News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi to File an NDA for the Treatment of Urinary Frequency and Urinary
Incontinence, YM905(solifenacin succinate), with the US FDA
-Accelerating Preparations for Independent Marketing in the US-

January 9, 2003

Tokyo-January 9, 2003-Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that its US subsidiary, Yamanouchi Pharma America Inc. (YPA: Paramus, NJ), has submitted a New Drug Application (NDA) for YM905 (solifenacin succinate), to the US Food and Drug Administration (FDA) for the relief of symptoms of urinary frequency, urinary incontinence or urgency associated with overactive bladder (OAB).

YM905 is a strategic product for Yamanouchi and will be the first product to be independently marketed in the United States through YPA. YPA will hire MRs (medical representatives) and accelerate preparations for independent marketing. Negotiations are also underway with potential candidates as a co-promotion sales partner. An NDA is being prepared in the Europe, and Phase III clinical trials are being conducted in Japan.

YM905 is an investigational muscarinic antagonist that acts on the receptors in the smooth muscle of the bladder. YM905 relaxes urinary bladder smooth muscles by blocking muscarinic receptors present in these muscles, thereby relieving symptoms such as urinary frequency, urinary incontinence or urgency associated with OAB and normalizing the voiding pattern.

OAB is caused by excessive contraction of the urinary bladder and is associated with symptoms such as urinary frequency, urinary incontinence and urgency. Because these symptoms cause a lot of physical, social and psychological discomfort and inconvenience in patients' activities of daily living, drugs that relieve these symptoms are needed. In the United States, more than 16 percent of men and women aged 40 or older are reported to experience these symptoms. The number of patients is estimated to be about 20 million, but only 20 percent of them are treated. The market for drugs to treat OAB has rapidly expanded to nearly US$ 1 billion over the last five years and is expected to continue to expand due to the large number of untreated patients.

Yamanouchi aims at becoming an "R&D-Driven Global Health Enterprise" and is making an increasing effort to develop its business in the United States, Europe, and Asia, including Japan. In Europe, the company has established an independent marketing system through Yamanouchi Europe B.V. In Asia, it has created independent marketing networks in China, South Korea, Taiwan and South-east Asia. The launching of YM905 in the United States will further strengthen the company's global marketing capacity. Yamanouchi will expand its new product pipeline in the field of urology, one of the company's priority fields, in order to efficiently develop its business in the United States.