LEL Lilly(Eli)

 
TIDMLEL 
 
Media contacts: Amylin - Anne Erickson 
 
Phone: (858) 754-4443 
 
Cell: (858) 349-3195 
 
Email: anne.erickson@amylin.com 
 
Lilly - Kindra Strupp 
 
Phone: (317) 277-5170 Cell: (317) 554-9577 
 
Email: kstrupp@lilly.com 
 
Alkermes - Rebecca Peterson 
 
Phone: (781) 609-6378 
 
Cell: (617) 899-2447 
 
Email: rebecca.peterson@alkermes.com 
 
                       BYDUREONtm REPLY SUBMITTED to FDA 
 
       New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines 
 
SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass. - July 28, 2011 - Amylin 
Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and 
Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted 
their reply to a complete response letter issued in October 2010 by the U.S. 
Food and Drug Administration (FDA) regarding BYDUREONtm (exenatide 
extended-release for injectable suspension), an investigational medication for 
type 2 diabetes. The companies expect to receive an updated Prescription Drug 
User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since 
the reply included additional data, it will likely be categorized as a Class 2 
resubmission requiring up to six months for review. 
 
The reply submission includes results from the recently completed thorough QT 
(tQT) study, which showed that exenatide, at and above therapeutic levels, did 
not prolong the corrected QT interval in healthy individuals as defined by the 
FDA's published guidance. The reply also contains results from the DURATION-5 
study, which compared the commercial formulation of BYDUREON to BYETTA® 
(exenatide) injection. Additionally, it includes an update of safety 
information from studies ongoing or completed since the last submission, as is 
standard practice in a complete response scenario. 
 
"We worked expeditiously to complete the requested tQT study and consulted with 
the FDA throughout the process," said Christian Weyer, M.D., senior vice 
president, research and development, Amylin Pharmaceuticals. "We are confident 
that the study results and our detailed submission have addressed the 
requirements outlined by the FDA, and we remain committed to making BYDUREON 
available to patients in the U.S. as soon as possible." 
 
BYDUREON is the proposed brand name for exenatide extended-release for 
injectable suspension. It is an investigational medication for type 2 diabetes 
designed to deliver continuous therapeutic levels of exenatide in a single 
weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active 
ingredient in BYETTA, which has been available in the U.S. since June 2005 and 
is used in more than 70 countries worldwide to improve glycemic control in 
adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like 
peptide-1 (GLP-1) receptor agonist class of medications. 
 
The New Drug Application (NDA) for BYDUREON was submitted in May 2009. It is 
based on safety and efficacy data from the DURATION clinical trial program and 
the BYETTA NDA, as well as post-marketing experience with BYETTA. The FDA 
issued complete response letters to the companies in March 2010 and October 
2010. 
 
BYDUREON received marketing authorization in the European Union in June 2011. 
It is available in the U.K. and will launch in other major European countries 
as soon as possible. 
 
About Diabetes 
 
Diabetes affects nearly 26 million people in the U.S. and an estimated 347 
million adults worldwide., Approximately 90-95 percent of those affected have 
type 2 diabetes. In the U.S., diabetes costs more than $174 billion per year in 
direct and indirect medical expenses. 
 
According to the Centers for Disease Control and Prevention's National Health 
and Nutrition Examination Survey, approximately 60 percent of people with 
diabetes do not achieve their target blood sugar levels with their current 
treatment regimen. In addition, 85 percent of type 2 diabetes patients are 
overweight and 55 percent are considered obese. Data indicate that weight loss 
(even a modest amount) supports patients in their efforts to achieve and 
sustain glycemic control., 
 
About BYETTA®(exenatide) injection 
 
BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be 
approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many 
of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood 
sugar after food intake through multiple effects that work in concert on the 
stomach, liver, pancreas and brain. 
 
BYETTA is an injectable prescription medicine that may improve blood sugar 
(glucose) control in adults with type 2 diabetes mellitus, when used with a 
diet and exercise program. BYETTA is not insulin and should not be taken 
instead of insulin. BYETTA is not currently recommended to be taken with 
insulin. BYETTA is not for people with type 1 diabetes or people with diabetic 
ketoacidosis. BYETTA has not been studied in people who have pancreatitis. 
 
