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Lilly ICOS Offers ’Cialis Promise’ Program to Men with ED - Pays for a Competing Product if They are Not Satisfied

BOTHELL, Wash. and INDIANAPOLIS, July 12 /PRNewswire-FirstCall/ -- In a first for the pharmaceutical industry, Lilly ICOS LLC, maker of Cialis® (tadalafil), is committing to pay for a competing erectile dysfunction (ED) product if men are not satisfied with Cialis. Through a limited-time special offer called "The Cialis Promise," men with ED who have never used Cialis can receive a voucher for a free trial. If they like Cialis, they can get a second trial at no charge. If they are not satisfied with Cialis, Lilly ICOS will pay for a trial of a competing oral ED product as prescribed by their doctor.

The Cialis Promise launches nationwide today through a print and broadcast ad campaign that features a twist on the signature Cialis advertising image of a couple watching a sunset while seated in side-by-side bathtubs. This time, the bathtubs are empty and the tagline reads, "Looks Like Someone Discovered The Cialis Promise." Cialis is the only oral ED treatment clinically proven to both act fast and work up to 36 hours for most men. In addition, Cialis can be taken without regard to food. These benefits allow a man and his partner to relax and let intimacy happen when the moment is right for them.

"We are so confident that men with ED will appreciate the benefits of Cialis that we're willing to go as far as offering to pay for our competitors' products if they are not satisfied," said Paul Clark, Chairman and CEO of ICOS Corporation. "Because Cialis provides a broad window of opportunity to choose the moment that's right for a man and his partner, we believe that most men will be satisfied with their experience with Cialis, and will want to stick with it beyond the free trial."

How The Cialis Promise Works

Men with ED can download a Free Cialis Voucher and the Cialis Promise Card from the Cialis Web site, http://www.cialis.com/ . A man would then talk to his doctor to determine if Cialis is right for him. If his doctor writes him a prescription for Cialis, he would take it and the Free Cialis Voucher to his local pharmacy to get a free trial. After taking Cialis as directed by his doctor, the man would fill out the Cialis Promise Card and send it, along with a copy of his pharmacy receipt from the Free Voucher to:

CIALIS PROMISE P.O. Box 4846 Trenton, NJ 08650

If he decides that Cialis is the treatment for him, Lilly ICOS will send him another voucher for an additional sample of Cialis tablets, as prescribed by his doctor. If he is not satisfied with Cialis, the company will send him a voucher for a trial of the oral ED treatment (PDE5 inhibitor) of his choice, as prescribed by his doctor. The Cialis Promise is a limited time offer, and Lilly ICOS reserves the right to end the promotion at any time. Men should note: only a doctor or other healthcare professional can determine if an ED medication is right for an individual patient.

What 36 Hours Means for Men with ED

Treating ED is about more than helping a man achieve an erection, according to noted sexologist Marian E. Dunn, Ph.D., Clinical Associate Professor and Director of the Center for Human Sexuality, Department of Psychiatry, State University of New York, Health Science Center, Brooklyn.

"Today, my patients tell me they want a treatment that allows them spontaneity in their relationship and time to connect as a couple," said Dr. Dunn. "Men who have ED already feel a great deal of pressure from their condition and from the need to plan intimacy. So men and their partners want a treatment option that will reduce time pressure."

A recent survey of 300 current Cialis users supports Dr. Dunn's conclusion and provides insight on why many men with ED are choosing Cialis. According to the survey results, more than 80 percent of respondents indicated that intimacy was best when there are no time constraints and when there is no need to plan the moment aside from taking the pill. Further, 77 percent of men surveyed indicated that with Cialis, they didn't have to worry about being intimate within a certain period of time.(1)

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 70 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than two 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.(2) 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.(3,4) In many cases, however, both psychological and physical factors contribute to the condition.(5)

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company , 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, cancer and inflammatory diseases.

(1) Cialis Patient Survey conducted between June 3 and June 9, 2004. Harris Interactive, Inc. sponsored by Lilly ICOS LLC.

(2) 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.

(3) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington.

(4) Diseases and Conditions: Impotence, http://www.impotence.org/FAQ/index.asp. Data accessed 11.20.03

(5) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813

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.

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