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AGI Therapeutics, plc Financial results for the twelve months ended 31 December 2006

Dublin, Ireland, 11th April 2007 - AGI Therapeutics plc ("AGI" or the "Company"), a speciality pharmaceutical company focused on gastrointestinal drug products, today reports audited financial results for the twelve months ended 31 December 2006.

Financial highlights:

  • Cash and short term deposits at 31 December 2006 of €40 million
  • R & D spend of €3.5 million
  • Net loss of €4.3 million
  • Loss per ordinary share of 6.9 cent

Operating highlights:

  • Positive Phase II data for arverapamil (AGI-003) in the treatment of non-constipation dominant Irritable Bowel Syndrome (IBS)
  • Co-development and license agreement with Axcan Pharma Inc. to jointly develop a controlled release omeprazole product based on AGI's CHRONAB formulation approach for North American markets
  • Phase I results for 4-ASA Na (AGI-022) supportive of further clinical development for ulcerative colitis

Corporate highlights:

  • Completed a successful listing on the AIM Market of the London Stock Exchange and the IEX Market of the Irish Stock Exchange on 27 February 2006, raising gross proceeds of €42.5 million (£29.2 million)
  • Strengthened the management team and Board through the appointment of:
    • Dr. David Young as President of U.S. Operations
    • David Kelly as Chief Financial Officer
    • Dr Chris Blackwell, Chief Executive of Vectura Group plc, as a non-executive director

Post year-end highlights:

  • Received FDA approval to file IND for Arverapamil Phase III study. See separate release issued today
  • Phase II results for arbaclofen (AGI-006) supportive of further clinical development for treatment of gastroparesis
  • Mecamylamine (AGI-004) - preliminary clinical results reported and further investigation being carried out on the role of this product in chemotherapy-induced diarrhoea (CID)
  • Appointment of Medical Advisory Panel, consisting of recognised international experts in the field of clinical and gastroenterological sciences, to advise management

Dr. John Devane, CEO of AGI, said:

"2006 has been an important year for AGI. In line with our stated objectives, we have advanced all of our product candidates through key clinical proof of concept trials and recently outlined to the market our plans for 2007. The proceeds from our successful IPO in February 2006 provide us with the financial resources to advance our chosen programmes to the next stage of their development. In particular, we are now getting ready to move arverapamil, our lead programme for IBS, into Phase III, and are delighted with the outcome of our discussions with the FDA in this regard. We continue to make progress in the development of omeprazole for nocturnal acid breakthrough in GERD (gastro-esophageal reflux disease) and plan to progress a number of our other pipeline products into further Phase II clinical evaluation.

"We look forward to establishing strong marketing positions for our products, through collaboration with pharmaceutical partners or by retaining marketing rights for products targeting important niche market segments."

Contact Information:

AGI Therapeutics   
David Kelly, Chief Financial Officer

  Tel: +353 1 449 3254

Financial Dynamics - UK
Anna Keeble

  Tel: +44 (0) 20 7831 3113

Financial Dynamics - Ireland   
Aisling Garvey

  Tel: +353 1 663 3607

For further information please see www.agitherapeutics.com

About AGI

AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastrointestinal (''GI'') diseases and disorders. AGI's common shares are listed on the Alternative Investment Market of the London Stock Exchange ("AIM") and on the Irish Enterprise Exchange of the Irish Stock Market ("IEX") as "AGI".

The Company has a portfolio of product candidates derived from the Known Molecular Entity (''KME'') approach to drug re-profiling and development. KME is a re-profiling methodology used by the Company to identify existing therapeutic drugs which typically have been marketed for a number of years, have established safety profiles and can be developed for new clinical indications or with improved profiles in their existing clinical indications. In this way, the Company seeks to reduce the risk, time and cost of new product development as compared to the development of new chemical entities.

AGI is developing a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. The Company is targeting areas of the GI therapeutic drug products market for its product candidates where there are currently unmet medical needs or where the effectiveness of existing drug therapies can be further improved.

The Company has six clinical stage product candidates which are either isomers or new drug delivery formulations of existing approved drugs, and which have established safety and tolerability profiles in their currently approved clinical indications. These product candidates are all in clinical development, including five Phase II trials.

AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.

Statements contained within this press release may contain forward-looking comments that involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this press release are subject to the satisfactory progress of research, which is, by nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.


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