Dr Huw Jones appointed CEO

Dr Huw Jones appointed CEO, Atlantic Pharmaceuticals to lead growth of Atlantic Healthcare’s therapeutics division

Cambridge UK, Sydney Australia, 2nd July 2010: Atlantic Healthcare Limited, an international specialist-led healthcare company, announces that Dr Huw Jones has been appointed Chief Executive of Atlantic Healthcare’s therapeutics division, Atlantic Pharmaceuticals Limited and joins the board of Atlantic Healthcare.

Huw becomes Chief Executive Officer, Atlantic Pharmaceuticals, with responsibility for Atlantic Healthcare’s pharmaceutical activities and, in particular, the development and international commercialisation of alicaforsen. Alicaforsen is an anti-inflammatory, intercellular adhesion molecule (“ICAM-1”) inhibitor that acts by switching off a key protein that causes inflammation in the gastro-intestinal tract. Alicaforsen is now available through a Named Patient Supply programme for patients suffering from pouchitis and is being developed for other inflammatory bowel disease (IBD) conditions.

Huw holds a PhD in pharmacology from the University of Birmingham, UK and has over twenty years experience in the pharmaceutical sector. He has supervised over fifteen product launches in Europe and has completed numerous product and company acquisitions and divestments.

Most recently Huw was a director of Ardana plc and was previously President, Europe for CV Therapeutics Inc, a NASDAQ-quoted pharmaceutical company recently acquired by Gilead Sciences Inc. for US$1.4bn. Other appointments include Senior Vice President, Northern Europe, for Elan Pharmaceuticals where he helped build the European operations from a start-up into a 600 person division and UK marketing director for SmithKlineBeecham Pharmaceuticals, now part of GlaxoSmithKline plc.

Toby Wilson Waterworth, Chief Executive Officer of Atlantic Healthcare said: “We are delighted to welcome Huw to his new position and the Board. His many years of experience in building companies and launching products across Europe in our sector will be invaluable as we progress to the next stage in the growth of Atlantic Healthcare.”

Dr Huw Jones commented: “Atlantic Pharmaceuticals provides me with a compelling personal challenge; to ensure alicaforsen and the company both realise their full potential and fulfil the substantial unmet medical need of patients with pouchitis and other related gastrointestinal conditions. We are starting this with our named patient programme in pouchitis shortly and I anticipate broadening the Atlantic portfolio through acquisition of further products and companies that fit our criteria. All in all a genuinely exciting prospect for me.” - Ends - __________________________________________________________________________ For further media information, please contact:

Atlantic Healthcare Toby Wilson Waterworth, Chief Executive Officer Tel: +44 1440 788 956 M: +44 7770 450 898

Atlantic Healthcare Asia Pacific Steve Hobbs, Director, Australia Tel Dir: +61 1300 533 432 M: +61 409 718 934

Corporate/financial media enquiries Lisa Baderoon, Buchanan Communications E : lisab@buchanan.co.com Dir: +44 20 7466 5111 M: +44 7721 413 496

Medical and trade enquiries Alexa Forbes, Packer Forbes Communications E : alexa@packerforbes.com Dir: +44 208 772 1551 M: +44 7944 605 147

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

Editors Notes and Further Information

Atlantic Healthcare Atlantic Healthcare Ltd is the holding company for a specialist-led pharmaceutical group which markets products to hospital-based specialists, principally in the United States and Europe.

Atlantic Pharmaceuticals Ltd is the pharmaceutical division of Atlantic Healthcare. Specialist-led pharmaceuticals are a $150bn sector showing one of the highest growth rates in the pharmaceuticals market. Atlantic Healthcare is acquiring companies and niche marketed products, with the potential for peak sales of up to $500m (??m) that are normally too small to be of interest to major pharmaceutical groups, from which it can build significant value for its investors.

The management team and Board consists of experienced senior executives with deep knowledge of and extensive networks within the pharmaceutical industry, including Elan Pharmaceuticals, Eli Lilly, Glaxo, Novartis, Pfizer, RPR, SmithKline Beecham and Wyeth. The team and Board have a track record of successful private and public-sector company building.

In 2007, Atlantic Healthcare completed the acquisition of its first product opportunity and signed an exclusive licensing agreement with Isis Pharmaceuticals, Inc (NASDAQ:ISIS), in which it acquired the rights to Isis’ late-stage anti-inflammatory antisense programmes for alicaforsen affecting RNA. Isis acquired shares and a 13.2% stake in the Company as part of the deal.

In 2007 Atlantic Healthcare also announced it had licensed commercialisation rights to its gastro-intestinal programmes to Orphan Australia, a hospital focused specialist sales and marketing group, for commercialisation in the Southern Hemisphere.

Dr Huw Jones Huw Jones is a highly experienced executive with over twenty years commercial activity in the pharmaceutical sector. He has supervised over fifteen product launches in Europe and numerous product and company acquisitions and divestments.

Most recently Huw was a director of Ardana plc and was previously President Europe for CV Therapeutics Inc, a NASDAQ-quoted pharmaceutical company that was recently acquired by Gilead Sciences Inc. for US$1.4bn. He was also Non-Executive Chairman of Ashbourne Pharmaceuticals Ltd, a UK speciality pharmaceutical company which in 2006 he led the sale of to Sinclair plc.

