News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Obtains Marketing Authorization for Vesicare in 17 EU Member States

July 9, 2004

Tokyo - July 09, 2004 - Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that marketing authorization for Vesicare (development code No., YM905; generic name, solifenacin succinate) has been granted in 17 European Union (EU) member states, including the Netherlands, the reference member state (RMS), for the treatment of overactive bladder syndrome(OAB*1).

Developed by Yamanouchi, Vesicare is a once-daily bladder-selective anti-muscarinic agent which relieves symptoms associated with overactive bladder syndrome. Vesicare is indicated for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

The marketing authorization application (MAA) for Vesicare was submitted in the EU through the Mutual Recognition Procedure (MRP*2) with the Netherlands as the RMS. Since first approval was obtained in the Netherlands last December, the application has been under review in other member states including France, Germany, Spain Italy, and the UK. Vesicare is expected to be launched in these countries after completing reimbursement price negotiations and other regulatory procedures in each country. In the US, an new drug application (NDA) is under review, and launching is expected in 2004. A Phase III clinical trial programme is underway in Japan.

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, UK: Flomax), a drug for the treatment of urinary disorders associated with benign prostatic hyperplasia (BPH). The company aims to maintain its leadership in the field of urology in Europe by adding Vesicare to its portfolio.

*1 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 Europe, more than 16% of men and women aged 40 or older are reported to experience symptoms of OAB. The number of OAB sufferers in Europe is estimated to be about 25 million, but only 20% have been treated.

*2 Mutual recognition procedure (MRP)
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 the file submitted, discusses the MAA with the RMS and applicant based on the review findings, and decides whether it approves the MAA.