Download An Fax-Nr. - Bayer Investor Relations

Corporate Investor Relations
New drug for improvement of erectile function
Bayer files applications for Vardenafil in
United States and Mexico
Leverkusen – Bayer Corporation today announced it has submitted vardenafil – its
treatment in development for men with erectile dysfunction (ED) – for regulatory
review in the United States and Mexico. Pending approvals, Bayer anticipates
launching vardenafil in the United States and Mexico in the second half of 2002, with
EU approval and launch shortly thereafter. Vardenafil is a highly potent and selective
phosphodiesterase-5 (PDE-5) inhibitor.
“The vardenafil submissions represent a major step toward achieving our goal of
offering more options to both physicians for treating ED, as well as to men suffering
from ED,” said David R. Ebsworth, Ph.D., President and General Manager, Business
Group Pharma, Bayer AG. “This milestone represents an aggressive 47-month
development period for Bayer from the beginning of pre-clincial testing to
submission. We are extremely encouraged by the strong efficacy results and safety
profile that have emerged from a very thorough clinical trial programme. ”
It is estimated that ED — the inability to sustain an erection sufficient for sexual
intercourse — affects more than half of all men aged over 40 years. While it is
estimated 140 million men worldwide are affected by ED, only one in 20 seeks
medical treatment, thus demonstrating the clear need for additional therapies in this
area. There are a number of causes for ED, including common medical conditions,
such as diabetes and cardiovascular disease, psychological factors, and
medications, such as anti-depressants.
2
Bayer AG’s research and development in the field of erectile function leverages the
strong foundation of the company’s expertise in urology. Bayer AG already has
established itself as a credible force in this arena with Cipro®* (ciprofloxacin HCl) to
treat chronic bacterial prostatitis. Bayer also is marketing Viadur™ in the United
States, the first and only, once-yearly continuous testosterone suppression therapy
to treat symptoms of advanced prostate cancer.
Leverkusen, September 25, 2001