VEC.L Regulatory News (VEC)

Vectura Group plc

Launch of SeebriTM Neohaler® in the US

Chippenham, UK - 19 October 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, confirms that Sunovion Pharmaceuticals Inc. ("Sunovion"), the US licensee of the Group's partner Novartis AG ("Novartis"), has launched the twice-daily long acting muscarinic inhibitor (LAMA) Seebri™ Neohaler® (glycopyrrolate 15.6mcg), in the US.

Sunovion entered into an exclusive license agreement with Novartis for the US commercialisation rights to three of Novartis' COPD treatments, including Seebri™ Neohaler® and Utibron™ Neohaler®, on 21 December 2016 and in April 2017 Sunovion confirmed it had launched the dual long acting bronchodilator and muscarinic combination therapy (LABA-LAMA) UtibronTM Neohaler®, in the US.

Vectura is eligible to receive royalties from Novartis on net sales of the product as well as certain milestones based on global calendar year combined net sales of Utibron™ Neohaler®, Seebri™ Neohaler®, Ultibro® Breezhaler® and Seebri® Breezhaler®. The royalties earned upon net sales of Seebri™ Neohaler® are the same as those for Seebri® Breezhaler®.

James Ward-Lilley, Chief Executive Officer of Vectura:

"Following the launch of Utibron in April we are pleased with the confirmation of launch of Seebri in the US. Whilst the commercial priority for 2017 has been securing market access and product listings we remain confident that Sunovion will be effective in the commercialisation of these products given its strong US respiratory track record and look forward to this being reflected in strong revenue growth in the US for these two products."

Ultibro® Breezhaler® Seebri® Breezhaler®,UtibronTM Neohaler®, Seebri™Neohaler® are trademarks of Novartis AG.

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About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. 

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams. The Group has a diverse portfolio of drugs in clinical development, including a number of novel and generic programmes which are partnered with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with two wholly owned nebulised development programmes.

About Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder

Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder, 15.6 mcg twice daily, is a long-acting muscarinic antagonist (LAMA) approved in the U.S. for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. SEEBRI NEOHALER is delivered by a dry powder inhaler (DPI), and its active ingredient, glycopyrrolate, has an established safety and efficacy profile. In clinical trials, SEEBRI NEOHALER improved lung function and showed reduced use of rescue medication and improvements in health-related quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, which is a composite of patient-reported symptoms, activities and impact on daily living.

The most common adverse reactions (≥1% and more common than placebo) reported in two 12-week clinical trials with SEEBRI NEOHALER (and placebo) were: upper respiratory tract infection, 3.4% (2.3%); nasopharyngitis, 2.1% (1.9%); urinary tract infection, 1.4% (1.3%); sinusitis, 1.4% (0.7%); oropharyngeal pain, 1.8% (1.2%).

About Long-Acting Muscarinic Antagonists (LAMAs)

A long-acting muscarinic antagonist (LAMA) is a type of long-acting bronchodilator, along with long-acting beta2 agonists (LABAs). According to the GOLD report, these are currently the first-line standard of care maintenance therapy for symptomatic patients with COPD, and help the muscles around the airways in lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness and shortness of breath.[i] LAMAs and LABAs are widely used and

important therapeutic approaches for people with COPD.

About COPD

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.i Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.[ii] It is estimated that several million more adults have undiagnosed COPD.[iii] COPD is responsible

for over 120,000 deaths per year, making it the third leading cause of death in the U.S.iii COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.ii Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.[iv] The symptoms of COPD can be most severe during the night and early morning.[v] Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation.[vi] Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality.[vii]

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.