Cambridge, UK; March 22, 2017. Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, is continuing to make good progress towards delivering the results from its pivotal Phase 3 clinical trial of alicaforsen enema in the treatment of pouchitis as well as undertaking steps to broaden its pipeline of development projects.

The Board of Directors believes that the next 18 months will be transformational for the company, including completing the trial, submission of regulatory filings in the U.S. and Europe and preparing to commercialise the product in key markets. Consequently, the Board has requested that all Directors commit additional time to the company during this critical period.

In this context, Richard Wood, who has chaired the Board of Directors for the last five years has elected to step down as Chairman and as a Non-Executive Director due to the weight of other commitments. Thomas Wellner, who has been a non-executive director for the last nine years, will act as interim Chairman until a permanent replacement is appointed.

Toby Wilson Waterworth, Chief Executive Officer of Atlantic Healthcare, said “Richard has added significant value for shareholders during his time with the Company. I have found him a valuable sounding board for ideas throughout the company’s development phase.”

Richard Wood said “The Company is moving into an exciting new commercialisation phase which will require the Chairman to commit more time over an extended period than I am able to. We have made excellent progress towards completing the work necessary for regulatory approval of alicaforsen, and I am confident that the Atlantic team will execute as effectively on preparations for commercialisation of the product.”

 

For more information please contact:

Atlantic Healthcare
Toby Wilson Waterworth (CEO)
+44 1799 513 391

Adam Michael (Head of Communications)

+44 1799 512 055
+44 777 588 1813

adam.michael@atlantichc.com

U.S. Investor Relations and Media
Lazar Partners
Fern Lazar / David Carey

+1 212-867-1762

atlantic.healthcare@lazarpartners.com

 

Notes to Editors:

About Atlantic Healthcare plc (www.atlantichc.com)

“Atlantic Healthcare” or “the Group” is an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal disorders including Inflammatory Bowel Disease (IBD). The Group’s lead product is alicaforsen enema, in a pivotal Phase 3 trial for pouchitis, and in preparation for Phase 3 clinical development in ulcerative colitis (UC). Alicaforsen is generating early repeat revenues in Europe through unsolicited requests via the Named Patient Supply protocols. The Group has FDA and EMA orphan drug designations, and FDA Fast-Track designation, in pouchitis. Atlantic Healthcare has a highly committed investor base, and an experienced international leadership team. Atlantic Healthcare’s fundraising to date includes £1.9m through SBRI funding with Innovate UK, the UK Government’s innovation agency (www.innovateuk.gov.uk). In 1Q 2016 the Group closed a $24m round led by LDC (the private equity division of Lloyd’s Banking Group) with new and existing investors.

About Alicaforsen

Alicaforsen is being developed as a locally active, topical treatment with the potential to establish a new class of therapy, with clear differentiating features, for the treatment of multiple inflammatory GI disorders.

Alicaforsen is currently in development for the treatment of inflammatory bowel disease (IBD). The enema formulation is currently in a Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active, chronic pouchitis. The trial is recruiting 138 patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel. Alicaforsen enema is in preparation to commence a pivotal Phase 3 for active distal ulcerative colitis (UC). There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC.

Atlantic Healthcare has received agreement from FDA to initiate a rolling submission of its New Drug Application (NDA) for alicaforsen to treat pouchitis. Alicaforsen has also been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations for this indication.

Alicaforsen enema has shown, in five Phase 2 clinical studies involving 377 patients, to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen also has a good safety profile based on data from more than 1,000 patients (enema, parenteral, and IV delivery).

Alicaforsen is also in development as an oral, tablet formulation for the treatment of Crohn’s disease and UC.

Alicaforsen is an antisense oligonucleotide which has been designed to interact with mRNA for ICAM-1, a well-recognised cell-surface protein that is involved in the inflammatory response of both the adaptive and innate components of the immune system, and is over-expressed in patients with IBD[1]. Research at Atlantic Healthcare has also provided evidence that alicaforsen can interact with TLR-9, an intracellular receptor involved in TLR-9 signalling pathways that activate cells of the innate immune system, and are involved in inflammatory responses[2].

Alicaforsen is generating early repeat revenues in Europe through unsolicited requests via Named Patient Supply protocols. This has demonstrated further evidence of efficacy and safety in the pouchitis[3] and UC indications[4,5].

References:
Inflammatory Bowel Disease. Imre Szabo.ISBN 978-953-51-0879-5
Toll-like receptors: the swiss army knife of immunity and vaccine development Jennifer K Dowling and Ashley Mansell.Clinical & Translational Immunology (2016) 5, e85; doi:10.1038/cti.2016.22
Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series. Thomas Greuter, Luc Biedermann, Gerhard Rogler, Bernhard Sauter and Frank Seibold.UEG Journal (2015) DOI: 10.1177/2050640615593681

Alicaforsen Retention Enema Induces Long-Term Remission in Patients with Ulcerative Colitis. Zaid Heetun, David Gibson, Denise Keegan, Kathryn Byrne, Hugh E Mulcahy, Garret Cullen, Glen A Doherty. Irish Soc Gastroenterol Nov 2014

Alicaforsen, ICAM-1 enema as a treatment option when treating distal ulcerative colitis . LA. Bark 1 , I. Löfberg 1 , B. Håkansson 1 , U. Sjöqvist 1 (www.atlantichc.com/la-bark-abstract-pdf)