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Vectura Group plc (VEC.L) Release: Presentations At ERS



9/2/2014 9:47:24 AM

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Chippenham, UK – 2 September 2014: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”), advises that the following presentations will be made at the European Respiratory Society (ERS) International Congress 2014, being held in Munich, Germany, 6-10 September 2014.

Novartis will unveil new data from three key clinical trials at European Respiratory Society International Congress 2014.

• First presentation of LANTERN study to confirm superior efficacy of once-daily Ultibro® Breezhaler® versus Seretide® Accuhaler®* in COPD patients1

• QUANTIFY study to show superiority of Ultibro® Breezhaler® in lung function and shortness of breath versus tiotropium plus formoterol2

• New data from GLISTEN study will provide important evidence for the benefits of once-daily Seebri® Breezhaler® as add on therapy to LABA/ICS**3

Data to be presented at ERS by Novartis will include:

Positive new results from the Phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone combination: LABA/ICS**), in patients with moderate-to-severe COPD1.

Analyses from the QUANTIFY study demonstrated that Ultibro® Breezhaler® significantly improved lung function and shortness of breath in patients with moderate-to-severe COPD, compared to the combination of tiotropium plus formoterol2. Results also showed that Ultibro® Breezhaler® is comparable to tiotropium plus formoterol in improving health-related quality of life2.

Data from the GLISTEN trial showed that Seebri® Breezhaler® (glycopyrronium bromide) when added to LABA/ICS provided significant improvements in lung function, health status and rescue medication use in moderate-to-severe COPD patients when compared to LABA/ICS alone3. This study provides much-needed evidence for add-on therapy to LABA/ICS in COPD, to support physicians care choices where very little data exist3.

The safety profiles of Ultibro® Breezhaler® and Seebri® Breezhaler® were similar to those of their respective study comparators in the LANTERN, QUANTIFY and GLISTEN studies1,2,3.

 

Key Novartis ERS Abstract Presentations

Lead Authors

Presentation Details

850533

Once-daily QVA149 improves lung function and dyspnoea compared with tiotropium plus formoterol: the QUANTIFY study

S. Korn

Poster Discussion

September 7

12:50-14:40

Hall B2-21     

700090

Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study

N. Zhong

Poster Session

September 8

12:50-14:40

Hall B2-43

700128

Glycopyrronium once-daily significantly improves lung function and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study

P. Frith

Poster Session

September 8

12:50-14:40

Hall B2-43

854774

Morning symptoms and acute breathing difficulties in the diagnosis of COPD

P. O'Hagan

Poster Session

September 9

12:50-14:40

Hall B2-16

 



Alongside abstract presentations at ERS 2014, Novartis is hosting a media briefing on September 7 (13.10-15.30 CET, Industry press briefing room, ERS Media Center) and will be holding the following symposia:

• COPD morning symposium: COPD exacerbations: from context to evidence to practice: September 8 (07:00-08:15 CET, Room 14C)

• COPD evening symposium: COPD patients’ needs and current treatment options: September 8 (17:15-19:15 CET, Auditorium)

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.erscongress.org.

-Ends-

Enquiries

Vectura Group plc +44 (0)1249 667700
Karl Keegan, Chief Corporate Development Officer

FTI Consulting 44 (0)20 3727 1000
Ben Atwell / John Dineen

About the LANTERN Study
The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro® Breezhaler® to SFC in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year1.

About the QUANTIFY Study
The primary objective of QUANTIFY was to demonstrate non-inferiority of Ultibro® Breezhaler® in HRQoL, as assessed by the St. George’s Respiratory Questionnaire-COPD (SGRQ-C), versus tiotropium plus formoterol after 26 weeks of treatment in patients with moderate-to-severe COPD2. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability2.

About the GLISTEN Study
The primary objective of GLISTEN was to demonstrate non-inferiority of Seebri® Breezhaler® 50 mcg versus tiotropium 18 mcg when added to salmeterol/fluticasone 50/500 mcg on trough FEV1 after 12 weeks of treatment in patients with moderate-to-severe COPD3. The secondary endpoints included comparison of Seebri® Breezhaler® 50mcg added to salmeterol/fluticasone compared with salmeterol/fluticasone plus placebo3.

About Novartis in Respiratory
Novartis is committed to addressing the unmet medical needs of COPD and severe asthma patients and improving their quality of life by providing innovative medicines and devices. The Novartis respiratory portfolio includes Ultibro® Breezhaler® (indacaterol/ glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler®/Arcapta™ Neohaler™ (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation4. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly4,5.

In addition, the portfolio also includes Xolair® for the treatment of severe persistent allergic asthma6,7. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.

Ultibro®, Seebri®, Breezhaler® and Onbrez® are registered trademarks of Novartis AG.

About Vectura
Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $46 billion worldwide8.

Vectura has eight products marketed by partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has disclosed development collaborations and licence agreements with several pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company Limited.

Vectura develops products for airways diseases and owns formulation and inhalation technologies that 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.

About the NVA237/QVA149 License Agreement with Novartis

NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. To date, Vectura has received $65m from Novartis and, under the terms of the license, could receive up to an additional $122.5m 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

. *The LANTERN study used Seretide® (salmeterol/fluticasone) 50/500 mcg, which is indicated in the UK for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy8. The patient population in the LANTERN study were stable moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. Seretide® is also known as Advair®, and Accuhaler® is also known as Diskus®. Seretide®, Advair®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies. **LABA (long-acting beta agonist); ICS (inhaled corticosteroid)

References

1. Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281; Date: September 8, 2014 Time: 12:50-14:40].
2. Korn S et al. Once-daily QVA149 improves lung function and dyspnoea compared with tiotropium plus formoterol: the QUANTIFY study [ERS abstract 850533; Session 101; Date: September 7, 2014 Time: 12:50-14:40].
3. Frith P et al. Glycopyrronium once-daily significantly improves lung function and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study. [ERS abstract 700128; Session 281; September 8, 2014 Time: 12:50-14:40].
4. Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527–2533. doi:10.1185/03007995.2010.518916.
5. Ultibro® Breezhaler® EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf. [Accessed 1 August 2014]
6. Xolair US Prescribing Information. 2003.
7. European Medicines Agency. Xolair EPAR summary for the public.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000606/WC500057293.pdf. [Accessed 2 August 2014].
8. Pharmaview Commercial Landscape Series Respiratory Decision Resources 2013
9. Seretide® Summary of Product Characteristics [Online] Available at: https://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler [Accessed 1 August 2014]

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