Product Update - AirFluSal® Forspiro®

Vectura Group plc

AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus® in persistence to treatment 

· New study shows that rate of patient persistence using Sandoz AirFluSal® Forspiro® is twice as high as for reference product Seretide® Diskus®

· Study highlights importance of improving treatment "persistence" over time for long-term respiratory diseases

· Analysis, published in leading medical journal, is largest European Real-World Evidence study ever conducted in asthma and COPD

Chippenham, UK - 31 August 2016: Vectura Group plc (LSE: VEC) ("Vectura"), an industry-leading inhaled airways disease focused business, confirms the announcement made by its partner Novartis, that new data just published in a leading medical journal, shows for the first time that the rate of treatment persistence for patients using the innovative Sandoz AirFluSal® Forspiro® respiratory inhaler is more than twice as high as for the reference product.

The results are reported in the latest edition of the leading Journal of Allergy and Clinical Immunology: In Practice. The comparative analysis study is the largest European Real-World Evidence (RWE) study ever conducted in asthma and COPD (chronic obstructive pulmonary disease).

The study, entitled "Comparative analysis of persistence to treatment among patients with asthma or COPD receiving AirFluSal® Forspiro® or Seretide® Diskus® salmeterol / fluticasone propionate combination therapy", concluded that patients using the Sandoz device showed a persistence rate of 22.9%, compared to 10.5% for those using the reference product device.

The study was designed to retrospectively analyse persistence rates between the two devices, using dispensing datas from a large German pharmacy database. While retrospective database analyses have some limitations, the strengths of this data include the fact that 11,744 patients were included in a matched pair analysis, controlled for gender, age and month of treatment initiation (to limit seasonal effects).

All patients were first time users of salmeterol/fluticasone propionate and persistence to treat was analysed for a 12 month period.

AirFluSal Forspiro has been launched to date in approximately 30 countries, in Europe and elsewhere.

James Ward-Lilley, Vectura's CEO commented:

"This announcement is further validation of our expertise in the development of inhaled respiratory products. In order to improve patient experience with inhalation devices, Sandoz and Vectura collaborated closely with patients during the development process. The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing and a simple lever arm to load the dose."

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Enquiries

About AirFluSal® Forspiro®

[1] Seretide® and Diskus® are registered trademarks owned by Glaxo Group Ltd.

AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. Safety, efficacy and equivalence have been proven in multiple clinical trials.

It was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz's (a division of Novartis) global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura Group plc, a respiratory product development company, in the design and development of the product. The innovative and intuitive-to-use inhaler was invented at Vectura and its design was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.

In order to improve patient experience with inhalation devices, Sandoz and Vectura collaborated closely with patients during the development process. The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing and a simple lever arm to load the dose.

About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading inhaled airways disease focused business with proprietary formulation and devices across DPI, pMDI and smart nebulisation platforms. With our extensive range of technologies, capabilities and collaborations, we believe we can become a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. In June 2016 Vectura completed a merger with Skyepharma PLC.

Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Chiesi, Almirall, Janssen, and Tianjin KingYork.

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.