REG-Lilly (Eli) & Co: FDA Approves Cialis for Once Daily Use

Date: January 8, 2008

For Release: Immediately

Refer to: Keri McGrath, Lilly, (317) 651-6001

mcgrathks@lilly.com

FDA Approves Cialis® (tadalafil) for Once Daily Use for the Treatment of
Erectile Dysfunction

-Approval Makes Available New Daily Dosing Option for the Treatment of ED-

INDIANAPOLIS, Ind., January 8, 2008 - Eli Lilly and Company (NYSE: LLY)
announced today that the U.S. Food and Drug Administration (FDA) has approved
Cialisტ (tadalafil) for once daily use (2.5 mg and 5 mg), an oral medication
taken once per day to treat erectile dysfunction (ED). When Cialis for once
daily use is taken daily, men can attempt sexual activity at anytime between
doses.

Currently available in parts of Europe, this low-dose daily treatment option of
Cialis may be most appropriate for men with ED who anticipate more frequent
sexual activity (e.g. twice weekly). For other men, Cialis taken as needed -
the previously approved dosing regimen - may be most appropriate.

In clinical trials, when taken without restrictions on the timing of sexual
activity, Cialis for once daily use improved erectile function over the course
of therapy.

"ED can be a chronic condition like diabetes or high blood pressure," said
Ridwan Shabsigh, M.D., Director of the Division of Urology at Maimonides
Medical Center in New York. "As a urologist, I know couples like to have
choices and will appreciate the availability of Cialis for once daily use."

Cialis for use as needed transformed the U.S. ED market when it was approved in
2003 as the first and only PDE5 inhibitor clinically proven to provide
sustained efficacy for up to 36 hours. Cialis for once daily use provides a new
option for men who may be looking for a dosing option that can be taken without
regard to timing of sexual activity. In consultation with their physician,
patients now have the freedom to choose the dosing regimen that is appropriate
for them.

"We strive to provide patients with solutions that fit their needs and Cialis
for once daily use delivers on this promise," said Shawn Heffern, Cialis U.S.
Director of Brand Marketing at Lilly. "Now, patients have two options - some
may prefer the up to 36 hours of efficacy provided by Cialis for use as needed
while others may want the unique benefit provided by this daily dosing option."

Additionally, Lilly's wholesale pricing for Cialis for once daily use will be
comparable to Cialis for use as needed such that patients who currently use two
or more pills per week of Cialis for use as needed should not experience higher
treatment costs with Cialis for once daily use.

The FDA's approval of Cialis for once daily use was based upon the evaluation
of the comprehensive data package for the daily dosing option. The data include
results from three phase III randomized, double-blind, placebo-controlled
studies. Men with ED who participated in these clinical studies and who took
tadalafil 2.5 mg and 5 mg once daily without regard to their timing of sexual
activity experienced improved erectile function compared with those taking
placebo. Cialis 5 mg, 10 mg and 20 mg have been approved in the United States
for as-needed treatment of ED since November 2003.

The most commonly reported adverse events were headache, indigestion, back
pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse
events reported with tadalafil were transient and generally mild or moderate.

About ED

ED is defined as the consistent inability to attain and maintain an erection
sufficient for sexual intercourse. Experts believe that 80 percent to 90
percent of ED cases are related to a physical or medical condition, such as
diabetes, cardiovascular diseases, and prostate cancer treatment, while 10
percent to 20 percent are predominantly due to psychological causes., In many
cases, however, both psychological and physical factors contribute to the
condition.

About Cialis

Cialis® (tadalafil) is approved for the treatment of erectile dysfunction on an
as-needed basis or in a daily regimen. The recommended starting dose of Cialis
for use as needed in most patients is 10 mg, taken prior to anticipated sexual
activity. The dose may be increased to 20 mg or decreased to 5 mg, based on
individual efficacy and tolerability. As part of a daily regimen, Cialis may be
taken as 2.5 mg or increased to 5 mg, based on individual efficacy and
tolerability.

Important Safety Information for Cialis

Cialis is available by prescription only and is not for everyone. Men should
discuss their medical conditions and all medications with their doctors to
ensure Cialis is right for them and that they are healthy enough for sexual
activity. Men taking nitrates, often used for chest pain, should not take
Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure.
Cialis for once daily use provides continuous plasma tadalafil levels which
should be considered when evaluating the potential for interactions with
certain medications (e.g., nitrates, alpha-blockers, anti-hypertensives and
potent inhibitors of CYP3A4) and with substantial amounts of alcohol. The most
common side effects with Cialis were headache, upset stomach, delayed backache
or muscle ache.

As with any ED tablet, in the rare event of priapism (an erection lasting more
than four hours), men should seek immediate medical attention to avoid
long-term injury.

In rare instances, men taking prescription ED tablets (including Cialis)
reported a sudden decrease or loss of vision or hearing (sometimes with ringing
in the ears and dizziness). It's not possible to determine if these events are
related directly to the ED tablets or to other factors. If a man has a sudden
decrease or loss of vision or hearing, he should stop taking any ED tablet and
seek medical attention right away.

Cialis does not protect a man or his partner from sexually transmitted
diseases, including HIV. Men should not drink alcohol in excess with Cialis.
Individual results may vary. Cialis has not been studied for multiple attempts
per dose.

Individual results may vary. Cialis has not been studied for multiple attempts
per dose. For full patient information and/or full prescribing information,
visit http://www.cialis.com.

About Eli Lilly and Company

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 world-wide 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.

P-LLY

###

Certain of the matters discussed herein with respect to clinical studies and
Lilly's products 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, governmental,
technological and other factors discussed in the respective filings with the
Securities and Exchange Commission, which may affect the business and prospects
of Lilly. 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.

Cialisგ is a registered trademark of Eli Lilly.

Cialis prescribing information, updated January 2008.

Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy.
New York: Kensington.

Erectile Dysfunction, http://kidney.niddk.nih.gov/kudiseases/pubs/impotence/.
Data accessed 09/28/07.

Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.

END