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Levitra (Vardenafil HCl), Treatment Option For Erectile Dysfunction, To Launch In Europe This Month -- New Flexible-Dose Study Shows Significant Improvement in Erections Among Men Taking Levitra -- WEST HAVEN, CT AND PHILADELPHIA, PA -- March 13, 2003 -- Bayer Pharmaceuticals Corporation and GlaxoSmithKline announced today the European launch and availability of Levitra® (vardenafil HCl) in many European markets at the 18th Congress of the European Association of Urology (EAU) in Madrid. Levitra is the newest oral treatment for the improvement of erectile function (EF) in men with erectile dysfunction (ED). The announcement comes days after the two companies received marketing authorization for Levitra from the European Commission. In the United States, the Food and Drug Administration (FDA) issued an approvable letter for Levitra in July 2002. In addition, new data from a flexible-dose study of Levitra will be presented at EAU. Results showed that among men who stayed on the starting dose of Levitra 10 mg throughout the 12-week study, 92 percent reported improved erections based on the global assessment question (GAQ).1,2 "The launch of Levitra in Europe is a truly important milestone because there is a great unmet need in the treatment of ED," said Colin J. Foster, president and CEO, Bayer Pharmaceuticals Corporation. "Together with Bayer, we are committed to bringing Levitra to patients and physicians who seek new treatment options," said David Pernock, senior vice president, General Pharmaceutical Business Unit, GSK. Study Shows Erection Improvement with Levitra Regardless of Dose In the flexible-dose study of 309 men with ED, investigators evaluated the efficacy, safety and tolerability of Levitra in men taking different doses of the drug. Patients were randomized to a starting dose of Levitra 10 mg (n=155) or placebo (n=154). After four weeks of treatment, investigators could adjust the starting dose to 20 mg or 5 mg based on the efficacy and tolerability of the drug. Another opportunity to adjust dosing was provided after an additional four weeks. Key results included: · Among all men taking Levitra who completed the GAQ at 12 weeks, 86 percent (n=130) reported improved erections regardless of the dose taken throughout the 12-week study.1a In contrast, only 36 percent of men taking placebo (n=109) reported improved erections at week 12.1b · Among men who stayed on the starting dose of Levitra 10 mg throughout the 12-week study, 92 percent reported improved erections based on the GAQ.1 "In this study, improved erections reported with Levitra were consistently maintained throughout the study in men who stayed on the 10 mg starting dose. Further improvement was seen in those who adjusted the dose to 20 mg. This consistency is important because men want a reliable therapy for ED,3" said Craig Niederberger, M.D., chief of the Division of Andrology at the University of Illinois at Chicago and a Levitra investigator. "This study was conducted under 'real world' conditions in which Levitra dosing could be changed. This is very reflective of everyday situations in which men and their physicians are working together to find optimal, individualized treatment solutions." Adverse events were generally mild to moderate. The most commonly reported adverse events were headache, flushing, rhinitis and flu syndrome. ED and LEVITRA Erectile dysfunction (ED) - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance4 - is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 405 - 152 million men worldwide6 and 30 million men in the United States alone.7 Despite the high prevalence, nine out of 10 men in the U.S. experiencing a decrease in sexual function have not yet sought treatment from a physician.8 Levitra was approved on March 7, 2003, by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The U.S. Food and Drug Administration (FDA) issued an approvable letter for Levitra in July 2002. Bayer and GlaxoSmithKline signed a worldwide co-promotion and co-development agreement for Levitra in November 2001. About Bayer Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry. Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease. This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. About GSK GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are discussed under risk factors in the Company's Preliminary Announcement of Results for the Year Ended 31st December 2002. # # # REFERENCES: 1. Hatzichristou D, Montorsi F, Porst H, Buvat J, Taylor T. and Bandel T. A flexible dose regimen of vardenafil for erectile dysfunction: a placebo-controlled trial. To be presented at the XVIII Congress of the European Association of Urology, March 15, 2003, Madrid, Spain. 2. The GAQ is a standard question utilized in ED studies to assess improvement of erectile function over a four-week period. 3. Sand M. Men's attitudes on life events and sexuality (MALES) survey. Presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 26, 2002, Montreal, Quebec, Canada. 4. Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-Sponsored by the World Health Organization (WHO), International Consultation on Urological Diseases (ICUD) and Societe Internationale d'Urologie (SIU) and held July 1-3, 1999, Paris. 2000, p. 713 5. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61. 6. Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int. 1999;84:50-56. 7. National Institutes of Health, Consensus Development Conference Statement, December 7-9, 1992. Online data: http://odp.od.nih.gov/consensus/cons/091/091_statement.htm. (accessed 8/26/02). 8. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544. SOURCE: Bayer Pharmaceuticals Corporation and GlaxoSmithKline E-mail this page to a friend or colleague! To print, use this version