Press release
Jun 20, 2005

Sosei’s SOU-001 Project Moves to Phase II Clinical Study

Tokyo, Japan / London, UK, 20 June, 2005 -- Sosei Co. Ltd., a leading Japanese biopharmaceutical company, announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK had approved the initiation of a Phase II, placebo-controlled, randomised clinical study in the UK of SOU-001 which is targeted for treatment of stress urinary incontinence (SUI) in oral formulation.

SOU-001 is the first successful demonstration of Sosei’s DRP® (Drug Reprofiling Platform®). Previously it was developed up to Phase II for a certain cardiovascular indication by a Japanese pharmaceutical company. Sosei’s DRP®, in collaboration with a UK based profiling partner, identified SUI as its new potential indication in 2001. Sosei has now acquired exclusive world wide rights for the development and commercialisation of this compound.

Since reprofiling, Sosei undertook a volunteer study to validate the effect using the intravenous route, which proved encouraging. Subsequently, Sosei undertook pharmaceutical studies to develop an oral formulation and carried out additional toxicological studies. A Phase I safety, tolerability and pharmacokinetic study in volunteers was completed in 2004 which confirmed SOU-001 could be used as an oral treatment.

The objectives of the Phase II clinical study is to evaluate efficacy, safety and tolerability of single oral doses of SOU-001 in female volunteers with SUI.
Shin-Ichi Tamura, President & CEO of Sosei commented: “I am very delighted that SOU-001 is moving forward to a Phase II clinical study as this is the first product developed from our distinctive DRP® programme. There is a strong unmet need in the therapeutic area of SUI and we look forward to the steady progress of this product towards marketing approval.”

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Notes for Editors:

*Stress Urinary Incontinence (SUI):

SUI is an uncontrollable, involuntary leaking of urine that occurs when abdominal pressure or stress is placed on a weakened urethral sphincter muscle. This muscle retains urine in the bladder and is relaxed under voluntary control when a person wishes to urinate. Every day occurrences, such as coughing, sneezing, exercise, laughing, or lifting can place stress on the bladder and may trigger an episode. SUI represents a large unmet medical need with significant commercial potential. It is predominantly a woman’s condition with 90% of sufferers being female. It is particularly prevalent in postmenopausal women and following childbirth. External sources indicate that it affects over 65 million people around the world.

*DRP® (Drug Reprofiling Platform®):
The aim of DRP® is to identify new medical uses and unexploited commercial potential in compounds licensed from Japanese pharmaceutical companies. Sosei’s substantial portfolio of secured compounds have been into clinical development but were halted for reasons other than serious toxicity or are already on the Japanese market. Sosei uses a combination of classical pharmacology and new technologies to re-evaluate these compounds. Through its extensive business development network established with US/EU platform technology companies, Sosei has signed DRP® agreements with 27 biotech companies to date representing leading profiling technologies.

About Sosei Co. Ltd.

Sosei Co. Ltd. founded in 1990 by Shinichi Tamura, the ex-CEO of Genentech Japan, is a leading Japanese biopharmaceutical company with significant expertise in drug development. It enriches its core product pipeline by in-licensing compounds from Western and Japanese companies, by its distinctive Drug Reprofiling Platform® (DRP®) and through new molecular entity (NME) research programmes in collaboration with biopharmaceutical companies and universities both in Japan and the West. Sosei is also developing its own sales and marketing organization in Japan. The company is capitalising on its extensive global network established over the past 10 years in its successful technology transfer business. For further information about Sosei, please visit