Investment secures funds to complete pivotal Phase 3 trial of alicaforsen in pouchitis and file for regulatory approval in North America and Europe

Dr Lorin K Johnson, Scientific Founder of Salix Pharmaceutical, joins Board and Leadership team

Cambridge, UK, 21 March 2016. Atlantic Healthcare plc (“Atlantic Healthcare”), an international specialty pharma company focusing on gastrointestinal disorders, today announces it has raised $24 million via an oversubscribed equity financing round with the founders of Salix Pharmaceuticals, Inc.; Fullbrook Thorpe Investments LLP (the family investment arm of Andy Leaver, founder of Clinigen Group plc); LDC (the private equity division of Lloyds Banking Group plc); and existing investors.

In addition, Dr Lorin K Johnson has been appointed to the Board of Directors and has joined Atlantic Healthcare as a member of the Leadership team as Chief Scientific Advisor, with immediate effect. Dr. Lorin K Johnson was previously the Scientific Founder of Salix Pharmaceuticals, Inc. (NASDAQ: SLXP) until its $15.8 billion acquisition in April 2015 by Valeant Pharmaceuticals International, Inc. Prior to Salix, Dr. Johnson was Chief Scientist at California Biotechnology, Inc, and held academic positions at Stanford University School of Medicine and the University of California, San Francisco.

The investment will fund the recently announced pivotal Phase 3 trial for alicaforsen enema, Atlantic Healthcare’s wholly-owned product to treat Inflammatory Bowel Disease (IBD) pouchitis, as well as the regulatory filings for approval with the U.S. FDA, EMA, and Health Canada.

In February 2016, Atlantic Healthcare commenced the recruitment of 138 patients at 40 trial centres across the United States, Canada, Europe and Israel. There are currently no approved drugs for pouchitis and this trial will be the largest ever conducted for this indication. The product is also ready to commence Phase 3 for acute ulcerative colitis.

“This funding round allows Atlantic Healthcare to take alicaforsen through to being “market-ready” by the completion of the Phase 3 trial in pouchitis and regulatory filing across the U.S., Canada and Europe,”said Toby Wilson Waterworth, CEO and founder of Atlantic Healthcare.“Today’s investment is a resounding endorsement of the Company’s product development to date and the potential of alicaforsen. We look forward to working with the LDC team, the founders of Salix and Clinigen, and our existing investors, as we accelerate the development of alicaforsen initially for patients with pouchitis, a debilitating disease with no approved treatments.

“I am also delighted to welcome Dr Lorin K Johnson to the Board of Atlantic Healthcare. Lorin’s previous experience was Scientific Founder at Salix Pharmaceuticals, where he helped grow the business through licensing, acquisitions and new indication development to being a $1 billion revenue-generating, world-leading gastrointestinal specialty pharma. We are already working with him and benefiting from his input and expertise.”

Commenting on his appointment to the Board, Dr. Lorin K Johnson said:“Atlantic Healthcare has successfully progressed alicaforsen, a potentially life-changing treatment for patients suffering from IBD pouchitis, into Phase 3 with a relatively modest amount of investment. With today’s fundraise in place, the Company is now positioned to accelerate development through to being market-ready. I am excited to be able to help with this project and the future prospects for Atlantic Healthcare.”

Commenting on its investment in Atlantic Healthcare, John Green, Investment Director at LDC said: “We are pleased to support Atlantic’s management team given their impressive track record to date and the fact that the Company is already generating revenues. Furthermore, with alicaforsen having been granted fast-track status and orphan drug designations, the business has a clear and cost effective route for filing first regulatory approvals, potentially taking the lead programme through to launch across Europe and the United States, in a relatively short time frame.”

Atlantic Healthcare has worldwide exclusive rights to alicaforsen, which has been licensed from Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) (formerly Isis Pharmaceuticals, Inc.) and has regulatory and patent exclusivity until circa 2030. Alicaforsen is generating early revenues in Europe through Named Patient Supply protocols. This has provided further evidence of efficacy and safety in the pouchitis indication [1]. Alicaforsen has FDA fast track designation, and FDA and EMA orphan drug designation in pouchitis.

