Sosei and Vectura Announce Start of Phase II Clinical Study with NVA237 in the USA
2007-08-06 · Nxera Pharma UK Limited · original nxera.life ↗
Sosei and Vectura Announce Start of Phase II Clinical Study with NVA237 in the USA Tokyo, Japan and Chippenham, UK – 6 August 2007 : Sosei Group Corporation (“Sosei”; TSE Mother s Index: 4565) and Vectura Group plc (“Vectura”; LSE: VEC) announce the commencement of a Phase II clinical study in the USA, by Novartis, with NVA237, a once daily long acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease (COPD). This follows the publication on the ClinicalTrials.gov website of a study being undertaken under a US IND regulatory authorisation to support the safety of NVA237 in a Novartis proprietary Single Dose Dry Powder Inhaler (SDDPI). The trial, a randomised, doubl e-blind, placebo-controlled, parallel group, multi- centre study will assess the safety of 28 days treatment of NVA237 in patients with moderate to severe COPD. NVA237 was licensed to Novartis by So sei and Vectura in 2005 in a deal in which the two companies could receive up to US$ 375 million in milestones as well as royalties on product sales. NDA s ubmissions are expected to be filed in 2010 for both NVA237 and the combinatio n product with indacaterol known as QVA149. Mr Shinichi Tamura, President & CEO of So sei, said: "I am pleased that clinical development of NVA237 has now comme nced in the USA and that work in support of Phase III studies is progressing to plan.” Dr Chris Blackwell, Chief Executive of Vectura added: “Continued good progress on NVA237 with a study under a US IND prov ides additional confidence that the development of both NVA237 and QVA149 by Novartis is on track.” - Ends - Enquiries: 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 Sosei R&D Ltd Chesterford Research Park, Saffron Walden, CB10 1XL England John DAFFURN, EVP Corporate Development, E-mail: [email protected] Tel: +44 (0)1799 532 350 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 Vectura Group plc Tel: + 44 (0) 1249 667700 Chris Blackwell, Chief Executive Anne Hyland, Chief Financial Officer Julia Wilson, Director of Investor Relations & Corporate Communications Financial Dynamics Tel: + 44 (0) 207 831 3113 David Yates / John Gilbert Notes for Editors: About the NVA237 licence agreement with Novartis Sosei and its co-development partner Vectur a Group plc concluded a global development and commercialisation agreement with Novartis in April 2005 for their collaborative product NVA237. Novartis is responsible for developing and co mmercializing NVA237 both as a monotherapy and in combination with indacaterol, its once daily, long acting beta 2 agonist, as QVA149. Under the terms of the agreement, Sosei and Vectura have already received $15 million each and will receive up to $172.5 million each for achi eving pre-agreed clinical, regulatory and commercialisation targets for both the monotherapy and combination product. These potential milestones thus total up to $375 million. In addition, royalties on product sales will be paid for the monotherapy and the combination product. If a third combination product is developed by Novartis, using NVA237, further milestones and royalties may be payable. About COPD COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of l ung function. COPD is currently the fourth most common cause of death and by 2020 is predicted to become the third most common cause of death and the fourth most important disability ca using illness. The total financial burden of lung disease in Europe amounts to nearly €102 billion with COPD contributing almost one half of this figure. Around three-quarters of patients with advanced COPD are unable to perform normal everyday activities. The current market for COPD drug therapy is estimated to be worth around $5.5 billion per annum and is predicted to double to over $11 billion by 2011 as a result of increasing diagnosis and treatment and the growth of high value new products. About Sosei Sosei 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 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
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