Rapid Uptake of LEVITRA(R) (vardenafil HCl) Seen Among U.S. Men with Erectile Dysfunction WEST HAVEN, Conn., and PHILADELPHIA, Nov. 21 /PRNewswire-FirstCall/ -- LEVITRA(R) (vardenafil HCl) (pronounced luh-VEE-tra) is rapidly capturing a growing percentage of new prescriptions in the oral erectile dysfunction (ED) treatment market, according to data from Verispan Source Prescription Audit (SPA) [formerly called Scott Levin]. In the weeks since Levitra became available in the U.S., more than 1.5 million Levitra pills have been dispensed nationwide.(1) Levitra is co-developed and co-promoted by Bayer AG (DAX and NYSE: BAY) and GlaxoSmithKline plc (LSE and NYSE: GSK). Recent results from two independent, comparative European studies conducted to evaluate patient preference for the three oral ED treatment options indicated that Levitra was preferred over Viagra(R)+ (sildenafil citrate) and Cialis(R) (tadalafil).* In a preliminary analysis, study investigator Frank Sommer, M.D., Ph.D., reported that more men chose Levitra as their preferred option (47 percent) compared with Viagra (34 percent) or Cialis (19 percent) at the recommended starting dose.(2) Levitra also was found to be the preferred option at the maximum dose (43 percent compared with 40 percent for Cialis and 17 percent for Viagra).(2) "Even though Levitra has been on the market for just a few months, there has been a tremendous amount of excitement among my patients. Many have specifically asked if Levitra is right for them," said Randall B. Meacham, M.D., associate professor and chief, Division of Urology, University of Colorado School of Medicine. "The fact that it has a rapid onset of action and provides a quality erection has a lot of men with ED asking for Levitra." The broad awareness of ED as a common health condition and Levitra as a new treatment option has been due, in part, to the extensive reach and frequency that the first pharmaceutical sponsorship of the National Football League (NFL) has provided. Never before has the League and its sponsors embarked on such a comprehensive campaign focusing on men's health. Football is the most watched sport among men in the target audience. Each week, 120 million fans tune in to NFL games on television providing Bayer and GSK with a unique opportunity to reach them with important messages about men's health. The national men's health education campaign, "Tackling Men's Health," is addressing critical health issues impacting millions of men. "Tackling Men's Health" features a brochure called the Tackling Men's Health Playbook, which covers a range of critical health issues. The Playbook can be ordered through a toll-free phone number (1-866-NFLHealth) or by logging on to http://www.tacklingmenshealth.com/. Unmet Needs in the ED Marketplace ED - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance(3) -- 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 40(4) -- 152 million men worldwide(5) and 30 million men in the United States alone.(6) Despite the high prevalence of sexual problems, nine out of 10 men in the U.S. have not yet sought treatment from a physician.(7) About Levitra Bayer and GSK evaluated Levitra in an extensive clinical trial program that included more than 50 trials involving more than 5,700 men. Results from phase III clinical studies showed that Levitra: * Helped men get and keep an erection sufficient for satisfactory sexual performance * Provided first-time success and reliable improvement of erection quality for many men(8,9) * Worked in men of various ages and race and in those with co-existing medical conditions, such as diabetes, and in men who have had their prostate removed * Demonstrated a rapid response, allowing a man to initiate or respond to sexual stimulation when the time is right(10) * Can be taken without regard to meals making it convenient for use Bayer and GlaxoSmithKline signed a worldwide co-promotion and co- development agreement for Levitra in November 2001. To date, Levitra has received regulatory approval for the treatment of ED in more than 50 countries. Levitra was approved by the U.S. Food and Drug Administration for the treatment of ED on August 19, 2003, providing men with their first new ED treatment choice in five years. For most patients, Levitra is a medicine that may be used once a day to treat ED. Levitra is for use by prescription only. Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take Levitra. Men who use alpha blockers, sometimes prescribed for high blood pressure or prostate symptoms, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. The most commonly reported side effects are headache, flushing and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention. For more information about Levitra, please visit http://www.levitra.com/. 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 healthcare and medical products industry. Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics 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 U.S. 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. Data from Verispan Source Prescription Audit (SPA) [formerly called Scott Levin]. 2. Sommer F, Mathers M, van Ahlen, et al. Which PDE5-inhibitor do patients prefer? A comparative randomized multicenter study of sildenafil, tadalafil and vardenafil. Presented at the 6th Congress of the European Society of Sexual Medicine, Istanbul, Turkey, November 2003. 3. 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. 4. 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. 5. 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. 6. 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). 7. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544. 8. Valiquette L, Hellstrom W, Gittelman M, et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 24, 2002, Montreal, Quebec, Canada. 9. Saenz de Tejada I, Glina S, Becher E, Ulbrich E, Vardenafil Study Group. Vardenafil exhibits long-term efficacy and safety for up to 52 weeks. Presented at the V Congress of the European Society for Sexual and Impotence Research (ESSIR), December 3, 2002, in Hamburg, Germany. 10. Padma-Nathan H, Kaufman J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. Presented at a satellite symposium at the 2003 Annual Meeting of the American Urological Association, April 25, 2003, Chicago. + Viagra (sildenafil citrate) is a registered trademark of Pfizer Inc. * Cialis(R) (tadalafil) is a registered trademark of Lilly ICOS LLC. DATASOURCE: GlaxoSmithKline plc; Bayer Pharmaceuticals Corporation CONTACT: Lara Crissey, +1-203-812-6558, for Bayer Pharmaceuticals Corporation; Danielle Halstrom, +1-919-483-2839, for GlaxoSmithKline; Melissa Luke, +1-212-880-5238, Ogilvy Public Relations Worldwide Web site: http://www.levitra.com/

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