Data on Novartis' Onbrez Breezhaler - Analyst Blog

Novartis NVS announced positive top-line results from a phase IV study, INSTEAD, on Onbrez Breezhaler.

We note that Onbrez Breezhaler is approved for maintenance bronchodilator treatment of airflow obstruction in adult patients suffering chronic obstructive pulmonary disease (COPD). It is approved in the U.S. under the trade name Arcapta Neohaler.

INSTEAD was a global, double-blind, parallel-group, 26-week study that randomized patients suffering from moderate COPD who had been taking Seretide for at least three months to either continue on Seretide or switch to Onbrez Breezhaler.

The study met its primary objective. The results from the study confirm non-inferiority of Onbrez Breezhaler in lung function compared to Seretide in the studied population.

Moreover, the study also showed similar symptomatic benefits in terms of shortness of breath and health status in patients treated with Onbrez Breezhaler as compared to those on Seretide.

Novartis expects to present data from this study later in 2014.

The COPD portfolio at Novartis looks strong. We remind investors that Onbrez Breezhaler/Arcapta Neohaler generated sales of $192 million in 2013, up 47% from 2012. 

Novartis also has Seebri Breezhaler and Ultibro Breezhaler in its product portfolio for treating COPD patients.  Ultibro Breezhaler is a fixed-dose combination of Onbrez Breezhaler and Seebri Breezhaler. We expect further traction in sales from the COPD portfolio.

Last week, Novartis reported disappointing results for the first quarter. We cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core portfolio of pharmaceuticals, eye care and generics. We believe the recent acquisition of oncology products from GlaxoSmithKline GSK and divestment of Vaccines business is a step in the right direction. It will broaden Novartis' portfolio and enable it to focus better on its core capabilities besides contributing immensely to the top line.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Allergan AGN and Johnson & Johnson JNJ look well positioned among the large cap pharmas. Both carry a Zacks Rank #2 (Buy).