Vectura Group plc Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD
GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50 mcg, placebo, or once-daily open-label tiotropium 18 mcg*. They were also permitted to use COPD background therapy and rescue medication.
The study met its primary endpoint by demonstrating superior 24-hour bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function. NVA237 was delivered using the Concept1® device, a single-dose dry-powder inhaler.
NVA237 was also compared with open-label tiotropium (Spiriva® HandiHaler®**) 18 mcg, another once-daily long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show that NVA237 produced similar improvements in lung function to tiotropium.
Key secondary endpoints were improvement in breathlessness assessed using the Transition Dyspnea Index (TDI) at 26 weeks, and improved quality of life as measured by the St George’s Respiratory Questionnaire (SGRQ) at 52 weeks. Important secondary endpoints were time to first COPD exacerbation and use of rescue medication during 52 weeks of treatment. The study met all of these endpoints.
The GLOW2 study also showed that NVA237 was well-tolerated with a similar incidence of adverse events for patients treated with NVA237, placebo and open-label tiotropium. Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011.
In April 2011 Novartis announced results from the first Phase III clinical trial with NVA237. 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 (p<0.001). The incidence of adverse events was similar in NVA237-treated patients and in those receiving placebo. Further data from GLOW1 will be presented at the European Respiratory Society congress in Amsterdam in September 2011.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
“GLOW2 is the second NVA237 Phase III study to meet its primary endpoint and further endorses the benefit of NVA237 in COPD patients. We look forward to Novartis filing the product in 2011, followed by the filing of QVA149, the fixed-dose combination of NVA237 and indacaterol, expected to occur in 2012.”
*Note that GLOW2 included comparison with open-label tiotropium as an exploratory arm but the study was not powered to show statistical superiority of NVA237 versus tiotropium.
**Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.
Enquiries
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
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Ben Atwell
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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 in 2012 as a once-daily monotherapy for COPD and as a combination with its once-daily, long-acting beta-agonist (LABA), indacaterol, known as QVA149, in 2013. Vectura believes that it 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.
About COPD
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.
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 $25 billion.
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