Indianapolis (ots/PRNewswire) -
- Daily dosing option is first prescription oral treatment to
offer uninterrupted management of erectile dysfunction in select men
Lilly (NYSE: LLY) 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 April 26, 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 physician assessment, 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. Tadalafil for once-a-day use is a daily
regimen of this therapy.
"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 uninterrupted
treatment for 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
The most commonly reported adverse events are indigestion, back
pain, muscle aches, facial flushing and nasal congestion. All adverse
events reported with tadalafil were transient and generally mild or
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 or in a daily regimen.
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).
ED is defined as the consistent inability to attain and maintain
an erection sufficient for sexual intercourse. As of 2004, it is
estimated that approximately 189 million men worldwide will have
ED.(4) 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 due to psychological causes.(5,6) In many
cases, however, both psychological and physical factors contribute to
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.
@@start.t1@@ (1) Cialis(R) is a registered trademark of Eli Lilly.
(2) Draft Summary of Product Characteristics, Data on file
(3) Annex II, section B, page. 37. Summary of Product Characteristics.
Data on file.
(4) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou
DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates:
Results of the Massachusetts Male Aging Study, Journal of Urology.
Vol. 151, 54-61, January 1994 and World Population Projection Program
Of United Nations (2002 Revision) with indirect standardization.
(5) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(6) Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp. Data accessed 11/20/03.
(7) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.@@end@@
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