1st Oct 2012 07:00
RNS Number : 5492N
Vectura Group plc
01 October 2012
The European Commission approves once-daily Seebri® Breezhaler® as maintenance COPD treatment in the European Union
·; Seebri® Breezhaler® 44 mcg delivered dose approved for maintenance treatment of COPD will be available to patients and physicians in some EU markets by year-end
·; In GLOW trials, Seebri® Breezhaler® improved lung function, reduced shortness of breath, reduced exacerbations, and improved quality of life over a 52 week period compared with placebo1,2,3
·; GLOW2 study showed Seebri® Breezhaler® provided 24-hour bronchodilation and is superior to placebo and similar to open-label tiotropium in improving lung function2
Chippenham, UK – 1 October 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis announcing that the European Commission has approved Seebri® Breezhaler® (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). This follows the September 28 approval of once-daily Seebri® (glycopyrronium bromide) Inhalation Capsules 50 mcg in Japan.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
“The approval of Seebri Breezhaler in Europe is an important development in providing access to new treatment options for patients with COPD. This innovative, once-daily therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life.
“The approval of this drug is a landmark and value-enhancing event for Vectura, who along with its partner, Sosei, developed the drug to a Phase II proof-of-concept before licensing it to Novartis. This approval will trigger a $10 million milestone to Vectura along with subsequent royalty streams.”
The European Commission approved Seebri® Breezhaler® based on data from the Novartis Phase III GLOW trials which demonstrated the safety and efficacy of glycopyrronium 44 mcg and involved 1,996 COPD patients who required maintenance treatment from around the world, with many in EU countries1,2,3.
-Ends-
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 Seebri® Breezhaler® (glycopyrronium bromide)
Seebri® Breezhaler® (glycopyrronium bromide) is a long acting muscarinic antagonist (LAMA) developed 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, and improved exercise endurance compared with placebo1,2,3. The US filing for Seebri® Breezhaler® is expected in 2014.
About the Phase III GLOW trials
The GLOW trials showed that glycopyrronium, when compared to placebo, significantly improved lung function over the first four hours after morning dosing and that this benefit was sustained for 24 hours over a 52-week period2. Patients on glycopyrronium demonstrated improved lung function, reduced shortness of breath, reduced exacerbations, reduced use of rescue medication, improved quality of life and improved exercise tolerance compared to placebo1,2,3.
GLOW1 was a 26-week, randomized, double-blind, placebo-controlled study. The study demonstrated the clinically significant superiority of glycopyrronium compared with placebo for lung function improvements at 12 weeks (primary endpoint) measured by trough FEV1 (p1.
GLOW2 demonstrated a similar magnitude of effect and also showed that glycopyrronium was similar to open-label (OL) tiotropium over a 52 week period measured by improvements in trough FEV1 compared to placebo. In addition to demonstrating benefits in terms of lung function, glycopyrronium exhibited a rapid onset of action within five minutes at first dose and reduced exacerbations. Significant benefits in both breathlessness and health-related quality of life (HRQL), as measured by the Transition Dyspnea Index (TDI) and St. George’s Respiratory Questionnaire (SGRQ) compared to placebo, were also demonstrated. GLOW2 was a 52-week, randomized, double-blind, placebo-controlled study with OL tiotropium 18 mcg as an active exploratory arm2.
The GLOW3 study showed that after glycopyrronium was administered in the morning, patients experienced improved exercise tolerance from the first dose onward. Overall, patients treated with glycopyrronium experienced a significant 21% improvement in exercise endurance compared with placebo at the end of the study (day 21), with a significant 10% increase from day one (both p3.
Novartis is currently developing a fixed-dose combination of glycopyrronium and indacaterol, QVA149, which is expected to be filed in the EU and Japan by the end of 2012. In addition, Novartis is committed to continue the study of glycopyrronium bromide in further clinical trials following this approval.
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 a 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 fast onset of action at first dose, and improved exercise endurance compared with placebo1,2,3. Novartis expects to launch NVA237 in 2012 as a once-daily monotherapy for COPD and subsequently 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.
Novartis received European regulatory approval for Onbrez® Breezhaler® in November 2009. It was first launched in the EU in 150 mcg and 300 mcg once-daily doses. Most recently, Novartis launched the 75 mcg once-daily dose in the US under the brand name ArcaptaTM NeohalerTM. It is also available as a 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.
To date, Vectura has received $35m from Novartis and, under the terms of the licence, could receive up to an additional $152.5m 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.
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 correctly4.
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.
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. 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.
5. 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.
6. 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.
7. 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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