Large-Scale Study in the British Journal of Urology Shows More Than One Out of Three Women With Urinary Incontinence Suffer From Stress Urinary Incontinence Journal Also Reports Duloxetine Significantly Reduces the Frequency of SUI Episodes and ImprovesQuality of Life for Women Globally INDIANAPOLIS and INGELHEIM, Germany, Feb. 9 /PRNewswire/ -- Two separate studies appear now on the British Journal of Urology International Web site: one addressing the prevalence of stress urinary incontinence (SUI) and the other highlighting data on duloxetine, an investigational agent for this medical disorder currently under regulatory review. The first is a large cross-country prevalence survey showing that 35 percent of the 17,080 women analyzed reported having urinary incontinence (UI). Thirty-seven percent of these incontinent women reported having SUI, the most prevalent form of UI(1). The second study, a global Phase III clinical trial comparing duloxetine versus placebo in the treatment of SUI, shows that duloxetine significantly decreased incontinence episodes frequency (IEF) with comparable significant Incontinence Quality of Life (I-QOL) in those women studied who suffer from SUI(2). Both studies will be published in the February print edition of the British Journal of Urology International. Prevalence Survey: SUI Most Common Form of Urinary Incontinence Among Women The study gathered data using a postal survey to randomly selected women ages 18 years and older in France, Germany, Spain and the United Kingdom. The prevalence of UI by type found in this study shows that SUI was the most common type of UI overall. The findings also revealed that over one-third of all women surveyed reported having experienced UI. However, two-thirds of those affected had never consulted a health care professional for treatment. "Many misperceptions and social embarrassment surround SUI, making this common disorder one which unfortunately is coped with in silence. Low consultation rates signal there is a great need to raise awareness of this bothersome condition affecting millions of women worldwide," said Professor Steinar Hunskaar, Section for General Practice, Department of Public Health and Primary Health Care, University of Bergen, Norway. Global Duloxetine Phase III Study: Reduced Frequency of Episodes of SUI The global Phase III clinical trial results of duloxetine, conducted in 38 study centers, randomized 458 women ages 27 to 79 from seven countries: Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain. The results showed that patients treated with 80 mg of duloxetine experienced a median reduction of 54 percent in the frequency of incontinence episodes (IEF), a primary measure of efficacy, compared to a median reduction of 40 percent in the placebo group. This difference accounted to be both statistically and clinically significant with 59.5 percent of duloxetine- treated women experiencing a 50 to 100 percent decrease in their IEF(2). Only 43.2 percent of subjects in the placebo group experienced a decrease in their IEF(2). "The safety and efficacy data from this late-stage study provide evidence for the value of duloxetine as potentially the first drug that will be widely available to women suffering from stress urinary incontinence," said Dr. Richard J. Millard, Associate Professor of Urology, The Prince of Wales Hospital, Sydney, Australia, and lead investigator in the study. Duloxetine Treated Patients Showed Significant Improvements in Quality of Life Measurements in Clinical Trial Subjects in the duloxetine group also showed significant improvements in their I-QOL scores compared to those in the placebo group. The I-QOL is a targeted condition-specific questionnaire that assesses the impact and distress of symptoms of incontinence in women who suffer from this medical disorder. I-QOL evaluates the disorder in three relevant domains: avoidance and limiting behavior, social embarrassment, and psychosocial impact. Duloxetine's improvements in incontinence frequency episodes and quality of life in this study confirm those observed in two other recently completed phase III trials in Europe and North America(2). Safety and Efficacy Profile In the study, the side effect profile of duloxetine was consistent with that seen with other drugs that have an impact on serotonin and norepinephrine. The most commonly reported adverse event (incidence of greater than or equal to 10.0 percent and at least twice placebo) was nausea, although it was usually mild to moderate and resolved within one week to one month in most patients participating in the trial. Other common adverse events included headache, insomnia, constipation, dry mouth, dizziness and fatigue(2), which tended to be non-progressive