News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Files a MAA for the Treatment of Urinary Frequency and Urinary Incontinence,
YM905(solifenacin succinate), in Europe Following the US

January 29, 2003

Tokyo-January 29, 2003-Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that its European subsidiary, Yamanouchi Europe B.V. (YEU: Leiderdorp, the Netherlands), has submitted a Marketing Authorization Application(MAA) for YM905 (solifenacin succinate), using the mutual recognition procedure*1 with the Netherlands as the reference member state. The drug is applied for the relief of symptoms of urinary frequency, urinary incontinence or urgency associated with overactive bladder (OAB). The MAA was filed using the electronic Common Technical Document (eCTD)*2. In the United States, an NDA was filed with the Food and Drug Administration in December 2002. Phase III clinical trials are underway in Japan.

YM905 is an investigational muscarinic antagonist, originated by Yamanouchi, 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 inconvenience and discomfort in patients' activities of daily living, drugs that relieve these symptoms are needed. In Europe, more than 16 percent of men and women aged 40 or older are reported to experience symptoms of OAB, and the number of OAB patients is estimated to be about 25 million, but only 20 percent 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 OmnicR (brand name in Japan: HarnalR), 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 YM905 to its portfolio.




*1 Mutual recognition procedure: The reference member state (RMS) submits its evaluation report to concerned member states (CMS) upon completion of the review of the MMA dossier. Each CMS reviews the report submitted, discusses the MAA with the RMS based on the review findings, and decides whether it approves the MAA. YEU submitted an MAA using this system with the Netherlands as the RMS. It aims at obtaining approval in the 15 EU member countries, including France, Germany, Italy and the United Kingdom.


*2 eCTD (electronic Common Technical Document): Electronic new drug application format agreed upon between Japan, the United States and the EU at ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). The EU introduced related guidelines in November 2002.