AD 923 Commences Phase I Clinical Development in the USA

AD 923 Commences Phase 1 Clinical Development in the USA Tokyo, Japan – 5 March 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), a biopharmaceutical company, today announces that AD 923, a novel sublingual fentanyl spray for the treatment of cancer breakthrough pain, has entered into a Phase I comparative pharmacokinetic study in the USA under an IND regulatory submission. The trial is a single centre, open-label, single dose, cross-ov er study to investigate the comparative pharmacokinetics of AD923 agai nst intravenous and oral transmucosal formulations of fentanyl in 24 healthy human volunteers. Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that we have been able to announce the progression of the AD 923 development programme into the USA. There is a major requirement for a si mple and manageable method of providing immediate-release fentanyl for the rapid re lief of breakthrough pain which AD 923 has been optimised to deliver.” 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, SVP Corporate Development, E-mail: [email protected] Tel: +44 (0)1799 532 350 Fax: +44 (0)1799 532 351 Financial Dynamics Tel: + 44 (0)207 831 3113 Julia Phillips The Trout Group Thomas Fechtner Tel: +1 646-378-2915 Brandon Lewis Tel: +1 646-378-2931 Notes for Editors: About Sosei Sosei Group Corporation is a leading international bioph armaceutical company with significant expertise in product discove ry and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique pos ition within Japanese, Eu ropean 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 overdosage. 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 commercialisation of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei are 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 “b reakthrough” their ar ound-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, representi ng a total population si ze of 2.3 million. Most current treatments for cancer breakth rough pain are consider ed sub-optimal. The market seeks products which have a rapid onset of action and are easy to use. The current worldwide market for cancer break through pain drug treatment is estimated to be worth $1.5bn and represents a growing market opportunity.

The release as fetched from its publisher. nxera.life ↗