Cialis(R) (tadalafil) for Once-a-Day Use Approved for the Treatment of Erectile Dysfunction by European Commission


BASINGSTOKE, England, June 25 /PRNewswire/ --

- Daily Dosing Option is First Oral Treatment to Offer an Everyday Way to 
Treat ED in Select Men

Lilly UK has announced today that the European Commission has granted
marketing authorization for Cialis(R) (tadalafil)(1) 2.5 mg and 5 mg, an oral
PDE5 inhibitor dosed once daily to treat erectile dysfunction (ED). The
approval decision follows a positive opinion adopted on 26 April 2007, by the 
Committee for Medicinal Products for Human Use (CHMP) of the European 
Medicines Agency. Lilly anticipates launch will begin in select countries 
during the second half of 2007 and continue throughout the EU in 2008.

Based on patient choice and assessment by a doctor, tadalafil for
once-a-day use is for patients who respond to PDE5 inhibitor therapy, and who
anticipate sexual activity at least twice weekly.(2)

The recommended dosing for tadalafil for once-a-day use for most patients
is 5 mg daily. The dose may be decreased to 2.5 mg once-a-day based on
individual tolerability.

Tadalafil 10 and 20 mg have been approved for as-needed (on-demand)
treatment of ED in all member states of the European Union since November
2002.

"ED is typically a chronic disease and, for some men, Cialis for
once-a-day use will eliminate the need to plan sex within a limited timeframe
as they would with other therapies," said Abbas Hussain, president of
European operations for Lilly. "The approval of Cialis for once-a-day use
marks the first time an oral ED prescription only medicine is available to
provide some men with an everyday way to treat their ED."

The European Commission based its decision on the review and evaluation
of the comprehensive data package for the daily dosing option of tadalafil.
The data include results from three phase III randomized, double blind,
placebo controlled studies. In these clinical studies, men with ED taking
tadalafil 2.5 mg and 5 mg once daily experienced improved erectile function
compared with those taking placebo.

The most commonly reported adverse events are headache, indigestion, back
pain, muscle aches, facial flushing and nasal congestion. All adverse events
reported with tadalafil were transient and generally mild or moderate.(3)

About Tadalafil

Tadalafil is approved for the treatment of ED and is currently available
in more than 100 countries, including Australia, Brazil, Mexico, Canada, the
United States and countries throughout Europe. More than 10 million patients
worldwide have been treated with tadalafil since its first introduction in
February 2003. In Europe, tadalafil is available by prescription only and is
taken as needed prior to sexual activity.

The most commonly reported adverse events with tadalafil on-demand are
headache, upset stomach, nasal congestion, backache, muscle ache, dizziness
and flushing. The adverse events reported with tadalafil were transient and
generally mild or moderate. As with other PDE5 inhibitors, the use of
tadalafil is contraindicated in patients who are taking nitrates, for those
who have cardiac disease in whom sexual activity is not advisable, and for
those patients with non-arteritic anterior ischemic optic neuropathy (NAION).

About ED

ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. Approximately 2.3 million men in
the UK are affected by ED.(4) Experts believe that 80 percent of ED cases are
related to a physical or medical condition, such as diabetes, cardiovascular
diseases, and prostate cancer treatment, while 10 percent are due to
psychological causes.(5),(6)

About Lilly

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.

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 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.

(1) Cialis(R) is a registered trademark of Eli Lilly.

(2) Annex 1, page 2. Draft Summary of Product Characteristics. Data on
file.

(3) Annex II, section B, page. 37. Summary of Product Characteristics.
Data on file.

(4) www.sexualdysfunctionassociation.com, accessed 25 June 2007

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

(6) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington. (pg 45)

© PR Newswire Association LLC.

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