Atlantic Healthcare initiates FDA rolling submission of its New Drug Application for alicaforsen in the treatment of pouchitis

Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that it has initiated the rolling submission of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and filed its nonclinical package for alicaforsen to treat pouchitis.

Pouchitis is a rare and serious form of inflammatory bowel disease (IBD) for which there are limited treatment options. Alicaforsen enema has been granted Orphan Drug designation by the FDA and European Medicines Agency (EMA), and FDA Fast-Track designation in recognition of the unmet medical need for this disease. Alicaforsen enema is currently being evaluated in a pivotal Phase 3 trial in pouchitis.

Toby Wilson Waterworth, CEO at Atlantic Healthcare, said: “The filing of the nonclinical data package initiates the regulatory process for obtaining marketing approval for alicaforsen in the treatment of pouchitis.This is a significant milestone in our corporate development.

“As an antisense therapy, alicaforsen enema has the potential to be first to market in a new class of drugs for the treatment of IBD. Alicaforsen also has the potential to treat multiple inflammatory diseases of the GI tract and elsewhere. Atlantic Healthcare is currently exploring additional formulations to extend the use of alicaforsen into other IBD indications.”

Janette Thomas, Director of International Operations at Atlantic Healthcare, said: “Earlier this year we reached agreement with the FDA on our request for a rolling submission for approval of alicaforsen in the treatment of pouchitis. We are delighted to announce today that the nonclinical data package has now been filed with the agency. This takes Atlantic Healthcare another step closer to bringing alicaforsen to market for patients with pouchitis, a debilitating disease where there remain unmet medical needs and no approved treatments.”

The rolling submission follows previously granted FDA Fast-Track designation for alicaforsen in the treatment of pouchitis. Fast-Track designation is designed to facilitate the development, and when appropriate expedite the review, of medicines that are intended to treat serious conditions and address unmet medical needs. It allows more frequent communication with the FDA, the option for rolling submission, and potential eligibility for FDA and EMA accelerated approvals.