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Novartis (NVS) Releases Positive Data on Ultibro Breezhaler

Novartis AG NVS announced results from the head-to-head randomized, double-blind, non-inferiority FLAME study on Ultibro Breezhaler. The trial compared the efficacy of once-daily Ultibro Breezhaler 110/50 mcg to twice-daily Seretide 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations. Results were published in the New England Journal of Medicine.

The FLAME study met its primary endpoint. Results from the study showed consistent superiority of Ultibro Breezhaler over Seretide across exacerbation outcomes, lung function and health-related quality of life in COPD patients.

Data also demonstrated that Ultibro Breezhaler was effective in reducing the rate and prolonging the time to the first moderate or severe exacerbation, when compared to Seretide.

We note that Ultibro Breezhaler 110/50 mcg was approved in Europe in 2013 as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.  The latest results from the FLAME trial bode well for the drug.

The combination was also approved in the U.S. under the name Utibron Neohaler in Oct 2015. Novartis’ COPD portfolio currently comprises Ultibro Breezhaler, Seebri Breezhaler and Onbrez Breezhaler/Arcapta Neohaler, which generated combined sales of $0.6 million in 2015, up 19% from 2014.

Approval of new drugs and label expansion of existing ones bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec. Additionally, its oncology drugs are facing competition from immuno-oncology therapies. Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets.

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pfizer Inc. PFE, Johnson & Johnson JNJ and Abbott Laboratories ABT. All three stocks sport a Zacks Rank #2 (Buy).

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