25th Nov 2011 07:00
Novartis files NDA for NVA237 as a treatment for chronic obstructive pulmonary disease (COPD) in Japan
Chippenham, UK - 25 November 2011: Vectura Group plc (LSE: VEC) ("Vectura"), the Company that specialises in developing inhaled therapies, principally for the treatment of respiratory diseases, announces that Novartis Pharma K.K. filed an application today for sales and marketing approval of NVA237 (glycopyrronium bromide) for the treatment of adult patients with chronic obstructive pulmonary disease (COPD) in Japan.
NVA237 is a long-acting muscarinic antagonist (LAMA) submitted for approval in the European Union in September as a once-daily treatment for COPD under the brand name Seebri® Breezhaler®.
Dr Chris Blackwell, Chief Executive of Vectura:
"The Japanese market is a large and growing market with an estimated 5 million people in Japan suffering from COPD. The filing of NVA237 in Japan therefore represents an important milestone for us ahead of an anticipated approval and launch of NVA237 in Europe over the course of the next 12 months. "
Furthermore, Novartis Pharma K.K. announced on 18 November that it had reached an agreement with Eisai Co. Ltd. regarding a co-promotion contract for up to three therapies for chronic obstructive pulmonary disease (COPD). These include Onbrez® 150 mcg Capsules for Inhalation (indacaterol maleate), and, if approved, NVA237 and QVA149 (a fixed-dose combination of indacaterol and NVA237).
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Enquiries
Vectura Group plc | +44 (0)1249 667700 |
Julia Wilson, Director of Investor Relations | |
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Ben Atwell | |
Susan Quigley |
Notes for Editors:
About the NVA237 Licence Agreement with Novartis
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. Novartis has stated that it intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD and as a fixed-dose combination with indacaterol, its once-daily, long-acting beta-agonist (LABA), known as QVA149, in 2013. The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be a potent bronchodilator and Vectura believes that QVA149 could be the first once-daily LAMA/LABA combination to come to market for COPD.
Novartis received European regulatory approval for indacaterol 150 mcg and 300 mcg once-daily doses, under the brand name Onbrez® Breezhaler® in November 2009. In July 2011, Novartis announced approval of the 75 mcg once-daily dose of indacaterol in the US under the brand name Arcapta™ Neohaler™, and of the 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.
To date, Vectura has received $35m from Novartis and, under the terms of the licence, could receive up to an additional $152.5m for achievement of regulatory and commercialisation targets for both the monotherapy and the combination product. In addition, royalties on product sales will be received in the event of successful product launches.
About Vectura
Vectura Group plc develops inhaled therapies principally for the treatment of respiratory diseases. Vectura's main products target diseases such as asthma and chronic obstructive pulmonary disease (COPD), a growing market that is currently estimated to be worth in excess of $25bn.
Vectura has six products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter and GlaxoSmithKline (GSK).
Vectura seeks to develop certain programmes itself where this will optimise value. Vectura's formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy. For further information, please visit Vectura's website at www.vectura.com
Forward-looking statements
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 programmes; failure to obtain patent protection for inventions; 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 statements. 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.
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