Phase III programme for alicaforsen enema in the orphan disease pouchitis

点击翻译按钮获取中文摘要

Atlantic Healthcare is focused on the development and commercialisation of niche profitable specialist drugs meeting unmet clinical needs of patients managed in the hospital and specialist care environments in Europe and the US, neglected by larger international pharmaceutical companies. Alicaforsen, Atlantic's first product, is a novel ICAM-1 inhibitor and a first in class drug for the treatment of Inflammatory Bowel Disease (IBD). This is a $3.5bn pa market growing at 10% pa, driven by the need for new & effective therapies. Alicaforsen has completed Ph2 development and been granted orphan designation and a letter of fast track for Europe and the US for the treatment of pouchitis, a rare disease for which there is no approved treatment. Atlantic Healthcare has obtained agreement from international regulators that only a small single pivotal placebo controlled Ph3 is necessary for marketing approval for Europe/US.