Date: March 23, 2004
For Release: Immediately
Refer to: Carole Copeland, (Lilly), 317-277-3661
Lacy Fitzpatrick, (ICOS), 425-415-2207
Lilly ICOS Enjoys Early Success For CialisA' in ED Marketplace, Surpasses
LevitraA' in New U.S. Prescriptions
-- Recent Head-to-Head Clinical Studies Indicated Patients Prefer Cialis --
BOTHELL, Wash. and INDIANAPOLIS, Ind. - After only three months on the U.S.
market, Lilly ICOS's (NYSE: LLY and Nasdaq: ICOS) erectile dysfunction (ED)
drug CialisA' (tadalafil) has already captured a significant share of new
prescriptions, beating LevitraA' (vardenafil HCl) and further eroding the U.S.
share of market for ViagraA' (sildenafil citrate). Cialis is the only oral ED
treatment on the market that has been shown to improve erectile function up to
36 hours in most men.
For three weeks running, Cialis has surpassed Levitra in share of new
prescriptions written in the United States. For the week ending March 12,
Cialis captured 18.1 percent of new prescriptions compared to Levitra's 15.4
"Cialis is the fastest growing oral ED treatment on the market; with its rapid
uptake we are clearly seeing that men are interested in the distinctive
benefits the brand offers," said Paul Clark, Chairman and CEO of ICOS
Corporation. "And, we are encouraged that our strategy for communicating about
Cialis to healthcare professionals and consumers is working with both
The success of Cialis in the U.S. market is supported by recently published
data in European Urology that showed that 73 percent of men preferred Cialis to
Viagra for treatment of their ED after receiving treatment with both products.
Further, an independent head-to-head trial also showed patient preference for
Cialis over both Levitra and Viagra.
"The progress we have made in just three short months, along with the newly
available published and independent clinical data, supports our long-standing
belief that Cialis is an attractive treatment for ED," said Gino Santini,
President, U.S. Operations, Eli Lilly and Company. "Cialis is the only oral ED
treatment that gives couples up to 36 hours to choose the moment for intimacy
that is right for them."
About the Paperin European Urology
In the study published in European Urology, which was sponsored by Lilly ICOS
and led by Alexander Von Keitz, M.D. of Marburg, Germany and Jacob Rajfer,
M.D., of Los Angeles, Cal., 181 patients (out of a total of 219 patients in the
preference assessment phase) chose between Cialis and Viagra to be used in the
extension phase of the trial. Of this group, 73 percent (132/181) preferred 20
mg Cialis, and 27 percent (49/181) preferred Viagra (p<0.001). In a subgroup of
patients who titrated up from 50 mg to 100 mg Viagra during the study, 69
percent of men preferred Cialis compared to 31 percent who preferred Viagra.
Preference for Cialis was not affected by patient age, country, co-morbid
conditions such as diabetes or cardiovascular disease, order of treatment, or
previous sildenafil use.
Both Cialis and Viagra were generally well tolerated. Only seven patients
discontinued the preference assessment phase of the study because of side
effects, four during Cialis treatment and three during Viagra treatment. Most
commonly reported side effects for Cialis included headache, upset stomach,
back pain and muscle ache. The most commonly reported side effects for Viagra
were headache, upset stomach, nasal congestion and flushing.
Success in Independent Three-Way Preference Study
In addition to the European Urology study, independent studies have been
presented that add to the growing body of evidence showing that the attributes
of Cialis drive patient preference. Among them is one presented at the 6th
European Society for Sexual Medicine (ESSM) in Turkey last November. This
interim cut of data from an independent study, which was presented by Professor
Hartmut Porst, shows that when given the choice, more men preferred Cialis than
the other two oral ED treatments, Levitra and Viagra. In the study of 222
participants, 44 percent preferred Cialis, 32 percent Levitra and 14 percent
Viagra. Only 10 percent expressed no preference but these patients responded
poorly to all three treatments.
