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February 26,  2002

Patients Reported Vardenafil Significantly Improved Erectile Function Following Radical Prostatectomy

First Study of its Kind of Treatment to Improve Erectile Function in Prostatectomy Patients

(SafetyAlerts) - In the first clinical study of its kind examining the use of drug therapy to improve erectile function in men who had undergone nerve-sparing radical prostatectomy (removal of the prostate gland), patients taking vardenafil reported statistically significant improvement in erectile function. Among men who had undergone bilateral nerve-sparing surgery, 71 percent of those taking vardenafil 20 mg experienced improved erections.

Vardenafil is an investigational treatment for erectile dysfunction (ED) discovered by Bayer AG and will be co-promoted and co-developed with GlaxoSmithKline plc (GSK). Vardenafil is being evaluated in a broad range of patient populations, including difficult-to-treat patients.

The new data, presented at the 17th Annual Congress of the European Association of Urology (EAU), are important because at least one third of men with prostate cancer who undergo nerve-sparing radical prostatectomy experience ED. Since 1991, radical prostatectomy has been the most common treatment for localized and regional cancers.(1) According to the American Cancer Society, 189,000 new cases of prostate cancer will be diagnosed this year.

"Men who have had a radical prostatectomy generally experience very severe ED, as was seen in this study population," said Gerald Brock, MD, Associate Professor, Department of Surgery, Division of Urology at St. Joseph's Health Care in London, Ontario, Canada. "The response rates seen in this study are impressive considering the severe level of ED."

First Study of its Kind Evaluating ED Drug Following Prostatectomy The multi-center, randomized, double-blind, placebo-controlled, fixed-dose prospective study was designed to evaluate the effect of vardenafil (a phosphodiesterase-5 [PDE-5] inhibitor) on erectile function as compared to placebo in men who had undergone either unilateral or bilateral nerve-sparing radical retropubic prostatectomy six months to five years prior to screening. The majority of men (70 percent) enrolled in the study presented with severe ED.

Following a four-week baseline period, 444 men were randomized to treatment with vardenafil 10 mg, vardenafil 20 mg or placebo for 12 weeks. Participants were evaluated using the erectile function (EF) domain of the International Index of Erectile Function (IIEF), a standard sexual function questionnaire used by urologists that includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse. Participants were also asked to track success in partner penetration and ability to maintain an erection in a patient diary. In addition, the global assessment question (GAQ) was used for those men completing the 12-week study to evaluate if patients experienced improved erections.

Positive Results Seen in Study Population

Patients at all ED severity levels -- mild, moderate, severe -- taking vardenafil 10 or 20 mg reported statistically significant improvement in erectile function. Results included:

-- Nearly half of men reported successful penetration compared to
only 22 percent in the placebo group (p<0.0001).
-- An almost four-fold increase in the ability to maintain an erection
was reported compared with the placebo group (p<0.0001).
-- Both doses of vardenafil were significantly superior to placebo
for the EF domain score.

For the 20mg group:

-- 65 percent reported improved erections compared to 13 percent in
the placebo group (p<0.0001).
-- Among the men with severe ED, a seven-fold improvement in
successful intercourse was reported.

The most commonly reported drug related adverse events were headache, flushing and nasal congestion.

ED and Vardenafil

Erectile dysfunction -- the inability to sustain an erection sufficient for sexual intercourse -- is a major medical condition among men that is largely untreated. There are a number of causes for ED, including prostatectomy, medical conditions, such as diabetes and cardiovascular disease, as well as psychological factors. Although ED affects an estimated 30 million men in the United States(2), research shows only 11 percent of men are being treated for the condition(3), demonstrating the clear need for additional therapies in this area.

Vardenafil is a PDE-5 inhibitor being researched and developed by Bayer. Its clinical development program to date has included eight phase III trials involving approximately 4,000 patients. In a published phase III study in a broad population, up to 85 percent of patients taking vardenafil reported statistically significant improvements in erectile function versus placebo.(4)

A new drug application for vardenafil was submitted in September 2001 and accepted for filing by the U. S. Food and Drug Administration (FDA). In November 2001, Bayer and GSK signed a worldwide co-promotion agreement for vardenafil. Vardenafil has been submitted for regulatory review for marketing approval in all major regions worldwide, including the United States, Europe and Japan.

Bayer Committed to Men's Health

Bayer is committed to improving men's health. Bayer Corporation already has established itself as a credible force in men's health with Cipro(R)* (ciprofloxacin HCl) to treat chronic bacterial prostatitis due to E. coli and P mirabilis. Bayer also is marketing Viadur(TM)**, the first and only, once- yearly, continuous testosterone suppression therapy to treat symptoms of advanced prostate cancer. Other men's health products include One-A-Day(R) Men's High Potency Multivitamin/Multimineral Supplement, One-A-Day(R) Prostate Health, and Bayer Immuno 1(TM) System Complexed Prostate Specific Antigen (cPSA) -- an assay used to measure prostate-specific antigen levels at the time of diagnosis and to monitor them over time.

Source: PRNewswire

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