Novartis Healthcare Private Limited launches Sequadra® Inhaler, an important advance in treatment of COPD; improves quality of life for COPD patients

  

·         Indacaterol/glycopyrronium is the first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator

 ·         Pivotal Phase III IGNITE data showed indacaterol/glycopyrronium combination significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standard of care

Mumbai, August 13, 2015 – Novartis Healthcare Private Limited (NHPL) announced today the launch of Sequadra^® Inhaler  (indacaterol/glycopyrronium) 110mcg/50mcg, a fixed dose combination (FDC) of two bronchodilating active ingredients, indacaterol maleate, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium bromide, a long-acting anticholinergic (LAMA), for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

“NHPL is working hard to optimize this important treatment to Indian patients in a timely way”, said Jawed Zia, Country President, Novartis India. “Once daily indacaterol/glycopyrronium combination reduces risk of annual rate of exacerbations by 31% compared to the current standard of care (twice-daily salmeterol + fluticasone* combination) in patients with moderate-to-severe chronic obstructive pulmonary           disease”.

Addressing the media, Prof Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Germany said, “Indacaterol/Glycopyrronium combination will offer these patients a much greater improvement in lung function and health related quality of life. This new therapy will change the management of COPD to the benefit of patients”.

This was reinforced by Dr Ashok Mahashur, Consultant Chest Physician, P.D. Hinduja National Hospital and Medical Research Centre Mumbai, who stated, “Good to know that combination of indacaterol/Glycopyrronium has been launched in India. Based on robust clinical data I feel this combination will be an effective bronchodilator and would reduce exacerbations in COPD patients”.

Indacaterol/glycopyrronium combination was developed for the treatment of COPD for patients in whom treatment with a single long acting bronchodilator (LABA or LAMA) does not provide an adequate control of respiratory symptoms. Indacaterol/glycopyrronium combination has demonstrated a statistically significant improvement in lung function at 2 hours post-dose at Week 26.

About Sequadra^® Inhaler

Sequadra^® Inhaler, is a once-daily dual bronchodilator approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium (18 mcg). India has been part of the global clinical development studies – CQVA149A2303 (n=167), CQVA149A2304 (n=147) and CQVA149A2307 (n=43) of QVA 149. A total of 357 Indian patients were randomized in the aforementioned global studies. Overall, the safety profile and efficacy results in the Indian sub-population were consistent with the global population. At present there are 191 patients from India in the two ongoing studies. Indacaterol/ glycopyrronium combination is currently approved for use in over 76 countries, including countries within the EU, Japan, Canada, countries within Latin America and Australia.

About NHPL’s COPD portfolio

NHPLis committed to addressing the needs of COPD patients and improving their quality of life by providing innovative medicines and devices. NHPL’s COPD portfolio includes indacaterol/ glycopyrronium combination and Onbrez^® Breezhaler (indacaterol) which are all indicated as maintenance treatments for COPD patients.

Globally, 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 limitation. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly.

About COPD

Chronic Obstructive Pulmonary Disease (COPD) is a progressive illness that includes the conditions emphysema and chronic bronchitis. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ fitness (i.e. activity limitation, decreased mobility) and quality of life. Whilst the symptoms of COPD can be experienced throughout the day, the morning is the most difficult time for patients, who find that their daily routines such as showering and getting ready are significantly slowed down due to COPD symptoms. COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are below the age of 65, resulting in increases in absenteeism, premature retirement and reductions in workforce participation.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

1.     India PI - Sequadra^® Inhaler27-02-14. 

2.     Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].

3.     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].

4.     Eur Respir J May 2013, Bateman et. al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study

5.     Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 

6.     Beeh et al. QVA149 once daily improves exercise tolerance and lung function in patients with COPD: the BRIGHT study. [BTS Winter Meeting 2012, Poster presentation P191; Date: 6 December; Time: 16:00-17:30]. 

7. Dahl et al, 2012. QVA administered once daily provides significant improvements in lung function over 1 year in patients with COPD: The ENLIGHTEN study. Volume abstract 853405.
8. Mahler D et al. Superior lung function with once-daily QVA149 translates into improvements in patient reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session C20; Date: May 21, 2013 Time: 8:15-10:45].

9.     ClinicalTrial.gov, n.d. A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD (FLAME).

 10.   Vogelmeier CF et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013; 1 (1): 51-60.

11. Welte T et al. QVA149 once daily is safe and well tolerated in patients with COPD: the SHINE study. [ATS abstract 41616; Session A43; Date: May 19, 2013, 8:15-16.30].
12. Vogelmeier C et al. QVA149 once daily is safe and well tolerated in patients with COPD: the ILLUMINATE study. [ATS abstract 41633; Session A43; Date: May 19, 2013, 8:15-16.30].
13. Lung India, Aug 2013, Gupta et. al.: Indian COPD guidelines VOL. 30; Issue 3.