BioCentury
ARTICLE | Company News

CHMP backs Almirall's Duaklir for COPD

September 26, 2014 3:20 AM UTC

EMA's CHMP recommended marketing authorization of Duaklir Genuair aclidinium bromide/formoterol fumarate ( LAS40464) from Almirall S.A. (Madrid:ALM) as a maintenance bronchodilator to treat symptoms of chronic obstructive pulmonary disease (COPD). Almirall expects a final decision from the European Commission within three months.

The product, a fixed-dose combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) respectively, is included in a July deal under which AstraZeneca plc (LSE:AZN; NYSE:AZN) is acquiring Almirall's respiratory disease business, including a suite of COPD and asthma treatments, for $875 million up front and up to $1.2 billion in milestones (see BioCentury, Aug. 18). ...