FOR IMMEDIATE RELEASE
Bayer and GlaxoSmithKline Announce "LevitraTM" as Global Trade Name for New Investigational Erectile Dysfunction Treatment
MONTREAL, Quebec (September 23, 2002) -- Bayer and GlaxoSmithKline (GSK) today announced that following regulatory approval, they will market vardenafil, an investigational treatment for erectile dysfunction (ED), under the global trade name LevitraTM (vardenafil HCI). 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.
LevitraTM, researched and developed by Bayer, will be marketed by Bayer and 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.
"Bayer and GSK are fully committed to developing and marketing LevitraTM for this significantly undertreated condition," said Dr. Oana Petrenciuc, Director Clinical Product Development, Bayer Healthcare. "We look forward to offering Canadian physicians a product that will help their patients who experience erectile dysfunction."
The LevitraTM clinical development program to date has involved approximately 4,000 patients and included eight phase III trials. Data from a published pivotal phase III study demonstrated that in a broad patient population of 805 men, up to 85 per cent of patients taking LevitraTM reported improved erections, which was significantly different from 28 per cent in the placebo group.1 In this phase III study, drug-related adverse events were reported as generally mild to moderate in intensity with the most frequent adverse events being headache, rhinitis, flushing and dyspepsia.
It is estimated that ED - the reduced ability to attain and/or maintain an erection sufficient for sexual intercourse - affects more than half of all men over 40 years of age.2 While it is estimated that 152 million men worldwide,3 including three to four million Canadian men4 are affected by ED, only one in 20 receives medical treatment.
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:
- Hellstrom W et al: Int J Imp Res 2001: 13 Suppl 5: S65.
- 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.
- 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.
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