SAN DIEGO and INDIANAPOLIS, Aug. 26 AmylinPharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) ina conference call today provided context and additional information regardingthe August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prioralert for BYETTA(R) (exenatide) injection referencing pancreatitis. Thecompanies were aware of the pancreatitis cases referenced in the alert, aswell as others, and previously reported these cases to the FDA. The completeconference call replay will be available through Amylin's and Lilly'scorporate websites after the call.
Since 2006, the U.S. prescribing information for BYETTA has includedinformation about pancreatitis. A recent study has also shown that patientswith type 2 diabetes were at nearly three times the risk of developingpancreatitis than those without diabetes.(1) While a definite causalrelationship between BYETTA and pancreatitis has not been proved, to betterunderstand the suspected relationship, Amylin and Lilly continue to pursue acomprehensive drug safety program that includes extensive internal andexternal review of individual cases, and clinical and epidemiologic studies.
"At Amylin and Lilly, patient safety is our foremost concern. We arecommitted to continuing to work closely with the FDA to ensure that physiciansand patients are provided with accurate information about any potential risksassociated with the use of our products," said Orville G. Kolterman, SeniorVice President, Research and Development at Amylin. "It is important tounderstand that pancreatitis, an inflammatory condition of the pancreas, is arare event. Further, the characteristics and complications of the pancreatitiscases in patients on BYETTA are consistent with pancreatitis in the generalpopulation. We believe BYETTA continues to have a positive benefit-riskprofile for patients with type 2 diabetes."
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 21 million in the United States and anestimated 246 million adults worldwide.(2,3) 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.(4)
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.(5) In addition, 85 percent of type 2 diabetespatients are overweight and 55 percent are considered obese.(6) Data supportthat weight loss (even a modest amount) supports patients in their efforts toachieve and sustain glycemic control.(7,8)
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