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Vectura Group plc (VEC.L) Release: New Data Presented at the American Thoracic Society Meeting Highlights Strength of Once-Daily COPD Portfolio in Improving Lung Function, Shortness of Breath and Reducing Rate of Exacerbations



5/21/2013 9:36:19 AM

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Chippenham, UK – 21 May 2013: Vectura Group plc (LSE: VEC) (“Vectura”), confirms the information released today by Novartis announcing that new data from the chronic obstructive pulmonary disease (COPD) portfolio were presented today at the American Thoracic Society (ATS) International Conference May 17-22, 2013 in Philadelphia, PA, USA. In total, 27 abstracts were presented, featuring latest findings from the IGNITE clinical trial program including BLAZE1 and SPARK2,3,6,7 studies, plus data from pooled GLOW1 and 2 studies4,8,9,10.

The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) when compared to placebo and blinded tiotropium 18 mcg1. The SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg2,3.

Dr Chris Blackwell, Chief Executive of Vectura, commented: "COPD is a progressive, debilitating disease, and a growing multi-billion dollar market. We are very encouraged by the substantial body of IGNITE and GLOW data presented at the American Thoracic Society meeting, which further underlines the potential of QVA149 to improve lung function, shortness of breath and reduce exacerbations in COPD patients, which is of significant benefit for patients.”

COPD affects an estimated 210 million people worldwide11 and is projected to be the third leading cause of death by 20205. New treatments which effectively manage COPD are very important to patients and physicians, as COPD can impose a significant burden on patients and reduce quality of life12,13.

The BLAZE study showed that after six weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus both placebo (p<0.001) and tiotropium 18 mcg (p=0.021)1. BLAZE was the first study to evaluate direct electronic patient self-reported shortness of breath and showed that QVA149 significantly improved lung function versus placebo and tiotropium 18 mcg (as demonstrated by mean FEV1) at all-time points (45 minutes pre-dose to four hours post-dose) after six weeks of treatment (p<0.001)1.

The SPARK study, recently published in Lancet Respiratory Medicine14, demonstrated that QVA149 significantly reduced the rate of all COPD exacerbations (mild, moderate and severe) by 15% versus glycopyrronium 50 mcg (p=0.0012) and 14% versus OL tiotropium 18 mcg (p=0.0017)2,3. The primary endpoint of the study was also met since QVA149 demonstrated a significantly reduced rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038)2,3. The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg2,3. SPARK also showed that patients receiving QVA149 had substantially improved lung function (measured by trough FEV1) compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg (both p<0.0001)2,6. In addition, QVA149 showed significant differences in healthrelated quality of life as demonstrated by St George’s Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium 50 mcg (p<0.01) and OL tiotropium 18 mcg (p<0.05)2,6.

All treatments in the BLAZE and SPARK studies had an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse or serious adverse events1,2,7. In a pooled analysis of GLOW1 and GLOW2 data, once-daily glycopyrronium 50 mcg (Seebri® Breezhaler®) demonstrated significant improvements in lung function during first 4 hours following morning administration (measured by FEV1 AUC0-4h) versus placebo and OL tiotropium 18 mcg, at Day 1, 12 weeks and 26 weeks4. Once-daily glycopyrronium 50 mcg also demonstrated sustained improvements in lung function (measured by trough FEV1) versus placebo over the long term4. Glycopyrronium 50 mcg was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium 18 mcg9.

Enquiries

Vectura Group plc +44 (0)1249 667700

Chris Blackwell, Chief Executive

Anne Hyland, Chief Financial Officer

Karl Keegan, Corporate Development Director

FTI Consulting +44 (0)20 7831 3113

John Dineen / Ben Atwell / Simon Conway

About the study designs

BLAZE was a 6-week, multicenter, blinded, double-dummy, placebo-controlled, 3-period crossover study1. Patients with moderate to severe COPD (N=247) were randomized to once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg), tiotropium 18 mcg or placebo to assess the effect of QVA149 on patient self-reported shortness of breath1.

SPARK was a 64-week, multicenter, double-blind, parallel-group, active controlled study assessing QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50 mcg and OL tiotropium 18 mcg on the rate of moderate to severe COPD exacerbations in 2,224 patients, =40 years with severe to very severe COPD14.

GLOW1 and GLOW2 were multicenter, randomized, double-blind, placebo-controlled, parallel group studies in patients with moderate to severe COPD15,16. GLOW1 was a 26 week study with 822 patients randomized to receive once-daily glycopyrronium 50 mcg (Seebri® Breezhaler®) or placebo15. GLOW2 was a 52 week study with 1,066 patients randomized to receive once-daily glycopyrronium 50 mcg or placebo, and included an exploratory arm to compare the effects of once-daily OL tiotropium 18 mcg versus placebo and glycopyrronium 50 mcg16.

About Onbrez® Breezhaler®

Onbrez® Breezhaler® (indacaterol maleate) is a long-acting beta2-agonist (LABA) that offers clinically relevant 24-hour bronchodilation combined with a rapid onset of action within five minutes at first dose, as demonstrated in the INERGIZE Phase III trial program17-31. Onbrez Breezhaler 150 mcg once-daily provided greater clinical benefit in terms of reduced shortness of breath, lower use of rescue medication and improved health status, compared with blinded tiotropium bromide 18 mcg28. Onbrez Breezhaler is approved in more than 100 countries around the world for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD32. It was first launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals in markets worldwide including Japan (Onbrez® Inhalation Capsules 150 mcg once-daily) and US (ArcaptaTM NeohalerTM 75 mcg once-daily).

About Seebri® Breezhaler®

Once-daily Seebri® Breezhaler® (glycopyrronium bromide) is a novel inhaled long-acting muscarinic antagonist (LAMA; also referred to as a long-acting anticholinergic) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD33. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium bromide 50 mcg delivered rapid and significant sustained improvements in lung function (measured by mean FEV1) post-morning dose on Day 1 compared with placebo and sustained this for 24 hours over 52 weeks, and significantly improved exercise endurance versus placebo15,16,34. There are eleven approvals for once-daily Seebri Breezhaler (glycopyrronium bromide) including Japan, the European Union, Canada, and Australia. Worldwide submissions and reviews of once-daily Seebri Breezhaler (glycopyrronium bromide) are ongoing.

About QVA149

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN) with more than 7,000* patients across 42 countries14,32,35-45. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE**, ARISE, BEACON**) have already completed in 2012. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life. *Total refers to all 10 IGNITE studies.

**BLAZE & BEACON were not included within the Q4 2012 filings to the EU and Japan. Onbrez Breezhaler and Seebri Breezhaler are registered trademarks of Novartis AG.

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients’ function and quality of life5,46. It affects an estimated 210 million people worldwide11 and is projected to be the third leading cause of death by 20205. 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 participation12.

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 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 alliance 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 licence 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 optimise value. Vectura’s formulation and inhalation technologies are available to other pharmaceutical companies on an outlicensing basis where this complements Vectura’s business strategy. For further information, please visit Vectura’s website at www.vectura.com.



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