Vectura Group PLC : QVA149 Phase III Data

QVA149 phase III COPD studies met primary endpoints

·     Efficacy, safety and exercise endurance primary endpoints all met

·     Studies are part of IGNITE Phase III clinical trial program intended to form the basis of an NDA filing in COPD

·     QVA149, a bronchodilator with dual mode of action, is Novartis' third innovation in its Breezhaler®Single Dose Dry Powder Inhaler

·     COPD is predicted to be the third leading cause of death in the world by 2020

Chippenham, UK - 2 April 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis that the first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.The SHINE, BRIGHT and ENLIGHTEN studies, which are part of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.

The results of SHINE, with an enrolment of more than 2,100 patients, met the primary endpoint, demonstrating the superiority in trough FEV1 (p<0.001) of="" once-daily="" qva149="" compared="" to="" once-daily="" indacaterol="" or="" once-daily="" nva237="" in="" patients="" with="" moderate="" to="" severe="" copd.="" in="" addition,="" qva149="" showed="" superiority="" in="" trough="">1 (p<0.001) compared="" to="" placebo="" and="" open-label="" tiotropium="" (18="" mcg).="">

The results of BRIGHT showed that patients experienced significantly better exercise endurance versus placebo (p=0.006). ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

"Achieving the primary endpoints in all three of the Phase III studies gives us confidence that QVA149 could be the first LAMA/LABA combination product to provide benefit to patients with COPD in a multi-billion dollar market that is still growing."

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.  Included in the programe is a head-to-head trial vs Seretide®1 (ILLUMINATE), which is also expected to complete during the second quarter of 2012 and will be incorporated into regulatory filings. These studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, dyspnoea and quality of life.

- Ends -

1Seretide® is a registered trademark of GSK

Enquiries

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

SHINE is a 26-week, multicenter, 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) is an investigational long-acting muscarinic antagonist (LAMA) developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that Seebri increased patients' lung function over a 24-hour period compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. 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 atwww.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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