Bayer Schering Pharma Presents Innovations in Men's Healthcare at the 22nd Annual Meeting of the European Association of Urology (EAU)

BERLIN, Germany, March 22, 2007 – Bayer Schering Pharma AG, Germany, highlighted their expanded new offerings in Men’s Healthcare during a press conference held at the 22nd Annual Meeting of the European Association of Urology (EAU) on March 22, 2007. The event focused on study results from their three products: Levitra®, Testogel® and Nebido®.

The Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy (REPEAT) study (1) has been designed to help researchers determine why over 50% of couples experiencing sexual problems discontinue treatment. This three year, innovative post marketing surveillance (PMS) study will follow men treated with Levitra® and their female partners in over 20 countries for 12 months. Understanding the couple’s attitude, perception and behaviour during treatment are crucial to good outcomes in PDE-5 therapy such as Levitra®.

Bayer Schering Pharma will use results from REPEAT as a part of their award-winning patient education programmes to help couples continue on treatment. This study is a further example of Bayer Schering’s commitment to ensure that Levitra® helps couples around the world; and follows on from the world-wide release of the very positive results of the Real-Life Safety and Efficacy of Vardenafil (REALISE) study (2). The REALISE study, the largest study of erectile dysfunction (ED) in the world, a PMS study covering 50 countries, 30,000 investigators and over 100,000 patients showed Levitra® to be efficacious and safe when used in the real-world.

“The results obtained from REPEAT will be extremely useful in understanding the interaction between patient, partner and physician when seeking treatment for erectile problems and what can be done to assist men and their partners to achieve optimal results. More importantly, it will help us to establish why some men discontinue treatment even though they continue to suffer from ED. ED can have a huge impact on a relationship and exploring these issues will help healthcare professionals to assist their patients to choose the best treatment” said Hermann Van Ahlen, MD, Professor of Urology, University of Muenster, Germany.

Levitra® is a proven ED treatment to help men and their partners. The COUPLES study (3), also released today at the EAU, compares patient and partner satisfaction with Levitra® as measured by the TSS (Treatment Satisfaction Scale) by exploring pooled results of three multi-centre 12-week randomised, double-blind, placebo-controlled studies of flexible-dose vardenafil versus placebo. Couples agree that Levitra® provided significantly greater satisfaction versus placebo and that satisfaction is achieved by not only to the man, but also to his partner.

The Levitra® CONFIRMED study was undertaken to compare the efficacy and safety of vardenafil (Levitra®) to that of sildenafil (Viagra®) when used on demand in a population of men with ED. The CONFIRMED study demonstrates the non-inferiority of Levitra® in comparison to Viagra® for overall preference and nominal statistical superiority of Levitra® to Viagra® for several frequently used efficacy variables. The results in a total of 1057 men who were randomised to treatment, showed that 38.9% of men expressed an overall preference for Levitra® over Viagra® (34.5%) and 26.6% of patients had no treatment preference. The difference found was not statistically significant. Regarding secondary measures, Levitra® achieved better response for men responding to the Sexual Encounter Profile questions 2 and 3; 83.9% of men taking Levitra® responded positively to SEP2 (p=0.0389) compared with 82.28% for Viagra® and 74.4% of men preferred Levitra® in response to SEP3 (p=0.0038) against 71.6% for Viagra®. 4

The CONFIRMED study avoided biases seen in other comparative trials by consciously creating an unbiased methodology that included 13 separate criteria. Beyond the randomised, double-blind, cross-over design, this trial additionally used equivalent drug doses, randomised the treatment sequence, used a neutral consent form, assessed preference after each treatment period and, importantly, did not eliminate previous non-responders or only include naïve patients.(4)

Levitra® may also be safe and effective in lessening the symptoms of bothersome lower urinary tract age related symptoms such as urgency and frequent urination. An in-vivo study released at the EAU, shows that Levitra® induced significant relaxation of the lower urinary tract tissues, inhibiting the proliferation of human prostate stroma cells and reducing the irritating symptoms of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) (5). The study investigators concluded that Levitra® could be developed to be used as an effective treatment of BPH/LUTS.

