Press release
Oct 17, 2005

Arakis and Vectura Announce Start of Phase IIb Trial of NVA237 for COPD


Tokyo, Japan/Little Chesterford, UK & Chippenham, UK – 17 October 2005: Arakis Ltd. (“Arakis”), a wholly-owned subsidiary of the biopharmaceutical company Sosei Co. Ltd. (“Sosei”; TSE Mothers Index: 4565), and Vectura Group plc (“Vectura”; LSE: VEC) announced today that their collaborative product, NVA237 (formerly AD 237), a novel inhaled once daily treatment for chronic obstructive pulmonary disease (COPD), has entered a Phase IIb multiple dose-ranging clinical trial. NVA237 is being developed and commercialised by Novartis both as a monotherapy and in combination with their once daily bronchodilator indacaterol (QAB149), under the terms of the agreement signed in April 2005.

The study is a randomised, double-blind, multi-centre, placebo-controlled trial designed to evaluate the efficacy, safety and dose response of NVA237 in patients diagnosed with COPD over a four week period.

COPD, the world’s fourth largest cause of death, is a chronic obstruction of the airways which is caused primarily by smoking. It is estimated that the disease is prevalent in 4% of the populations of the USA, Europe and Japan and that at least 15% of smokers will go on to develop the disease. Symptoms include chronic bronchitis and emphysema or both conditions, which slowly progress and eventually lead to a largely irreversible loss of lung function. The current market for COPD drug therapy is estimated to be worth $4 billion per annum and is predicted to grow to $10 billion by 2010.

Mr Shinichi Tamura, President & CEO of Sosei, said: "COPD is increasingly being recognised as a common and costly disease with high patient unmet need. The commencement of the Phase IIb trial represents a further important step in validating the clinical profile of NVA237, which we believe to be a very promising product with the potential to improve upon existing therapies”.

Dr Chris Blackwell, Chief Executive of Vectura, added: “The momentum for the clinical development of NVA237 also underpins the development of the NVA237/indacaterol combination product that we believe will play a major role in the future treatment of COPD. We are delighted to be able to announce the start of the Phase IIb programme”.

 

Notes for 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 organisation in Japan. The company is capitalising on its extensive global network established over the past 10 years in its successful technology transfer business.

Sosei acquired Arakis in August 2005. For further information about Sosei, please visit www.sosei.com.

About Arakis
Arakis is a UK based biopharmaceutical 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.
In addition to NVA237, Arakis has three other products in clinical development: AD 452 for rheumatoid arthritis (RA) which has completed Phase IIa trials, and AD 337 for fibromyalgia syndrome and AD 923 for cancer breakthrough pain (CBP) which are both in Phase I. In addition, there is a preclinical pipeline of other opportunities, two exploratory developments and a number of research projects.

About Vectra
Vectura’s (LSE: VEC) principal focus is to combine its proprietary pulmonary formulation and device technologies with existing, off-patent drugs to develop inhaled drugs for the treatment of both lung diseases and conditions where delivery via the lungs can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.

The Company will seek to license its lead products to pharmaceutical companies with established sales and marketing infrastructures for the later stages of development and for commercialisation, typically prior to Phase III clinical development. The Company has development collaborations with a number of companies, including GSK, Chiesi and Arakis. For further information, please visit Vectura’s website at www.vectura.com


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