Almirall/Forest set to file aclidinium for COPD by early 2012

Leading Spanish drugmaker Almirall and its US partner Forest Laboratories have started implementing a program aimed at satisfying  both US and European regulatory requirements to provide further support  for higher and/or more frequent dosage regimens of aclidinium bromide,  their late-stage drug candidate for chronic obstructive pulmonary  disease. Their tentative target filing date for this program is late  2011/early 2012 for both major territories. Last year, the product  suffered a setback when Almirall presented disappointing late-stage data  on the compound, which many analysts had expected to become a  best-in-class treatment. The drug had surprisingly low efficacy compared  to rival product, Boehringer Ingelheim's Spiriva (tiotropium;  Marketletter September 15, 2008).