ATLANTIC HEALTHCARE receives orphan drug designation for alicaforsen for the treatment of pouchitis

Cambridge UK, 8^th July 2008:  Atlantic Healthcare Limited (“Atlantic” or the “Company”) today announced that its lead clinical candidate alicaforsen (AP 1007) has been granted orphan drug status by the US Food and Drug Administration (“FDA”) for the treatment of pouchitis.

Atlantic is an emerging specialist-led pharmaceutical company focused on in-licensing and acquiring products for prescription by hospital based specialists. The Company is completing clinical development and registration and will market products in the United States and Europe.

Atlantic’s three Phase III programmes are targeting inflammatory bowel disease (including Crohn’s disease, ulcerative colitis and pouchitis), a major unmet medical need and a $2bn annual market. Surgical treatment of ulcerative colitis involves removal of all or part of the colon. The majority of such patients elect to undergo treatment to create an ileal pouch (see notes). Approximately 150,000 patients have undergone this surgery in the United States and Europe.

Pouchitis is a common post-operative, chronic inflammatory condition arising from the creation of the ileal pouch, occurring in half the patients concerned. The Office of Orphan Products of the FDA has granted orphan drug designation for alicaforsen (AP 1007) for the treatment of pouchitis in recognition of the unmet medical need and patient numbers concerned.

Atlantic licensed worldwide rights to alicaforsen for the treatment of inflammation from Isis Pharmaceuticals Inc., in March 2007. It also acquired exclusive rights to second generation compounds targeting ICAM-1. In December 2007 Atlantic announced it had licensed commercialisation rights to its three Phase III programmes for the Southern Hemisphere to Orphan Australia, part of Sigma Pharmaceuticals.

Atlantic is currently raising finance to complete Phase III clinical development and registration of alicaforsen and to prepare the product for marketing.

Toby Wilson Waterworth, Chief Executive of Atlantic Healthcare, said: “We are delighted to have been granted orphan drug designation. It is a reflection of the team’s experience and hard work that the submission was accepted first time. The grant confirms a number of assumptions in the AP 1007 development plans and we can now move forward to completing phase III clinical development and registration.”  

Notes to Editors

Atlantic Healthcare
Atlantic Healthcare Ltd. is the holding company for a specialist-led pharmaceutical company, Atlantic Pharmaceuticals Ltd, which is in-licensing and acquiring therapeutic products prescribed by hospital based specialists to complete clinical development, registration and marketing of these products in the United States and Europe.

Specialist-led pharmaceuticals are a $150bn sector showing one of the highest growth rates in the pharmaceuticals market. Atlantic is acquiring niche products and companies with products in Phase III or later, with the potential for peak sales of up to $500m (£250m), 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 senior executives with deep knowledge, experience and networks in the healthcare industry (Glaxo, Elan, Alizyme) and a track record of successful private- and public-sector company-building.

In March, 2007, Atlantic signed an exclusive licensing agreement with Isis Pharmaceuticals, Inc (NASDAQ:ISIS), in which it acquired the rights to late-stage anti-inflammatory antisense programmes affecting RNA. Isis took a 13.2% stake in Atlantic as part of the deal.

Atlantic’s three Phase III programmes are targeting gastrointestinal disease, a major unmet medical need and a $2bn annual market. The peak sales for the initial suite of products are projected at $400m. Its lead programme for pouchitis will enter its pivotal Phase III clinical trial four months after Atlantic closes this financing. The compound used in these programmes provides benefits with the potential for clear product differentiation and has shown significant safety, efficacy and tolerability in its prior clinical trials along with durable responses.

Atlantic’s product portfolio currently consists of the following programmes:

In December, 2007, Atlantic announced an agreement with Sigma Pharmaceuticals subsidiary Orphan Australia, a hospital focused specialist sales and marketing group, for commercialisation of its three Phase III programmes for the Southern Hemisphere. Atlantic is engaged in discussions to out-license the programmes in other areas and also to in-license late-stage or marketed clinical therapeutics for North America and Europe.


Pouchitis
Surgical treatment of ulcerative colitis involves removal of all or part of the colon. Approximately 80% of patients undergoing surgery elect to undergo treatment to create an ileal pouch to retain the faeces for evacuation through the anus. There are approximately 150,000 patients in the United States and Europe who have undergone such surgery.

Pouchitis is a common post-operative complication of the creation of the ileal pouch. The exact aetiology of the chronic inflammation seen in pouchitis remains elusive. As a result of the low patient numbers, the disease falls in to the orphan drug category in each continent. Atlantic’s application for orphan drug designation for the AP 1007 programme was granted by the Office of Orphan Products in June 2008.


Orphan Drug Status
Orphan drug status is designed to encourage development and marketing of treatments for rare clinical disorders with unmet medical need. In the United States, orphan drug status is granted for conditions where there are less than 200,000 patients.

Orphan drug status bestows certain benefits on companies developing such treatments including priority hearings with the FDA, a requirement for a reduced Phase III clinical development programme and no fees for marketing authorisation applications.
 

The identification of healthcare products for successful research, their progress through development and the obtaining of regulatory approvals or authorisations before marketing, manufacture and/or sale of such products is not certain or a formality. .