Cambridge, UK, April 24, 2017. Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that is has extended its agreement with Durbin plc, for the supply of alicaforsen enema in response to unsolicited requests from physicians and healthcare professionals, to the Nordic regions under the provisions of Named Patient Programme (NPP) schemes. Durbin becomes the sole NPP distributor of alicaforsen throughout Europe.

Durbin, one of the world’s leading specialist medical suppliers and distributors of pharmaceuticals, is licensed for the international supply of unlicensed medicines in response to requests from specialist clinicians to treat patients on an individual basis.
Alicaforsen enema is currently being evaluated in a pivotal Phase 3 trial for the treatment of pouchitis, a rare and serious form of inflammatory bowel disease (IBD) with limited treatment options.

Toby Wilson Waterworth, CEO at Atlantic Healthcare said: “Atlantic Healthcare has supplied alicaforsen enema, throughout Europe for a number of years, in response to unsolicited requests from physicians looking for novel therapies to treat patients with pouchitis and ulcerative colitis (UC) that have failed other treatment options. As such, we are delighted to extend our relationship with Durbin into the Nordic regions, to continue the provision of alicaforsen on a ‘Named Patient’ basis.”

Robert Donnell, Head of Business Development at Durbin said: “We are delighted to have been appointed by Atlantic Healthcare as its sole European distributor for alicaforsen enema; a treatment option in an area of high unmet clinical need where there are no licensed alternatives. A project of this scale requires a specialist global distributor, and our previous work positions us well to support Atlantic Healthcare in providing better patient care in this area.”

Physicians can find contact details for Durbin, and further information on requesting alicaforsen through the NPP, on the website (www.atlantichc.com/for-physicians), or by contacting Amjid Shah, Medical Liaison Manager – Europe (details below).

Contacts at Atlantic Healthcare:

Toby Wilson Waterworth (CEO)
+44 1799 513 391

Amjid Shah (Medical Liaison Manager – Europe)
+44 1799 512 055

+44 7850 647767

amjid.shah@atlantichc.com

Adam Michael (Head of Communications)
+44 1799 512 055

+44 777 588 1813

adam.michael@atlantichc.com

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 for the treatment of 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 a durable effect. Based upon clinical studies involving more than a 1,000 patients (enema, parenteral, and IV delivery) alicaforsen has been shown to be safe and well tolerated.

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].

Atlantic Healthcare has made alicaforsen available to patients in Europe in response to unsolicited requests via Named Patient Supply protocols. Data from these patients 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)