INDIANAPOLIS and SAN DIEGO, September 6 /PRNewswire/ --

- Can now be kept for 30 days at room temperature not to exceed 25 
degrees C after first use -

Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) announced today that the European Commission has approved an
extended room temperature in-use period storage instruction for BYETTA(R)
(exenatide) injection. BYETTA Pens can now be kept for up to 30 days at room
temperature not to exceed 25 degrees C after first use.

Patients can now keep a BYETTA Pen at a temperature anywhere from 2
degrees C to 25 degrees C after first use. Until first use, BYETTA Pens must
continue to be stored in a refrigerator between 2 degrees C and 8 degrees C.
These new storage instructions will be provided to patients and healthcare
professionals during the next few weeks. BYETTA Pens should be protected from
light and never frozen.

"We are pleased with the approval of the updated label in Europe," said
James Malone, M.D., global medical director at Eli Lilly and Company. "The
ability to store the pen, after first use, without the need for
refrigeration, makes it convenient for people with type 2 diabetes who use
BYETTA."

Exenatide is formulated for self-administration as a fixed dose,
subcutaneous injection within the 60 minute period before the morning and
evening meals, or the two main meals of the day, approximately six hours or
more apart. Exenatide is available in both a 5-microgram per dose and
10-microgram per dose pre-filled pen-delivery system. Unlike insulin,
exenatide does not require day-to-day dose adjustments.

About BYETTA(R) (exenatide) injection

BYETTA is the first in a class of medicines for the treatment of type 2
diabetes called incretin mimetics. BYETTA exhibits many of the same effects
as the human incretin hormone glucagon like peptide-1 (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 approved in the European
Union as adjunctive therapy to improve blood sugar control in patients with
type 2 diabetes who have not achieved adequate glycaemic control on maximally
tolerated doses of metformin and/or a sulphonylurea, two common oral diabetes
medications.(1) BYETTA provides sustained HbA1c control, low incidence of
hypoglycaemia when used with metformin and progressive weight loss. In three
separate insulin comparator studies, patients initiating exenatide generally
lost weight while patients initiating insulin therapy generally gained
weight.(2,3,4) In addition, when compared to insulin glargine, exenatide was
associated with a lower incidence of hypoglycaemia when used with
metformin.(5)

Important Safety Information for BYETTA(R) (exenatide) injection
In clinical studies, the most common side effects were hypoglycaemia (low
blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomiting
and diarrhoea. For the full list of all side effects reported with BYETTA,
see the Package Leaflet. BYETTA should not be used in people who may be
hypersensitive (allergic) to exenatide or any of the other ingredients.

About Diabetes

Diabetes affects an estimated 246 million adults worldwide and more than
48 million in Europe.(6,7) Approximately 90 to 95 percent of those are
affected by type 2 diabetes, a condition characterized by failure of the
pancreatic beta cells to adequately respond to the increased demands for
insulin that occur as a result of obesity-related insulin resistance.(8) Type
2 diabetes usually occurs in adults over the age of 40, but is increasingly
common in younger people.(7) In virtually every developed society, diabetes
is ranked among the leading causes of blindness, renal failure and lower limb
amputation, as well as death through its effects on cardiovascular
disease (70-80 percent of people with diabetes die of cardiovascular
disease)(9). The calculated estimates of the costs of diabetes care in Europe
amount to 42.8 billion International Dollars per year.(10)

About Lilly and Amylin

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 health care 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 first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations.

Headquartered in Indianapolis, Indiana, Lilly provides answers -- through
medicines and information -- for some of the world's most urgent medical
needs.

Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first-in-class medicines for diabetes. Amylin's research and development
activities leverage the company's expertise in metabolism to develop
potential therapies to treat diabetes and obesity. Amylin is located in San
Diego, California with over 1,700 employees nationwide.

This press release contains forward-looking statements about Lilly and
Amylin. 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, technical issues, clinical
trials not confirming previous results or predicting future results, label
expansion requests not being submitted in a timely manner or receiving
regulatory approval, 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. These and additional risks and uncertainties are
described more fully in Lilly and Amylin's most recently filed United States
Securities Exchange Commission documents such as their Quarterly Reports on
Form 10-Q. Lilly and Amylin undertake no duty to update these forward-looking
statements.

REFERENCES
    (1)  The European Public Assessment Report for Byetta. Available at
         http://www.emea.europa.eu/humandocs/Humans/EPAR/byetta/byetta.htm.
         Accessed July 5, 2007.
    (2)  Barnett AH, Trautmann M, Burger J, Johns D, Kim D, Brodows R, Festa
         A, Roberts A. A comparison of exenatide and insulin glargine in
         patients using a single oral antidiabetic agent. Data disclosure at
         the 42nd annual meeting of the European Association of the Study of
         Diabetes. September 16, 2006.
    (3)  Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG.
         Exenatide versus insulin glargine in patients with suboptimally
         controlled type 2 diabetes: A randomized trial. Annals of Internal
         Medicine 2005; 143(8):559-69.
    (4)  Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows B,
         Trautmann M. A comparison of twice-daily exenatide and biphasic
         insulin aspart in patients with type 2 diabetes who were 
         suboptimally controlled with sulfonylurea and metformin: A 
         noninferiority study. Diabetologia 2007; 50:259-267
    (5)  Trautmann ME., Burger J., Johns D., Brodows R., Okerson T., Roberts
         A., and Barnett A. Less hypoglycemia with exenatide versus insulin
         glargine, despite similar HbA1c improvement, in patients with T2DM
         adjunctively treated with metformin. Data disclosure at the 67th
         Scientific Sessions of the American Diabetes Association, June 24,
         2007, Abstract # 0172-OR.
    (6)  The International Diabetes Federation Diabetes Atlas. Available at:
         http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-
         87B73F80BC22682A. Accessed June 14, 2007.
    (7)  The International Diabetes Federation, Prevalence / All diabetes.
         Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.
    (8)  Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet,
         sulfonylurea, metformin, or insulin in patients with type 2 diabetes
         mellitus: progressive requirement for multiple therapies (UKPDS 49).
         JAMA 1999; 281(21):2005-2012.
    (9)  The International Diabetes Federation, Complications. Available at
         http://www.eatlas.idf.org/Complications/
    (10) The International Diabetes Federation, Diabetes Atlas, Second
         edition. The Economic Impact of Diabetes. 2003:186.

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