Press release
Nov 1, 2005

Arakis Completes Phase I Trials of AD 337 in Fibromyalgia Syndrome

Tokyo, Japan / Little Chesterford, UK – 1 November 2005: Sosei Co. Ltd (“ Sosei€35 ; TSE Mothers Index: 4565), a leading biopharmaceutical company, today announces that its wholly-owned subsidiary Arakis Ltd (“ Arakis” ), has successfully completed Phase I single and multidose studies of AD 337, a novel enantiomer of an approved centrally acting non-opioid analgesic, which is under investigation for the treatment of fibromyalgia syndrome. AD 337 has been shown to have activity against central monoamines which are thought to be implicated in the pathogenesis of fibromyalgia.

The multidose trial was a double blind, randomised, placebo-controlled, dose escalation study to evaluate the pharmacokinetics, safety and tolerability of multiple oral doses of AD 337 in healthy volunteers and comprised two groups of ten subjects. AD 337 was observed to be well tolerated. Two earlier single dose studies, involving a total of 28 subjects, showed that the PK profile of AD 337 appeared to be linear and almost proportional to dose over the administered range.

Preparations are now underway to initiate a Phase II proof of principle (PoP) trial in the first half of 2006 in patients with active fibromyalgia.

Fibromyalgia syndrome is a poorly diagnosed condition affecting predominantly women with an estimated prevalence of 2% in the USA. The disease is characterised by widespread musculoskeletal pain that presents with a number of co-morbidities including fatigue, sleep disturbance and depression. The aetiology of the syndrome is not well understood but serotonin (5-HT) and noradrenalin (NA) dysfunction is believed to be a contributory factor. There are no drugs specifically approved as yet for fibromyalgia.

The global market for current fibromyalgia treatments is worth some $300m and is expected to grow to over $1 billion in the next 10 years as new therapeutic options become available.

Shinichi Tamura, President and CEO of Sosei, said: €34 Fibromyalgia is increasingly being recognised as a disease with a high level of disability that causes substantial socio-economic burden. We believe that, with AD 337, we have a very promising product with the potential to provide significant patient benefit.€35


Notes to Editors:

About Sosei

Sosei Co. Ltd., founded in 1990 by Shinichi Tamura, the former 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.

In August 2005, Sosei expanded its international presence through the acquisition of the UK-based private biopharmaceutical company Arakis Limited.

For further information about Sosei, please visit

About Arakis

Arakis is a UK based b i opharmaceutical company that discovers, develops and commercialises innovative medicinal products based on established drugs and drug templates. Its main therapeutic areas are inflammatory disease and pain.

Arakis has four products in clinical development: NVA237 (formerly AD 237) for chronic obstructive pulmonary disease (COPD) and AD 452 for rheumatoid arthritis (RA) which have both completed Phase IIa trials, AD 337 for fibromyalgia syndrome which has just completed Phase I and AD 923 for cancer breakthrough pain (CBP) in Phase I development. In addition, there is a preclinical pipeline of other opportunities, two exploratory developments and a number of research projects.

For further information about Arakis, please visit