Glaxo, Theravance Breo lung drug fails to extend life in huge study

GlaxoSmithKline Plc (GSK) and its partner Theravance Inc on Tuesday said their inhaled medicine Breo failed to prolong life of patients with chronic respiratory disease in a high-stakes clinical trial of 16,500 people.

Theravance shares plunged 14 per cent on Breo's failure to meet the study's primary goal. Shares of far-larger Glaxo rose 2.2 per cent in New York, lagging a 2.5 per cent gain for the broader stock market.

Investors had hoped the large study would greatly increase sales for the medicine. It was approved in 2013 for chronic obstructive pulmonary disease (COPD), a leading cause of death worldwide that is often referred to as smoker's cough. It also includes chronic bronchitis and emphysema.

Breo lowered risk of dying by 12.2 per cent, compared with placebo. But that benefit was not deemed statistically significant.

Had it succeeded, Breo would have been the first drug to show a survival benefit in patients with COPD.

It was shown to reduce the rate of decline in lung function, compared with a placebo, and also showed improvement by a half dozen other measures. But because Breo failed its main study goal, statistical significance could not be inferred for any of those secondary objectives.

The risk of having a heart attack, stroke or other cardiovascular incident was reduced by 7.4 per cent, but was not statistically significant.

Incidence of serious adverse events, including cardiovascular episodes and pneumonia, were similar in the Breo and placebo groups.

Nine years ago, a similar study with GSK's older drug Advair, involving 6,100 patients, narrowly failed.

GSK has also chosen higher-risk patients with heart issues for the new study.

Inhaled drugs like Breo that combine a steroid and a long-acting beta agonist (LABA) help patients breathe more easily but their effect on survival has been unclear.

The drug, like Advair, is also widely used to treat asthma, but has generated disappointing sales for Glaxo, a longtime leader in respiratory medicine.

Sometimes known as "son of Advair", once-a-day Breo has a dosing advantage over twice-daily Advair. But the market for inhaled lung drugs is fiercely competitive and Breo has struggled at a time when GSK has been forced to cut Advair prices.

"Even if results had been positive, it was never clear how impactful they would be because physicians largely view Breo and Advair as interchangeable, and Advair is very well-entrenched," Sanford Bernstein analyst Tim Anderson said in a research note.