Novartis AG (NOVN) said an experimental treatment for smoker’s cough met the main goal of three late- stage trials, advancing the company’s plan to apply for regulatory approval of the drug.
The treatment, QVA149, is a combination of two other Novartis drugs, the Arcapta Neohaler and the Seebri Breezhaler, which are approved in some countries for chronic obstructive pulmonary disease. In a trial involving 2,144 patients, QVA149 improved lung function more than either drug on its own, the Basel, Switzerland-based company said in a statement today. It was also better than Spiriva, a treatment sold by Boehringer Ingelheim GmbH and Pfizer Inc. (PFE)
The three studies are among 10 that the company plans to use to apply for regulatory approval in Europe and Japan, it said. Analysts predict QVA149 will garner sales of $700 million in 2017, according to the average of four estimates compiled by Bloomberg.
Two smaller studies showed patients taking QVA149 were able to exercise for longer than those getting a placebo, and that the drug had a similar safety profile to placebo, Novartis said.
The Arcapta Neohaler, which goes by the chemical name indacaterol, was approved in the U.S. in July and has been sold in Europe since December 2009 as the Onbrez Breezhaler. Novartis is awaiting European approval of Seebri, also known as NVA237. Novartis bought marketing rights to Seebri from Chippenham, England-based Vectura Group Plc (VEC) in 2005.
Vectura gained 18 percent to 64 pence in London, the biggest advance since July 2004. Novartis rose 1.8 percent to 50.85 Swiss francs in Zurich. That pared the stock’s decline this year to 5.3 percent.
The Swiss company said in October that marketing approval for QVA149 in the U.S. would be delayed after the U.S. Food and Drug Administration requested more data on Seebri.
More than 12 million people are diagnosed with chronic obstructive pulmonary disease, or COPD, and another 12 million probably have it and don’t know, according to the Bethesda, Maryland-based National Institutes of Health. COPD, sometimes referred to as emphysema, chronic bronchitis or smoker’s cough, kills more than 120,000 Americans a year as blockages in the lungs lead to shortness of breath and disability.
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