CAMBRIDGE UK – 10th April 2015 – Atlantic Healthcare plc (‘Atlantic Healthcare’), the Cambridge, UK specialty pharmaceutical company targeting treatments for gastrointestinal disorders, announced today that Dr Lorin K. Johnson has been appointed to the Board of Directors. This follows Dr Johnson’s investment in the company.
Dr Johnson, a Founder and member of the leadership team of Salix Pharmaceuticals Inc., joins the Board to support progression of the company’s late stage clinical programs for inflammatory bowel disease towards marketing approvals for Europe, United States and elsewhere.
Dr Johnson, a founder of Salix Pharmaceuticals, Inc. (NASDAQ: SLXP) held senior positions in Salix prior to its recent $15.8 billion acquisition by Valeant Pharmaceuticals International, Inc. (NYSEA: VRX). Salix Pharmaceuticals is a global leader in the in-licensing, development and commercialisation of treatments for gastroenterology disorders for the North American healthcare market. Together with his co-founder Randy W. Hamilton, Dr Johnson took the company from a “bedroom” start-up in 1989 to one with 22 marketed products, revenues of $1.1 billion pa, listings on the Toronto and NASDAQ stock exchanges and a $2.7bn acquisition of Santarus, Inc., prior to Valeant’s acquisition.
Toby Wilson Waterworth, Chief Executive said: “I am delighted to welcome Lorin to Atlantic Healthcare. We are privileged to have a seasoned industry veteran of Lorin’s experience join the company. His appointment builds on the company’s recent progress and further strengthens our deep understanding of gastroenterology as we move into the next phase of development of the company.”
Dr Johnson, Director, Atlantic Healthcare plc said: “Atlantic Healthcare offers a great opportunity to get back to where Salix started.
Atlantic’s lead asset, alicaforsen for the treatment of IBD, is being developed on a robust platform of clinical data. Anecdotal feedback and publications on treatment outcomes from Named Patient use of alicaforsen enema in pouchitis and ulcerative colitis are very encouraging. Together with its unique mechanism of action, good safety track record and convenience of use, alicaforsen has an important potential position and can offer a much needed new treatment option in the treatment pathway for IBD patients.
I look forward to helping the company build on the previous successes and execution of the Phase 3 plans that offer the potential to deliver two exciting product treatments to market and significant revenues.”
For more information
Toby Wilson Waterworth, Chief Executive: Toby@atlantichc.com, +44 1799 512 055
Atlantic Healthcare plc,
Atlantic House, 12 Rose and Crown Walk, Saffron Walden, Essex, CB10 1JH, United Kingdom
Editor’s notes:
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 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 global pharmaceutical sector.
The company’s strategy has two elements. Firstly, to complete development of alicaforsen ahead of international marketing approvals and commercialisation. Secondly to broaden applications for alicaforsen and 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: www.atlantichc.com
Lorin K. Johnson, PhD
Founder, Salix Pharmaceuticals, Inc.
Dr Johnson is a Founder of Salix Pharmaceuticals, Inc. and until recently served as Chief Scientific Liaison, and was an active member of the Salix Business development team. Previously, Dr Johnson served as Senior Vice President and Chief Scientific Officer (1999-2002) and was Vice President of Research and a member of the Salix Board of Directors (inception, 1989 to 2000).
Prior to founding Salix, Dr Johnson served as Director of Scientific Operations and Chief Scientist at California Biotechnology, Inc, (Scios, Inc), where he headed research on anti-inflammatory therapeutics targeting secretory phospholipase A2. Before joining California Biotechnology, Dr Johnson was an Assistant Professor of Pathology at Stanford University Medical Center. Dr Johnson received his BS and PhD in Molecular Biology from the University of Southern California and was a postdoctoral fellow at the University of California, San Francisco, researching molecular mechanisms of corticosteroid action.
Dr Johnson is the co-author of 75 journal articles and book chapters and is the co-inventor on 18 issued patents. 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 U.S. there are approximately 1.5 million UC patients of whom up to 40% 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 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 gastrointestinal 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 healing 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 for the treatment of the gastrointestinal tract.
Based on data demonstrating safety, efficacy and tolerability in five Phase 2 studies of alicaforsen enema involving approximately 360 patients, and a safety database in over 1,000 patients receiving alicaforsen in parenteral or enema administration, alicaforsen enema has been prepared for Phase 3 clinical studies for two indications. Following discussions with regulatory agencies, the company has prepared plans for a single pivotal Phase studies in the Orphan indication pouchitis, a sub-condition of ulcerative colitis and a further single pivotal Phase 3 study in moderate-severe active distal ulcerative colitis.
Successful Phase 3 studies would be the basis for submission for Marketing Approvals in the United States, Europe, Canada and elsewhere.
Currently there is no approved pharmaceutical for pouchitis. Because of the number of patients with pouchitis, the US, EU and Swiss regulatory agencies have granted the company Orphan Drug designation and a Letter of Fast Track providing a potentially lower cost faster route to market.
The U.S. Patent Office recently advised the company that its patent application for treatment of ulcerative colitis has been allowed for issuance. Together with the award of Orphan Drug designations and Data Exclusivity, the company now has confirmed market exclusivity for pouchitis and ulcerative colitis for the U.S. and Europe extending up to 2030.
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