FOR IMMEDIATE RELEASE

Newly-approved LevitraTM Provides A Satisfying Sexual Experience

The Erectile Dysfunction Market "Heats Up"

Toronto, Ontario (March 22, 2004) -- They say the third time is the charm and that's just the case with the approval and availability of LevitraTM, the newest oral prescription medication approved by Health Canada for the treatment of erectile dysfunction (ED). In clinical trials, Levitra has been shown to work the first time in the majority of men and reliably thereafter1 and to provide sexual satisfaction to men suffering from ED.2 Co-developed and co-promoted by Bayer HealthCare (Bayer) and GlaxoSmithKline Inc. (GSK), Levitra offers a rapid 2 and reliable1 new ED treatment option. In the United States alone, more than half a million prescriptions have already been filled for Levitra since its approval in August 2003. Levitra is now approved in 69 countries including Canada. Levitra is now available.

There is an unmet medical need for a new ED treatment option. Although ED affects more than one half of men over the age of 40,3 152 million men worldwide4 and three-to-four million Canadian men,5,6,7 only 12 per cent of men worldwide have received treatment.8

"When I treat men for erection difficulties, what they really want is to return to the way they were. They want to be spontaneous and they want to rely on their bodies," said Dr. Stacy Elliott, Sexual Medicine Physician and Clinical Professor, Departments of Psychiatry and Urology, Faculty of Medicine, University of British Columbia. "I have found that Levitra re-establishes feelings of confidence and intimacy allowing men to reconnect with their partners."

As a man experiencing ED, Trevor participated in a clinical trial for Levitra. "I was looking for a medication that would restore my confidence," said Trevor from London, Ontario. "I was able to regain my self-esteem. I strongly recommend that any male who has any of the symptoms of ED visit his doctor, have an open and frank discussion and get treatment."

A treatment preference study recently showed that in terms of overall preference, most men rated Levitra as the preferred option (47 per cent) 9 over all other ED medications.

According to Trevor's partner, Alice, Levitra also improves the sexual experience of the partner. "Trevor and I were a very, very lusty couple back in the early stages of our relationship before Trevor needed Levitra," said Alice. "Levitra has allowed us to regain the romance and intimacy, and has truly helped us reconnect as a couple.

"We are very pleased to bring Levitra to Canadians," said Philip Blake, President and CEO, Bayer Inc. "We know that physicians and patients are looking for an effective new treatment option for erectile dysfunction, and we believe that Levitra will meet the needs of men across Canada."

Advertisement

To support the launch of Levitra, a national television brand advertisement has been created. Building on the melody from a popular 70s television show, the Levitra advertisement will reach out to men between 50 and 65 years of age to inform them of the new product. The Levitra 30-second television advertisement will begin to air across the country. In addition, Levitra billboards will begin appearing in high-profile locations in Toronto, Montreal, Calgary, Edmonton and Vancouver.

"Both Bayer Healthcare and GlaxoSmithKline are committed to the well-being of Canadians," said Paul Lucas, President and CEO, GlaxoSmithKline Inc. "We believe that our new advertising campaign will help increase the awareness of this important new therapy option for Canadian men."

The Clinical Trials

Bayer and GSK have evaluated Levitra in an extensive clinical trial program that included more than 7,000 men of varying ages (18-89 years).10

In a double-blind, placebo-controlled clinical trial conducted in North America in more than 800 men with ED, a majority of men (61 per cent) were able to successfully complete intercourse the first time they used Levitra 20 mg, and they experienced an 85 per cent success rate in subsequent attempts.1

In the same study, the ability of Levitra to provide reliable efficacy over time was examined. The results show that for "successful intercourse (SEP 3)" the first attempt success rate to subsequent success rates up to 12 weeks were 61 per cent to 85 per cent and 29 per cent to 57 per cent for 20 mg Levitra and placebo, respectively. At the end of the one year treatment period, the incidence of successful intercourse was 82 per cent in the 10 mg Levitra group and 86 per cent in the 20 mg Levitra group.10

In a placebo-controlled clinical trial, in patients with ED, erections considered sufficient for penetration (greater than or equal to 60 per cent rigidity as measured by RigiScan® device) occurred in 64 per cent of men on 20 mg Levitra as rapidly as 15 minutes post-dosing compared to 52 per cent of men on placebo.10

Data also showed Levitra was an effective first-line therapy in a broad range of men, regardless of the patient's age or duration of ED. Levitra also was effective in those patients considered difficult to treat, such as men with diabetes, and those who have had a prostatectomy due to prostate cancer.11,12,13,14,15,16,17,18

"With the approval of Levitra, physicians can offer men a new treatment option that has been shown to be very selective, potent and highly effective in treating ED in a broad range of patients," said Dr. Gerald Brock, Associate Professor, Department of Urology, St. Joseph's Health Care London.

