Forest Laboratories ($FRX) says that its inhaled COPD drug aclidinium bromide hit all its goals in a Phase III study, laying the foundation for regulatory applications in the U.S. and Europe in the middle of this year. Forest is partnered with Spain's Almirall on the drug, which produced disappointing results in a separate Phase III study last October.
Investigators recruited 828 patients for the late-stage study, registering improved breathing among people with moderate to severe COPD when compared with a placebo. And the drug hit a slate of secondary goals, including a reduction in breathlessness and improved health status when compared to a placebo effect.
"We are very pleased with these results, which demonstrate that aclidinium provided consistent bronchodilation and symptom control in COPD patients suffering from this debilitating disease," said Almirall CEO Jorge Gallardo. "With these results, we anticipate regulatory filings for aclidinium BID monotherapy this year".
Last fall, Almirall shares plunged after researchers said that a separate late-stage study failed to demonstrate the same impressive results that had been recorded in earlier studies. Both companies badly needed a win in this study in order to push for regulatory approval. If approved, the product will compete with Boehringer Ingelheim's Spiriva.
- here's the Forest press release
- get the report from Reuters