Vectura Group plc (VEC) - QVA149 marketing application filed in Japan
RNS Number : 5150Q
Vectura Group plc
07 November 2012
QVA149 marketing application filed in Japan for once-daily maintenance
treatment of COPD
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
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^ÒInhalation Capsules, 50 mg), and was approved in the
EU during the same month (under the trade name 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
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Karl Keegan, Corporate Development Director
FTI Consulting +44 (0)20 7831 3113
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 placebo^1,2,3,4. In all studies,
glycopyrronium was shown to have an overall safety profile similar to
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 placebo^1,2,3. The US filing for Seebri^® Breezhaler^® is
expected in 2014.
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 worldwide^5 and is predicted to be the third
leading cause of death by 2020^6. 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 responsibilities^7.
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.
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
1. 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,
2. 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.
3. 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.
4. 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.]
5. Onbrez^® Breezhaler^® (indacaterol) EU Summary of Product
Characteristics. Available at:
Last Accessed 12 September 2012.
6. 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.pdfLast accessed 21
7. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2011.
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.
This information is provided by RNS
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MSCBRBRTMBBMMBT -0- Nov/07/2012 07:20 GMT
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