News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Obtains Marketing Authorization for the Treatment of Urinary Frequency and Urinary Incontinence, Vesicare, in the Netherlands

January 20, 2004

Tokyo-January 20, 2004-Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that its European subsidiary, Yamanouchi Europe B.V. (YEU: Leiderdorp, the Netherlands), has obtained marketing authorization for Vesicare (development code No., YM905; generic name, solifenacin succinate) in the Netherlands.

The drug relieves symptoms of urinary frequency, urinary incontinence or urgency associated with overactive bladder (OAB) and normalizes the voiding pattern. YEU submitted a marketing authorization application (MAA) in January 2003 using the mutual recognition procedure* with the Netherlands as the reference member state (RMS). YEU expects to obtain approval in the 17 concerned member states including France, Germany, Italy, and the UK following the Netherlands. YEU will decide the timing of launching depending on when approval will be obtained in each country.

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. Because these symptoms cause a lot of inconvenience and mental stress in patients' activities of daily living, drugs that relieve these symptoms are needed. In Europe, more than 16% of men and women aged 40 or older are reported to experience symptoms of OAB. The number of OAB patients is estimated to be about 25 million, but only 20% of them are treated.

Yamanouchi has established a seamless pharmaceutical business system from research and development to production and marketing in Europe and has enhanced its presence in the European drug market, especially in the field of urology, through the marketing of Omnic (brand name in Japan: Harnal), a drug for the treatment of functional symptoms of benign prostatic hyperplasia (BPH). The company aims at becoming a leading company in the field of urology in Europe by adding Vesicare to its portfolio. In the US, Yamanouchi has received an approvable letter from the FDA and expects launching within 2004. In Japan, Phase III clinical trials are underway.

* Mutual recognition procedure: The reference member state (RMS) submits its assessment report to concerned member states (CMS) upon approval of the MAA dossier. Each CMS reviews the assessment report and file submitted, discusses the MAA with the RMS and applicant based on the review findings, and decides whether it approves the MAA.