Sosei Announces Approval to Start AD 923 Phase III Studies in Europe

Sosei Announces Approval to Start AD 923 Phase III Studies in Europe Tokyo, Japan – 28 November 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), a biopharmaceutical compan y, today announces that it has received approval from the UK Medicines and Health care products Regulatory Agency (MHRA) for the Phase III clinical trial pr ogramme for its fentanyl subli ngual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain. The clinical trial authorisation (CTA) covers two multi-centre pivotal Phase III efficacy studies followed by an open label safety study. Pa tient enrolment in the UK is expected to commence before the end of the year and will be the subject of a separate announcement. Applications have been made in other European countries and fu rther patient recruitment will be initiated as soon as approval is received from the relevant local regulatory body. This first CTA in a major European country will also trigger the re ceipt of a project milestone payment under the AD 923 Licence Agreement signed with Mundipharma in June 2006. Mr Shinichi Tamura, President & CEO of Sosei, said: "Receipt of our first Phase III CTA represents an important milestone in the evolution of Sose i and the continuing progress of the AD 923 development programme. We look fo rward to enlisting our first patients in the trial”. 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 John DAFFURN, EVP Corporate Development, 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 upon identifying new uses for established drugs and exploiting its unique position withi n 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. 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. Sosei has concluded a range of studies that confirm the potential of this novel product. In June 2006, Sosei entered into an agreem ent with Mundipharma International Corporation Limited for the development and commercialisati on of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei is currently evaluating its commercialisation options for the un-partnered territories. About Cancer Breakthrough Pain Cancer breakthrough pain is characterised by temporary exacerbations of moderate to severe pain in cancer patients that “breakthrough” their around-the-clock opioid treatments. Each episode may be spontaneous or incidental to an activity. It is estimated that the condition is prevalent in approximately 60% of cancer pain patients across Europe, the US and Japan, representing a total population size of 2.3 million. Most current treatments for cancer breakthrough pain are considered sub-optimal. The market seeks products which have a rapid onset of action and are easy to use. The current worldwide market for cancer breakthrough pain drug treatment is estimated to be worth $1.5bn and represents a growing market opportunity.

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