Novartis Progresses with NVA237

Switzerland-based pharmaceutical company, Novartis AG ( NVS - Snapshot Report ) recently announced positive phase III data from the GLOW 2 study of its pipeline candidate NVA237. The candidate is being studied for the treatment of chronic obstructive pulmonary disease (COPD). The study showed rapid improvement in lung function and symptom relief over one year in COPD patients.

Data from the phase III GLOW 2 study showed that once-daily NVA237 had a rapid onset of action at the first dose, which sustained 24-hour bronchodilation over 52 weeks.

The study also revealed that the once-daily NVA237 was better than placebo in improving lung function, symptom relief and quality of life, while reducing exacerbations. It also increased the percentage of days with no symptoms during daytime.

NVA237’s efficacy in increasing lung function, improving COPD symptoms and reducing exacerbations was found to be similar to open-label tiotropium.

Novartis submitted NVA237 for approval in Europe with the proposed brand name of Seebri Breezhaler. Novartis also plans an early 2014 U.S. filling. Notably, NVA237 was submitted for regulatory approval in Europe and Japan during the third and fourth quarters of last year, respectively. Novartis has a co-promotion agreement with Eisai and Co. Ltd ( ESALY ) in Japan.

Our Recommendation

Though we are pleased with Novartis’ wide range of products and its efforts to diversify further, we prefer to remain on the sidelines in the long term. We remain concerned about the patent expirations of key drugs like Femara and Diovan. Thus, we have a Neutral recommendation on Novartis. The company carries a Zacks #4 Rank (“Sell” rating) in the short run.