Lilly ICOS Announces FDA Approval of Cialis -- tadalafil -- A New Oral Treatment for Erectile Dysfunction

    Eli Lilly and Company
Carole Copeland (media), 317-277-3661 
    or
ICOS
Lacy Fitzpatrick (investor relations), 425-415-2207

Lilly ICOS LLC (NYSE:LLY) (Nasdaq:ICOS) announced today that the U.S.
Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil),
a new oral PDE5 inhibitor, for the treatment of erectile dysfunction
(ED). Cialis (pronounced see-AL-iss) was shown to improve erectile
function compared to placebo up to 36 hours following dosing. In
clinical studies, the ability to have sexual activity was improved in
some patients at 30 minutes after taking a dose. Cialis will be
available in pharmacies in early December.

"Cialis is an exciting new option for men with ED," said Dr. Francois
Eid, Clinical Associate Professor of Urology, Weill Cornell Medical
College. "Because Cialis works for up to 36 hours, it provides a man
and his partner substantial freedom to choose the moment that is right
for intimacy. With Cialis, the need for planning intimacy may be
reduced."

The safety and efficacy of Cialis was evaluated in 22 clinical trials
in more than 4,000 patients. Cialis was shown to be effective in
treating ED in patients 27 to 87 years old, including patients with
other underlying medical conditions. In two of these trials, men had
ED associated with diabetes or following radical prostatectomy for
prostate cancer.

"Cialis is a new treatment option for erectile dysfunction that will
be available for men in the United States," said Sidney Taurel,
chairman and chief executive officer of Eli Lilly and Company.
"Erectile dysfunction is a significant medical condition that affects
millions of men in the U.S. Men tell us they want an ED treatment that
will reduce the constraints of planning and allow them to choose the
moment that is right for intimacy."

"Cialis is now available in approximately 50 countries and has been
used by more than one million men worldwide," said Paul Clark, ICOS
chairman and chief executive officer. "The early success of Cialis in
other markets makes us confident that American men and their partners
will appreciate this new treatment option."

Safety Profile

Cialis is not for everyone. Men taking any form of nitrates (often
used to control anginal chest pain) should never take Cialis, as the
combination may cause an unsafe drop in blood pressure. Men taking
medicines called "alpha blockers" (sometimes prescribed for prostate
problems or high blood pressure), with the exception of
Flomax(R)(1)(tamsulosin HCl) 0.4 mg once-daily, should not take
Cialis. This combination could also cause a significant drop in blood
pressure.

In clinical trials, the most common side effects with Cialis were
headache, upset stomach, backache, and muscle ache. Most men weren't
bothered by the side effects enough to stop taking Cialis. In placebo
controlled Phase III clinical trials, discontinuation rates in
patients treated with Cialis 10 mg or 20 mg was 3.1%, compared to 1.4%
in placebo treated patients. Cialis is not recommended in patients who
have suffered a heart attack or stroke within the last six months, or
patients who have significantly low blood pressure, uncontrolled high
blood pressure, unstable angina, severe liver impairment, or retinitis
pigmentosa (a rare eye disorder). Men should discuss their health
status with their doctors to ensure that Cialis is right for them and
that they are healthy enough to engage in sexual activity. Cialis does
not protect a man or his partner from sexually transmitted diseases,
including HIV.

About ED

ED is defined as the consistent inability to attain and maintain an
erection sufficient for satisfactory sexual intercourse.(2) It is
believed that 85 - 90 percent of ED cases are related to a physical or
medical condition, like diabetes or cardiovascular disease, while 10 -
15 percent are due to psychological causes.(3) In many cases a
combination of both contribute to ED.

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly
and Company, was formed to develop and market Cialis.

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, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about Lilly
is available at www.lilly.com.

ICOS Corporation is a product-driven company that has expertise in
both protein-based and small molecule therapeutics. ICOS combines its
capabilities in molecular, cellular and structural biology, high
throughput drug screening, medicinal chemistry and gene expression
profiling to develop highly innovative products expected to have
significant commercial potential. ICOS applies its integrated approach
to erectile dysfunction and other urologic disorders, sepsis and
inflammatory diseases. ICOS' strategy targets multiple therapeutic
areas with drugs that act through distinct molecular mechanisms,
increasing ICOS' opportunities to market breakthrough products.

For full prescribing information, visit www.cialis.com.

Certain of the matters discussed herein may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are based on
current expectations, estimates and projections about the industry,
management beliefs and certain assumptions made by management.
Investors are cautioned that matters subject to forward-looking
statements involve risks and uncertainties, including economic,
competitive and other factors discussed in the two companies'
respective filings with the Securities and Exchange Commission, which
may affect the business and prospects of the two companies. More
specifically, there can be no assurance that this product will achieve
commercial success or that competing products will not pre-empt any
market opportunity that might exist for the product. The companies
undertake no duty to update forward-looking statements.

(1) Flomax(R) is a registered trademark of Boehringer Ingelheim.

(2) NIH Consensus Development Panel on Impotence. NIH Consensus
Conference. Impotence. JAMA. 1993:270:83-90.

(3) Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp. Accessed on November 19, 2003.

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