and mild to moderate in almost all subjects. About duloxetine Duloxetine is a balanced potent dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine based on pre-clinical studies. Duloxetine is believed to affect SUI by blocking the reuptake of serotonin and norepinephrine in the spinal cord, and the increase in the neurotransmitters in turn stimulates increased activity of the nerve that stimulates the urethral sphincter. This stimulation is believed to increasecontraction of the urethral sphincter at the opening of the bladder, thereby helping prevent accidental urine leakage with physical activity. The U.S. Food and Drug Administration recently issued an approvable letter for duloxetine for SUI. About Stress Urinary Incontinence SUI, with nearly twice the prevalence as urge incontinence, is the most common form of urinary incontinence among women. In the United States alone it affects approximately 30 million women over the age of 18(i). Although common, SUI is a medical condition that is not normal at any age, but unfortunately many women do not seek treatment because they are embarrassed, fear surgery, or believe it is a normal part of aging and that nothing can be done about it. Primary causes of SUI are nerve damage, muscle damage or weakness, and damage to the support of the bladder and urethra. Risk factors include childbirth, obesity, chronic coughing and constipation. About Eli Lilly and Boehringer Ingelheim In November 2002, Eli Lillyand Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the USA, the collaboration focuses on SUI. Eli Lilly and Company 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 on http://www.lilly.com/ . Boehringer Ingelheim Pharmaceuticals, Inc. Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largestU.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. The Boehringer Ingelheim group of companies ranks among the 20 leading pharmaceutical corporations in the world. Headquartered in Ingelheim, Germany, it operates globally with 156 affiliates in 44 countries and a total of about 32,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2002, Boehringer Ingelheim posted net sales of $7.2 billion (7.6 billion euro) while spending about one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information on Boehringer Ingelheim, please see the international Internet website http://www.boehringer-ingelheim.com/ . (1) Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence in women in four European countries. British Journal of Urology International. 2004 Feb: 324-330: http://www.blackwell-/ synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b ju&volume=93&issue=2&year=2004&part=null (2) Millard M J, Moore K, Rencken R, Yalcin I, Bump R C. Duloxetine vs. placebo in the treatment of stress urinary incontinence: A four continent randomized clinical trial. British Journal of Urology International, 2004 Feb: 311-318 http://www.blackwell-/ synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b ju&volume=93&issue=2&year=2004&part=null (3) Abrams P, Cardozo L, Fall M, Griffiths, D, Rosier P, Ulmsten U, et al. The standardization of terminology of lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Neurourol Urodyn, 2002;21(2):167-178 (4) Viktrup L, Female stress and urge incontinence in family practice: insight into the lower urinary tract, International Journal of Clinical Practice, 2002 Nov;56 (9)694-700 (5) Bymaster F.P, Dreshfield-Ahmad L.J, Threlkeld P.G, et al. Comparative Affinity of Duloxetine and Venlafaxine for Serotonin and Norepinephrine Transporters in vitro and in vivo, Human Serotonin Receptor Subtypes, and Other Neuronal Receptors. Neuropsychopharmacology, 2001: 25(6):871-880 (i) Estimated that 29.5 million women have SUI in pure or mixed forms, based on 2000 US census bureau figures and incontinence prevalence rate of 35% as cited in Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff. Definition of overactive bladder and epidemiology of urinary incontinence. Urol 1997:50(S6A):4-14 This press release contains forward-looking statements about the potential of duloxetine for the treatmentof stress urinary incontinence and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and/regulatory review. There is no guarantee that the product will receive regulatory approvals and any indication for which it is approved will be determined at the discretion of the Food and Drug Administration. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO ) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO DATASOURCE: Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc. CONTACT: Tammy Hull of Lilly, +1-317-651-9116, ; or Pam DeMala of Boehringer Ingelheim, +1-203-798-4700,

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