CAMBRIDGE UK – October 18, 2013 – Atlantic Healthcare plc (‘Atlantic Healthcare’) announced today that the management team has been strengthened by the appointment of Dr Chris Dunk as Director of Clinical Development, Mr Simon Kerr as Director of Business Development and Ms Fiona Crawley as Head of Legal Affairs.
Dr Chris Dunk assumes responsibility for managing and progressing the company’s clinical programs towards marketing approvals. Dr Dunk has held senior management positions within pharmaceutical companies and international Clinical Research Organisations (e.g. Glaxo Pharmaceuticals, KuDOS, Quintiles) and has particularly relevant experience of running international clinical trials in Inflammatory Bowel Disease, the company’s current area of focus. Dr Dunk was instrumental in the company’s recent discussions with the European Medicines Agency (EMA), and obtaining the EMA’s confirmation of its plan for a single pivotal Phase 3 study as the pathway to marketing approval of alicaforsen enema for the treatment of ulcerative colitis.
As Director of Business Development Simon Kerr is responsible for leading the out-licensing negotiations in conjunction with Commerzbank AG. Mr Kerr will also be leading the assessment and licensing of products fitting the company’s criteria for acquisition. Mr Kerr’s experience includes commercial roles in publicly and privately held companies (e.g. Imperial Innovations, Wellcome Foundation, Cambridge Drug Discovery Ltd) where he has identified, negotiated and concluded 50 life science related transactions and has led or worked on deals with a cumulative value circa £150m.
Ms Fiona Crawley joins the team following a successful legal career as a partner leading esteemed healthcare teams including international firms Bryan Cave and Covington & Burling. Ms Crawley has particular experience in corporate development and commercial licensing arrangements in the pharmaceutical industry.
Toby Wilson Waterworth, Chief Executive said: “I am delighted to welcome Chris, Simon and Fiona to the Atlantic Healthcare Management Team. This important extension of our managerial expertise reflects the company’s recent progress and builds on our deep understanding of the pharmaceutical industry.”
Chris Dunk, Director of Clinical Development said: “Atlantic Healthcare’s lead asset, alicaforsen enema, is being developed on a robust platform of clinical data. I look forward to building on our previous successes and executing the plan to deliver two exciting product treatments to market.”
Simon Kerr, Director of Business Development said: “Atlantic has made excellent progress with defining the clinical and regulatory pathway to take its first product to market. The company is now poised to initiate pivotal Phase 3 studies in areas of high unmet need and significant market size. I’m pleased to be working with such an experienced team in leading the company’s commercial activities.”
Fiona Crawley, Head of Legal Affairs, said: “After many years in private practice, I am looking forward to being part of Atlantic Healthcare’s successful management team, the future commercialisation of alicaforsen, and in due course the pursuit of other opportunities for the growth of the company.”
Chris Dunk is an employee of the Atlantic Healthcare plc group of companies. Simon Kerr and Fiona Crawley are consultant to Atlantic Healthcare plc.
For more information
Toby Wilson Waterworth, Chief Executive: Toby@atlantichc.com +44 1799 513 391
Guy Sanders, Press Officer: Guy.Sanders@atlantichc.com +44 1799 513 391
Atlantic House, 12 Rose and Crown Walk, Saffron Walden, Essex, CB10 1JH, UK
About Atlantic Healthcare plc
Atlantic Healthcare plc is an international specialty pharmaceutical company. The company is 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 growing $160bn global hospital specialist sector and the key markets of Europe and the United States. The hospital specialist sector is showing one of the highest growth rates in the parent pharmaceutical sector.
The company’sstrategy has two elements. Firstly, to complete development of alicaforsen ahead of international marketing approvals and commercialisation. Secondly to acquire other late stage development, or already marketed, lower risk specialist products and companies that can help address patient needs in the hospital specialist sector.
Further information on Atlantic Healthcare can be found on the company’s website at http://www.atlantichc.com/company-strategy.htm.
Inflammatory Bowel Disease (“IBD”)
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 include inflammation of the gut, ulceration, abdominal pain, increased and uncontrolled stool frequency and bleeding. It is estimated that approximately 5 million people suffer from IBD worldwide. Of these patients the greater majority reside in the United States and Europe. IBD is a progressive disease and existing drugs only slow its progress. IBD is becoming a significant health problem. The global IBD market for ulcerative colitis (“UC”) and Crohn’s disease is currently estimated to be $5.1 billion a year.
In the EU and US there are approximately 1.5 million UC patients of whom up to 40 per cent. ultimately require surgery and a total colectomy to remove the diseased tissue. The majority of these patients 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
Alicaforsen is an anti-inflammatory, intercellular adhesion molecule (ICAM-1) inhibitor that acts by inhibiting a key protein in the inflammation process.
ICAMs are proteins that induce inflammatory responses in bodily tissues, including those in the gastro-intestinal tract. Alicaforsen switches off the production of the protein ICAM-1 by binding to and degrading the mRNA that encodes for it, and so blocks its production. It is intended that in treating ulcerative colitis and pouchitis alicaforsen will block the mechanism for local inflammatory reaction in the intestine.
Alicaforsen is currently being developed in a topical enema formulation for treatment of acute flares of disease, promoting mucosal and thereby alleviating the symptoms of ulcerative colitis and pouchitis. Alicaforsen has the potential to broaden into other inflammatory conditions through the development of alternative formulations.
Based on data demonstrating safety, efficacy and tolerability in five Phase 2 studies involving approximately 360 patients, and a safety database in over 1000 patients receiving alicaforsen in parenteral or enema administration, alicaforsen enema has been prepared for Phase 3 clinical studies in two indications. There will be a single pivotal study for each indication. The first phase 3 study will be undertaken in pouchitis, a sub-condition of ulcerative colitis, and a further study will be undertaken in moderate-severe active distal ulcerative colitis.
Successful Phase 3 studies would be the basis for submission for Marketing Approvals in the United States and Europe.
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