For many men, testosterone levels decline naturally as they age. This effect goes unnoticed and is often regarded as a natural phenomenon of aging. However, low testosterone levels can have a serious effect on the quality of life of men and is commonly associated with a decrease in libido, lean body mass and bone density and an increase in visceral fat as well as disturbances in well-being and mood. Eight centres in Austria, Finland, Germany, Ireland, Spain, Sweden and UK recruited 365 patients with decreased testosterone levels and hypogonadal symptoms in this multi-centre, placebo controlled, double-blind, randomised study(6). This study found that treatment with Testogel®, a transdermal 1% hydroalcoholic gel restored testosterone levels in hypogonadal men to normal range. Testogel® treatment had a statistical significant effect on lean body mass versus placebo. Body composition was also favourably influenced by Testogel® treatment compared to placebo.

Nebido®, an intramuscular depot formulation of testosterone undecanoate, can provide safe and effective drug treatment with high satisfaction for men. An open label prospective, one arm study in 16 centres in Germany included 96 hypogonadal patients, with a mean age of 48.6 years. The men received 6 injections of Nebido® over a period of 63 weeks. The results showed that Nebido® not only improved the lipid pattern (reduction of total cholesterol and LDL cholesterol) as well as glycaemia control (levels of blood sugar) but also improved psychological, somatic, and sexual symptoms of testosterone deficiency. There were no clinically relevant side effects and 92.5% of patients assessed treatment with Nebido® as satisfying.(7)

Abstracts and further information about all of the studies will be available on the Levitra® World of Flame press centre. For a copy of the materials, please visit www.world-of-flame.info/en/press.

About Erectile Dysfunction
Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance.(8) It is estimated that some degree of ED affects about half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED.(9) The number of men with ED is expected to more than double to 322 million by 2025.(10) Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated.(11)

References
1. Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy (REPEAT) Post Marketing Surveillance Study, Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
2. NN, Kathrin Stauch, Herald Landen et al. Real-Life Safety and Efficacy of Vardenafil (REALISE), Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
3. R.C Rosen, W.A Fisher, et al. Couples’ agreement concerning erectile dysfunction is greater with vardenafil than placebo, Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
4. H. Porst, E. Rubio-Aurioles, I. Eardley, et al. Vardenafil versus Sildenafil in men with erectile dysfunction and cardiovascular risk factors: a subgroup analysis, Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
5. P. Sandner, H. Tinel, B. Stelte-Ludwig, et al. Vardenafil Reduces Prostate Hyperplasia and Improves Lower Urinary Tract Symptoms in Rat, Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
6. Pierre-Marc Bouloux for the European Testogel Study Group: Late Onset Hypogonadism in the Aging Male: New Results after 6 Months Treatment with Testosterone Gel (Testogel), Symposium presentation at the 22nd Annual European Association of Urology (EAU), 2007
7. H. M. Behre, J. Elliesen: Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations, Abstract Presented at the 22nd Annual European Association of Urology (EAU), 2007
8. A. Jardin, G. Wagner, S. Khory et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-sponsored by the World Health Organisation (WHO), International Consultation on Urological Diseases (ICUD) and Societé Internationale D’Urologie (SIU). p.713
9. R. C Rosen, W. A Fisher, I. Eardley, C. Neiderberger, A. Nada, M. Sand: The Multinational Men’s Attitudes to Life Events and Sexuality (MALES) Study I, Prevalence of Erectile Dysfunction and Related Health Concerns in the General Population. Cur Med Res Op.
10. I. A Aytac, J. B McKinlay, R. J Krane: The likely world increase in erectile dysfunction between 1995 and 2065 and some possible policy consequences. BJU International 1999; 84:50-56
11. J. Southgate: New rivals to Viagra expand the market. Scrip World Pharmaceutical News, 2002


Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.


Forward-looking statements
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 Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact
Name: Oliver Renner 
Address: Bayer Schering Pharma AG
Germany-13342 Berlin
 
Telephone: +49 30 468 12431
E-Mail: oliver.renner@schering.de

Posted: March 2007


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