Lilly and Amylin Mutually Agree to End Diabetes Alliance and Transition Exenatide Responsibility to Amylin

SAN DIEGO and INDIANAPOLIS, Nov. 8, 2011 /PRNewswire/ — 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, BYDUREON(TM) (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 host a 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.