Yamanouchi Launches Vesicare in EU for the Treatment of Urinary Frequency and Urinary Incontinence

Main Category: Urology / Nephrology
Article Date: 31 Aug 2004 - 0:00 PDT

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Yamanouchi Pharmaceutical Co, Ltd announced that it will launch its drug to treat urinary frequency and urinary incontinence Vesicare (generic name: solifenacin succinate) in the European Union (EU) through its wholly-owned subsidiary Yamanouchi Europe B.V. Vesicare is Yamanouhi's global strategic product under development in Japan, the US, and EU. The EU will be the first market to launch Vesicare.

Developed by Yamanouchi, Vesicare improves various symptoms associated with overactive bladder (OAB*) when administered once a day by blocking muscarine receptors on bladder smooth muscles. It 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.

An MAA for Vesicare was submitted in the EU in January 2003, and marketing approval was obtained in 17 EU member states in June 2004. Yamanouchi has obtained public prices in major EU member states and has started shipment of the product to wholesalers in the Netherlands, Germany, the UK, France, and Denmark making it ready for prescription by physicians. Marketing will be started on a full scale in these countries in September. The product will be launched in succession in other member states.

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). Yamanouchi aims at becoming a leading company in the field of urology in Europe by adding Vesicare to its portfolio.

In the US, an NDA has been filed, and its launching is expected at the end of 2004. Development in Japan also has been accelerated.

*OAB:Overactive Bladder

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 patients is estimated to be about 25 million, but only 20% of them are treated.

About Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi Pharmaceutical Co., Ltd. (TSE: 4503) is promoting collaboration with other pharmaceutical companies as well as bioventure companies and academia to raise the quality and speed of its R&D activities. Yamanouchi is accelerating new drug discovery research not only with its own R&D capability but also through alliances with a wide range of partners. Yamanouchi's primary objective in R&D is to create a steady stream of innovative new drugs.

Contact:
Yamanouchi Pharmaceutical Co., Ltd.
Yutaka Yamada
yamada@yamanouchi.co.jp
+81-3-3244-3000

http://www.japancorp.net

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