| Lilly ICOS' Cialis(R)
(tadalafil) Shows Steady Growth in First Nine
Months On the U.S. ED Treatment Market
August 19, 2004
BOTHELL, Wash. and INDIANAPOLIS, Ind., Aug.
19 /PRNewswire-FirstCall/ -- Cialis(R) (tadalafil)(1)
has steadily increased its market share and
gained against Viagra(R) (sildenafil citrate)
in the nine months since it was introduced in
the U.S. to treat erectile dysfunction (ED).
Recent surveys reinforce that the main reason
for this growth is because Cialis
works for upto 36 hours, allowing a man
and his partner time to relax, not worry about
planning and be intimate when they want to be.(2)
For the week ended August 6, weekly new prescription
data show Cialis has 20.1 percent of new oral
ED treatment prescriptions in the U.S., compared
to 14.1 percent for Levitra(R) (vardenafil HCl)
and 65.8 percent for Viagra.(3)
In total oral ED
prescriptions, Cialis has 15.7 percent in
the U.S., compared to 11.3 percent for Levitra
and 73 percent for Viagra. Cialis has increased
its share of total prescriptions every month
since its introduction in the
U.S.(4)
According to the findings from two recent surveys,
one with men who are being treated with Cialis
and the other with physicians who prescribe
the product, which were sponsored by Lilly ICOS
and conducted by Harris Interactive(R):
Patient Survey (300 patients taking Cialis)
* Of men in the survey who indicated they
preferred Cialis and had used other oral ED
treatments, 81 percent stated they preferred
Cialis specifically because it works for up
to 36 hours.
* In the survey, 77 percent of the men surveyed
either agreed or strongly agreed with the statement,
"with Cialis, I don't have to worry about
being intimate within a certain period of time."
Physician Survey (202 primary care physicians
(PCPs) and 208 urologists who prescribe Cialis)
* The top (81 percent) reason physicians surveyed
indicated they recommended Cialis to their patients
who have not tried other oral ED
treatments was that it works up to 36 hours.
* An average of 90 percent of doctors surveyed
agreed or strongly agreed with the statement,
"I prescribe Cialis to men with ED who
desire greater freedom from planning" (92
percent of 202 primary care physicians and 89
percent of 208 urologists).
* An average of 97 percent of physicians surveyed
believe that their patients are "satisfied"
to "extremely satisfied" with Cialis
(96 percent of primary care physicians and 98
percent of urologists).
"These results support what we are already
seeing in markets around the world," said
Leonard Blum, vice president of marketing, ICOS
Corporation."Men and their doctors who
are choosing Cialis as their ED treatment are
doing so because of the distinctive attributes
it offers patients."
In addition to working up to 36 hours in most
men, Cialis can be taken on an empty stomach
or with a meal, without concern that high-fat
food will reduce the absorption of the medicine.
These benefits allow a man and his partner to
relax and let intimacy happen when the moment
is right for them.
About the Surveys
The two surveys, sponsored by Lilly ICOS LLC,
were conducted online by Harris Interactive(R)
between June 3 and June 9, 2004. PCPs (202)
and urologists (208) who were all current Cialis
prescribers were recruited from the Harris Interactive
Physicians Panel via an email invitation, which
outlined the purpose of the survey in general
terms. Physicians were given anhonorarium in
exchange for their participation.
The patient sample was recruited from the Harris
Interactive Chronic Illness and general panels.
To qualify for this survey, patient respondents
had to meet the criteria of being male between
the ages of 40 and 70 years, be a U.S. resident,
have erectile dysfunction and be taking Cialis.
Data from the physicians' sample were unweighted
and data from the patients' sample were weighted
for age, sex, race/ethnicity, education,income,
religion and propensity to be online to align
them with population proportions. In theory,
with probability samples of this size, one could
say with 90 percent certainty that the results
have a sampling error of plus or minus seven
percentage points of what they would be if the
entire U.S. online population of PCPs and urologists
who currently prescribe Cialis to patients OR
the total U.S. population of men who currently
take Cialis for ED had been
surveyed with complete accuracy.These online
samples were not probability samples.
About Cialis
Cialis, approved
by the FDA in November 2003 for the treatment
of erectile dysfunction, is the only 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 reduced by food, including high-fat foods.
Cialis is currently available in approximately
90 countries, including Australia,Brazil, Mexico,
Canada, the United States and countries throughout
Europe.
Nearly three million patients worldwide have
been treated with Cialis since its first introduction
in February 2003.
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,delayed backache
and muscle ache. Although rare, men who experience
an erection for more than four 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.
About ED
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.(5)
Experts believe that 80 - 90 percent of ED cases
are related to a physical or medical condition,
like diabetes, cardiovascular diseases, and
prostate cancer treatment, while 10 -
20 percent are due to psychological causes.(6),(7)
In many cases, however, both psychological and
physical factors contribute to the condition.(8)
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS
Corporation (Nasdaq: ICOS) and Eli Lilly and
Company (NYSE: LLY), developed tadalafil for
the treatment of erectile 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 http://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, 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, benign prostatic hyperplasia,
cancer and inflammatory diseases.
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.
(1) Cialis(R) is a registered trademark of
Lilly ICOS LLC. All other trademarks are the
property of their respective owners.
(2) Individual results may vary. Not studied
for multiple attempts per dose.
(3) IMS National Prescription Audit Plus7(TM),
August 2004.
(4) IMS National Prescription Audit Plus(TM)
June 2004.
(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) Shabsigh, R. (2002). Back To Great Sex:
Overcome ED and Reclaim Lost Intimacy. New York:
Kensington.
(7) Diseases and Conditions: Impotence,http://www.impotence.org/FAQ/index.asp
. Data accessed 11.20.03
(8) Lue, Tom F. Erectile Dysfunction. N Engl
J Med 2000; 342: 1802-1813
source:-http://www.prnewswire.com
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