NDA acceptance for QVA149 and NVA237

Vectura Group plc

US FDA filing acceptance of NDAs for QVA149 and NVA237

Chippenham, UK - 5th March 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms that Novartis' New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) have been accepted for review by the US Food and Drug Administration (FDA). The filings were submitted by Novartis in Q4 2014. The acceptances trigger milestone payments to Vectura of $12.5m and $7.5m respectively.

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Enquiries

About QVA149

Twice-daily QVA149 (indacaterol/glycopyrronium bromide), 27.5/12.5 mcg, has been submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro® Breezhaler® 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD1. Once-daily Ultibro® Breezhaler® is currently approved for use in over 50 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia.

About NVA237

Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, has been submitted for US registration only. Outside of the US, NVA237 has been developed/marketed as Seebri® Breezhaler® 50 mcg, which is a once daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD and is approved for use in over 70 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia2.

Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

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

About COPD

COPD is associated with chronic morbidity and mortality and The World Health Organization (WHO) estimates that 210 million people worldwide have COPD3. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed4. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 20105 and is now also the third leading cause of death worldwide6.

COPDis progressive (usually gets worse over time), and can be a life-threatening disease3. It makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life5. 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 participation7,8.

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 in excess of $46 billion worldwide.9

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 license 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.

References

1. Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf [Accessed 23 July 2014].

2. EMA (2012). Seebri Breezhaler EU Summary of product characteristics. [Online] Revised 28 September 2012 http://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44mcg/ [Accessed 1 August 2014].

3. Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed on 17 November 2014].

4. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/respiratory/copd/en/ [Accessed 12 December 2014]

5. National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf. [Accessed 09 December 2014].

6. World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. http://www.who.int/mediacentre/factsheets/fs310/en/ . [Accessed 09 December 2014].

7. 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 17 November 2014].

8. 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.

9. Pharmaview Commercial Landscape Series Respiratory Decision Resources 2013

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.