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Data on Novartis' Ultibro Breezhaler

Zacks Equity Research

Novartis (NVS) announced positive data on Ultibro Breezhaler from the QUANTIFY study at the American Thoracic Society (:ATS) International Conference.

Novartis conducted this multicenter, randomized, parallel group, blinded study (n=934) to assess the efficacy and safety of once-daily Ultibro Breezhaler in patients suffering from moderate-to-severe chronic obstructive pulmonary disease (:COPD) vis-à-vis the free-combination of Spiriva plus Foradil.

We remind investors that Ultibro Breezhaler was approved in the EU in Sep 2013 as a maintenance bronchodilator treatment to relieve symptoms in adults suffering from COPD.

It was observed in the study that once-daily Ultibro Breezhaler showed superior improvements in lung function as compared to once-daily Spiriva plus twice-daily Foradil at the end of 26 weeks.

In addition, it was seen that patients taking Ultibro Breezhaler were more likely to show a meaningful improvement in shortness of breath and health-related quality of life compared to Spiriva plus Foradil.

The COPD portfolio of Novartis includes Seebri Breezhaler and Arcapta Neohaler/Onbrez Breezhaler. Ultibro Breezhaler is a fixed-dose combination of Onbrez Breezhaler and Seebri Breezhaler.

Last month, Novartis announced positive top-line results from the INSTEAD study on 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. Onbrez Breezhaler generated sales of $192 million in 2013, up 47% from 2012.

We expect further traction in sales from the COPD portfolio in 2014.

Meanwhile, we cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core business 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.

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Allergan (AGN) and Gilead Sciences (GILD). Both carry a Zacks Rank #1 (Strong Buy).

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