Refill Rates Underscore Long-Term Potential for LEVITRA(R) (vardenafil HCl) Success - Data Show Prescription Refill Rate for Levitra Nearly Triple That for Cialis(R) (tadalafil) - WEST HAVEN, Conn., and PHILADELPHIA, March 25 /PRNewswire-FirstCall/ -- Bayer AG (DAX and NYSE: BAY) and GlaxoSmithKline plc (LSE and NYSE: GSK) today announced data showing that the refill rate for LEVITRA(R) (vardenafil HCl), their erectile dysfunction (ED) drug, is three times higher than that for Cialis(R) (tadalafil), the most recent entry in the ED market. For the month of February, refill rates were 61 percent for Levitra compared to 22 percent for Cialis, according to the IMS National Prescription Audit.(1) In a recent patient survey, 94 percent of the 240 surveyed patients taking Levitra reported positive levels of satisfaction.(2) For these patients, satisfaction with Levitra was generally attributed to efficacy, side effect profile, firmness of erection, and that it works quickly.(2) "In the fierce battle between oral ED therapies, a brand's ability to retain patients is a linchpin for sustained market growth," said Colin J. Foster, president and CEO, Bayer Pharmaceuticals Corporation and Region Head North America. "Typically, men who are satisfied with the treatment will refill their prescription, building a strong customer base." Survey Information A national survey of patients was conducted in December 2003 by Verispan on behalf of Bayer and GSK to determine the current level of satisfaction among men with ED who had taken Levitra more than three times. Patients (n=240) were recruited through patient flyers posted in their physician's offices. The men were asked about their satisfaction levels with Levitra. ED and Levitra 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) 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 63 countries. Levitra was approved by the U.S. Food and Drug Administration for the treatment of ED on August 19, 2003, providing American men with their first new ED treatment choice in five years. Levitra is a prescription medicine that is used to treat erectile dysfunction (ED). Men taking nitratedrugs, 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 problems, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. You should not take Levitra if your doctor determines that sexual activity poses a health risk for you. Men who experience an erection for more than four hours should seek immediate medical attention. Levitra doesnot protect against sexually transmitted diseases. The starting dose of Levitra is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking certain medications such as ritonavir, indinavir, ketoconazole, itraconazole, and erythromycin, lower doses of Levitra are recommended, and time between doses of Levitra may need to be extended. In clinical trials, the most commonly reported side effects are headache, flushing, and stuffy or runny nose.Levitra is available in 2.5 mg, 5 mg, 10 mg and 20 mg tablets. Individual patient results may vary. 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 Resultsfor the Year Ended 31st December 2002. REFERENCES 1. Data from IMS National Prescription Monthly Audit, March 12, 2004 2. Data from Verispan Patient Satisfaction Study, December 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 heldJuly 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. DATASOURCE: Bayer AG; GlaxoSmithKline plc CONTACT: Lara Crissey of Bayer Pharmaceuticals Corporation, +1-203-812-6558; or Melissa Luke of Ogilvy Public Relations Worldwide, +1-212-880-5238

Copyright