FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations

Novartis International AG / FLAME study shows superiority of Novartis' Ultibro® Breezhaler® over Seretide® in reducing COPD exacerbations . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Ultibro^® Breezhaler^® met primary endpoint and demonstrated superiority to Seretide^® in reducing COPD exacerbations during 52 weeks of treatment
   

First large-scale study to confirm Ultibro Breezhaler is an effective steroid-free option that both reduces exacerbations and improves lung function in COPD patients with one or more exacerbations in the past year, compared to Seretide
 

Full FLAME study results to be shared in 2016

Basel, November 17, 2015 - Novartis today announced positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro^® Breezhaler^® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide^® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.

This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.

"Today's FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease," said Vasant  Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients."

The full FLAME study results, including data from further secondary endpoints, will be reported at an appropriate scientific forum in due course.

About FLAME
FLAME was a randomized, double-blind, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries[1]. The primary objective of the study was to demonstrate that Ultibro Breezhaler 110/50 mcg was non-inferior to salmeterol/fluticasone (SFC) 50/500 mcg  in terms of rate of all COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment[1].