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European Medicines Agency Accepts Proposed Single Pivotal Phase 3 for Second IBD Indication for Alicaforsen Enema for European Marketing Approval



8/29/2013 1:03:37 PM

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Cambridge UK: Atlantic Healthcare plc (“Atlantic Healthcare”) has received Scientific Advice from the European Medicines Agency (EMA) agreeing the pathway towards marketing approval for alicaforsen enema in acute left-sided ulcerative colitis.

Upon completion of a single, pivotal Phase 3 study, the EMA will consider alicaforsen enema as a second line treatment for patients who fail to respond to mesalazine in this area of patient need. The announcement follows the recent publication of a meta-analysis study of patient records data from alicaforsen’s four Phase II clinical trials in the highly regarded journal Alimentary Pharmacology and Therapeutics (38:3 284–293, 2013).

Following discussion with EU and US regulatory agencies, Atlantic Healthcare is also ready to commence a single pivotal Phase 3 study for alicaforsen enema in pouchitis; a form of inflammatory bowel disease (IBD) for which there is no approved treatment. Alicaforsen has been granted orphan status for this indication in both the US and EU and will be reviewed in the US under the fast-track approval process.

Alicaforsen is an antisense oligonucleotide which if approved would be a first-in-class treatment for IBD. The recent approval by the FDA in January of this year of Sanofi’s Kynamro has validated the acceptance of antisense oligonucleotides. Toby Wilson Waterworth, Chief Executive Officer said: “We are delighted that the EMA has agreed our plans to our proposal for an expedited development plan for alicaforsen as we believe the product represents a significant innovation in the treatment of inflammatory bowel disease, offering substantial benefits to patients. We plan to initiate Phase III trials in the near future and are in the process of identifying a European co-development and commercialisation partner to assist us with this.”

Professor Derek Jewell, Oxford University, commented:

“Alicaforsen enema is a well-tolerated agent with promising efficacy in ulcerative colitis and other indications. The recently published meta analysis provides a strong signal that alicaforsen enema will be effective for ulcerative colitis patients with moderate-to-severe flares of disease in the lower gastrointestinal tract. Based on the Scientific Advice from EMA, the single pivotal phase 3 trial will enable the company to confirm the utility of alicaforsen enema in this patient group, where there remain few alternative treatment options.”

Atlantic Healthcare plc

Toby Wilson Waterworth, Chief Executive Officer

O: +44 1799 513 391 M: +44 7770 450 898

Mark Donaldson, Chief Financial Officer

O: +44 1799 513 391 M: +44 7940 306 900

Editors Notes and Further Information

About Atlantic Healthcare

Atlantic Healthcare is an international specialty pharmaceutical company, focused on the development and commercialisation of products that address niche unmet needs of patients under the management of physicians in the hospital and specialist care sector.

Atlantic Healthcare is focused on the key markets of Europe (“EU”) and the United States (“US”), within the emerging $160 billion global hospital specialist sector that is showing one of the highest growth rates in the pharmaceutical sector. The Company is currently generating revenues from the sale of its first product, alicaforsen, under European Named Patient Supply regulations (which allow the sale of certain drugs in response to requests for treatment from medical professionals). The strategy is to complete development and commercialise alicaforsen and to acquire other later stage development, or already marketed, lower risk specialist products and companies that can help address current patient needs in this market.

Further information on Atlantic Healthcare can be found on the Company’s website: www.atlantichc.com.

Alicaforsen for Inflammatory Bowel Disease (“IBD”)

Alicaforsen is delivered as an enema treatment initially targeting pouchitis and acute left-sided ulcerative colitis, with the potential to broaden into other inflammatory conditions through the development of alternative topical formulations. The global IBD market for ulcerative colitis and Crohn’s disease is currently estimated to be $5.1 billion a year. Alicaforsen is currently being developed for use in alleviating the symptoms of ulcerative colitis and pouchitis in the key markets of the EU and US. In these markets there are approximately 1.5 million UC patients with such symptoms, of which up to 40 per cent. will ultimately require surgery and a total colectomy to remove the diseased tissue. The majority of these undergo further surgery to create an artificial rectum known as an ileal pouch. Inflammation of this pouch is called pouchitis, for which there is currently no approved treatment. There are approximately 200,000 pouchitis patients in total across the EU and the US.

The growth in the market for hospital treatment of IBD is being driven by the increasing use of high cost therapies (biologicals) to treat moderate to severe forms of IBD. Alicaforsen has a novel antisense mode of action which reduces the expression of a protein called ICAM-1, reducing inflammation in IBD and promoting tissue healing. It has a confirmed health economic advantage when compared with more expensive biologics and/or surgery.

Alicaforsen Enema for Acute Left-Sided Ulcerative Colitis

Ulcerative colitis and Crohn’s disease are the two major forms of IBD. IBD is caused by a chronic activation of the immune system in the gastro-intestinal tract, the symptoms of which include inflammation of the gut, ulceration, abdominal pain, uncontrolled and increased stool frequency and bleeding.

Ulcerative colitis is a disease caused by inflammation and ulceration in the tissue of the colon. 70% of patients experience disease restricted to the descending colon, referred to as left-sided ulcerative or distal colitis. Sufferers can become withdrawn, unable to work and housebound.

Alicaforsen enema is being developed for treatment of acute left-sided ulcerative colitis in which patients require treatment for periodic “flares” of active disease. Whilst many patients remain well-controlled on maintenance therapy, smaller numbers of patients need active intervention for flares of disease from time to time. For these reasons and alicaforsen’s unique mode of action, the EMA accepted that a single, pivotal Phase 3 study in moderate to severe distal ulcerative colitis refractory to mesalazine (5ASA) could be considered grounds for approval of alicaforsen enema in this area of unmet patient need.

The announcement follows the recent publication of a meta-analysis of alicaforsen’s Phase II clinical trial data in Alimentary Pharmacology and Therapeutics (38:3, 284–293, 2013). This meta-analysis re-evaluated all patients with ulcerative colitis who had received alicaforsen enema (240mg), and concluded that those patients with moderate-to-severe disease, with disease up to 40cm from the anal verge responded best to treatment. This patient population demonstrated clinical and statistical superiority to placebo, both for short-term and sustained responses, and a more durable response compared to high dose (4g) mesalazine, as assessed by a number of variables (including remission and symptomatic end-points).

For further information please contact Toby Wilson Waterworth, CEO (Toby@atlantichc.com) or Dr Chris Dunk, Director of

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