Study shows Novartis Ultibro Superior to Seretide

Vectura Group plc

FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations

· Ultibro® Breezhaler® met primary endpoint and demonstrated superiority to Seretide® in reducing COPD exacerbations during 52 weeks of treatment

· First large-scale study to confirm Ultibro® Breezhaler® is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide® 

· Full FLAME study results to be shared by Novartis in 2016

Chippenham, UK - 16 November 2015: Vectura Group plc (LSE: VEC; "Vectura" or the "Company"), which specialises in the development of products for the treatment of airways-related diseases, confirms the information released today by Novartis announcing positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide®(salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.

This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.

The full FLAME study results, including data from further secondary endpoints, will be reported at an appropriate scientific forum in due course.

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About Vectura

Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth $44 billion worldwide.*

Vectura now has eight products marketed by partners with growing global royalty streams and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura currently has disclosed development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols, Janssen Biotech and Tianjin KingYork Group Company.

Vectura develops products for airways diseases and owns formulation and inhalation technologies that 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.

About FLAME

FLAME was a randomised, double-blind, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries1. The primary objective of the study was to demonstrate that Ultibro® Breezhaler® 110/50 mcg is non-inferior to salmeterol/fluticasone 50/500 mcg (SFC) in terms of rate of all COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment1.

Secondary endpoints for the study comparing Ultibro® Breezhaler® to SFC included superiority in terms of rate of all COPD exacerbations over the study duration and efficacy in terms of the following: time to first COPD exacerbation (mild/moderate/severe); rate and time to first moderate-to-severe COPD exacerbation; lung function (trough FEV1); health-related quality of life (as measured by the shortened version of the St George's Respiratory Questionnaire [SGRQ-C]); rescue medication use and safety1.

FLAME is the last of 11 studies in the IGNITE Phase III clinical trial program exploring Ultibro® Breezhaler® for the treatment of COPD.

About Ultibro® Breezhaler®

Ultibro Breezhaler 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 currently approved for use in over 70 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About the Novartis COPD portfolio

The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler®/ArcaptaTM NeohalerTM (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

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 limitation6. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly2,6.

About COPD

COPD affects an estimated 210 million people worldwide7 and is the third leading cause of death8. It is progressive (usually gets worse over time), and can be a life-threatening disease9,10. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life9,10. It 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 participation11,12.

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.

References

1. Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study (FLAME). NCT01782326. Available at: https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 22 October 2015].

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 22 October 2015].

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. 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.

7. Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf [Accessed 22 October 2015].

8. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 22 October 2015].

9. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf [Accessed 22 October 2015].

10. 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 22 October 2015].

11. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.

12. daCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280 [Accessed 22 October 2015].

*Decision Resources 2014

**a long-acting beta2-adrenergic agonist

 ***a long-acting muscarinic antagonist