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Lilly ICOS' Cialis(R) (tadalafil) European Label Changed to Include
Effectiveness up to 36 Hours
Labelled Duration of Cialis Now Globally Consistent
BOTHELL, Wash. and INDIANAPOLIS, Feb. 24 /PRNewswire-FirstCall/ -- Lilly ICOS
LLC announced today that the European Commission has adopted changes to the
European label for Cialis(R) (tadalafil), Lilly ICOS' oral PDE5 inhibitor for
the treatment of erectile dysfunction (ED). The new label indicates that Cialis
may be effective for up to 36 hours after taking the tablet, which makes it
generally consistent with product labelling throughout the world, including in
the United States, where Cialis was approved late last year.(1)
"In the year that Cialis has been available in Europe, we have seen thatmen and
their partners appreciate Cialis because it gives a man and his partner a broad
window of opportunity so they can choose the moment for intimacy that is right
for them," said Mark Barbato, executive director and product team leader, the
PrimaryCare Products Group, Lilly. "This label change, to 36 hours, is an
important milestone for Cialis because the European label is now consistent with
other labels around the world."
"Product labeling worldwide reinforces how Cialis is different from other oral
ED tablets," said Paul Clark, ICOS Chairman and Chief Executive Officer. "We
believe men and their partners understand and appreciate the attributes of
Cialis and we see them voting with their prescriptions. The market share for
Cialis in some European countries exceeds 25 percent."
European Label Changes
The European label change became effective on January 27, 2004 when it was
adopted by the European Commission. The European Committee for Proprietary
Medicinal Products (CPMP), issued a positive opinion on the label update in
October. The CPMP, comprised of regulators from the European Union countries,
based its opinion on two placebo-controlled studies that were designed to
measure the effectiveness of Cialis at 24 and 36 hours aftertaking the tablet.
It also considered an integrated analysis of 11 studies to determine the
effectiveness of Cialis in men with ED at all time points they chose to have
intercourse from 30 minutes to 36 hours after dosing.(2) In the analysis of 580
men taking 20 mg Cialis, who attempted sexual intercourse between 12 and 24
hours after dosing, 73 percent of intercourse attempts were successful in
response to sexual stimulation. Cialis studies were not designed to assess
multiple intercourse attempts after a single dose.
The new EU label also includes new safety information including updated dosing
instructions for patients with liver and kidney impairments.
Independent Study Shows Men May Prefer Extended Period of Effectiveness
The importance of the duration of effectiveness is emphasized by a recent
clinical study involving Cialis and assessing patient preference versus
Viagra(R) (sildenafil citrate). The independent study, conducted by recognized
experts in the field, will be presented atthe 4th World Congress on the Aging
Male (WCAM) later this month. The study showed that more former Viagra users
preferred Cialis to Viagra(3). In this study, men were also asked which
treatment they would choose to continue to take after the trial. The results
showed that 62 percent of men who had used both drugs chose to continue with
Cialis, compared to 20 percent who opted for Viagra.
"The revised EU label reflects my clinical experience that Cialis is effective
up to 36 hours," said ProfessorJacques Buvat, President of the International
Society for Sexual and Impotence Research (ISSIR). "As our research indicates,
this 36-hour period of effectiveness has made Cialis the preferred choice for
many of my patients. Our data support a number of studies that now show men
with ED value this longer period of effectiveness."
Cialis has successfully captured a significant share of unit (tablet) sales in
Europe among the three PDE5 inhibitors. For December 2003, based on pharmacy
purchases fromwholesalers,(4) Cialis had a 33 percent share in France, 30
percent in Germany, 27 percent in Italy and 18 percent in both Spain and the
United Kingdom.
About Cialis
Cialis is currently available in more than 55 countries, including Australia,
Brazil, Mexico, Canada, the United States and countries throughout Europe. Well
over one million patients worldwide have been treated with Cialis since its
first introduction in February 2003. Cialis can be taken without regard to
food, and is the only available PDE5 inhibitor for which it has been shown that
absorption is not affected by a high-fat meal. Sexual stimulation is needed for
a man to obtain an erection.
Cialis is available by prescription only and is not for everyone. Men taking
nitrates, often used for chest pain, or certain alpha-blockers for prostate
problems or high blood pressure, should not take Cialis. Such combinations
could cause a sudden, unsafe drop in blood pressure.
Men should discuss their health status with their doctorsto ensure Cialis is
right for them and that they are healthy enough for sexual activity.
The most common side effects with Cialis were headache, upset stomach, delayed
backache or muscle ache. Although rare, men who experience an erection for more
than 4 hours should seek immediate medical attention. Men should not drink
alcohol in excess with Cialis.
About Erectile Dysfunction
Erectile dysfunction is defined as the consistent inability to attain and
maintain an erection sufficient for sexual intercourse. ED affects an estimated
152 million men and their partners worldwide.(5) Up to 80 percent of ED cases
are caused by physiological conditions, including cardiovascular disease and
diabetes, with psychological factors accounting for the remaining 20 percent.
In many cases, however, both psychological and physical factors contribute to
the condition.(6)
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and
Company, developed tadalafil for the treatment of sexual dysfunction.
Eli Lilly and Company, 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 laboratoriesand 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.
ICOS Corporation, a biotechnology company, is dedicated to bringing innovative
therapeutics to patients. Headquartered in Bothell, Washington, ICOS is
marketing its first product, Cialis(R) (tadalafil), for the treatment of
erectile dysfunction. ICOS is working to develop treatments for serious unmet
medical conditions such as chronic obstructive pulmonary disease, cancer and
inflammatory diseases.
Certain of the matters discussed herein with respect to clinical studies and
ICOS 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 the 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. Neither company undertakes any duty to update
forward-looking statements.
(1) Section 5.1, European Summary of Product Characteristics.
(2) Hatzichristou D, Eid J-F, Whitaker S, Denne J, Ahuja S. Tadalafil is
effective for 36 hours in men with erectile dysfunction - Results from
an 11 study integrated analysis. Presented at ESSM, Istanbul, Turkey
19 November 2003. Abstract MP-10-6 available from URL
http://www.essm2003.org/pages/1313.htm.
(3) J. Buvat J, Bou-Jadoue G, Colson M-H, Lemaire A. Real World
Experience With Tadalafil In Aging Patients With Erectile Dysfunction
(ED). Abstract submitted to The World Congress of the Aging Male.
Prague, Czech Republic .26th-29th February 2004.
(4) IMS Health. IMS MIDAS, Copyright 2003. Growth rates are based on
three-month moving total tablet inflow to pharmacies.
(5) Aytac IA, McKinlay JB, Krane RJ. The Likely Worldwide Increase in
Erectile Dysfunction Between 1995 and 2025 and Some Possible Policy
Consequences. BJU Int 1999; 84: 50-56.
(6) Impotency Information from NIH. NIH Publication No. 03-3923, November
2002.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILICOSLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILICOSLOGO
DATASOURCE: Lilly ICOS LLC
CONTACT: Carole Copeland, Lilly, +1-317-277-3661; Lacy Fitzpatrick,
ICOS, +1-425-415-2207