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Monday September 06, 2010

Berlin, Germany, September 6, 2010 - The European Commission has approved a new formulation of Levitra® (vardenafil HCI). Levitra 10mg orodispersible tablet will be the first erectile dysfunction (ED) medication available in this novel and convenient formulation. In contrast to other drugs of the same class, Levitra 10mg orodispersible tablet allows men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour. In Europe the launch roll-out will start as of November 2010. In the United States the medication has been approved in June 2010 and will be marketed by GlaxoSmithKline and Merck & Co., Inc. under the tradename STAXYNTM.

"Bayer Schering Pharma is committed to men's health and continuously striving to find new and innovative treatment options in the treatment of erectile dysfunction," said Dr. Flemming Oernskov, Head of the Business Unit Women's Healthcare and General Medicine at Bayer Schering Pharma in Berlin. "As part of these efforts, we believe men with ED will appreciate a convenient and easy to take medication. Levitra orodispersible tablet allows men with ED to be prepared, anytime, anywhere. This should help to bring spontaneity into the sex life of men with ED."

The overall efficacy and safety of vardenafil has been widely demonstrated in numerous clinical trials (1-10). For this registration, Levitra 10mg orodispersible tablet was tested in the Phase III multinational trials POTENT I and II (Pivotal phase III trial to investigate the efficacy and safety of an O rodispersible Tablet vardenafil versus placebo in the treatment of men with E rectile dysfunction: a fixed-dose, double-blind, raNdomized multicenter Trial). These pivotal studies compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED. These two international twin studies were conducted with identical study design, enrolling a total of 882 men above the age of 18 years who had ED for more than 6 months. (11,12), For both POTENT I and POTENT II studies, vardenafil orodispersible therapy was statistically significantly superior to placebo for all primary (IIEF-EF, SEP2, SEP3) and secondary efficacy measures (all p<0.0001).

About Erectile Dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. An estimated 152 million men worldwide, 16 percent of all men aged 20-75 worldwide (13), experience erection difficulties. It is predicted that the worldwide prevalence of ED will increase to 322 million by 2025 (14). Despite its wide prevalence, recent data suggest that many men with ED do not seek treatment. Moreover, ED can be a first signal for cardiovascular comorbitidies and should therefore be taken seriously by patients and physicians (15). More education and information on the physicians and patient side is needed to change this. Find more information about ED at www.in-bed.info.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. 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, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and markets products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About 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, General Medicine, Specialty Medicine 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. Find more information at www.bayerscheringpharma.de.

Forward-looking statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Reference

1) Cheng, E. Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction - results from 30,010 U.S. patients. J Sex Med 2007;4:432-439. 2) Eardley, I, Lee, JC, Shabsigh, R, Dean, J, Maggi, M, Neuser, D, Norenberg, C. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med 2009:In press. 3) Edwards, D, Hackett, G, Collins, O, Curram, J. Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners. J Sex Med 2006;3:1028-1036. 4) Fisher, WA, Rosen, RC, Mollen, M, Brock, G, Karlin, G, Pommerville, P, Goldstein, I, Bangerter, K, Bandel, TJ, Derogatis, LR, Sand, M. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005;2:699-708. 5) Giuliano, F, Rubio-Aurioles, E, Kennelly, M, Montorsi, F, Kim, ED, Finkbeiner, AE, Pommerville, PJ, Colopy, MW, Wilkins, HJ, Wachs, BH. Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006;66:210-216. 6) Hatzichristou, D, Montorsi, F, Buvat, J, Laferriere, N, Bandel, TJ, Porst, H. The efficacy and safety of flexible-dose vardenafil (Levitra®) in a broad population of European men. Eur Urol 2004;45:634-641; discussion 641. 7) Hellstrom, WJ, Gittelman, M, Karlin, G, Segerson, T, Thibonnier, M, Taylor, T, Padma-Nathan, H. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002;23:763-771. 8) Ralph, D, Eardley, I, Kell, P, Dean, J, Hackett, G, Collins, O, Edwards, D. Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners. BJU Int 2007;100:130-136. 9) Rosen, R, Shabsigh, R, Berber, M, Assalian, P, Menza, M, Rodriguez-Vela, L, Porto, R, Bangerter, K, Seger, M, Montorsi, F. Efficacy and tolerability of vardenafil in men with mild depression and erectile dysfunction: the depression-related improvement with vardenafil for erectile response study. Am J Psychiatry 2006;163:79-87. 10) Stief, C, Porst, H, Saenz De Tejada, I, Ulbrich, E, Beneke, M. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract 2004;58:230-239. 11) Sperling H et al. The POTENT I randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction. The Journal of Sexual Medicine. 12) Gittleman M et al. The POTENT II randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction. 13) Rosen RC, Fisher WA, Eardley I, et al; Men's Attitudes to Life Events and Sexuality (MALES) Study. The multinational men's attitudes to life events and sexuality (MALES) study: Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin. 2004;20(5):607-617 14) Aytac IA, McKinlay JB, Krane RJ. The likely world increase in erectile dysfunction between 1995 and 2065 and some possible policy consequences. BJU Int. 1999; 84:50-56 15) Haro JM, Beardsworth A, Casariego J, et al.Treatment-seeking behavior of erectile dysfunction patients in Europe: Results of the Erectile Dysfunction Observational Study.J Sex Med. 2006 May;3(3):530-40.

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