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Media contacts: Amylin - Alice Izzo 
 
Phone: (858) 642-7272 
 
Cell: (858) 232-9072 
 
Email: alice.izzo@amylin.com 
 
Lilly - Kelley Murphy 
 
Phone: (317) 277-4607 
 
Cell: (317) 701-4007 
 
Email: kmurphy@lilly.com 
 
        CHMP Recommends Approval of BYETTA® for Use with Basal Insulin 
 
          Patients in Pivotal Study Achieved Better Glycemic Control 
  Without Weight Gain or Increased Hypoglycemia Risk Versus Optimized Insulin 
                                   Glargine 
 
SAN DIEGO and INDIANAPOLIS - February 17, 2012 - Amylin Pharmaceuticals, Inc. 
(Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the 
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines 
Agency (EMA) has issued a positive opinion in the European Union (EU) for the 
expanded use of BYETTA® (exenatide twice-daily) as an add-on therapy to basal 
insulin, with or without metformin and/or Actos® (pioglitazone), for the 
treatment of type 2 diabetes in adults who have not achieved adequate glycemic 
control with these agents. The CHMP's decision is now referred for final action 
to the European Commission, which has the authority to approve medicines for 
the EU. The Commission usually decides on CHMP recommendations within two to 
three months. 
 
"The combination of BYETTA with basal insulin has potential as a complementary 
treatment approach for several reasons," said Christian Weyer, M.D., senior 
vice president, research and development, Amylin Pharmaceuticals. "BYETTA is 
given in a fixed-dose regimen. Its effects contribute to improved glycemic 
control after meals, complementing the control of fasting blood sugar achieved 
with basal insulin. And in a clinical study, patients using BYETTA with insulin 
glargine achieved better glycemic control, without weight gain or an increased 
risk of hypoglycemia, than patients using insulin glargine without BYETTA." 
 
The double-blind clinical trial evaluating BYETTA as an add-on therapy to 
insulin glargine was published in Annals of Internal Medicine. In the 30-week 
study, BYETTA 10 micrograms or placebo was added to existing insulin glargine 
therapy (with or without metformin, pioglitazone or both), which was titrated 
to achieve target fasting glucose levels. At study entry, patients who may have 
been at increased risk of hypoglycemia (A1C less than or equal to 8 percent) 
reduced their dose of insulin glargine by 20 percent. Five weeks after 
randomization, all patients had insulin doses titrated to achieve target 
fasting glucose levels. The primary endpoint was reduction in A1C, a measure of 
average blood sugar over three months; secondary endpoints included change in 
body weight along with other parameters of glucose control, cardiovascular 
health, hypoglycemia and patient-reported outcomes. 
 
After 30 weeks of treatment, BYETTA demonstrated a statistically significant 
reduction in A1C compared to placebo, lowering A1C by 1.7 percentage points 
from a baseline of 8.3 percent. Patients treated with optimized insulin 
glargine plus placebo experienced a 1.0 percentage point decrease in A1C from a 
baseline of 8.5 percent. Patients who added BYETTA to their insulin glargine 
regimen saw their weight decrease by an average of 4 pounds, compared with an 
increase of 2 pounds in patients who were treated with optimized insulin 
glargine plus placebo. BYETTA is not indicated for the management of obesity 
and weight loss was a secondary endpoint in the trial. Fasting glucose change 
and hypoglycemia incidence were similar between treatment groups. 
 
Thirteen BYETTA recipients and one placebo recipient (9 percent vs. 1 percent) 
discontinued the study because of adverse events (p less than 0.010); rates of 
nausea (41 percent vs. 8 percent), diarrhea (18 percent vs. 8 percent), 
vomiting (18 percent vs. 4 percent), headache (14 percent vs. 4 percent) and 
constipation (10 percent vs. 2 percent) were higher with BYETTA than with 
placebo. Hypoglycemia was similar for both groups; major hypoglycemia occurred 
twice in one patient receiving insulin glargine without BYETTA. 
 
In November 2011, Lilly and Amylin announced that they amicably terminated 
their decade-long collaboration. As part of the transition plan outside the 
U.S., Amylin will assume responsibility for exenatide product commercialization 
efforts on a market-by-market basis by the end of 2013. Amylin will work with 
Lilly on plans for markets outside the U.S. during the transition period. 
Amylin intends to provide uninterrupted patient supply in all markets where 
exenatide products are launched, as well as additional markets in the future. 
Both companies are committed to ensuring a seamless transition of global 
product responsibility to Amylin while maintaining continuity of patient care. 
Amylin anticipates working with one or more partners outside the U.S. in order 
to maximize the global potential of this innovative molecule and achieve 
greater operational flexibility and efficiency. 
 
About Diabetes 
 
Diabetes affects an estimated 347 million adults worldwide and nearly 26 
million people in the U.S., 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. It can also be used with metformin, a sulfonylurea, 
a thiazolidinedione or Lantus® (insulin glargine), which is a long-acting 
insulin. 
 
BYETTA is not insulin and should not be taken instead of insulin. BYETTA should 
not be taken with short- and/or rapid-acting insulin. BYETTA is not for people 
with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been 
studied in patients with a history of pancreatitis. Other antidiabetic 
therapies should be considered for these patients. 
 
BYETTA provides sustained A1C control 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 of getting low blood sugar is higher if BYETTA is taken with another 
medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The 
dose of sulfonylurea or insulin may need to be lowered while BYETTA is used. 
BYETTA should not be used in people who have severe kidney problems and may 
cause or worsen problems with kidney function, including kidney failure. 
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. 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, 
feeling jittery, dizziness, headache, acid stomach, constipation and weakness. 
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 Pharmaceuticals 
 
 
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving 
lives of patients through the discovery, development and commercialization of 
innovative medicines. Amylin is committed to delivering novel therapies that 
transform the way diabetes, obesity and related metabolic disorders are 
treated. Amylin is headquartered in San Diego and has a commercial 
manufacturing facility in Ohio. More information about Amylin Pharmaceuticals 
is available at www.amylin.com. 
 
About Lilly 
 
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. 
 
This press release contains forward-looking statements about Amylin and Lilly. 
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 BYETTA and the revenues generated from BYETTA may be affected by 
competition; unexpected new data; safety and technical issues; clinical trials 
not confirming previous results or not being predictive of real-world use; 
pre-clinical trials not predicting future results; label expansion requests not 
being submitted in a timely manner or receiving regulatory approval; approved 
label expansions not producing the results we expect, or manufacturing and 
supply issues. The potential for BYETTA 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 
commercialization of pharmaceutical products including those inherent in the 
collaboration with and dependence upon Amylin and/or Lilly. These and 
additional risks and uncertainties are described more fully in Amylin's and 
Lilly's most recent SEC filings including their Quarterly Reports on Form 10-Q 
and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update 
these forward-looking statements. 
 
BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.All other marks 
are the marks of their respective owners. 
 
P-LLY 
 
                                     # # # 
 
                                       1 
 
Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in basal 
insulin-treated patients with type 2 diabetes: A randomized, controlled trial. 
Ann Intern Med. 2011;154:103-112. 
 
Danaei G, Finucane MM, Lu Y, 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. 
 
Diabetes Statistics. American Diabetes Association. Available at: http:// 
www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed February 15, 
2012. 
 
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 February 15, 2012. 
 
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. 
 
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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