A COPD outcomes trial could give GSK a $3B-plus Breo boost--or not

GlaxoSmithKline ($GSK) has quite a bit riding on results from a trial of respiratory newcomer Breo--as in, billions of dollars in sales. And those data could come along as soon as next month.

Details from SUMMIT, a 16,500-patient study designed to show the drug can extend the lives of COPD patients, could vault Breo ahead of its competition if the data comes up positive, reports. That would make Breo the first med to show a survival benefit in that patient pool. Right now, long-acting beta agonist (LABA) therapies like Breo are only known to help patients with breathing.

The way HSBC analyst Stephen McGarry sees it, SUMMIT could be the difference between $5 billion in peak sales or $1.8 billion, he told the news service.

"If this study is positive, it could lead to a paradigm shift," in prescribing strategies, Courtney Crimm, a pulmonologist overseeing the trial, told Reuters. One reason: SUMMIT recruited patients with cardiovascular risk factors, which accounts for 50% to 70% of COPD patients, Crimm said.

Breo, which won its COPD nod in 2013 and followed up with an asthma go-ahead this April, has gotten off to a sluggish start. For the week ended Aug. 7, total prescriptions stood at 20,020, according to a recent note from Leerink Partners, putting projected Q3 revenue at $73 million. While that's ahead of consensus, they wrote—which stands at $41 million for the quarter—it still puts Breo a long way from fulfilling Glaxo's blockbuster ambitions.

And Breo's slow launch has come at a time when Glaxo needs revenue most. Payer pressure has forced the pharma giant to cut prices on best-seller Advair, sending that drug's sales crashing and leaving big shoes to fill for Breo and fellow new approvals, including combo lung drug Anoro.

If Breo succeeds in SUMMIT, though, it'll go one place Advair couldn't: The respiratory behemoth narrowly flunked  a similar 6,100-person trial, known as TORCH, 9 years ago, Reuters notes.

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