News Release
Yamanouchi Pharmaceutical Co., Ltd.
Yamanouchi Submits a MAA for an Additional Dosage Form Using Its Proprietary OCAS Technology for Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Europe
February 2, 2004
Tokyo - January 30, 2004 - Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"; President and CEO: Toichi Takenaka) announced that its European subsidiary, Yamanouchi Europe B.V. (YEU: Leiderdorp, the Netherlands), submitted a marketing authorization application (MAA) for its treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. YM 617 TOCAS (Tamsulosin-OCAS) was developed using its proprietary OCAS (oral controlled absorption system) technology and will be registered using the mutual recognition procedure* (MRP) with the Netherlands as the reference member state (RMS).
OCAS is a Drug Delivery System technology developed by Yamanouchi. It is a once-daily oral controlled-release system which makes it possible for a drug to be absorbed from not only the upper GI tract (including the stomach and duodenum) but also the lower GI tract (colon), from which drug absorption is usually difficult. This technology makes drugs less liable to the effects of meals than conventional capsule formulations. Because of its pharmacokinetic profile, it is expected to provide a better efficacy/safety profile.
Tamsulosin is an
1 blocking agent developed by Yamanouchi with a great 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 and is marketed under the brand name of Omnic
in Europe and Harnal in Japan. It is the company's top-selling product with consolidated sales of about
110 billion in the fiscal year ended March 2003. Yamanouchi plans to maximize the value of tamsulosin as a global strategic product.
*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 submitted, discusses the MAA with the RMS and applicant based on the review findings, and decides whether it approves the MAA. YEU has decided to submit an MAA using this procedure with the Netherlands as the RMS in order to obtain approvals in Europe.