FOR IMMEDIATE RELEASE

Canadian-Led International Studies Show Men Treated with LevitraTM Report Reliable Improvement in Erectile Function Over Time and Improvements in Erection Quality Following Prostate Cancer Surgery

Canadian Lead Investigators Available for Interviews

MONTREAL, Quebec (September 23, 2002) - Findings from two clinical trials investigating the efficacy of LevitraTM (vardenafil HCI) will be presented at the 10th World Congress of the International Society for Sexual and Impotence Research (ISSIR) in Montreal. In Canada, the Therapeutic Products Directorate of Health Canada is presently reviewing LevitraTM for efficacy and safety, and market authorization has not yet been obtained.

STUDY SHOWS RELIABLE IMPROVEMENT IN ERECTILE FUNCTION OVER TIME

In the first study, men with erectile dysfunction (ED) who were taking the oral investigational drug LevitraTM reported consistently improved erectile function the first time they took the drug and subsequently thereafter. For the three months of the study involving more than 800 ED patients, LevitraTM was reported to consistently improve rates of successful penetration, intercourse success and overall satisfaction during the first and subsequent attempts.1

Investigators evaluated the ability of LevitraTM to provide reliable efficacy over time in a broad population of men with ED. They analyzed data from a phase III, randomized, double-blind study in which 805 men, including 100 Canadian men with ED and 11 Canadian trial sites, received LevitraTM 5, 10 or 20 mg or placebo for up to 26 weeks. The analysis showed that at a 20 mg dose:

  • On average men were successful in 74 per cent of their first attempts in penetrating their partner compared with 46 per cent of men taking placebo.
  • Of those men taking LevitraTM who were successful the first time, they continued to achieve successful penetration in 91 per cent of subsequent attempts.1

"Men want to be confident that the ED drug they are taking works the first time and time after time," said Dr. Luc Valiquette, Professor of Urology at the Hospital Saint-Luc du CHUM in Montreal, Quebec. "I've seen frustration in some of my patients because the current treatments do not consistently work, and their efficacy may diminish over time. This reinforces the need for new oral ED therapies that are effective, consistent and safe."

STUDY SHOWS IMPROVEMENT IN ERECTION QUALITY FOLLOWING PROSTATE CANCER SURGERY

In another study - the first of its kind to assess the effect of a phosphodiesterase (PDE-5) inhibitor on erectile function and depressive symptoms among men with ED resulting from prostate cancer surgery - men taking LevitraTM were more likely to report improved erections and fewer depressive symptoms than men taking placebo.2

In this phase III clinical trial, 440 men aged 44 to 77 years with ED following prostatectomy and who experienced ED for six months before entering the study, were randomly assigned to placebo or LevitraTM (at a dose of 10 or 20 mg) for 12 weeks. This study included 24 Canadian trial sites with 176 patients. After 12 weeks:

  • Up to 71 per cent of patients who had undergone a specific type of prostatectomy, known as bilateral nerve-sparing prostatectomy, reported statistically significant improvement in erections with LevitraTM 20 mg versus 12 per cent of men taking placebo.
  • A significant decrease in depressive symptoms was observed among a small subset of depressive prostatectomy patients taking LevitraTM 20 mg.

"Men who suffer from ED following prostatectomy are among the most difficult to treat because their ED is typically severe. The finding that LevitraTM significantly improved erectile function in our study-patients is important because more than two-thirds of these men had severe ED," said Dr. Gerald Brock, lead study investigator and Associate Professor, Department of Surgery, Division of Urology at St. Joseph's Health Centre in London, Ontario. He also added: "The finding that LevitraTM eased depressive symptoms in these men is very good news, because it means that LevitraTM helps improve quality of life in men who are often suffering both emotionally and physically from this condition."

In these studies, drug-related adverse events were reported as generally mild to moderate in intensity with the most frequent adverse events being headache, flushing and rhinitis.

ED - the persistent inability to attain and maintain an erection adequate to permit satisfactory sexual intercourse - 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 40.3 Worldwide, an estimated 152 million men4 and three to four million Canadian men5 suffer from ED.

LevitraTM, researched and discovered by Bayer, will be marketed by Bayer and GlaxoSmithKline (GSK) through a worldwide co-promotion and co-development agreement that the two companies signed in November 2001. Marketing Authorization Applications have been approved by regulatory authorities in several Latin American countries and have been submitted for regulatory review in all major regions worldwide, including Canada, the United States, Europe and Japan.

ABOUT BAYER

Bayer Inc. is the Canadian subsidiary of Bayer AG (Germany), an international research-based group with core businesses in health care, crop science, polymers and specialty chemicals. Headquartered in Toronto, Ontario, with a rubber manufacturing site in Sarnia, Ontario, and the new home office of Bayer CropScience established in Calgary, Alberta, Bayer Inc. employs approximately 2,100 people across Canada. For more information, please go to www.bayer.ca and/or www.bayerhealth.com.

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 employs approximately 1,800 people and is a top 25 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $6.5 million annually and is recognized as one of the 50 best companies to work for in Canada.

For more information, or to set up an interview with one of the lead Canadian investigators, please contact:

Edelman Public Relations Canada

Lisa Morlock/Bev Warford

Tel.: 416-979-1120, ext. 234/305

Bayer Healthcare

Lisa Milburn

Tel.: 416-240-5372

GlaxoSmithKline Inc.

Carlo Mastrangelo/Alison Steeves

905-819-7129/905-819-3452

References:

  1. Valiquette et al. Vardenafil provides reliable efficacy over time in men with erectile dysfunction. Poster to be presented at the 10th World Congress of the International Society for Sexual and Impotence Research, 24 September 2002, Montreal, Quebec, Canada.
  2. Brock G, Nehra A, Lipshultz L, et al. Influence of vardenafil on erectile dysfunction and depressive symptoms post radical prostatectomy. To be presented at the 10th World Congress of the International Society for Sexual and Impotence Research, September 24, 2002, Montreal, Quebec, Canada.
  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. The Canadian Male Sexual Health Council.

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