News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Applies NDA for YM905 in Japan for the Treatment of Urinary Frequency and Urinary Incontinence

August 30, 2004

Tokyo - August 30, 2004 - Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that it submitted an application for the treatment of urinary frequency and urinary incontinence YM905 (development code No.) (generic name: solifenacin succinate) to the Ministry of Health, Labor and Welfare in Japan. The applied indication is the relief of symptoms of urinary frequency, urinary incontinence or urgency associated with overactive bladder (OAB*).

Developed by Yamanouchi, YM905 improves various symptoms associated with OAB such as urinary frequency, urinary incontinence and urgency, and normalizes the urination pattern when administered once a day by blocking muscarine receptors on bladder smooth muscles and relaxing these muscles. Yamanouchi obtained approval in 17 EU member states in June 2004 and recently started marketing as a global strategic product in some major member states following agreement on public prices. In the US, an NDA has been applied, and launching is expected at the end of 2004. In Japan, clinical studies were started in December 1999 and the application was submitted ahead of schedule as a result of concentration of resources in its clinical development.

Yamanouchi treats urology as one of its global strategic fields and is enhancing its presence in this field through marketing of Harnal (Omnic in Europe and FLOMAX in the US), a drug for the treatment of functional symptoms of benign prostatic hyperplasia (BPH). The company plans to further strengthen its competitiveness in the field of urology in Japan by launching YM905.

OAB is caused by excessive contraction of smooth muscles of the urinary bladder and is associated with symptoms such as urinary frequency, urinary incontinence and urgency. In Japan, the number of OAB patients is estimated to be about 8.1 million, nearly 12% of men and women aged 40 or older. These symptoms cause so significant inconvenience and distress in patients' activity of daily living that drugs that improve these symptoms are greatly needed.