Press release
Jun 15, 2004

Sosei Initiates Phase I Clinical Trial of Oral SOU-001

[Tokyo, Japan / London, UK] Sosei Co. Ltd., a leading Japanese biopharmaceutical company, announced today that the Medicines and Healthcare products Regulatory Agency had approved the initiation of a Phase I clinical trial in the UK of SOU-001 in oral formulation, which is targeted for stress urinary incontinence (SUI) indication.
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 profiling partner, identified SUI as its new potential indication in 2001 and Sosei undertook a volunteer study to validate the effect via the intravenous route. Subsequently, Sosei undertook pharmaceutical studies of an oral formulation and carried out additional pharmacological and toxicological studies. The objectives of this Phase I clinical study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of SOU-001 in healthy female volunteers. Sosei acquired exclusive world wide rights for commercialisation of this compound.
Shin-Ichi Tamura, President & CEO of Sosei commented: “We are very pleased with the progress of SOU-001 as this is the first product to validate DRP® as an efficient drug discovery engine. The patient population for SUI is quite large, but there are not many products available or under development. We therefore recognise the clinical and business significance of SOU-001 in this area.”


Note to 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 20 biotech companies to date representing leading profiling technologies.

About Sosei Co. Ltd.

Sosei Co. Ltd. (Tokyo, Japan and London, UK), founded in 1990, by Mr. Shinichi Tamura the ex-CEO of Genentech Japan, is a leading Japanese biopharmaceutical company with significant expertise in drug development. It enriches the core product pipeline via 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 organisation. The company is capitalising on its extensive global network established over the past 10 years in its successful technology transfer business. Sosei's investors include experienced US/EU funds and Japanese institutional investors. For further information about Sosei, please visit