GSK hopes clinical trial can breath new life into lung drug
LONDON, August 14, 2015
GlaxoSmithKline is banking on a major clinical trial to revive its flagging respiratory medicine business, with billions of dollars of sales riding on a positive result.
Data from the so-called SUMMIT study, designed to show GSK's Breo can prolong lives of patients with chronic lung disease, are expected as early as next month, nine years after a similar study with GSK's older drug Advair failed by a whisker.
This time GSK reckons it has a better chance, since the new trial, with 16,500 patients, has more statistical power than the 6,100-patient Advair trial, known as TORCH. GSK has also chosen higher-risk patients with heart issues for the new study.
At present, inhaled drugs such as Breo that combine a steroid and a long-acting beta agonist (LABA) are known to help patients breath more easily but their effect on survival is unclear.
If it succeeds, Breo would be the first drug to show a survival benefit in patients with chronic obstructive pulmonary disease (COPD), potentially turning around its fortunes.
While Breo was approved for COPD in 2013 and won a US green light for asthma in April, it has been slow to take off commercially.
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.
HSBC analyst Stephen McGarry thinks Breo could eventually achieve peak annual sales of $5.0 billion if SUMMIT succeeds, or $1.8 billion if it fails.
Other analysts are more cautious and the current consensus is for sales of $1.55 billion in 2020, according to Thomson Reuters Cortellis.
GSK's partner Theravance is entitled to royalties of 15 percent on the first $3 billion of annual sales and 5 percent beyond that.
Britain's GSK has been a world leader in respiratory medicine since launching the Ventolin inhaler back in 1969, but weak sales in recent quarters are a mounting concern for its investors.
&nbs
Tags: Drug | GSK | respiratory |
