effects as thehuman incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves bloodsugar after food intake through multiple effects that work in concert on thestomach, liver, pancreas and brain. BYETTA is approved by the FDA for use bypeople with type 2 diabetes who are unsuccessful at controlling their bloodsugar levels. BYETTA is an add-on therapy for people currently usingmetformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustainedA1C control, low incidence of hypoglycemia when used with metformin or athiazolidinedione, and progressive weight loss. BYETTA was approved in April2005 and has been used by approximately one million patients since itsintroduction. For full prescribing information, visit www.BYETTA.com.
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione.BYETTA is not a substitute for insulin in patients whose diabetes requiresinsulin treatment. BYETTA is not recommended for use in patients with severeproblems digesting food or those who have severe disease of the stomach orkidney.
When BYETTA is used with a medicine that contains a sulfonylurea,hypoglycemia (low blood sugar) is a possible side effect. To reduce thispossibility, the dose of sulfonylurea medicine may need to be reduced whileusing BYETTA. Other common side effects with BYETTA include nausea, vomiting,diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea isthe most common side effect when first starting BYETTA, but decreases overtime in most patients.
If patients experience the following severe and persistent symptoms (aloneor in combination): abdominal pain, nausea, vomiting, or diarrhea, they shouldtalk to their healthcare provider because these symptoms could be signs ofserious medical conditions. BYETTA may reduce appetite, the amount of foodeaten, 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 healthcareprovider should be consulted about any side effect that is bothersome or doesnot go away.
For full prescribing information, visit www.BYETTA.com.
About Amylin, Lilly and Alkermes
Amylin, Lilly, and Alkermes are working together to develop exenatide onceweekly, a subcutaneous injection of exenatide for the treatment of type 2diabetes based on Alkermes' proprietary technology for long-actingmedications. Exenatide once weekly is not currently approved by any regulatoryagencies.
Amylin Pharmaceuticals is a biopharmaceutical company committed toimproving lives through the discovery, development and commercialization ofinnovative medicines. Amylin's research and development activities leveragethe company's expertise in metabolism to develop potential therapies to treatdiabetes and obesity. Amylin is headquartered in San Diego, California.
Through a long-standing commitment to diabetes care, Lilly providespatients with breakthrough treatments that enable them to live longer,healthier and fuller lives. Since 1923, Lilly has been the industry leader inpioneering therapies to help healthcare professionals improve the lives ofpeople with diabetes, and research continues on innovative medicines toaddress the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Indiana, Lilly provides answers -- through medicines andinformation -- for some of the world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company committed todeveloping innovative medicines to improve patients' lives. Alkermes' robustpipeline includes extended-release injectable, pulmonary and oral products forthe treatment of prevalent, chronic diseases, such as central nervous systemdisorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts,Alkermes has research facilities in Massachusetts and a commercialmanufacturing facility in Ohio.
This press release contains forward-looking statements about Amylin, Lillyand Alkermes. Actual results could differ materially from those discussed orimplied in this press release due to a number of risks and uncertainties,including the risk that BYETTA and/or exenatide once weekly and the revenuesgenerated from BYETTA may be affected by competition; unexpected new data;safety and technical issues; clinical trials, including the clinical trialsmentioned in this press release, not being completed in a timely manner, notconfirming previous results, or not achieving the intended clinical endpoints;the DURATION-1 study extension results potentially not being accepted tosupport comparability; pre-clinical trials not predicting future results;label expansion requests or NDA filings, including the NDA filing mentioned inthis press release, not being submitted in a timely manner; regulatoryapproval being delayed or not received; or manufacturing and supply issues.The potential for BYETTA and/or exenatide once weekly may also be affected bygovernment and commercial reimbursement and pricing decisions, the pace ofmarket acceptance, or scientific, regulatory and other issues and risksinherent in the development and commercialization of pharmaceutical productsincluding those inherent in the collaboration with and dependence upon Amylin,Lilly and/or Alkermes. These and additional risks and uncertainties aredescribed more fully in Amylin's, Lilly's and Alkermes' most recent SECfilings including their Quarterly Reports on Form 10-Q and Annual Reports onForm 10-K. Amylin, Lilly and Alkermes undertake no duty to update theseforward-looking statements.
(i) The International Diabetes Federation Diabetes Atlas. Available at:http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.Accessed June 2, 2008.
(ii) "All About Diabetes." American Diabetes Association. Available at:http://www.diabetes.org/about-diabetes.jsp. Accessed June 8, 2008.
(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 forVascular 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 todiabetes mellitus, hypertension and dyslipidaemia: comparison of data from twonational surveys. Int J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for Diabetes: a positionstatement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl1:S48-65.
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight managementin type 2 diabetes: review with meta-analysis of clinical studies. J Am CollNutr. 2003;22:331-9.
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SOURCE Eli Lilly and Company