GlaxoSmithKline's hopes flag as Breo flunks COPD outcomes study

GlaxoSmithKline's ($GSK) respiratory business, struggling in the face of Advair price cuts, could use the few billion dollars analysts predicted it could generate if newcomer Breo aced an outcomes study. But no dice, the company reported Tuesday.

In the words of Bernstein analyst Tim Anderson, the SUMMIT trial--which sought to show the so-called "son of Advair" helped COPD patients live longer--"did not deliver the goods." The drug missed statistical significance on that endpoint, as well as several secondary endpoints, just as Advair did in a similar study 9 years back.

Without that rosy data in hand, Breo lacks a clear commercial advantage over drugs like Advair and AstraZeneca's ($AZN) Symbicort, Bernstein analyst Ronny Gal wrote in a separate note to clients. Though Breo is taken once a day--as opposed to twice-daily Advair--"physicians largely view Breo and Advair as interchangeable, and Advair is very well-entrenched," Anderson added.

As HSBC analyst Stephen McGarry told Bloomberg last month, the failure could mean the difference between $5 billion in peak sales or $1.8 billion. To Gal, though--who modeled peak sales of $1.6 billion before the data hit--reaching that benchmark is still possible, though it's "likely more of an upside case,"  he noted.

Glaxo has been looking for big things from Breo, meant to help fill Advair's giant shoes as generics in Europe and aggressive payer tactics in the U.S. take their toll on sales. But Breo--which won its FDA COPD nod in 2013 and followed up with an asthma green light this April--hasn't gotten off to the start the company expected.

When it comes to giving the drug a leg up over its declining predecessor, though, all hope is not lost, Gal pointed out. There's another potentially valuable study in the works in SALFORD, a trial intended to show Breo's real-life benefit over Advair. That trial should read out in the middle of next year, he wrote.

- read Glaxo's release

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