KW-7158,
a therapeutic agent for urinary incontinence,
will enter Phase II in Europe

 Kyowa Hakko (President: Dr. Tadashi Hirata) proudly announces that KW-7158 (code name), now under development in Europe for the treatment of urinary incontinence, will enter clinical Phase II studies in June 2001 following the successful completion of Phase I studies.

 KW-7158, a novel compound independently discovered by Kyowa Hakko, has been shown to act on the peripheral sensory nerves and control bladder activities. Through this unique action, it is expected to be clinically effective against "urinary urgency," "frequent urination" and "urinary incontinence" associated with bladder overactivity (involuntary abnormal contraction of the bladder).

 As the aging of population progresses, an increasing number of people are likely to suffer from urinary incontinence. Bladder overactivity, the indication for this compound, is estimated to affect around 2.4 million people in Japan and around 20 million in the US and Europe combined. We consider that the market for this therapeutic domain, which is characterized by the predominance of untreated patients, tends to grow. The current mainstay of treatment for bladder overactivity is anti-cholinergic agents, which, however, are associated with high incidences of adverse reactions such as thirst and urination disorder. The development of a new type of drugs, particularly those causing fewer side effects, is thus anticipated. KW-7158 is being developed with the concept of "a new therapeutic agent for urinary incontinence with high safety," and there are great expectations that it will become a product indispensable for the future society.

 We also plan to commence clinical studies of KW-7158 in the US and Japan in addition to Europe. KW-7158 is expected to grow into an innovative new product with estimated peak sales of more than \60 billion/year. To commercialize the compound as soon as possible, we are making every effort to speed up development activities.