QVA149 is filed as a treatment for COPD in Europe
Chippenham, UK – 25 October 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis that QVA149, (indacaterol maleate / glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million milestone payment to Vectura.
Novartis filed a marketing authorisation application to the EMA for QVA149, an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of adult patients with COPD. The first five studies in the Phase III IGNITE clinical trial programme for QVA149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to placebo.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
"The IGNITE programme is among the largest COPD clinical trial programmes performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease, a multi-billion dollar market that is expected to see continued growth. Today's news follows the recent approval of Seebri® Breezhaler® in Europe and Canada and Seebri® Inhalation Capsules in Japan, further highlighting Vectura's expertise in the respiratory therapeutic area."
|Vectura Group plc||
+44 (0)1249 667700
Chris Blackwell, Chief Executive
+44 (0)20 7831 3113
Notes for editors
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. Seebri® Breezhaler® recently received approval in the EU and Canada, and Seebri® Inhalation Capsules received approval in Japan – all are approved as a once-daily inhaled maintenance therapy for COPD. Novartis expects to launch a fixed-dose combination of glycopyrronium bromide (Seebri® Breezhaler®) 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 Seebri® Breezhaler® (glycopyrronium bromide)
Seebri® Breezhaler® (glycopyrronium bromide) is a long acting muscarinic antagonist (LAMA) recently approved in the EU and Canda and Seebri Inhalation Capsules was also recently approved in Japan – 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, and improved exercise endurance compared with placebo1,2,3. 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 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.
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 otherwise.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.