BYETTA provides sustained A1C control and low incidence of hypoglycemia when 
used alone or in combination with metformin or a thiazolidinedione, with 
potential weight loss (BYETTA is not a weight-loss product). BYETTA was 
approved in the U.S. in April 2005 and in Europe in November 2006 and has been 
used by more than 1.8 million patients since its introduction. See important 
safety information below. Additional information about BYETTA is available at 
www.BYETTA.com. 
 
Important Safety Information for BYETTA? (exenatide) injection 
 
Based on post-marketing data BYETTA has been associated with acute 
pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing 
pancreatitis. Patients should be observed for signs and symptoms of 
pancreatitis after initiation or dose escalation of BYETTA. The risk for 
getting low blood sugar is higher if BYETTA is taken with another medicine that 
can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in 
people who have severe kidney problems and should be used with caution in 
people who have had a kidney transplant. Patients should talk with their 
healthcare provider if they have severe problems with their stomach, such as 
delayed emptying of the stomach (gastroparesis) or problems with digesting 
food. Antibodies may develop with use of BYETTA. Patients who develop high 
titers to exenatide could have worsening or failure to achieve adequate 
glycemic control. Consider alternative therapy if this occurs. Severe allergic 
reactions can happen with BYETTA. There have been no clinical studies 
establishing conclusive evidence of macrovascular risk reduction with BYETTA or 
any other antidiabetic drug. 
 
The most common side effects with BYETTA include nausea, vomiting, diarrhea, 
dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly 
happens when first starting BYETTA, but may become less over time. 
 
These are not all the side effects from use of BYETTA. A healthcare provider 
should be consulted about any side effect that is bothersome or does not go 
away. 
 
For additional important safety information about BYETTA, please see the full 
Prescribing Information (www.byetta.com/pi) and Medication Guide ( 
www.byetta.com/mg). 
 
About Amylin, Lilly and Alkermes 
Amylin and Lilly partnered to develop and market BYDUREON, which is based on 
proprietary technology for long-acting medications developed by Alkermes, Inc. 
BYDUREON is approved in the EU and is under regulatory review in the U.S. 
 
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 and has a commercial 
manufacturing facility in Ohio. 
 
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, 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, Mass., 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 BYDUREON may not be approved by the FDA in a timely 
manner or at all; the information provided in the companies'responseto the 
FDA's complete response letter may not satisfy the FDA; the FDA may request 
additional information prior to approval; BYETTA and/or the approval of 
BYDUREON and the revenues or royalties 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 BYDUREON mentioned in this press release, not receiving regulatory 
approval; the commercial launch of BYDUREONin the U.S., if approved, being 
delayed; or manufacturing and supply issues. The potential for BYETTA and/or 
BYDUREON 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. 
 
BYDUREONtm and BYETTA® are trademarks of Amylin Pharmaceuticals, Inc. 
 
P-LLY 
 
                                      ### 
 
                                       1 
 
Diabetes Statistics. American Diabetes Association. Available at: http:// 
www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed July 19, 2011. 
 
Danaei G, et al. National, regional, and global trends in fasting plasma 
glucose and diabetes prevalence since 1980: systematic analysis of health 
examination surveys and epidemiological studies with 370 country-years and 2.7 
million participants. Lancet. 2011;DOI:10.1016/S0140-6736(11)60679-X. 
 
Direct and Indirect Costs of Diabetes in the United States. American Diabetes 
Association. Available at: http://www.diabetes.org/how-to-help/action/resources 
/cost-of-diabetes.html. Accessed July 19, 2011. 
 
Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular 
disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42. 
 
Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes 
mellitus, hypertension and dyslipidaemia: comparison of data from two national 
surveys. Int J Clin Pract. 2007;61:737-47. 
 
Nutrition Recommendations and Interventions for Diabetes: a position statement 
of the American Diabetes Association. Diabetes Care. 2008;31 Suppl 1;S61-78. 
 
vii Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in 
type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 
2003;22:331-9. 
 
 
 
END 
 

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