References:
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

 

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

European Investor Relations and Media
Consilium Strategic Communications

Mary-Jane Elliott / Matthew Neal

+44 20 3709 5700

atlantichealthcare@consilium-comms.com

 

Notes to Editors:

About Atlantic Healthcare plc (www.atlantichc.com)

Atlantic Healthcare is an international specialty pharmaceutical company focussed on diseases of the gastrointestinal tract and Inflammatory Bowel Disease (IBD). The Company’s lead product is alicaforsen enema, in Phase 3 development for pouchitis, and in preparation for Phase 3 clinical development for Ulcerative Colitis. Alicaforsen is also generating early repeat revenues in Europe through Named Patient Supply protocols. The Company has FDA and EMA orphan designation, and an FDA letter of fast-track in pouchitis. In addition, the Company is targeting the use of alicaforsen for the treatment of other inflammatory bowel diseases including left-sided (distal) colitis. Atlantic Healthcare has a highly committed investor base, and an experienced international Board and management team. Atlantic fundraising to date includes £1.9m through SBRI funding with InnovateUK, the UK Government’s innovation agency. (www.innovateuk.gov.uk)

About LDC

LDC is the private equity division of Lloyds Banking Group plc, one of the UK’s national banks, and is authorised and regulated by the Financial Conduct Authority.
LDC back ambitious management teams from UK-based companies seeking between £2m and £100m of equity for management buy-outs, institutional buy-outs or development capital transactions.

LDC invests in a broad range of sectors and has particular experience in Construction & Property, Financial Services, Healthcare, Industrials, Retail & Consumer, TMT, Travel & Leisure and Support Services.

About Fullbrook Thorpe Investments LLP

Fullbrook Thorpe Investments LLP (“FTI”) is a Family Investment Fund established in April 2015. Investing worldwide in a broad spectrum of companies, FTI has grown a diverse portfolio of investments in a short time, the majority of which are in the pharmaceutical industry. The fund was founded by Andy Leaver (Chairman), Andrew Borkowski (CEO) and Andy’s son Tom Leaver. Andy Leaver is an entrepreneur who has built a reputation in the pharmaceutical industry for successfully developing and selling businesses. Andy’s recent success was the floatation of Clinigen Group plc, on the AIM market of the London Stock Exchange.

About Alicaforsen

Alicaforsen enema is currently in a Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active, chronic, antibiotic refractory pouchitis. The trial will recruit 138 patients to 40 trial centres across the U.S., Canada, Europe and Israel. Alicaforsen is an antisense oligonucleotide with a novel mode of action (MOA) for treatment of IBD. Alicaforsen is targeted to ICAM-1, a cell-surface protein which is involved in the inflammatory response and over-expressed in patients with inflammatory disease. Originally developed as an IV formulation for Crohn’s disease, alicaforsen enema is being developed as a locally active topical formulation which has demonstrated, in five Phase 2 clinical studies involving 377 patients, an ability to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen enema has commenced Phase 3 for pouchitis and is ready to commence Phase 3 for active distal UC. There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC. Alicaforsen enema has the potential to establish a new class of therapy with clear differentiating features. Alicaforsen has FDA fast track designation, and FDA and EMA orphan drug designation in pouchitis.

About Pouchitis

Pouchitis is the inflammation of the internal pouch, an artificial rectum created from the terminal ileum (small bowel) in patients with severe Ulcerative Colitis (UC) who have undergone surgery to remove diseased tissue of the colon (colectomy). The procedure is known as Ileal-pouch anal anastomosis (IPAA). Like UC, pouchitis is a progressive disease characterised by inflammation, ulceration, increasingly uncontrolled, frequent and urgent emptying of the bowel (up to 10 or more times a day and night) with a corresponding reduction in quality of life. For pouchitis patients there is a significant unmet medical need and currently no approved treatment in North America or Europe.

Existing treatment is via certain off-label therapies involving a step by step “try and see” approach, often with limited effectiveness. Most physicians begin therapy with antibiotics, only prescribed for short-term use due to long-term safety issues (including neuropathy, tendonitis and potentially fatal C. difficile). Patients can become unresponsive (refractory) to antibiotics over time and require alternative therapeutic approaches.

In the absence of further treatment options, for some patients the only other avenue is surgery to remove the pouch and divert the bowel through the abdominal wall (ileostomy) for collection of the bowel contents using a stoma bag. Infection and other complications can require additional surgeries throughout the patient’s lifetime, to repair and/or relocate the stoma.

There is a significant need for a convenient, effective, localised, topical therapy with a well tolerated side-effect profile.