Ultibro Breezhaler delivers strong growth in Q3

Vectura Group plc

Ultibro® Breezhaler® continues to deliver strong underlying growth in Q3

Chippenham, UK - 24 October 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, confirms that Novartis Pharma AG ("Novartis"), has today reportedi Q3 2017 net sales of $101 million for Ultibro® Breezhaler® and $37 million for Seebri® Breezhaler®. Total reported net sales for Ultibro grew 6%, and were impacted by short term normalisation of stocking effects in certain territories outside Europe. In Europe, which accounts for the majority of reported net sales, Ultibro grew 18% year-on-year. Total Seebri net sales were in line with the comparative prior year quarter, as expected. The Vectura Board confirms its continued growth expectations for Ultibro's long term sales potential and outlook for recurring revenue generation for the Group.

James Ward-Lilley, Chief Executive Officer of Vectura commented:

"Ultibro remains the leading LAMA/LABA with greater than 50% share of total class sales outside the United States. The growth of the class and Ultibro's differentiated profile are reflected in its continued progression particularly in Europe. Net sales in Europe are growing strongly despite increasing competition, underpinned by notable performances in Germany and France. With strong growth in Europe, along with the recent US launches of Utibron Neohaler and Seebri Neohaler in the US by Sunovion, we remain confident in the outlook and future revenue generation for Vectura from these products."

The following is an excerpt from Novartis' Q3 2017 results showing headline net sales performance of both Ultibro and Seebri:

Ultibro Breezhaler (USD 101 million, +3% cc), a LAMA/LABA, grew driven by positive FLAME study results and the GOLD guidelines, which recommended LAMA/LABA as the preferred option in the majority of symptomatic patients regardless of their exacerbation risk. Ultibro Breezhaler, a first-in-class dual bronchodilator, is approved in over 90 countries, including Japan and EU countries. It is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide, and in the EU is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Seebri Breezhaler (USD 37 million, +2% cc), an inhaled LAMA is approved in over 100 countries and indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

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 Ultibro Breezhaler/Utibron Neohaler

Ultibro Breezhaler (indacaterol maleate/glycopyrronium bromide), a first-in-class dual bronchodilator, is approved in over 90 countries, including the EU and Japan. It is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide, and in the EU is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. In the US, it was approved in October 2015 as a twice-daily inhaled, fixed-dose combination of indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, under the brand name Utibron™ Neohaler®.

About LAMAs and LABAs

Long-acting bronchodilators currently are the first-line standard of care maintenance therapy for symptomatic patients with COPD.ii Within that class there are long-acting muscarinic antagonists (LAMAs) and long-acting beta agonists (LABAs), both of which are widely used and important therapeutic approaches. LAMA and LABA medicines dilate, or open, the airways in the lungs to reduce symptoms such as wheezing, cough, chest tightness and shortness of breath. Combining a LAMA and a LABA may offer additive benefits, including increased efficacy, compared with the LAMA or LABA alone. As a result, patients with increasing severity are often treated with both a LAMA and LABA. Total LAMA/LABA ex US sales MAT Q2 $783 millioniii.

About Seebri Breezhaler/Seebri Neohaler

Seebri Breezhaler (glycopyrronium bromide), an inhaled LAMA is approved in over 90 countries and indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with COPD. In the US, it was approved in October 2015 as a twice-daily inhaled monotherapy for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, under the brand name Seebri™ Neohaler® (glycopyrrolate 15.6 mcg).

Glycopyrronium and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

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.ii 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 alveolar abnormalities usually caused by significant exposure to noxious particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.ii Approximately 15.7 million adults in the US report that they have been diagnosed with COPD.iv It is estimated that several million more adults have undiagnosed COPD.v  COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the US.v  COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.iv 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.vi The symptoms of COPD can be most severe during the night and early morning.vii Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation.viii 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.ix

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.