Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight on the commercial potential of the candidate once it is successfully developed and commercialized.
Novartis (NVS) recently announced positive top-line results from phase III trials on chronic obstructive pulmonary disease (COPD) drugs Ultibro Breezhaler 110/50 mcg and Seebri Breezhaler 50 mcg. Both drugs are approved in the EU.
Results from these phase III trials (FLIGHT 1 and 2; and GEM 1 and 2) will support the drugs’ New Drug Applications (NDAs) to the FDA submitted in the fourth quarter of 2014. The FLIGHT 1 and 2 studies met their primary objectives as the treatment with twice-daily Ultibro Breezhaler demonstrated statistically- and clinically-significant improvements in lung function at week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients.
Similarly, the GEM 1 and 2 studies showed that twice-daily treatment with Seebri Breezhaler demonstrated clinically significant improvement in lung function at week 12 in moderate-to-severe COPD patients compared to placebo thereby meeting its primary objective.
Generating sales of $335 million in the first nine months of 2014, up 93% year over year, the COPD portfolio is expected to gain further traction in 2015. It presently includes Onbrez Breezhaler/Arcapta Neohaler, Seebri Breezhaler and Ultibro Breezhaler.
An approval in the U.S. will further strengthen Novartis’ COPD portfolio.
We cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core portfolio of pharmaceuticals, eye care and generics. Successful development and commercialization of its pipeline is important at this stage as the company faces generic competition for several key drugs such as Gleevec and Diovan.
Novartis, a large-cap pharma, currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the health care sector may consider Allergan (AGN), Astrazeneca plc (AZN) and AbbVie (ABBV). While Allergan carries a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy).
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