4th Sep 2013 07:00
Vectura Group plc
4th September 2013
Vectura Group plc
Presentations at ERS
Chippenham, UK - 4 September 2013: Vectura Group plc (LSE: VEC) ("Vectura"), advises that the following presentations will be made at the European Respiratory Society (ERS) Annual Congress 2013, being held in Barcelona, Spain, 7-11 September 2013.
Data to be presented at ERS by Novartis will include the latest analyses from the Phase III IGNITE clinical trial program on Ultibro® Breezhaler® (QVA149 - indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule)1,2,3. QVA149 is a once-daily investigational fixed dose combination of a long-acting beta2-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA), that received a positive opinion for approval from the European Medicine Agency's (EMA) Committee for the Human use of Medicinal Products (CHMP) in July 2013 as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
New exacerbation, lung function and safety data will also be presented on Seebri® Breezhaler® (glycopyrronium 44 mcg delivered dose equivalent to 50 mcg metered dose per capsule)4,5 and efficacy data on Onbrez® Breezhaler® (indacaterol maleate 150 mcg)6, which are the monotherapy components of QVA149.
Key Novartis ERS Abstract Presentations | Lead Author | Presentation Details |
COPD | ||
851270 Once-daily glycopyrronium improves lung function and reduces exacerbations in severe-to-very severe COPD patients: The SPARK study4 | J. Wedzicha | Oral presentation September 808:30 - 10:30 Room 2.4 |
851178 Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes1 | C. Vogelmeier
| Thematic poster September 8 12:50 - 14:40 HALL 1-10 |
851279 Safety of once-daily glycopyrronium in patients with severe-to-very severe COPD: The SPARK study5 | M. Decramer | Poster discussion September 10 08:30 - 10:30 Room 3.5 |
851388 Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: The IGNITE trials2 | D. Banerji | Poster discussion September 10 08:30 - 10:30 Room 3.5 |
851415 Dual bronchodilation with once-daily QVA149 improves lung function and reduces exacerbations in patients with COPD: The IGNITE trials3 | D. Banerji | Poster discussion September 10 08:30 - 10:30 Room 3.5 |
851296 Patients with severe COPD show significant improvements in dyspnea and lung function with once-daily QVA149: The BLAZE study7 | D. Mahler | Poster discussion September 10 08:30 - 10:30 Room 3.5 |
851282 QVA149 improves lung function and reduces exacerbations compared to tiotropium in patients with severe-to-very severe COPD: The SPARK study8 | J. Ficker | Poster discussion September 10 10:45 - 12:45 Room 3.8 |
Alongside abstract presentations, Novartis will also be holding the following two symposia relating to COPD at ERS:
· Rethinking the treatment landscape of COPD: September 8 (17:15-19:15 CET, Room 3.13)
· Dual bronchodilation: A new treatment option for COPD patients: September 9 (17:15-19:15 CET, Room 3.13)
Vectura will be hosting a dinner on Monday 9 September for analysts and investors with a number of key opinion leaders. For further details please contact [email protected].
ERS is the largest respiratory meeting in the world, with delegates attending from more than 100 countries. All abstracts and details on timings can be accessed through the ERS website: http://www.erscongress2013.org.
-Ends-
Enquiries
Vectura Group plc | +44 (0)1249 667700 |
Chris Blackwell, Chief Executive | |
Karl Keegan, Corporate Development Director | |
FTI Consulting | +44 (0)20 7831 3113 |
John Dineen / Ben Atwell |
About the NVA237/QVA149 Licence Agreement with Novartis
NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. It is an investigational LAMA developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW1, 2 and 3 studies demonstrated that glycopyrronium bromide increased patients' lung function over a 24-hour period compared to placebo with a rapid onset of action at first dose, and improved exercise endurance versus placebo. Seebri® Breezhaler® has been launched in the UK, Germany, and is currently being rolled out across other countries. Seebri® Inhalation Capsules were launched in Japan in Q4 2012. QVA149, (glycopyrronium / indacaterol), as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) is a fixed-dose combination with indacaterol (Onbrez® Breezhaler®),once-daily, long-acting beta-agonist (LABA). 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 received $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.
All of the Novartis COPD portfolio products are being developed for delivery via the Breezhaler® device, a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it particularly suitable for patients with airflow limitation, such as COPD patients. The Breezhaler® device allows patients to hear, feel and see that they have taken the drug correctly.
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 leading to a negative impact on quality of life9,10. It affects an estimated 210 million people worldwide11 and is predicted to be the third leading cause of death by 20209. 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 responsibilities12.
About Vectura
Vectura Group plc and its subsidiaries ("Vectura" or the "Group") is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway-related diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $30 billion worldwide.
Vectura has seven products marketed by its partners and a portfolio of drugs in 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, GlaxoSmithKline (GSK) and Tianjin King York Group Company Limited (KingYork).
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.
References
1. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].
2. Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS abstract 851388; Session 346; Date: September 10 2013 Time: 8:30-10:30].
3. Banerji D et al. Dual bronchodilation with once-daily QVA149 improves lung function and reduces exacerbations in patients with COPD: the IGNITE trials. [ERS abstract 851415; Session 346; Date: September 10 2013 Time: 8:30-10:30].
4. Wedzicha JA et al. Once-daily glycopyrronium improves lung function and reduces exacerbations in severe-to-very severe COPD patients: the SPARK study. [ERS abstract 851270; Session 41; Date: September 8, 2013 Time: 8:30-10:30].
5. Decramer M et al. Safety of once-daily glycopyrronium in patients with severe-to-very severe COPD: the SPARK study. [ERS abstract 851279; Session 346; Date September 10, 2013 Time: 8:30-10:30].
6. Kerstjens H et al. Once-daily indacaterol 150μg or 300μg and other bronchodilators in COPD patients of GOLD 2011 groups A and B. [ERS abstract 852515; Session 85; Date: September 8 2013 Time: 12:50-14:40].
7. Mahler D et al. Patients with severe COPD show significant improvements in dyspnea and lung function with once-daily QVA149: the BLAZE study. [ERS abstract 851296; Session 346; Date: September 10, 2013 Time: 8:30-10:30].
8. Ficker J et al. QVA149 improves lung function and reduces exacerbations compared to tiotropium in patients with severe-to-very severe COPD: the SPARK study. [ERS abstract 851282; Session 369; Date: September 10, 2013 Time: 10:45-12:45].
9. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. [Accessed 2 August 2013].
10. Joshi M et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Obstructive, occupational and environmental diseases. 2012;18(2).
11. 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. [Accessed 2 August 2013].
12. 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.
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.
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