Product approval

Vectura Group plc

US FDA approves new dual combination bronchodilator Utibron™ Neohaler® and stand-alone monotherapy Seebri™ Neohaler® for patients with chronic obstructive pulmonary disease

· Utibron™ Neohaler® (formerly QVA149;indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to placebo at 5 minutes after the first dose and throughout the dosing interval.1 It does not replace the use of a rescue inhaler

· Utibron™ Neohaler® also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo1

· Approval of Utibron™ Neohaler® brings an important new dual combination bronchodilator option to patients with chronic obstructive pulmonary disease (COPD)

· COPD, a chronic lung disease that makes it hard to breathe, affects nearly 27 million people and is the third leading cause of death in the US2,3,4,5

Chippenham, UK - 30 October 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 our alliance partner Novartis announcing that the US Food and Drug Administration (FDA) has approved the dual combination bronchodilator Utibron™ Neohaler® (indacaterol/glycopyrrolate) and the stand-alone monotherapy Seebri™ Neohaler® (glycopyrrolate) - which is one component of Utibron™ Neohaler®. Utibron™ Neohaler® and Seebri™ Neohaler® are approved for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

The approval of Utibron™ Neohaler® and Seebri™ Neohaler® triggers a $22.5m milestone payment from Novartis to Vectura.

James Ward-Lilley, Chief Executive of Vectura commented:

"The launches of Novartis' Ultibro® Breezhaler® and Seebri® Breezhler® ex-US have demonstrated the effectiveness of these products and the need for new treatment options for patients with COPD in the US. For the first 9M 2015, Novartis reported $297m in sales for these products which represented 174% growth. Once launched, the products will bring a new royalty stream for Vectura and we look forward to confirmation from our partner in due course on their plans for the commercialisation of these products."

COPD is a progressive and life-threatening lung disease that makes it difficult to breathe2. Nearly 27 million people in the US are affected by COPD3, which ranks as the third leading cause of death in the US4,5 and is a major cause of serious long-term disability6.

Novartis expects that Utibron™ Neohaler® and Seebri™ Neohaler® (formerly NVA237; glycopyrrolate) will be available in the first quarter of 2016.

The FDA's decision to approve Utibron™ Neohaler® is based on results of the phase III EXPEDITION trial program, which included 2,654 patients with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2) and one 52-week safety study (FLIGHT 3)1.

In the efficacy studies, Utibron™ Neohaler® demonstrated superior and sustained improvements in lung function (FEV1 AUC0-12)* at week 12, compared to its individual bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo, all dosed twice-daily1. Improvements in lung function were seen compared to placebo at 5 minutes after the first dose and sustained through the 12 hour dosing interval1. Utibron™ Neohaler® is not a rescue medication and is not indicated to treat asthma or sudden symptoms of COPD.

Utibron™ Neohaler® also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo1. Health status was assessed using the St. George's Respiratory Questionnaire (SGRQ)1 total score, which is a composite of symptoms, activities and impact on daily living..

Long-acting beta2-adrenergic agonists, such as indacaterol, one of the active ingredients in Utibron Neohaler, increase the risk of asthma-related death. Utibron™ Neohaler® is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. The most common adverse reactions seen in the efficacy studies (incidence greater than or equal to 1% and higher than placebo) were sore throat, runny nose, high blood pressure and back pain1. Adverse reactions reported in the long-term safety trial were generally consistent with those observed in the 12-week studies1.

Utibron and Seebri are delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.

About Utibron™ Neohaler®

Utibron™ Neohaler®, previously known as QVA149, is a twice-daily fixed-dose combination of the long-acting beta2-adrenergic agonist (LABA) indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, a long-acting muscarinic antagonist (LAMA). Glycopyrrolate 15.6 mcg is the active ingredient of Seebri™ Neohaler®. Utibron™ Neohaler®is not indicated to treat asthma or for the relief of sudden symptoms of COPD.

About Seebri™ Neohaler®

Seebri™ Neohaler®, previously known as NVA237, is a twice-daily long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Glycopyrrolate (also known as glycopyrronium bromide) was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

UTIBRON and SEEBRI are trademarks of Novartis AG. NEOHALER is a registered trademark of Novartis AG.

-Ends-

Enquiries

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.

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. Utibron™ Neohaler® (indacaterol and glycopyrrolate) inhalation powder. East Hanover, NJ: Novartis Pharmaceuticals Corporation, -October 2015.

2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2015. Available at http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Feb18.pdf. Accessed August 11, 2015.

3. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. Bethesda, Maryland: U.S Department of Health and Human Services, NIH, NHLBI. February 2012.

4. Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease. Page last updated: March 12, 2015. http://www.cdc.gov/copd/index.html. Accessed August 27, 2015.

5. Hoyert DL, Xu JQ. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012;61(6):1-65. Hyattsville, MD: National Center for Health Statistics.2012.

6. Sin DD, Stafinski T, NG YC, Bell NR, Jacobs P. The impact of chronic obstructive pulmonary disease on work loss in the United States. Am J RespirCrit Care Med. 2002; 165: 704-707.

7. Seebri™ Neohaler® (glycopyrrolate) inhalation powder. East Hanover, NJ: Novartis Pharmaceuticals Corporation, October 2015.

* FEV1 AUC0-12 is the repeated measurement over 12 hours of FEV1 (forced expiratory volume in 1 second), a common measure of lung function.