Vectura and Sosei Announce Start of Phase II Clinical Study with NVA237 in the USA
06 August 2007
Chippenham, UK and Tokyo, Japan – August 6 2007: Vectura Group plc (“Vectura”; LSE: VEC) and Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) 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, double-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 Sosei 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 submissions are expected to be filed in 2010 for both NVA237 and the combination product with indacaterol known as QVA149.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am pleased that clinical development of NVA237 has now commenced 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 provides additional confidence that the development of both NVA237 and QVA149 by Novartis is on track.”
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Enquiries:
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
Sosei Group Corporation
Ichiban-cho FS Bldg., 8 Ichiban-cho, Chiyoda-ku, Tokyo 102-0082 Japan
Hiroki MAEKAWA, Representative Executive Officer,
E-mail: hmaekawa@sosei.com Tel: +81-3-5210-3399
Sosei R&D Ltd
Chesterford Research Park, Saffron Walden, CB10 1XL England
John DAFFURN, EVP Corporate Development,
E-mail: daffurnj@sosei.com 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
Notes for Editors:
About the NVA237 licence agreement with Novartis
Sosei and its co-development partner Vectura 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 commercializing 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 achieving 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 lung 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 causing 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 Vectura
Vectura is a pulmonary drug development company focused principally on the development of a range of inhaled therapies for the treatment of respiratory and neurological diseases. The respiratory market is forecast to achieve sales of $32 billion by 2011. Vectura develops products to treat respiratory diseases such asthma, COPD and cystic fibrosis. Vectura also develops products where optimised delivery via the lungs into the blood stream can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies.
Vectura has eight marketed products and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. The Company also seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation technologies to other pharmaceutical companies on a licensing basis where this complements Vectura’s business strategy.
Vectura has development collaborations with a broad range of pharmaceutical companies including Boehringer Ingelheim, Novartis, and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, GSK, Merck KGaA, UCB and Otsuka as well providing revenue streams, complementary products and critical mass.
For further information, please visit Vectura’s website at www.vectura.com
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
Vectura Forward Looking Statement
This press release contains “forward-looking statements,” including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura’s actual results to differ materially from those expressed or implied by the forward-looking statements, including adverse results in clinical development programs; failure to obtain patent protection for discoveries; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
