Vectura Group plc VEC QVA149 marketing application filed in Japan

  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
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^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
sufferers."





Enquiries

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
Ben Atwell

Simon Conway
Susan Stuart





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 
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  placebo^1,2,3.  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 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.



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.



References

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,
12:156.

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:
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.

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
August 2012.

7. 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.







                     This information is provided by RNS
           The company news service from the London Stock Exchange

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