Astra cannot breathe easy despite first triplet approval

Astrazeneca hopes that its new COPD triplet can gain share from Glaxosmithkline’s rival, but it is not planning a price war.

Astrazeneca now has a COPD triplet, Breztri Aerosphere, to compete with Glaxosmithkline’s Trelegy Ellipta. But Astra is not planning to go hard on price, the company told Vantage, and instead will rely on clinical data to grab market share.

Breztri Aerosphere, previously known as PT010, bagged its first approval today, in Japan. Still, investors in the product’s originator, Pearl Therapeutics, will have to wait a bit longer for their payday: their first milestone of $150m is not due until approval in the US, where a decision is expected in 2020.

This also puts Astra’s inhaler well behind Trelegy Ellipta, which got the FDA nod for COPD in 2017, and has since become a surprise success story for Glaxo. Both inhalers combine a long-acting beta agonist (LABA), long-acting muscarinic antagonist (LAMA) and corticosteroid in a single inhaler.

Competitive?

Despite Glaxo’s head start, its rival believes that it can claw back ground. Tom Keith-Roach, vice-president of Astra's respiratory division, would not give details of Breztri Aerosphere’s price in Japan or elsewhere, but said this would not be a major point of differentiation, and instead highlighted the product's “highly competitive clinical profile” and potentially more patient-friendly device. 

He pointed to the pivotal Kronos trial, which found a 52% reduction in the rate of moderate or severe COPD exacerbations with Breztri Aerosphere compared with Astra’s marketed LAMA/LABA Bevespi Aerosphere; there was also a 17% reduction versus Astra’s LABA/steroid inhaler Symbicort.

According to its label, Trelegy Ellipta reduced rates of moderate to severe exacerbations by 25% compared with Anoro Ellipta, Glaxo’s LAMA/LABA combo, and by 15% versus Breo Ellipta, Glaxo’s LABA/steroid doublet.

Still, the use of different comparators makes it hard to ascertain whether Breztri Aerosphere is truly superior to Trelegy Ellipta here. And stacking Breztri Aerosphere up against Trelegy Ellipta on measures of respiratory function like forced expiratory volume in one second (FEV1) is even trickier. As well as the usual issues with cross-trial comparisons, and different control medications, the task is made more difficult by the use of slightly different outcome measures.

The only way to answer the question of the triplets' respective merits definitively would be a head-to-head study, but Astra said it was not planning one, and presumably neither is Glaxo.

Breztri Aerosphere vs Trelegy Ellipta
Project Company Status Reduction in exacerbations vs LAMA/LABA 2024e sales ($m)
Breztri Aerosphere Astrazeneca Approved Japan; filed elsewhere 52% $400m
Trelegy Ellipta Glaxosmithkline Approved US, EU, Japan 25% $1,584
Source: EvaluatePharma, company releases, product label.

Mr Keith-Roach also contended that patients might prefer Breztri Aerosphere, which comes in a pressurised metered-dose inhaler, over Trelegy Ellipta, which is delivered via a dry-powder device.

Many COPD patients initially receive reliever therapies given via pressurised metered-dose inhalers, so are more familiar with these, he argued.

He added that dry-powder inhalers were not always suitable for patients with more severe COPD, as these might lack the lung function needed to draw dry powder into the lungs.

Both companies are also evaluating their products in asthma where, again, Glaxo is ahead after recently reporting a win in the phase III Captain trial. Meanwhile, Breztri Aerosphere is in a phase II dose-ranging study in asthma, but Mr Keith-Roach would not say when Astra was expecting data.

The coming months could give some clues about whether Breztri Aerosphere has enough of an edge to challenge its more entrenched rival. The sellside certainly thinks that Glaxo will retain its upper hand: EvaluatePharma consensus forecasts 2024 sales of $1.6bn for Trelegy Ellipta and just $400m for Breztri Aerosphere.

Perhaps if Astra wants to build a bigger franchise for its triplet it might have no choice but to compete on price.

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