Other appointments include Senior Vice President, Northern Europe, for Elan Pharmaceuticals plc for which he helped build the European operations from a start-up into a 600 person turnover division and UK marketing director for SmithKline Beecham Pharmaceuticals, now part of GlaxoSmithKline plc.

Huw holds a PhD in Pharmacology from the University of Birmingham.

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 tissues in the body, including 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. This alters and reduces the local inflammatory reaction in the intestinal wall.

Atlantic Healthcare is delivering alicaforsen using an enema for topical treatment for IBD conditions in the gastro-intestinal tract including pouchitis and left-sided colitis.

Based on data demonstrating safety, efficacy and tolerability in five Phase II studies involving approximately 300 patients, Atlantic Healthcare’s enema formulation of alicaforsen has been prepared ready for a short single pivotal Phase III clinical trial in pouchitis, a sub-condition of ulcerative colitis, prior to submission for Marketing Authorisation.

In June 2008, Atlantic was granted Orphan Drug status for alicaforsen in the treatment of pouchitis in the USA by the US Food and Drug Administration (“FDA”). The FDA has also granted Fast Track Approval to alicaforsen for the treatment of chronic and recurrent pouchitis. In April 2009, Atlantic was also granted Orphan Drug status for the product in the treatment of pouchitis in Europe by the European Medicines Agency (“EMEA”).

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 of which include inflammation of the gut, ulceration, abdominal pain, increased stool frequency and bleeding. It is estimated that over 2 million people suffer from IBD worldwide. Of these patients, the greater majority resides in the United States and Northern Europe. It is clear that IBD is rapidly becoming a major global health problem. The pharmaceutical market for IBD is currently valued at approximately US$2bn and growing at approximately 10-15% per annum, driven by unsatisfactory existing treatments and the need for and use of new therapies. In spite of the wide range of prescription products available, IBD remains a poorly served market and there is a need for more effective and safer treatments.

Pouchitis Most patients with IBD will require surgery at some time; in ulcerative colitis, this is likely to involve removal of the large intestine (colon and rectum) and the surgical creation of an artificial rectum, known as a pouch, to retain the faeces for evacuation through the anus. Pouchitis is a common post-operative inflammatory complication of the pouch. About 50% of patients will develop at least on attack of acute pouchitis within 5 years of the pouch being constructed and about a third of those will develop a chronic, recurrent pouchitis. This is a debilitating condition for which there is no approved treatment. Ultimately the only cure is further surgery to remove the diseased tissue and creation of a stoma for use with an ostomy bag. There are around 100,000 pouchitis sufferers in the United States and 100,000 in Europe. As a result of these relatively low numbers the disease falls into the Orphan Drug category. Orphan Drug designation has been granted to Atlantic for alicaforsen for the treatment of pouchitis. It is granted to encourage development of drugs for the treatment of rare diseases and conditions where there are low numbers of patients and where it would otherwise be prohibitively expensive or unprofitable for a company to do so. Incentives include smaller clinical trials, Fast Track Approval, Priority Review and market exclusivity.

Named Patient Supply Atlantic Healthcare is initially making alicaforsen enema available internationally in the autumn, 2010, under its Named Patient Supply programme. Treatment with an alicaforsen enema has been clinically shown to have a number of significant benefits and unique differentiating points compared to existing drugs. A considerable body of safety and other data, and the results of five Phase II clinical trials in ulcerative colitis and pouchitis, and trials in 900 patients with Crohn’s disease suggest that Atlantic’s product could be of benefit in the treatment of IBD. Of note was the finding that alicaforsen did not only bring patients with active disease into remission but maintained patients in remission without further ongoing treatment for an average of six months. Alicaforsen enema has the potential to be used as a first line treatment that is well tolerated. Early data, if borne out in large scale clinical trials suggest that alicaforsen may offer a superior safety profile in the treatment of IBD. Patients, on average may need only two, six week treatment courses per year, rather than daily treatment common to gastro-intestinal anti-inflammatory products, which can result in better patient compliance and fewer physician visits. Having been granted Orphan Drug status in the USA and Europe and USA FDA Fast Track Approval, and based upon positive results in Phase II, Atlantic is commencing the supply in Europe and elsewhere of alicaforsen enema under the “Named Patient Supply” regulations, ahead of its pivotal Phase III clinical programme and registration.

European IBD Faculty Under the Chairmanship of Professor Derek Jewell, Atlantic Healthcare is establishing a European Inflammatory Bowel Disease Faculty, comprising the leading specialists in gastroenterology and colorectal surgery across Europe. Professor Jewell, of Oxford University and John Radcliffe Hospital, Oxford, is one of Europe's leading experts in the treatment of IBD and has been Chairman of the International Organisation for the Study of IBD and is a past-President of the British Society of Gastroenterology. Part of the remit of Atlantic’s European IBD Faculty will be to help the Company to progress alicaforsen for the treatment of pouchitis and explore its use in the treatment of other IBD conditions. The European Faculty complements Atlantic Healthcare’s North American Medical Advisory Board, which is chaired by Professor William Sandborn, Mayo Clinic, one of North America’s leading gastroenterologists (www.atlantichc.com/medical_advisory_board.html).
 

Posted: July 2010

View comments

Hide
(web3)