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Atlantic Healthcare announces strengthening of the Board as it prepares for commercialisation of alicaforsen in its first indication

CAMBRIDGE, U.K., May 22, 2017 (GLOBE NEWSWIRE) -- Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces the strengthening of the Board for the next stage of the company’s development, with the appointments of William (Bill) Ringo and Andrew Boyce as non-executive directors. Additionally, Thomas Wellner has agreed to become Chairman of the Board, following his appointment as interim Chairman in April 2017.

Bill steps up to the Board from his role as a U.S. commercial and corporate advisor to the company. Bill currently serves on the Boards of several NASDAQ-listed U.S.-based companies, including as Chairman of Assembly Biosciences Inc., and as director of Sangamo Therapeutics Inc., Immune Design Corp., Dermira Inc., and Five Prime Therapeutics Inc.

His previous leadership roles include Chairman and Interim Chief Executive Officer of NASDAQ-listed InterMune, Inc (acquired by Roche) and Senior Vice President of Strategy and Business Development at Pfizer, Inc., overseeing its acquisition of Wyeth. Before joining Pfizer, he was President and Chief Executive Officer of NASDAQ-listed Abgenix, Inc., a biotechnology company acquired by Amgen, Inc. and, prior to this, a senior executive and member of Eli Lilly and Company’s operating committee.

Andrew represents a significant family office shareholding in Atlantic Healthcare and was one of its founding investors in 2006. Since 1987, Andrew has managed a private family office, which has diverse commercial interests including technology and medical investments, property, and farming. He is a member of the board of UK AIM-listed Hardide plc, an advanced surface coating technology company, where he has served as a non-executive director since June 2012.

After serving as non-executive director since 2015, Lorin Johnson has stepped down from Atlantic Healthcare's Board to focus on earlier stage emerging opportunities. He will continue to support the company as a senior scientific adviser.

Atlantic Healthcare's lead product, alicaforsen, is in a pivotal Phase 3 trial to treat pouchitis, a rare and serious form of inflammatory bowel disease (IBD) for which there are no approved and limited treatment options. The company has initiated a rolling submission to the U.S. Food and Drug Administration (FDA), and plans to commercialise alicaforsen in the U.S. and Europe itself, and licence commercial rights in the rest of the world.

Thomas Wellner, Chairman of Atlantic Healthcare, said: “Lorin has been a tremendously engaged and dedicated member of our Board, providing invaluable scientific advice in the deepening of the alicaforsen product pipeline with multiple potential indications. As we enter the commercialisation phase of the company, and seek regulatory approval for the first indication of alicaforsen, Lorin has decided to pursue opportunities with earlier-stage drug development companies and will continue to provide scientific advice to Atlantic.”

“I am excited to welcome Bill and Andrew to the Board. They have broad and diverse experience across a range of emerging and publicly-listed entities that will serve the company well for the next phase of its development.”

Toby Wilson Waterworth, CEO at Atlantic Healthcare, said: Firstly, I'd like to thank Lorin for the support and experience that he brought to the board and Atlantic Healthcare. His scientific expertise has been important in helping us deepen our pipeline and build the alicaforsen programmes. We wish him well with his future endeavours and appreciate his offer to continue to support the company in future.

“I am delighted to welcome Bill and Andrew to the Board and the additional corporate and U.S. commercial expertise they bring.

“The ability to attract someone of Bill’s standing and expertise in the pharmaceutical industry is a testament to the progress and prospects for Atlantic Healthcare.”

“Andrew is one of the founding investors in Atlantic Healthcare, and a long-term advocate for the business. Andrew's experience across diverse businesses is a valuable addition to the Board as we progress the commercialisation of alicaforsen.”

“I am also delighted that Tom, who has been a director of the company since its founding, has accepted the invitation to be Chairman on a permanent basis. His agreement to take on the role provides the Board with leadership and expertise as Atlantic Healthcare prepares for its next growth phase.”

“These Board changes are part of an ongoing process of optimising the Board's structure and composition in support of the next stage of development of Atlantic Healthcare.”

Bill Ringo, Non-Executive Director, said: Atlantic Healthcare is entering an exciting phase as it initiates the regulatory filing of alicaforsen in the U.S. and Europe. It is one of very few companies in Europe close to bringing its first drug to market, and has an exceptional leadership team heading that process. I look forward to working with Toby and the Board as we build momentum behind alicaforsen, a product with multiple potential indications.”

Andrew Boyce, Non-Executive Director, said: “I have been a passionate advocate of Atlantic Healthcare and its leadership team since the company was founded just over 10 years ago. As we now enter this pivotal phase for the company, I am delighted to add my commercial knowledge and corporate experience to the Board.”

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 IBD. The enema formulation is currently in a pivotal Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active 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.

Under a rolling submission agreement with the FDA, Atlantic Healthcare has filed the nonclinical data package of its New Drug Application (NDA) for alicaforsen to treat pouchitis with the regulator. 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 with UC and pouchitis, 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 an antisense oligonucleotide, which has been designed to interact and down regulate 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 involved in inflammatory responses[2].

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

References:

  1. Inflammatory Bowel Disease. Imre Szabo. ISBN 978-953-51-0879-5
  2. 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
  3. 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
  4. 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
  5. 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 (http://www.atlantichc.com/la-bark-abstract-pdf)
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 / Jessica Hodgson / Melissa Gardiner +44 20 3709 5700 atlantichealthcare@consilium-comms.com

Source:Atlantic Healthcare plc