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Atlantic Healthcare Granted U.S. Patent Extending IP Cover Of Alicaforsen In The Treatment Of Inflammatory Bowel Disease



11/7/2016 9:34:52 AM

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Patent covers use of antisense oligonucleotides to treat rectal stump inflammation and pain

Cambridge, UK, and Raleigh, NC 7 November 2016. Atlantic Healthcare plc, an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that the U.S. Patent and Trademark Office has granted U.S. Patent No. 9453221.

The Group's product, alicaforsen, is targeting the treatment of inflammatory bowel disease (IBD) and its most advanced programme is undergoing Phase 3 clinical development for the treatment of IBD pouchitis. With the Group's strategy to broaden the indications and formulations based on alicaforsen, the granted patent extends the use of alicaforsen in IBD-related rectal stump inflammation and pain.

In the treatment of IBD, a rectal stump is formed through a surgical procedure in order to rest a diseased colon, as an alternative to total colectomy. Patients with a rectal stump can experience inflammation, pain, and discharge for which there is no approved therapy. They can also experience a significant reduction in quality of life.

Toby Wilson Waterworth, CEO at Atlantic Healthcare said: “This latest granted patent extends the family of intellectual property protection covering Atlantic Healthcare's product, alicaforsen, for the treatment of multiple indications within inflammatory bowel disease (IBD). The IP protection, which includes the use of alicaforsen in ulcerative colitis and pouchitis, provides protection for alicaforsen out to 2030 and beyond.

As with other forms of IBD, existing therapies to treat pain and inflammation in a rectal stump have limited efficacy, with patients often becoming resistant to treatment. With no approved therapy there is a clear unmet clinical need, which alicaforsen has the potential to address as a first in class drug, harnessing an alternative mode of action.”

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

Consilium Strategic Communications Mary-Jane Elliott / Matthew Neal / Jessica Hodgson / Melissa Gardiner +44 20 3709 5700 atlantic@consilium-comms.com

Notes to Editors:

About Atlantic Healthcare plc (www.atlantichc.com)

Atlantic Healthcare 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 also 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 an FDA letter of fast-track, 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 InnovateUK, the UK Government's innovation agency (www.innovateuk.gov.uk). In Q1 2016 the Group closed a $24m round led by LDC (the private equity division of Lloyd's Banking Group), with investment from founders of both Salix Pharmaceuticals and Clinigen Group, and existing shareholders.

About Alicaforsen

Alicaforsen enema has the potential to establish a new class of therapy for the treatment of inflammatory bowel disease (IBD), with clear differentiating features. Alicaforsen enema 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 is an antisense oligonucleotide with a novel mode of action for treatment of IBD. Alicaforsen targets ICAM-1, a cell-surface protein which is involved in the inflammatory response and is over-expressed in patients with IBD.

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 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.

As noted above, alicaforsen in pouchitis has an FDA letter of fast track plus U.S. and European orphan drug designations. Alicaforsen is generating early repeat revenues in Europe through unsolicited requests via the Named Patient Supply protocols. This has demonstrated further evidence of efficacy and safety in the pouchitis[1] and UC indications [2,3].

About Rectal Stump

A rectal stump is formed when the rectum is closed and excluded from faecal transit after surgical removal of diseased sections of the colon; it can be up to 25cm in length from the anus. Patients with a rectal stump will also have a colostomy.

The temporary procedure is used in patients suffering from various intestinal diseases, including inflammatory bowel disease and colon cancer, where “resting” of diseased tissue can enable it to recover. As such, rectal stumps can be inflamed, causing patients both pain and discharge. Once the tissue has returned to a healthy state, rectal stump patients undergo further surgery (reanastomosis) to reconnect the stump to the remaining colon. There is no approved treatment for rectal stump inflammation. Existing treatments for rectal stump inflammation and pain include steroids, antibiotics, and immunomodulating biologics, but patients often become resistant to such therapies. As such, there is an unmet clinical need, which alicaforsen has the potential to address. Studies have shown that up to 90% of patients with a rectal stump experience inflammation, of which around half experience moderate to severe inflammatory symptoms.4

References:

1. 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

2. 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

3. 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/newsdocs/PT-603.pdf)

4. Diversion colitis. A prospective study. Whelan RL, Abramson D, Kim DS, Hashmi HF. Surg Endosc. 1994;8(1):19.

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