GlaxoSmithKline’s triple therapy for chronic obstructive pulmonary disease (COPD) is a big piece of its growth plans, but AstraZeneca has data on a rival therapy that suggests it could be challenging for market share in 2019 in some markets.
AZ has reported phase III data from the KRONOS trial of its PT010 triple – combining long-acting beta agonist (LABA) formoterol fumarate, long-acting muscarinic antagonist (LAMA) glycopyrronium and inhaled corticosteroid budesonide – showing that the product achieved significant improvements in a range of lung function tests in COPD patients compared to various two-drug combinations.
Armed with the results, it now intends to press ahead with regulatory filings for PT010 in Japan and Chine later this year – setting up potential approvals in 2019 – and is also hoping to file in the US and Europe next year.
At present GSK is the only company to have approval for a three-drug combination for COPD on b both sides of the Atlantic, winning approval for its Trelegy triple – based on LABA vilanterol, LAMA umeclidinium and ICS fluticasone furoate – in the US and Europe last year.
In Europe it was pipped to the post by Chiesi, which got a green light for its Trimbow (formoterol fumarate, glycopyrronium and beclomethasone) product, but this medicine must be administered twice-daily rather than once daily as with Trelegy and PT010.
GSK has a lot riding on Trelegy as it tries to restore growth in its respiratory business, which has been hit by patent expiries for two-drug COPD blockbuster Seretide/Advair (salmeterol and fluticasone propionate) that was a $7bn product at its peak but has seen sales slip of late, coming in at $3.3bn in the first nine months of 2017.
The company pulled out all the stops to secure approval of Trelegy quickly in order to claim a valuable lead in the race with AZ and Novartis, which is a little further back in development with its triple.
GlobalData says AZ’s PT010 is the main rival to Trelegy as they both jostle for a share of a market that could reach $3.1bn in sales by 2025, accounting for a sizeable slice of the $14.1bn overall COPD market in that year in nine countries – the US, France, Germany, Italy, Spain, the UK, Japan, and Australia.
AZ’s chief medical officer Sean Bohen said the company is “encouraged by the results of the KRONOS trial that has demonstrated PT010’s efficacy in improving lung function and look forward to the ETHOS exacerbation trial results in 2019 that will further characterise the role of this potential treatment for patients with COPD”.