QVA149 Phase III COPD study meets primary endpoint

QVA149 ILLUMINATE Phase III COPD study meets primary endpoint and clarification of anticipated timing of US filings for NVA237 and QVA149

·; Superior lung function with once-daily QVA149 compared with twice-daily Seretide®1 

·; Study is part of IGNITE Phase III clinical trial program intended to form the basis of regulatory filings in COPD

·; US filings for NVA237 and QVA149 expected in 2014

Chippenham, UK - 24 April 2012:Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis that a fourth study in the IGNITE programme has met its primary endpoint. All four QVA149 Phase III studies have now met their primary endpoints, including the latest, ILLUMINATE, a head-to-head study against Seretide®, demonstrating its strong potential to address the unmet needs of patients with chronic obstructive pulmonary disease (COPD).

The ILLUMINATE study in more than 500 patients demonstrated superior lung function (measured by FEV1 AUC0-12h with a p value ® (fluticasone 500mcg / salmeterol 50mcg) in patients with moderate to severe COPD.

The studies, ILLUMINATE, SHINE, BRIGHT, and ENLIGHTEN, have all met their respective primary endpoints, and are part of the IGNITE clinical trial program intended to form the basis for filing of QVA149 in COPD in the EU, Japan and other countries. Three more QVA149 Phase III studies (SPARK, BLAZE and ARISE) are expected to complete in 2012. 

After discussions with the Food and Drug Administration (FDA), Novartis also confirmed today that they have agreed on the Phase III trial design for QVA149 as well as NVA237 for the US and that they expect the filing for NVA237 to take place at the beginning of 2014 with QVA149 following at the end of 2014.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

"The ILLLUMINATE study will be an important part of the regulatory submission for QVA149 and achieving superior lung function given once-daily compared with twice-daily Seretide® gives us more confidence in the potential of QVA149 in the treatment of patients with COPD. We now have clarity on US filing timelines for both NVA237 and QVA149 and we look forward to a decision from the EU regulators on NVA237 in the near future."

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1 Seretide® is a registered trademark of GSK

Notes for editors

About the NVA237/QVA149 Licence Agreement with Novartis

NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. Novartis expects 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. 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 fixed-dose combination, has the potential to improve compliance and address a large and unmet need for COPD sufferers.

Novartis received European regulatory approval for Onbrez®Breezhaler® in November 2009. In July 2011, Novartis announced approval of the 75 mcg once-daily dose 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 the QVA149 Phase III Studies

Data from three other studies in the IGNITE program were announced recently. SHINE demonstrated superiority in trough FEV1 (p1 (p

QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). Data from the IGNITE clinical trial program, examining QVA149 in a number of settings, will be submitted for presentation to a major medical congress later this year.

IGNITE is one of the largest international patient registration programs in COPD, comprising 10 studies in total. The first seven studies (ENLIGHTEN, BRIGHT, SHINE, ILLUMINATE, SPARK, BLAZE, ARISE) are expected to complete in 2012 and include more than 5,700 patients across 42 countries and support the planned filings in EU and Japan. These studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, dyspnoea and quality of life.

ILLUMINATE is a 26-week, multi-center, randomized, double-blind, double-dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 compared to fluticasone 500mcg/ salmeterol 50 mcg (Seretide®) in patients with moderate to severe stable COPD.

SHINE is a 26-week, multi-center, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with moderate to severe COPD to assess efficacy in terms of trough FEV1.

BRIGHT is a three-week, randomized, blinded, double-dummy, multi-center, placebo controlled, three-period crossover pivotal trial of 85 patients with moderate or severe COPD to assess the effect on exercise tolerance of QVA149.

ENLIGHTEN is a 52-week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate or severe COPD to assess the safety and tolerability of QVA149.

QVA149 would be the third innovation in the Novartis COPD portfolio to be delivered using the Breezhaler® Single Dose Dry Powder Inhaler, along with Onbrez® Breezhaler® (indacaterol) and investigational Seebri® Breezhaler® (glycopyrronium bromide/NVA237).

Onbrez® Breezhaler® (indacaterol maleate) is the only COPD treatment to offer clinically relevant 24-hour bronchodilation combined with a rapid onset of action at first dose and has shown significant symptomatic improvement especially on breathlessness. In March 2012, Novartis launched the 75 mcg once-daily dose in the US under the brand name Arcapta™ Neohaler™. It is also available as a 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.

Seebri® Breezhaler® (glycopyrronium bromide/NVA237) is an investigational long-acting muscarinic antagonist (LAMA) developed as a once-daily inhaled maintenance therapy for the treatment of COPD. It was submitted for regulatory approval in Europe in Q3 2011 and Japan in Q4 2011.

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide and is predicted to be the third leading cause of death by 2020. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted 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 $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

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