Ultibro Breezhaler improved lung function

Ultibro® Breezhaler® improved lung function and COPD symptoms after direct switch from previous treatment

· Ultibro® Breezhaler® improved lung function and breathlessness after direct switch from long-acting bronchodilators or steroid-containing combination therapies

· Results further support the 2017 GOLD recommendations that dual bronchodilation should be the foundation treatment for the majority of symptomatic COPD patients

· Data from the pragmatic CRYSTAL study showcased for the first time at the 2016 British Thoracic Society Winter Meeting in London, UK

Chippenham, UK - 8 December 2016: Vectura Group plc (LSE: VEC) (gVecturah, gthe Grouph), an industry-leading inhaled airways disease focused business, confirms the announcement by Novartis of positive results from the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments, including steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg.

In the CRYSTAL study, patients with moderate COPD who were switched to Ultibro Breezhaler from their previous therapy (LABA+ICS or LABA or LAMAõ) experienced superior improvements in lung function (trough FEV1) and breathlessnessǂ at week 12 (p1.

Ultibro Breezhaler was also well tolerated in the CRYSTAL study1.

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Enquiries

About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading inhaled airways disease focused business with proprietary formulation and devices across DPI, pMDI and smart nebulisation platforms. With our extensive range of technologies, capabilities and collaborations, we believe we can become a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. In June 2016 Vectura completed a merger with Skyepharma PLC.

Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Chiesi, Almirall, Janssen, and Tianjin KingYork.

For further information, please visit Vectura's website at www.vectura.com.

About CRYSTAL

CRYSTAL was a prospective, multicenter, 12-week, randomized, pragmatic, open-label trial. Patients were recruited into four groups according to previous medication and symptoms, and randomized to a direct switch to Seebri® Breezhaler® (glycopyrronium) 50 mcg or Ultibro® Breezhaler® (indacaterol/glycopyrronium)110/50 mcg once daily vs. continuation of previous treatment. The study enrolled a total of 4,389 symptomatic, non-frequently exacerbating (up to one exacerbation in the previous year) patients with moderate COPD and 2,159 patients received Ultibro Breezhaler or continued their baseline therapy. The Seebri Breezhaler treatment arms of the study were underpowered due to sample size.

Co-primary objectives of the study were:

• Superiority of Ultibro Breezhaler vs. LABA, LAMA and LABA+ICS in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12.

• Superiority of Seebri Breezhaler vs. previous SABA and/or SAMA˜ treatment in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12

• Non-inferiority of Seebri Breezhaler vs. previous LABA or LAMA treatment in terms of improvement of lung function (trough FEV1) and breathlessness (transition dyspnoea index) at week 12.

About Ultibro Breezhaler

Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg is a once-daily LABA/LAMA dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD2. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg3-5 and open-label tiotropium (18 mcg). Ultibro Breezhaler is also currently the only steroid-free treatment to offer prescribers clinically proven superiority over the most prescribed ICS/LABA combination** in preventing COPD exacerbations6. Ultibro Breezhaler is currently approved for use in over 90 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About Seebri Breezhaler

Seebri Breezhaler (glycopyrronium) 50 mcg is a once-daily LAMA bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD7. Seebri Breezhaler is approved for use in over 90 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

Glycopyrronium and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

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 limitation8. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly2,8.

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

About COPD

Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide9 and is the third leading cause of death10. It is progressive (usually gets worse over time), and can be a life-threatening disease9,11. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patientsf function (i.e. activity limitation, decreased mobility) and quality of life9,11.

Notes

1 Long-acting beta2-adrenergic agonist + inhaled corticosteroid (free or fixed-dose combinations)

õ Long-acting muscarinic antagonist

ǂ Transition dyspnea index (TDI)

˜ Short-acting beta agonist and/or short-acting muscarinic antagonist

** Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder. Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies

References

1. Vogelmeier C, Aalamian-Mattheis M, Greulich T, et al. Efficacy and safety of the direct switch from various previous treatments to glycopyrronium or indacaterol/glycopyrronium in patients with moderate COPD: The CRYSTAL Study. Abstract presented at the British Thoracic Society Winter Meeting: 6 December 2016

2. Ultibro Breezhaler EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf [Accessed 21 November 2016].

3. Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].

4. Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].

5. Banerji D, et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30].

6. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 21 November 2016].

7. Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 19-Oct-2016. Available at: http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44mcg/ [Accessed 21 November 2016].

8. Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26; 11:2527-2533.

9. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 21 November 2016].

10. World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 21 November 2016].

11. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. Available at: http://goldcopd.org/ [Accessed 21 November 2016].

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.