Vectura Group plc Release: Phase 3 Data Show NVA237 Significantly Improves Lung Function with Good Safety Profile in COPD Patients
The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function (p<0.001).
The incidence of adverse events was similar in the NVA237 treated patients and in those receiving placebo. Detailed data will be presented at a scientific congress in H2 2011.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
“The fact that NVA237 achieved its primary endpoint in the GLOW1 Phase III study, producing statistically significant superior bronchodilation in lung function over placebo (p<0.001), provides encouraging evidence that NVA237 could offer important benefits for patients with COPD; a multi-billion dollar market that is still growing.”
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD. The first launch for QVA149; the combination of NVA237 with Novartis’ once-daily, long-acting beta2-agonist (LABA), indacaterol, is planned for 2013. Indacaterol is now approved in more than 50 countries and available in more than 20, with US approval dependent on an FDA decision expected in July 2011.
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Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Julia Wilson, Director of Investor Relations and Corporate Communications
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About the NVA237 Licence Agreement with Novartis
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. Novartis intends to launch NVA237 as a once-daily monotherapy for COPD and as a combination with its once-daily, long-acting beta-agonist (LABA), indacaterol, known as QVA149. Vectura believes that QVA149 could be the first once-daily LAMA/LABA combination to come to market for COPD. The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be a potent bronchodilator and, with convenient once-daily dosing as a co-formulation, has the potential to improve compliance and address a large and unmet need for COPD sufferers.
NVA237 entered Phase III trials in June 2009 followed by QVA149 in April 2010, triggering a total of $15m in milestone receipts to Vectura. Novartis received European regulatory approval for indacaterol (Onbrez® Breezhaler® - indacaterol maleate) in November 2009 and it is now approved in more than 50 countries and available in more than 20. US approval is dependent on an FDA decision expected in July 2011. To date, Vectura has received $30m from Novartis and, under the terms of the licence, could receive up to an additional $157.5m 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.
COPD is a progressive, life-threatening disease associated with tobacco smoking, air pollution or occupational exposure, which causes obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2020. Although often considered a disease of the elderly, research has shown that a majority of COPD patients are under the age of 65 when they are likely to be at the peak of their earning power and family responsibilities.
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 $25 billion. Vectura also develops products for other lung pathologies and non-respiratory diseases.
Vectura has six products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. 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.
Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK) and Otsuka. 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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