MADRID, April 30 (Reuters) - Spanish drug maker Almirall (ALM.MC) said on Thursday it had begun a programme to comply with U.S. and EU authorities’ recommendations regarding phase III trials of lung drug aclidinium bromide.
Almirall and U.S. partner Forest Laboratories FRX.N had planned to submit the drug to treat chronic obstructive pulmonary disease (COPD) in the fourth quarter of 2009 or the first quarter of 2010.
But following a meeting with the U.S. Food and Drug Administration in March when the FDA asked for more information, Almirall said it would delay a drug application.
Almirall said based on meetings with the FDA and various EU member countries in 2009 it and Forest had agreed a clinical and regulatory strategy for the monotherapy of aclidinium bromide.
“Almirall and Forest have begun a programme aimed to meet the regulatory requirements, both U.S. authorities’ and EU, that support aclidinium in higher and/or more frequent doses,” it said in a statement, adding: “In the course of 2009 more details about this programme will be communicated.”
Almirall also said it had received positive results from a third phase II study of another treatment for COPD, labelled LAS100977, for asthma treatment. (Reporting by Ben Harding; Editing by Dan Lalor)