AstraZeneca has won approval in the EU for a new combination therapy for chronic obstructive pulmonary disease (COPD) that is expected to become a big seller for the company.
Duaklir combines the long-acting muscarinic antagonist (LAMA) aclidinium bromide with formoterol fumarate, a long-acting beta agonist (LABA), in the proprietary Genuair device and the approval gives AZ a product in a class that is expected to become a dominant force in COPD therapy in the coming years.
LAMAs are a well-established class in COPD therapy, with Boehringer Ingelheim’s leading Spiriva (tiotropium) product achieving sales of nearly $5bn last year, but LAMA/LABA combinations have only recently become available.
Duaklir reaches the market just behind rival LAMA/LABA combinations from GlaxoSmithKline/Theravance and Novartis and a little ahead of Boehringer’s tiotropium/olodaterol candidate. Both GSK’s Anoro (umeclidinium bromide/vilanterol) and Novartis’ Ultibro (glycopyrronium bromide/indacaterol) were approved in their first markets last year.
Market research firm Decision Resources (DR) predicted earlier this year that LAMA/LABA combinations will capture more than 35% of a COPD market tipped to reach $14bn in the top seven pharma markets alone by 2022, up from around $10bn in 2012, displacing Spiriva and other top sellers notable GSK’s beta agonist/corticosteroid combination Advair/Seretide (salmeterol/fluticasone).
AZ owns the rights to develop and commercialise Duaklir in the EU after taking ownership of former partner Almirall’s respiratory portfolio in a $1.2bn deal that was completed last month.
At last week’s strategy update, AZ told investors that its COPD portfolio was a key element behind two of its six growth platforms – respiratory drugs and emerging markets – as the disease affects around 300 million people worldwide and is increasingly prevalent in developing countries such as China and Russia.
AZ already sells a combination beta agonist/corticosteroid product for COPD called Symbicort (fotmoterol/budesonide), although this has now started to face generic competition in some markets.
Its intention is to develop a portfolio of COPD therapies that addresses “all disease severities”, according to Bing Yao, head of respiratory, inflammation and autoimmunity R&D at AZ’s MedImmune subsidiary.
Other drugs in the pipeline for COPD include anti-interleukin-5 therapy benralizumab – due to be filed in 2018 – as well as a triple therapy for the disease based called PT010 which combines formoterol, another LAMA called glycopyrrolate and an inhaled corticosteroid that was acquired along with Pearl Therapeutics last year.