Breo trial failure upsets GSK's respiratory recovery

GlaxoSmithKline's (GSK) hopes of a return to growth for its embattled respiratory division in 2016 have been knocked back after the failure of a large-scale trial of new drug Breo/Relvar.

The SUMMIT trial was designed to test whether treating chronic obstructive pulmonary disease (COPD) patients with Breo (fluticasone furoate/vilanterol) improved survival compared to placebo and, if positive, could have added another $1 billion to sales projections for the drug.

Unfortunately for GSK the trial missed its endpoint and the company's hopes of Breo becoming the only long-acting beta agonist (LABA) and inhaled corticosteroid (ICS) product able to trumpet a survival claim for a COPD therapy have vanished.

For GSK the failure comes at a time when it desperately needs Breo to gain momentum in order to offset a decline in sales of its predecessor Advair (fluticasone propionate/salmeterol), which saw sales decline 14 per cent in the first six months of 2015 to £1.86 billion, thanks to downward pressure on pricing in the US and competition from other new COPD therapies.

During GSK's second-quarter results call, chief executive Sir Andrew Witty described the SUMMIT data as a "central part of the profile of Breo" and the concern is now that the product has little to differentiate it from its predecessor other than a higher price.

Adding to the disappointment is that Breo is seen as a more important asset than GSK's other new combination drug Anoro, which combines LABA vilanterol with long-acting muscarinic antagonist (LAMA) umeclidinium – at least in the near-term.

Anoro is treading a new path in COPD therapy and progress is expected to be slow while physicians develop confidence in its use. First-half sales of the drug were £27 million, while Breo contributed £97 million.

Despite the setback, Breo should still help to grow GSK's respiratory franchise, albeit at a lower rate than hoped and not in the timeframe the company predicted.

A recent approval for asthma in the US will add some much-needed momentum – even though it was only licensed for this indication in adults – and it is also positive that Breo is now listed on two-thirds of pharmacy benefit manager (PBM) formularies in the US two years after launch and has 75 per cent coverage on Medicare Part D.

That suggests its reimbursement status in the US has improved dramatically in recent months, while the product is also starting to make headway in Europe, particularly in some countries like Italy, Spain and France, according to Sir Andrew.

It could also get a boost if the Salford Lung Study in COPD, which is comparing the drug with standard care in a real-world setting, yields positive results next year.

Overall however the likelihood is that without the survival claim Breo will struggle to make the kind of headway in the market needed by GSK, a situation which will only be exacerbated when generic versions of Advair reach the US market in 2017.