In Professor Porst's study, men tried all three currently available PDE 5
inhibitors, and the doctor provided men the opportunity to choose which one
they preferred for continued treatment. The most common reason patients cited
for their preference for Cialis was how long Cialis worked. Porst, a private
urologist and andrologist in Hamburg, Germany, and associate professor of
urology at the University of Bonn, is one of the world's leading ED experts.
Other patient preference studies by independent investigators with various
designs and outcomes have recently been presented at scientific meetings.
European Urology Study Design
In the double-blind, international, randomized, multi-center crossover study
published in European Urology, 219 men with erectile dysfunction were randomly
assigned to complete 12 weeks of treatment with either Cialis or Viagra,
followed by an additional 12 weeks of treatment with the other therapy after a
washout interval. At the end of the second treatment phase, the patients chose
which treatment they wished to receive free of charge in the study's extension
In this study, dosing instructions for Cialis were significantly different from
those for Viagra. Cialis dosing instructions included information about the
period of effectiveness of the drug (stated in the study to be 24 hours).
Additionally, they also included recommendations on how to optimize use of the
drug, highlighting the benefits of the possible time intervals between dosing
and sexual attempt. The dosing instructions for Viagra were based on that
product's label, which instructs men with ED to take the drug about 1 hour
prior to anticipated sexual relations, but indicates that the drug may be taken
30 minutes to four hours before sexual activity. Patients were also advised, as
noted in the label, that absorption of Viagra may be adversely affected by a
high-fat meal. The study was conducted in such a way that the different dosing
instructions did not unblind study participants nor study physicians.
Cialis, approved by the FDA in November 2003 for the treatment of erectile
dysfunction, is the first oral ED treatment shown to improve erectile function
up to 36 hours in most men. Cialis can be taken without regard to food. The
absorption of Cialis is not affected by food, including high-fat foods. Cialis
is currently available in more than 55 countries including Australia, Brazil,
Mexico, Canada, the United States and countries throughout Europe. Nearly two
million patients have been treated with Cialis since its first introduction in
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 doctors to 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, backache
and 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. Cialis studies were not designed to assess multiple
intercourse attempts after a single dose.
For full patient information, visit www.cialis.com.
ED 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. 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 physiological factors contribute to the
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.
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, a biotechnology company, is dedicated to bringing innovative
therapeutics to patients. Headquartered in Bothell, Washington, ICOS is
marketing its first product, CialisA' (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
Except for historical information contained herein, this press release contains
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 of ICOS and Lilly.
Investors are cautioned that matters subject to forward-looking statements
involve risks and uncertainties, including economic, competitive, governmental,
technological, legal 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 and Lilly ICOS. Results
and the timing and outcome of events may differ materially from those expressed
or implied by the forward-looking statements in this press release. More
specifically, there can be no assurance that Cialis will achieve commercial
success or that competing products will not pre-empt market opportunities that
might exist for the product.
IMS NPA Plus 7ao, March 2004
A Multicenter, Randomized, Double-Blind, Crossover Study to Evaluate Patient
Preference between Tadalafil and Sildenafil. Alexander Von Keitz, MD; Jacob
Rajfer, MD; Scott Segal, MD; Aileen Murphy, MPH; Jonathan Denne, PhD; Timothy
Costigan, PhD; Daniel Lockhart, PhD; Charles Beasley, MD; Jeffrey T Emmick, MD,
PhD. European Urology (Vol. 45, issue 4)
All patients in the Viagra groups were started on a 50 mg dose and given the
option to titrate up to 100 mg. Titration to 100 mg was capped at 35 percent to
reflect dispensing patterns at the time the study was designed. Preference for
Cialis was similar for those who did not request titration, for those received
titration, and those that were denied titration.
What Patients Prefer and Why - Sildenafil (Viagra) vs. Tadalafil (Cialis) vs.
Vardenafil (Levitra) in a Post-Launch Real-Life Setting, Symposium presented at
6th European Society for Sexual Medicine. Istanbul, Turkey 16th-19th November
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.
Impotence Information from NIH. NIH Publication No. 03-3923, November 2002.