VEC.L Regulatory News (VEC)

flutiform® receives positive opinion in Europe for the Treatment of Children with Asthma

Mundipharma's combination treatment will soon be available in Europe as a maintenance treatment for asthma in children aged 5 to <12 years

Chippenham, UK - 9 November 2018: The Mundipharma global network of independent associated companies has announced that the European Decentralised Procedure (DCP) for flutiform® for the treatment of asthmatic children has closed with a positive opinion.

flutiform® is now indicated at a dose of two puffs (actuations) 50/5 µg for regular twice-daily, maintenance treatment of asthma in children aged 5 to [1].

The existing flutiform® pMDI (pressurised metered dose inhaler) combination treatment was developed by Vectura and launched in 2012 in Europe and ROW by Mundipharma, and in 2013 in Japan by Kyorin.

Gonzalo de Miquel, Chief Medical Officer and Executive Vice president Development, Vectura, commented: "flutiform® is already a well-established treatment for asthma in adults and adolescents, and this approval will provide children suffering from uncontrolled asthma with a much-needed treatment option. Use of pressurised metered dose devices is common in the paediatric setting. flutiform® remains a key growth driver for Vectura and, together with the recent launch of the enhanced flutiform®k-haler® device in September, this approval further reinforces flutiform® lifecycle management".

flutiform® has been available in Europe for the treatment of asthma in adults and adolescents (≥12 years old) since 2012 and has a tolerability profile supported by extensive clinical evidence and real-world use for six years across Europe and Asia-Pacific regions in this age group.

Vectura earns revenue from product supply and royalties from in-market net sales. In 2017 flutiform® generated total product supply and royalty revenue for Vectura of £68.5 million.

For further information on the DCP's positive opinion for flutiform®, please visit Mundipharma's website at https://www.mundipharma.com/category/media-release/

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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.

® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence

® K-HALER is a registered trade mark of Mundipharma