Atlantic Healthcare Release: Pharma Receives FDA Agreement To Initiate Rolling Submission Of Its New Drug Application For Alicaforsen In The Treatment Of Pouchitis

- FDA to accept sections of the regulatory application ahead of final Phase 3 data expected in the second half of 2017

Cambridge, UK, and Raleigh, NC; 24 January 2017. Atlantic Healthcare plc, an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that it has received agreement from the U.S. Food and Drug Administration (FDA) to initiate a rolling submission of its New Drug Application (NDA) for alicaforsen to treat pouchitis, a serious form of inflammatory bowel disease (IBD) that has limited treatment options.

Toby Wilson Waterworth, CEO at Atlantic Healthcare, said: “Following a meeting with the FDA in December 2016, in which we discussed the preclinical (safety) package for alicaforsen, we are delighted to announce that the FDA accepted our request for a rolling submission of the NDA for alicaforsen in pouchitis. We expect to complete the NDA submission, following successful completion of our ongoing pivotal Phase 3 trial of alicaforsen in pouchitis.”

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 accelerated approval.

For more information please contact:

Atlantic Healthcare
Toby Wilson Waterworth (CEO)
+44 1799 512 055

Adam Michael (Head of Communications)
+44 1799 512 055; +44 777 588 1813
adam.michael@atlantichc.com

U.S. Investor Relations
Lazar Partners
Fern Lazar / David Carey
+1 212-867-1762
atlantic.healthcare@lazarpartners.com

European Media and Investor Relations
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Neal
+44 20 3709 5700
atlantichealthcare@consilium-comms.com

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