Results for VR475 in severe uncontrolled asthma

Vectura announces results for late stage clinical asset VR475 in severe uncontrolled asthma

Chippenham, UK - 26th November 2018: Vectura Group plc (LSE: VEC) ("Vectura" or the "Group") announces that its phase III study of VR475 in adult and adolescent patients with severe uncontrolled asthma did not meet its primary endpoint.

VR475 is a drug device combination consisting of budesonide delivered by Vectura's proprietary nebuliser inhalation system.

Top-line results indicate a trend in the reduction of the annualised rate of clinically significant exacerbations among patients receiving either VR475 1mg or VR475 0.5mg doses twice daily during a 52-week treatment period compared to placebo, but the results did not reach statistical significance. The open label arm with conventional nebuliser also failed to reach statistical significance vs placebo.

Available safety data for VR475 are consistent with the known profile of inhaled budesonide.

Based on these results, Vectura has decided to not pursue further the development and partnering of VR475. The company will complete the full analysis of the primary and secondary data and intends to present the complete study results at an upcoming medical conference and seek to have the data published in a peer-reviewed journal.

An initial review of the available secondary endpoints and the safety data show certain endpoints achieving statistically significant and clinically meaningful differences between VR475 and placebo, and versus conventionally nebulised budesonide. These results reinforce the differential characteristics of our guided inhalation system versus conventional nebulisation, and confidence in the ongoing VR647 programme and three additional early stage nebulisation programmes, using non- budesonide molecules, announced earlier this year.

Principal Investigator Professor Tim Harrison, of the Faculty of Medicine and Health Sciences at the University of Nottingham, said: "The study outcome is disappointing, however the primary endpoint in this difficult-to-treat patient population presented a high hurdle from the outset. The results suggest that in these study patients with severe asthma, nebulised budesonide is not an appropriate treatment alternative to biologic therapy. Whether there is a specific severe asthma phenotype who could gain greater benefit remains a distinct possibility. I believe the technology behind VR475 has the potential to be beneficial in the treatment of a wide range of respiratory diseases including asthma."

Gonzalo de Miquel, Vectura's Chief Medical Officer & Executive Vice President Development, said: "Although we are disappointed that these results missed statistical significance, I remain confident in our proprietary technology and development capabilities. Vectura remains fully committed to enhancing respiratory medications by developing better formulations and superior inhalation systems for patients. I would like to thank patients, caregivers, investigators and our staff for their participation in what has been a well conducted and executed study."

Financial impact: As part of the acquisition of Activaero in March 2014, Vectura recognised an intangible asset for the VR475 programme. Following the results of this study, this asset will be fully impaired in the current financial year, resulting in a negative impact on the Group's loss before tax of £40m, and loss after tax of £29m. With respect to 2019, we expect the net impact to EBITDA of revenue and R&D cost movements, to be broadly neutral, as a result of our decision to cease development of VR475. R&D guidance for 2019 will be communicated as part of a trading update early in the New Year.

Ends

Conference Call

James Ward-Lilley, Chief Executive Officer, will be joined by Paul Fry, Chief Financial Officer, and Gonzalo de Miquel, Chief Medical Officer, for a live conference call today at 09.30 GMT to discuss the results. A copy of the presentation will be available on Vectura's website 30 minutes before the call. Link: http://www.vectura.com/investors/presentations-webcasts/

Dial-in details:

Participant local dial-in: 084457 18892 (UK) and 1 631 510 7495 (US)

Participant free phone dial-in: 0800 376 7922 (UK) and 1 866 966 1396 (US)

International dial-in: +44 (0) 2071 928000

Conference ID: 2386984

For more information

About the study

The phase III study was a randomised, double-blind placebo-controlled study which assessed the efficacy and safety of two doses of nebulised budesonide delivered by the VR475 inhalation system (VR475 1mg and VR475 0.5mg) versus placebo, with an open-label comparison to conventionally nebulised budesonide. The study was conducted in 713 patients from 7 European countries, the Ukraine and the Philippines. The patients had severe, uncontrolled asthma in spite of stable high doses of inhaled corticosteroids plus a second controller medication. The primary endpoint was the annualised rate of clinically significant exacerbations during a 52-week treatment period. The study was powered at 80% to show (>40%) superiority vs. placebo for the VR475 1mg treatment arm on the Primary Endpoint.

About severe asthma

Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids) to prevent it from becoming 'uncontrolled' or which remains 'uncontrolled' despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids. In the EU 45 % of all asthmatic patients are uncontrolled with severe uncontrolled[i] asthma-related healthcare costs accounting for > 50 % of the overall asthma-related costs[ii].

About Vectura

Vectura is an industry-leading inhaled product formulation, device design and development business offering a uniquely integrated inhaled drug delivery platform. We develop inhalation products to help patients suffering from airways diseases.

Vectura has eight key inhaled, two non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork.

Vectura's strategy is to fully leverage its differentiated technology and skills, maximising value by enhancing the delivery and performance of inhaled products and through the development of high-quality generic alternatives to branded therapies.

For further information, please visit Vectura's website at www.vectura.com