Approval of Ultibro Inhalation Capsules in Japan

Vectura Group plc

Approval of once-daily dual bronchodilator Ultibro® Inhalation Capsules in Japan (QVA149) for the treatment of COPD

· Once-daily Ultibro® Inhalation Capsules (QVA149) (glycopyrronium / indacaterol), delivered through the Breezhaler® device, approved for relief of various symptoms due to airway obstruction in COPD

· IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care1

· QVA149 significantly reduced the rate of all COPD exacerbations compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg2,3

Chippenham, UK - 20 September 2013: Vectura Group plc (LSE: VEC) ("Vectura"), confirms that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Novartis' once-daily Ultibro® Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered through the Breezhaler® device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). Ultibro® Inhalation Capsules were developed under the name of QVA149 and will be available to the 5.3 million Japanese patients who may be living with COPD4.

Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments; the LABA*, Onbrez® Inhalation Capsules (indacaterol), and the LAMA**, Seebri® Inhalation Capsules (glycopyrronium bromide). Both these components are delivered through the Breezhaler® device, as is QVA149, and are widely available in many countries around the world including Japan.

The efficacy and safety of QVA149 is supported by the comprehensive IGNITE Phase III clinical trial program, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries1-3,5-14.

In July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for approval of QVA149. US submission is anticipated at the end of 2014.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

"The approval in Japan of QVA149, delivered through the Breezhaler® device is an important first step towards making new treatment options available globally for patients with COPD. This innovative, once-daily therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life. The approval of QVA149 in Japan further de-risks Vectura's business strategy and brings a new royalty stream from a first in class asset, as well as triggering a $2.5 million milestone to Vectura."

About QVA149

QVA149 is an inhaled, once-daily, fixed-dose combination of glycopyrronium bromide and indacaterol maleate being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE was one of the largest international clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52 countries1-3,5-14. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 20121-3,5-9. The studies were designed to investigate efficacy (lung function, exercise endurance, exacerbations, shortness of breath and quality of life), safety and tolerability of patients treated with QVA149,1-3,5-12.

\* Total refers to all 11 IGNITE studies.

Results from the Phase III IGNITE trials have demonstrated statistically significant improvements in bronchodilation with QVA149 versus several treatments1-3,5 widely used as current standards of care. Data showed that QVA149 significantly improved lung function compared to OL tiotropium 18 mcg, fixed dose combination SFC 50 mcg / 500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo providing a rapid onset of action within five minutes, and sustained bronchodilation during a 24 hour period which was maintained for up to 26 weeks1. In the IGNITE phase III trial program, QVA149 also showed symptomatic improvements versus placebo in COPD patients1,5,7. These symptomatic improvements included breathlessness, exercise tolerance, rescue medication use and health-related quality of life1,2,5. QVA149 also significantly improved the rate of all COPD exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg1-3,5-9.

In clinical studies, QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, salmeterol / fluticasone (SFC) 50 mcg / 500 mcg) in the incidence of adverse and serious adverse events1-3,5. The safety profile was characterized by typical anticholinergic and beta-adrenergic effects related to the individual components of the combination

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

About COPD

COPD is a chronic, progressive lung disease that is commonly caused by tobacco smoking, air pollution or occupational exposure, and results in airflow obstruction and debilitating bouts of breathlessness15. Although the latest figures show only 173,000 people have been diagnosed with COPD in Japan16, epidemiological data suggest that the total number of patients could be as high as 5.3 million4. There are concerns that the number of patients could grow in Japan where smoking rates are high and many people are starting to smoke at an increasingly early age.

References 

1. Bateman ED, Feruson GT, Barnes N et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. European Respiratory Journal [Published on May 30 2013]. doi: http://dx.doi.org/10.1183/09031936.00200212. [Accessed 12 September 2013].

2. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1): 51-60.

3. Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respiratory Medicine 2013;1(3): 199-209.

4. Fukuchi, et al. The Nippon COPD Epidemiology (NICE) Study. Respirology 2004.

5. Beeh K et al. QVA149 once daily improves exercise tolerance and lung function in patients with COPD: the BRIGHT study. Thorax. 2012;67(2) A147.

6. Dahl R et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respiratory Medicine Journal 2013.. 107:1558-1567.

7. Mahler D et al. Superior lung function with once-daily QVA149 translates into improvements in patient reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session C20; Date: May 21, 2013 Time: 8:15-10:45].

8. ClinicalTrials.gov, n.d. Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) (ARISE). [Online] Available at: http://www.clinicaltrials.gov/ct2/show/NCT01285492?term=%28ARISE%29&rank=4. [Accessed 12 September 2013].

9. ClinicalTrials.gov, n.d. Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BEACON). [Online]Available at: www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6. [Accessed 12 September 2013].

10. ClinicalTrials.gov, n.d. Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation (RADIATE). [Online] Available at: www.clinicaltrials.gov/ct2/show/NCT01610037?term=GLISTEN&rank=1. [Accessed 12 September 2013].

11. ClinicalTrials.gov, n.d. A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. [Online]. Available at: www.clinicaltrials.gov/ct2/show/NCT01709903?id=01709903&rank=1. [Accessed 12 September 2013].

12. ClinicalTrial.gov, n.d. A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD (FLAME). [Online] Available at: http://clinicaltrials.gov/ct2/show/NCT01782326?term=COPD+novartis+52&rank=2. [Accessed 12 September 2013].

13. FDA Access Data, n.d.Spiriva Medical Review Part 2. [Online]Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm. [Accessed 12 September 2013].

14. FDA Access Data, 2003.Advair Medical Review. [Online]Available at: www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf. [Accessed 12 September 2013].

15. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. [Accessed 12 September 2013].

16. Patient Study 2008. Ministry of Health, Labor and Welfare.

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Enquiries

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. It is an investigational LAMA developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW1, 2 and 3 studies demonstrated that glycopyrronium bromide increased patients' lung function over a 24-hour period compared to placebo with a rapid onset of action at first dose, and improved exercise endurance versus placebo. Seebri® Breezhaler® has been launched in the UK, Germany, and is currently being rolled out across other countries. Seebri® Inhalation Capsules were launched in Japan in Q4 2012. QVA149, (glycopyrronium / indacaterol), as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) is a fixed-dose combination with indacaterol (Onbrez® Breezhaler®),a once-daily inhaled long-acting beta2-adrenergic agonist (LABA) and glycopyrronium bromide(Seebri® Breezhaler®), a once-daily inhaled long-acting muscarinic antagonist (LAMA). The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be an effective bronchodilator and, with convenient once-daily dosing as a fixed-dose combination, has the potential to improve patient compliance and address a large and unmet need for COPD sufferers.

To date, Vectura has received $52.5m from Novartis and, under the terms of the license, could receive up to an additional $135m 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.

All of the Novartis COPD portfolio products are being developed for delivery via the Breezhaler® device, a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it particularly suitable for patients with airflow limitation, such as COPD patients. The Breezhaler® device allows patients to hear, feel and see that they have taken the drug correctly.

About Vectura

Vectura Group plc and its subsidiaries ("Vectura" or the "Group") is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway-related diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $30 billion worldwide.

Vectura has seven 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 development collaborations and license agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK) and Tianjin King York Group Company Limited (KingYork).

Vectura seeks to develop certain programmes itself where this will optimize 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 commercialization 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 commercialize 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 commercialization 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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