Can easier dosing propel AstraZeneca's severe asthma med past Glaxo's Nucala?


AstraZeneca may not be first with its severe asthma med. But it’s hoping it can still be best, and new study data have some analysts believing that’s possible.

In results unveiled last week at the European Respiratory Society International Congress, AZ’s candidate, benralizumab--when added to the standard of care--cut down on disease exacerbations by up to 51% and improved lung function and asthma symptoms in severe eosinophilic asthma patients.

What’s more, a four-week dosing regimen showed no additional benefit over an 8-week dosing regimen--a factor that “may support less-frequent dosing,” the British drugmaker said in a statement.

If that’s the case, the data could set benralizumab apart from its on-market rivals, GlaxoSmithKline’s Nucala and Teva’s Cinqair, both of which are dosed every four weeks. AZ’s prospect is “late to the game, but potentially best in class in class in terms of dose,” Shore Capital analyst Tara Raveendran said, as quoted by Français Express.

Bernstein’s Ronny Gal, though--who called the results “decent”--noted to clients this week that the exacerbations data is “similar” to what benralizumab’s rivals have already posted. That echoes his assessment in late 2014 that “the efficacy and safety differences between the various drugs are rather small, and thus we expect the primary adoption factors would be order of market entry and formulation.”

When it comes to order of market entry, the point goes to Glaxo, which won FDA approval for Nucala late last year. On the company’s Q2 conference call, CEO Andrew Witty told investors that GSK was “ahead of our expectations in the U.S. and Europe” with the drug, with 3,100 patients already taking it.

And Gal has predicted GSK has the edge in the formulation department, too: Nucala is administered subcutaneously, compared with Cinqair, which is an intravenous formulation. And while AZ’s contender will also be a subcutaneous med, the company's development “program was rushed forward and is thus a bit riskier,” Gal wrote in 2014.

Of course, by the time benralizumab hits the scene, AZ won’t have to go through the same market-building exercise that’s currently occupying Glaxo’s time. It’s “very complex to get patients on these kinds of drugs,” Witty said on the call, noting that “it takes a few months to set up a process, and on average it takes us about 6 weeks to get the patient from a point where a physician says ‘I want to prescribe’ to actually being able to administer the drug."

The reason? “It takes so long to go through all the various reimbursement insurance triggers,” he said.

Glaxo, though, believes all the hard work will pay off--and it isn’t scared of AZ jeopardizing Nucala’s future, either.

As Witty explained, the potential for triple combinations that include Nucala reminds him of the scenario 20 years ago, when Glaxo launched the components that later made up blockbuster Advair. “It was only when we brought Advair out that it really drove the dominance of GSK in that space.” It would take nemesis AZ “another 5 or 6 years to try and catch up," and they have never really been able to in terms of share.

“I think this may be somewhat similar,” he noted, suggesting that there’s potential for the triple combo “to be the absolute clincher of the whole respiratory strategy for GSK.”

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