SAN DIEGO and INDIANAPOLIS, Dec. 8 AmylinPharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY)today announced that the U.S. Food and Drug Administration (FDA) is continuingwith its review of the regulatory application for use of BYETTA(R) (exenatide)injection as stand-alone therapy (monotherapy) in people with type 2 diabeteswho are not achieving acceptable blood sugar control. It is likely that thisreview will not be complete by the end of 2008, and may extend into 2009.
"Our discussions with the FDA continue to progress and we remain confidentin the strength of our regulatory submission," said Orville G. Kolterman,senior vice president of research and development at Amylin Pharmaceuticals."Importantly, we have not received any request for additional studies. We lookforward to working closely with the agency as needed throughout the reviewprocess."
The regulatory application for use of BYETTA as monotherapy was submittedin the first quarter of 2008. The FDA is also reviewing several other BYETTAprescribing information updates submitted by the companies, including revisionof safety language and conversion of physician labeling to the new standardformat.
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.
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)
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 and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed toimproving lives through the discovery, development and commercialization ofinnovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection andBYETTA(R) (exenatide) injection. Amylin's research and development activitiesleverage the company's expertise in metabolism to develop potential therapiesto treat diabetes and obesity. Amylin is headquartered in San Diego,California. Further information about Amylin Pharmaceuticals is available atwww.amylin.com.
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. For more information about Lilly'scurrent diabetes products visit, www.lillydiabetes.com.
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. Additionalinformation about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about Amylin andLilly. Actual results could differ materially from those discussed or impliedin this press release due to a number of risks and uncertainties, includingthe risk that BYETTA and the revenues generated from BYETTA may be affected bycompetition; unexpected new data; safety and technical issues; clinical trialsnot confirming previous results; pre-clinical trials not predicting futureresults; or regulatory applications, including the regulatory applicationmentioned in this press release, not being submitted in a timely manner orreceiving regulatory approval. The potential for BYETTA may also be affectedby government and commercial reimbursement and pricing decisions, the pace ofmarket acceptance, or scientific, regulatory and other issues and risksinherent in the commercialization of pharmaceutical products. These andadditional risks and uncertainties are described more fully in Amylin's andLilly's most recent SEC filings including their Quarterly Reports on Form 10-Qand Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to updatethese forward-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.(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO ) P-LLY
SOURCE Eli Lilly and Company