LEL Lilly(Eli)

 
TIDMLEL 
 
Contacts: 
 
Amylin - Anne Erickson (Media) Michael York (Investors) 
 
Phone: (858) 754-4443 Phone: (858) 458-8602 
 
Email: anne.erickson@amylin.com Email: michael.york@amylin.com 
 
Lilly - Tarra Ryker (Media) Phil Johnson (Investors) 
 
Phone: (317) 332-7502 Phone: (317) 655-6874 
 
Email: ryker_tarra@lilly.com Email: johnson_philip_l@lilly.com 
 
FOR IMMEDIATE RELEASE 
 
    Lilly and Amylin Mutually Agree to End Diabetes Alliance and Transition 
                      Exenatide Responsibility to Amylin 
 
        Agreement Will Resolve All Litigation Between the Two Companies 
 
SAN DIEGO and INDIANAPOLIS - November 8, 2011- Amylin Pharmaceuticals, Inc. 
(NASDAQ: AMLN) ("Amylin") and Eli Lilly and Company (NYSE:LLY) ("Lilly") today 
announced an agreement to terminate their alliance for exenatide and resolve 
the outstanding litigation between the companies. As part of the agreement, the 
parties will transition full responsibility for the worldwide development and 
commercialization of exenatide to Amylin, starting in the United States (U.S.) 
on November 30, 2011, and progressing to all markets by the end of 2013. 
 
After nearly a decade-long partnership that achieved a number of important 
milestones on behalf of people living with diabetes, the companies determined 
it was in the best interest of all constituents to amicably terminate the 
collaboration. Both companies are committed to ensuring a seamless transition 
of global product responsibility to Amylin while maintaining continuity of 
patient care. 
 
"As pioneers in the GLP-1 market, we are proud of the truly innovative diabetes 
products that our two companies have provided patients," said Daniel M. 
Bradbury, president and chief executive officer of Amylin Pharmaceuticals. 
"Amylin is excited to assume full responsibility for developing and 
commercializing exenatide. We anticipate 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. This 
clarity of focus will provide us with an enhanced opportunity to increase 
shareholder value." 
 
Under the terms of the new global agreement, Amylin will make a one-time, 
upfront payment to Lilly of $250 million. Amylin will also agree to make future 
revenue sharing payments to Lilly in an amount equal to 15 percent of global 
net sales of exenatide products until Amylin has made aggregate payments to 
Lilly of $1.2 billion plus accrued interest. Amylin will issue a secured note 
in the amount of $1.2 billion to Lilly under which any revenue sharing payments 
made to Lilly will reduce amounts outstanding under the note. If Amylin's 
investigational once weekly version of exenatide, BYDUREONtm (exenatide 
extended-release for injectable suspension), has not received U.S. Food and 
Drug Administration (FDA) approval prior to June 30, 2014, Amylin's revenue 
sharing obligations will terminate, and Amylin shall thereafter pay Lilly 8 
percent of global net sales of exenatide products. Amylin will also pay a $150 
million milestone to Lilly contingent upon FDA approval of a once monthly 
suspension version of exenatide that is currently in Phase 2. The companies 
have also agreed that the maturity date for the $165 million line of credit 
that Amylin drew from Lilly earlier in the year will be extended from the 
second quarter of 2014 to the second quarter of 2016. 
 
"This marks an amicable end to a very productive 10-year collaboration that 
will continue to benefit many people worldwide. Lilly and Amylin are proud of 
the important accomplishments we achieved together," said Enrique Conterno, 
president of Lilly Diabetes. "Lilly remains confident that the resubmission 
package for BYDUREON has addressed the requirements outlined by the FDA and 
looks forward to Amylin achieving the alliance's long-held goal of making 
BYDUREON available to patients in the U.S. Looking forward, Lilly Diabetes 
remains committed to providing a comprehensive portfolio of diabetes treatment 
options for patients through our currently marketed products and robust 
clinical pipeline." 
 
The transition of commercial operations to Amylin in the U.S. will be complete 
by November 30, 2011. Outside the U.S., Lilly will transfer responsibility for 
commercialization of BYETTA® (exenatide) injection and BYDUREON to Amylin on a 
market-by-market basis in 2012 and 2013. Amylin will work with Lilly on all 
plans for markets outside the U.S. during the transition period and will 
guarantee that Lilly does not experience losses on exenatide-related activities 
during that period, up to a total cap of $60 million. 
 
The Amylin and Lilly alliance resulted in several innovations in the diabetes 
market. These innovations include the 2005 launch of the first-in-class GLP-1 
receptor agonist, BYETTA, a treatment that has been used by 1.8 million 
patients worldwide, and submission of the first once-weekly GLP-1 receptor 
agonist, BYDUREON, an investigational medication for type 2 diabetes designed 
to deliver continuous therapeutic levels of exenatide in a single weekly dose. 
BYDUREON received marketing authorization in the European Union in June 2011 
and is currently under review in the U.S., with a Prescription Drug User Fee 
Action (PDUFA) date of January 28, 2012. Amylin will continue to evolve the 
GLP-1 market with the exenatide franchise through the development of a pen 
device for BYDUREON and the exenatide monthly suspension program. 
 
Amylin to Host Investor Conference Call 
 
Amylin will hosta conference call to discuss the transition of the exenatide 
franchise today at 8:30 a.m. ET/5:30 a.m. PT. Daniel M. Bradbury, president and 
chief executive officer, Amylin Pharmaceuticals, will lead the call. A slide 
presentation accompanying the conference call will be available through the 
"Investors" section of Amylin's corporate website at www.amylin.com. 
 
The call will be webcast live through the "Investors" section of Amylin's 
corporate website and a recording will be made available following the close of 
the call. To access the webcast, please log on to www.amylin.com approximately 
15 minutes prior to the call to register, download and install any necessary 
audio software. For those without access to the Internet, the live call may be 
accessed by phone by calling (800) 857-5738 (U.S./Canada) or (415) 228-4970 
(international), conference access code 7156306. A replay of the call will also 
be available by phone beginning approximately two hours after the close of the 
call and can be accessed at (866) 470-8790 (U.S./Canada) or (203) 369-1490 
(international). 
 
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 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, 
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 and Lilly 
 
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. 
C-LLY 
 
Forward Looking Statement 
 
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 BYDUREON may not be approved by the FDA in a timely manner or at all; the 
information provided in the companies' response to 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 not receiving regulatory approval; the 
commercial launch of BYDUREON in the United States, if approved, or in certain 
European countries 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. Each company's 
results may also be affected by risks inherent in the termination of their 
collaboration and the risk that Amylin may not have the financial resources to 
meet the obligations mentioned in this press release. Amylin's results may also 
be affected by risks associated with its assumption of full responsibilities 
for the worldwide development and commercialization of exenatide, including the 
risks that the transition of Lilly's collaboration responsibilities to Amylin 
will not proceed according to plan, and risks that Amylin's future efforts to 
further develop and commercialize the exenatide franchise, including any 
efforts to re-partner the development and commercialization of exenatide 
outside the United States, may not produce the results Amylin expects. Lilly's 
results may be affected by the risks inherent in the development of Lilly's 
pipeline, and there can be no guarantees that pipeline products will receive 
the necessary clinical and manufacturing regulatory approvals or that they will 
prove to be commercially successful. 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. 
 
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END 
 

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