QVA149 marketing application filed in Japan for once-daily maintenance treatment of COPD

QVA149 marketing application filed in Japan for once-daily maintenance treatment of COPD
07 November 2012

Chippenham, UK – 7 November 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis Pharma K.K., announcing that it has submitted an application in Japan for the registration of QVA149, an investigational fixed dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide) as a once-daily treatment for chronic obstructive pulmonary disease (COPD).

COPD is a chronic, progressive lung disease that is caused by the inhalation of harmful substances such as cigarette smoke over a long period. Its major symptoms include cough, sputum, and dyspnea on exertion. COPD not only greatly decreases the quality of life for patients, but is also a life-threatening disease because its symptoms progress and might eventually lead to respiratory failure.

The application for QVA149 was filed to the European Medicines Agency in October 2012 and the US application is planned for 2014.

Novartis also received approval for glycopyrronium bromide in Japan in September 2012 (Seebri® Inhalation Capsules, 50 mg), and was approved in the EU during the same month (under the tradename Seebri® Breezhaler®). The product has since been launched in Germany and the UK and approvals have also been granted in Canada and Australia.

Dr Chris Blackwell, Chief Executive of Vectura:

"QVA149 continues to make excellent progress with its potential to treat patients suffering from COPD. This disease is progressive and debilitating for sufferers."


Notes for editors

About the NVA237/QVA149 License Agreement with Novartis
Vectura and its co-development partner, Sosei licensed NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) to Novartis in April 2005. NVA237 is a long-acting muscarinic antagonist (LAMA) approved as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW1, 2,3 and 4) studies demonstrated that glycopyrronium bromide increased patients' lung function over a 24-hour period compared to placebo with a fast onset of action at first dose compared with placebo1,2,3,4. In all studies, glycopyrronium was shown to have an overall safety profile similar to placebo4.

Following its launch of NVA237 in 2012 as a once-daily monotherapy for COPD, Novartis is expected to launch NVA237 as a fixed-dose combination with indacaterol (Onbrez® Breezhaler®), its once-daily, long-acting beta-agonist (LABA), known as QVA149. The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be an effective bronchodilator and, with convenient once-daily dosing as a fixed-dose combination, has the potential to improve compliance and address a large and unmet need for COPD sufferers.

To date, Vectura has earned $52.5m from Novartis and, under the terms of the licence, could receive up to an additional $135m for achievement of regulatory and commercialisation targets for both the monotherapy and the combination product. In addition, royalties on product sales will be received in the event of successful product launches.

About Seebri® Breezhaler® (glycopyrronium bromide)
Seebri® Breezhaler® (glycopyrronium bromide) is a long-acting muscarinic antagonist (LAMA) recently approved in the EU, Canada and Australia and Japan (as Seebri Inhalation Capsules) – all are approved as a once-daily inhaled maintenance therapy for the treatment of COPD. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium increased patients' lung function over a 24-hour period compared to placebo with a fast onset of action at first dose, compared with placebo1,2,3. The US filing for Seebri® Breezhaler® is expected in 2014.

About COPD
COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide5 and is predicted to be the third leading cause of death by 20206. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted at the peak of their earning power and family responsibilities7.

About Vectura
Vectura Group plc develops inhaled therapies principally for the treatment of respiratory diseases. Vectura's main products target diseases such as asthma and chronic obstructive pulmonary disease (COPD), a growing market that is currently estimated to be worth in excess of $25bn.

Vectura has six products marketed by its partners and a portfolio of drugs in clinical and pre-clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter and GlaxoSmithKline (GSK).

Vectura seeks to develop certain programmes itself where this will optimise value. Vectura's formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy. 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.


    D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011, 12:156.
    Kerwin E, et al. Efficacy and safety of NVA237compared with placebo and tiotropium in patients with moderate-to-severe COPD over 52 weeks: The GLOW2 study. Eur Resp J. 2012. Published on July 26, 2012 (doi:10.1183/09031936.00040712). Last accessed 12 September 2012.
    Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves exercise endurance from first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012; 7:503-513.
    Sekiya M et al. Safety and efficacy of NVA237 once daily in Japanese patients: the GLOW4 trial. [ERS abstract 853970; Session 245; Hall A-7; Date: Mon 3 Sep Time: 12:50-14:40.]
    Onbrez® Breezhaler® (indacaterol) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/human_med_001219.jsp&mid=WC0b01ac058001d124. Last Accessed 12 September 2012.
    Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 21 August 2012.
    Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Last accessed 21 August 2012.
    8. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health. 2011;11:612.

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