About Levitra

Levitra was also proven to be generally safe and well-tolerated, is highly selective for PDE-5 inhibition (according to in vitro studies), and has shown significant improvements in intercourse satisfaction, orgasmic function and overall sexual experience in men taking 10 mg or 20 mg of Levitra compared with men taking placebo.10

Levitra is a medicine that may be used up to 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. Concomitant use of Levitra with ritonavir, indinavir, ketoconazole, and itraconazole, is contraindicated.10Men 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 headaches, flushing, and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention.10

About Bayer HealthCare AG

Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 9,4 billion Euro in 2002, is one of the world's leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve 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 Glaxosmithkline

GlaxoSmithKline Inc. - 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. In Canada, GlaxoSmithKline is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also among the top 10 corporate charitable donors and is recognized as one of the 50 best companies to work for in Canada.

T LEVITRA is a trademark of Bayer AG used under license.

® RigiScan device (RigiScan Ambulatory Rigidity and Tumescence Monitor, Dacomed Corp., Minneapolis, USA).

For more information please contact:

Lisa Morlock/Sandra Da Silva Lisa Milburn/Lori Ann Horrigan

Edelman Bayer Healthcare

Tel.: 416-979-1120, ext. 234/272 Tel.: 416-248-0771, ext. 5372/5466

Daphne Weatherby/Sylvie Lafrance

Edelman (Quebec)

Tel.: 514-844-6665, ext. 225/244

Alison Steeves / Catherine Jackson

GlaxoSmithKline Inc.

905-819-3363

Marie-Christine Beauchemin

GlaxoSmithKline Inc. (Quebec)

Tel.: 514-956-3121

References:

  1. Valiquette L, Hellstrom W, Gittelman M et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Int J Impot Res 2002; 14(suppl 3): S88.
  2. Padma-Nathan H, Kaufman J and Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. J Androl 2003; 24 (2) Annual Mtg Supplement: 48.
  3. 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.
  4. Aytac IA, McKinlay JB, Krane RJ The likely worldwide increase in erectile dysfunction between 1995 and 2065 and some possible policy consequences. BJU International 1999; 84:50-56.
  5. Barkin J, Carrier S, Gajewski J, Brock G. Erectile function and male sexual satisfaction: A national survey. J Sex Reprod Med 2003; 3:10B-14B.
  6. Brock G, Carrier S, Gajewski J, Barkin J. Erectile dysfunction and the primary care physician's perspective: A comparison with the patient's perceptions. J Sex Reprod Med 2003; 3:19B-22B.
  7. Gajewski J, Carrier S, Brock G, Barkin J. Erectile dysfunction and the female partner's perspective: A comparison with the man's perceptions. J Sex Reprod Med 2003; 3:15B-18B.
  8. Chew KK, et al. Erectile dysfunction in general medicine practice: prevalence and clinical correlates. Int J Impot Res 2000; 12:41-45.
  9. Sommer F, Mathers M, Klotz T, et al. Which PDE-5 inhibitor do patients prefer? A comparative randomised multicenter study of sildenafil, tadalafil and vardenafil. Presented at the 6th Congress of the European Society of Sexual Medicine in Istanbul, Turkey in November 2003.
  10. LevitraTM Product Monograph.
  11. Hatzichristou D, Montorsi F, Porst H, Buvat J, Taylor T, Bandel T. A flexible dose regimen of vardenafil for erectile dysfunction: a placebo-controlled trial. Eur. Urol 2003; Suppl 2: 176.
  12. Stief C, Porst H, Saenz de Tejada I, Ulbrich E. Sustained efficacy and tolerability of vardenafil over two years in men with erectile dysfunction. Progrès en Urologie 2003; 13 (Suppl 2): 31.
  13. Goldfischer E, Eardley I and Segerson T. Vardenafil improves erectile function in men with significant comorbidities associated with erectile dysfunction (ED). J Urol 2002; 167 (Supplement): 178.
  14. Porst H, Young J, Schmidt AC, Buvat J, and the International Vardenafil Study Group. Efficacy and tolerability of vardenafil for the treatment of erectile dysfunction in patient subgroups. Urology 2003; 62:519-524.
  15. Donatucci C, Eardley I, McVary KT and Thibonnier M. Vardenafil improves erectile function regardless of etiology or baseline severity in men with erectile dysfunction. J Urol 2002; 167 (Supplement): 178.
  16. Donatucci C, Karlin G, Goldfischer E, Cohen S and Thibonnier M. Influence of age on the efficacy and safety of vardenafil, a novel phosphodiesterase-5 inhibitor, for the treatment of erectile dysfunction. J Amer Ger Soc 2002; 50 (4 Suppl): S107.
  17. Goldstein I, Young J, Fischer J, et al. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes. Diabetes Care 2003; 26(3):777-783.
  18. Brock G, Nehra A, Lipshultz L, et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003; 170: 1278-1283.
^ Back to top