News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Obtains Approval for an Additional Dosage Form Using Its Proprietary OCAS Technology for Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in the Netherlands

September 22, 2004

Tokyo - September 22, 2004 - Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that it obtained approval for the treatment for functional symptoms of benign prostatic hyperplasia Omnic-OCAS (tamsulosin-OCAS) developed using its proprietary OCAS*1 technology in the Netherlands.

Omnic-OCAS was developed by applying OCAS technology, a DDS*2 technology developed by Yamanouchi, to tamsulosin, a drug developed by Yamanouchi for the treatment of functional symptoms of benign prostatic hyperplasia. Yamanouchi markets it under the brand name Omnic in Europe and Harnal in Japan. A marketing authorization application (MAA) was submitted in the EU in January 2004 using the mutual recognition procedure (MRP) with the Netherlands as the reference member state (RMS). Yamanouchi will continue to work to obtain approval in other EU member states. The launching timing will be determined depending on the approval date in each country.

OCAS technology enables a drug to be absorbed not only from the upper GI tract (including the stomach and duodenum) but also in the lower GI tract (colon), from which drug absorption is usually difficult. It makes drugs less liable to the effects of meals than conventional capsule formulations providing a better efficacy/safety profile. Omnic-OCAS is available as a once-daily controlled-release tablet. It is the first drug approved using OCAS technology.

Tamsulosin is an1 blocking agent developed by Yamanouchi with a high selectivity for prostatic and urethral smooth muscles. It improves the functional symptoms of benign prostatic hyperplasia by relaxing the urethra with almost no effect on vascular smooth muscles, which affect blood pressure. It was launched in 1993 in Japan and is now in the market in 65 countries with worldwide sales*3 of over 190 billion yen in 2003. It has steadily penetrated the market because of its excellent efficacy and safety and has been established as the leading brand in the field of prostatic hyperplasia-related drugs. Yamanouchi plans to maximize the value of tamsulosin as a global strategic product.

*1 OCAS:OralControlledAbsorptionSystem

*2 DDS:DrugDeliverySystem

*3 Local sales including sales by licensees