Giant German pharma set to launch newest anti-"ED" preparation

Leverkusen, Germany - First Pivotal Phase III data for vardenafil, Bayer’s new, highly selective phosphodiesterase-5 inhibitor for erectile dysfunction (ED), show statistically significant improvements in erectile function and consistency in response among up to 85 percent of the broad population of men treated. The data was presented last December at the Annual Meeting of the Sexual Medicine Society of North America (SMSNA) in Charleston, South Carolina/USA.

"The Phase III Pivotal data show vardenafil works across the spectrum - consistently achieving highly positive results across a broad range of men with erectile dysfunction, regardless of the cause or severity of the condition," said Wayne J.G. Hellstom, M.D., chief specialist in the treatment of erectile dysfunction and fertility at Tulane University School of Medicine, New Orleans, and lead investigator of the study.

Wide range of improvements in the general population

The study involved 736 men with varied severities (mild to severe) and causes (organic to psychogenic) of ED. Organic causes include such co-morbid conditions as hypertension, diabetes, and enlarged prostate (non-cancerous).

Study results showed improved erections in 85 percent of men treated with 20 mg of vardenafil, compared to improvements in 28 percent of those taking placebo. In this study, the broad population also showed significant improvement with vardenafil over placebo in the frequency at which they were able to attain an erection strong enough for penetration and how often they were able to maintain their erection during intercourse - both key measures of the International Index of Erectile Function (IIEF).

The impact beyond efficacy

In a second study, also presented by Dr. Goldstein, patients at the 20 and 10 mg dose reported improved satisfaction in their sexual life. Patients also reported statistically significant improvements (over placebo) in satisfaction with their relationships and their lives as a whole. The studies found vardenafil was well tolerated, with side effects that were mild to moderate, and transient in nature.

"Vardenafil represents one of the most important products in the Bayer pipeline. Both physicians and patients are telling us they look forward to having more options available to treat ED," said David R. Ebsworth, Ph.D., president and general manager, Business Group Pharma, Bayer AG.

The new substance is a highly selective phosphodiesterase-5 inhibitor being developed by Bayer. The company submitted vardenafil for regulatory approval in the United States and Mexico in September 2001, and filed for approval in Canada, South Africa, and Japan shortly thereafter. The company expects to gain its first marketing approval for vardenafil in the second half of 2002. Bayer and GlaxoSmithKline plc (GSK) recently announced that they have signed a worldwide co-promotion agreement for vardenafil - excluding Japan. The drug will be marketed under the brand name NUVIVA.

More than half men over age 40 experience some loss of erectile function. Men with diabetes are three times more likely to have ED than other men because of complications related to their condition, and have been shown to be less responsive to available ED therapies. Prevalence of ED in men with diabetes over the age of 50 is reported to be as high as 50 to 60 percent.