Lilly ICOS LLC

New Data Show Cialis(R) (tadalafil) May Effectively Treat ED in Men With Clinical Depression, Diabetes and Traumatic Spinal Cord Injuries

    London (ots/PRNewswire) -

    - Patients with moderate-to-severe ED and comorbid conditions respond  to Cialis

    Cialis(R)(1) (tadalafil) may effectively treat erectile dysfunction (ED) in men with a variety of comorbidities that can make the condition more difficult to manage, according to new studies released at the 7th Annual Congress of the European Society for Sexual Medicine (ESSM). In the studies, Cialis was shown to significantly improve erectile function in men suffering from ED and comorbid clinical depression or comorbid diabetes mellitus. Cialis also showed efficacy in improving erectile function in men who developed ED as a result of traumatic spinal cord injuries.

    "Erectile dysfunction on its own can be difficult for men to cope with and treat. Comorbid conditions such as clinical depression or diabetes, or ED caused by a traumatic spinal cord injury, can make treating ED more challenging," said Allen D. Seftel, MD, Department of Urology, Case Western Reserve University, Cleveland, Ohio, U.S.A. "These studies show that Cialis works in patients with moderate-to-severe ED and other disorders, and that it is an important treatment option to consider."

    Treating ED in Men with Comorbid Clinical Depression

    A multicentre, open-label study demonstrated that 89 percent of men who had ED along with clinical depression reported improved erections after taking 20 mg Cialis, based on the question of whether the treatment they were taking improved their erections.

    - 86 percent of men reported successful penetration after treatment, while 77 percent reported successful completion of intercourse

    - Of those men able to complete intercourse (positive response to SEP question 3), in 87 percent of the episodes they were satisfied with the hardness of their erections and in 82 percent of the episodes they reported satisfaction with the overall sexual experience while using Cialis

    The data were based on a subset of 178 patients who were identified as having a diagnosis of clinical depression at the time of their first visit to their doctor to participate in the trial. This group was one of the prospectively recruited populations of a multicentre, open label trial of 1,911 men with ED. Men were given 12 weeks of treatment with 20 mg Cialis and asked to record responses to the Sexual Encounter Profile (SEP)(2), as well as the International Index of Erectile Function (IIEF)(3) and the Global Assessment Questionnaire (GAQ).(4) The most common treatment emergent side effects were headache (8 percent), flushing (4 percent), upset stomach (3 percent), flu (3 percent), nasal congestion (3 percent), and back pain (3 percent).

    ED and Diabetes

    In a retrospective analysis of data from 12 placebo-controlled, clinical trials among a population of 637 men with ED and diabetes and 1,681 men with ED but without diabetes, 10 mg and 20 mg Cialis each demonstrated an improvement in IIEF scores in both groups. Improvement also was noted in the SEP, question 3 (regarding successful intercourse)(5).

    Importantly, although men with diabetes had more severe ED than those men who did not have diabetes at the beginning of the trials, both groups showed significant improvement after taking Cialis, regardless of whether they took 10 mg or 20 mg Cialis. In terms of efficacy, neither dose of Cialis was influenced by the patients' glycosated haemoglobin levels (higher levels indicate more severe or less controlled diabetes) or by diabetes medications, including insulin or other oral agents. The most commonly reported adverse events were headache, upset stomach, back pain, muscle ache and runny nose.

    ED in Men With Traumatic Spinal Cord Injuries

    A multicentre, open-label exploratory study of 49 patients demonstrated that 88 percent of men who developed ED as a result of traumatic spinal cord injuries reported improved erections after taking 20 mg Cialis, based on the GAQ.

    - In the study, 73 percent of patients indicated that they were able to successfully achieve penetration of their partner, while 64 percent reported the ability to maintain an erection through successful intercourse

    - The most commonly reported treatment-emergent adverse events with Cialis in the study were headache (12 percent), upset stomach (2 percent), and flushing (2 percent)

    This study, which was a subgroup of a larger study that attracted 1,911 men with various comorbidities, examined men with ED due to traumatic spinal cord injury, including men with paraplegia and tetraplegia (quadriplegia). The trial consisted of a four-week run-in period to determine baseline measurements, followed by a 12-week treatment period with 20 mg Cialis. Men were asked questions from the IIEF, as well as for their responses to SEP, questions 2 (regarding penetration)(6) and 3 (regarding successful intercourse). Men were also asked GAQ questions about whether they experienced improved erectile function.

    About Cialis

    Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than 3 million patients worldwide have been treated with Cialis since its first introduction in February 2003. Cialis is available by prescription only.

    The most commonly reported adverse events with Cialis are headache, upset stomach, nasal congestion, backache, muscle ache, dizziness and flushing. The adverse events reported with Cialis were transient and generally mild or moderate. As with other PDE5 inhibitors, the use of Cialis is contraindicated in patients who are taking nitrates or for those who have cardiac disease and for whom sexual activity is not advisable.

    About ED

    ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. As of 2004, it is estimated that approximately 189 million men worldwide will report having ED.(7) Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are due to psychological causes.(8,9) In many cases, however, both psychological and physical factors contribute to the condition.(10)

    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.

    ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is marketing its first product, Cialis (tadalafil), through Lilly ICOS LLC. 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.

@@start.t1@@      (1) Cialis(R) is a registered trademark of Lilly ICOS LLC. All other
            trademarks are the property of their respective owners.
      (2) The Sexual Encounter Profile, SEP, is a patient self-administered
            diary completed by clinical trial participants after each sexual
            encounter.
      (3) The International Index of Erectile Function, IIEF, is an
            international scale that assesses erectile function in cross-cultural
            settings by measuring treatment-related responses in patients.
      (4) The Global Assessment Questionnaire, GAQ, is a self-administered
            questionnaire that allows patients to rate improvement in erectile
            function.
      (5) SEP 3 - "Did your erection last long enough for you to successfully
            complete intercourse?"
      (6) SEP 2 - "Were you able to achieve an erection sufficient to achieve
            penetration with your partner?"
      (7) Data were extrapolated from Feldman HA, Goldstein I, Hatzichistou DG,
            Krane RJ. Impotence and its Medical and Psychosocial Correlates:
            Results of the Massachusetts Male Aging Study, Journal of Urology.
            Vol 151, 54-61, January 1994 and World Population Projection Program
            of United Nations (2002 Revisions) with indirect standardization.
      (8) Shabsigh R (2002). Back to Great Sex: Overcome ED and Reclaim Lost
            Intimacy. New York: Kensington.
      (9) Diseases and Conditions: Impotence,
            http://www.impotence.org/FAQ/index.asp . Data accessed 11.20.03
      (10) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.@@end@@

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Jane Calloway of Lilly, +1-317-651-5870; or Lacy Fitzpatrick of ICOS,
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