Sosei Announces Temporary Halt to AD 923 CBP Phase III Studies in Europe

Sosei Announces Temporary Halt to AD 923 CBP Phase III Studies in Europe Tokyo, Japan – 26 March 2008 : Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), a biopharmaceutical company, today announces that it has notified the UK Medicines and Healthcare products Regulatory Agency (MHRA) and other relevant EU Competent Authorities that it has suspended further patient recruitment into the Phase III clinical trial programme for its fentanyl sublingual spray (AD 923), in CBP (Cancer Breakthrough Pain) pending resolution of a technical issue. The problem concerns a supplied compo nent in the device used to deliver the fentanyl spray which may result in patients receiving a sub-optimal dose of medication. A detailed investigation is underway but, as a precautionary measure to ensure patient safety, a temporary halt to the study has been implemented and all affected clinical trial supplies will be recalled. Sosei Group Corporation Ichiban-cho FS Bldg., 8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan Hiroki MAEKAWA, Representative Executive Officer, E-mail: [email protected] Tel: +81 3 5210 3399 Fax: +81 3 5210 3291 Sosei R&D Ltd. Chesterford Research Park, Saffron Walden, CB10 1XL England Robin BANNISTER, Managing Director Sosei R&D Ltd, E-mail: [email protected] Tel: +44 1799 532 350 Fax: +44 1799 532 351 The Trout Group Seth Lewis Tel: +1 617 583 1308 Brandon Lewis Tel: +1 646 378 2915 Notes for Editors: About Sosei Sosei Group Corporation is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily up on identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan. For further information about Sosei, please visit www.sosei.com About AD 923 AD 923 is an optimised, sublingual formulation of the strong opioid analgesic fentanyl for the treatment of cancer breakthrough pain. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosing. Phase III studies in Europe commenced in February 2008.

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