GlaxoSmithKline’s (GSK) chronic obstructive pulmonary disease (COPD) portfolio received a significant boost yesterday with the US approval of combination product Anoro Ellipta.
The product combines long-acting beta agonist (LABA) vilanterol with long-acting muscarinic antagonist (LAMA) umeclidinium bromide and is one of the key products GSK has developed to replace COPD blockbuster Seretide/Advair (salmeterol and fluticasone) when it finally succumbs to generic competition.
Anoro is the first once-daily LAMA/LABA product to be cleared as a maintenance treatment for COPD in the US, according to GSK, which intends to launch it in early 2014. Darrell Baker, head of the company’s global respiratory franchise, described the US approval as a “significant achievement”.
The product has been developed in collaboration with Theravance, which will pay a $30m milestone to GSK following the US approval with another $30m due on launch.
GSK was prevented from being first to market with a LAMA/LABA in Europe by Novartis, which secured EMA approval for Ultibro (glycopyrronium bromide and indacaterol) in September. Anoro was filed for approval in the EU in January, and Novartis has not yet filed for approval of Ultibro in the US.
A recent report from Decision Resources (DR) predicts that LAMA/LABA combinations will capture more than 35 per cent of a COPD market tipped to reach $14bn in the top seven pharma markets alone by 2022, up from around $10bn in 2012.
DR believes Anoro will share around $4bn in sales in the top seven markets with Boehringer Ingelheim’s rival LAMA/LABA combination based on tiotropium and olodaterol, with GSK’s recently-approved Breo/Relvar (vilanterol and fluticasone) also a “key growth driver” capturing a sizeable chunk of Seretide’s market share thanks to its once- versus twice-daily administration.
Seretide currently dominates the COPD market alongside Boehringer’s tiotropium monotherapy Spiriva. GSK’s drug garnered sales of $7.6bn last year but has started to lose patent protection in key markets, while Spiriva brought in $4.7bn for Boehringer.