Cialis Shows Steady Growth in First Nine Months On the US ED Treatment Market

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Aug 2004 - 10:00 PST

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Cialis®(tadalafil) has steadily increased its market share and gained against Viagra® (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 up to 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® (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®:

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® 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 an honorarium 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.

For full patient information, visit http://www.cialis.com.

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® (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® 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 ™ August 2004.
4. IMS National Prescription Audit Plus™ 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

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