Ultibro Breezhaler superior efficacy vs Seretide

Vectura Group plc

Ultibro® Breezhaler® showed superior efficacy versus Seretide®* for COPD patients in second head-to-head study, and the anticipated timing of China filing

· Ultibro® Breezhaler® demonstrated superiority in lung function compared to Seretide® Accuhaler®* in chronic obstructive pulmonary disease (COPD) patients with or without exacerbations in the previous year

· Primary and key secondary objectives met in pivotal Phase III LANTERN study

· Positive results to be part of the regulatory submission for Ultibro Breezhaler in China later this year

Chippenham, UK - 30 April 2014: Vectura Group plc (LSE: VEC) ("Vectura"), confirms the information released today by Novartis announcing positive first results from the Phase III head-to-head LANTERN study, which showed the superiority of once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg in improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone (SFC)) 50/500 mcg in COPD patients with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler met both the primary and key secondary objectives.

The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to SFC in terms of lung function (trough FEV1) after 26 weeks of treatment in patients with moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. These results will be part of the regulatory submission of Ultibro Breezhaler in China later this year.

The LANTERN study also showed superiority of Ultibro Breezhaler compared to SFC for the key secondary objective of lung function (FEV1 AUC0-4h) over the first four hours post dose at week 26. The safety and tolerability profile of Ultibro Breezhaler was comparable to SFC.

COPD is a major public health concern in China, ranking first in terms of the country's disease burden1. Recent estimates suggest that in China over 40 million people have COPD2 and the overall prevalence in people aged 40 years or older is 8%1.

COPD symptoms can have a major, negative impact on a patient's ability to breathe and function and they reduce their quality of life3. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens4. There is a need for new treatment options in COPD because many patients remain symptomatic despite medical therapy5.

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Enquiries

About LANTERN and ILLUMINATE studies

LANTERN was a randomized, double-blind, parallel-group, 26-week study conducted at 56 sites across China, Argentina, Chile and Taiwan6. The study randomized 741 patients to assess the efficacy and safety of Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg compared to SFC 50/500 mcg in patients with moderate-to-severe COPD6, with or without exacerbations in the previous year.

ILLUMINATE was the first study to demonstrate that Ultibro Breezhaler achieved superior lung function in patients with moderate-to-severe COPD and no history of exacerbations in the previous year, compared with twice-daily salmeterol/fluticasone 50/500 mcg7 administered with the Accuhaler®* dry powder inhaler.

About Ultibro® Breezhaler®

Ultibro Breezhaler (indacaterol/glycopyrronium bromide) is a novel, once-daily dual bronchodilator approved in the EU as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD8. Clinical trials have shown that Ultibro Breezhaler offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg, in patients with no history of moderate or severe exacerbations over the last year9-11 and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 30 countries, including the EU, Japan, Canada and Australia.

About the NVA237/QVA149 License Agreement with Novartis

NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. To date, Vectura has received $65m from Novartis and, under the terms of the license, could receive up to an additional $122.5m 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.

Novartis COPD Portfolio

The Novartis COPD portfolio includes Onbrez® Breezhaler®/ArcaptaTM NeohalerTM (indacaterol), Seebri® Breezhaler® (glycopyrronium bromide) and Ultibro Breezhaler (indacaterol/ glycopyrronium bromide), which are all indicated as maintenance treatments for COPD patients.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation12. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly12,13.

Ultibro®,Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.

About COPD

COPD is a progressive life-threatening disease that makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life3,14. It affects an estimated 210 million people worldwide15 and is projected to be the third leading cause of death by 202014. COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation16,17.

About Vectura

Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $46 billion worldwide.18

Vectura has eight products marketed by its partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has disclosed development collaborations and licence agreements with several pharmaceutical and biotechnology companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company Limited.

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.

\* The LANTERN study used Seretide®(salmeterol/fluticasone) 50/500 mcg, which is indicated in the UK for the symptomatic treatment of patients with COPD, with a FEV1 18. The patient population in the LANTERN study who received salmeterol/fluticasone administered via the Accuhaler® dry powder inhaler, were moderate-to-severe COPD patients with or without exacerbations in the previous year. Seretide® is also known as Advair® and Accuhaler® is also known as Diskus®. Seretide®, Advair®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies.

References

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12. Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527-2533. doi:10.1185/03007995.2010.518916.

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18. Pharmaview Commercial Landscape Series Respiratory Decision Resources 2014