MADRID (Reuters) - Spain’s Almirall and Forest Laboratories said results of a first phase III clinical trial for Almirall’s Genuair inhaler were positive and they would seek regulatory approval to sell the drug if further results proved positive.
Results of a second phase III trial for the inhaler, which delivers fixed dose combinations of alclidinium bromide and formoterol fumarate to treat chronic obstructive pulmonary disease (COPD), are expected in the coming weeks.
“In addition to the improved efficacy shown in this study, the safety profile was comparable to placebo,” Bertil Lindmark, Almirall’s Chief Scientific Officer, said on Tuesday.
If the next round of results are also positive, the companies will file new drug applications to medical authorities in the United States and Europe, Almirall said.
Almirall’s share price has risen 70 percent over the past year to close at 10.43 euros ($13.65) on Monday.
Reporting by Clare Kane; Editing by Mark Potter