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AZ's new COPD therapy gets green light in Europe

EC backs Duaklir in chronic respiratory condition

AstraZeneca AZ headquarters London UK 

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.

Article by
Phil Taylor

24th November 2014

From: Sales



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