AGI Therapeutics plc Announces Final Results

DUBLIN, IRELAND--(Marketwire - April 01, 2009) -

 AGI Therapeutics, plc Financial results for the 12 months ended 31 December 2008 Dublin, Ireland, 1st April 2009 - AGI Therapeutics plc (“AGI” or the"Company”), a speciality pharmaceutical company focused on gastrointestinal drug products, today reports audited financial results for the 12 months ended 31 December 2008. Financial highlights - Revenue of USD577,000 (2007: USD577,000) - Cash and short-term deposits at 31 December 2008 of USD23.6 million, (2007: USD45.5 million) - R&D spend of USD15.9 million (2007:USD19.4 million) - Net loss of USD18.2 million (2007: USD20.7 million) - Loss per ordinary share of 27.0 cents (2007: 30.7 cents) Operational highlights RezularTM - AGI’s lead product for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D), a chronic, relapsing condition that affects millions of people. - Primary focus on ARDIS, our Phase III programme, comprising of ARDIS-1(efficacy) and ARDIS-3 (safety), both studies to be included in future New Drug Application to US FDA - Key findings of study to assess pharmacokinetic profile announced in February; possible MoA and further analysis of Phase II data presented at DDW in May - FDA agreed on the statistical approach for analysis of ARDIS-1 in June and reaffirmed the key parameters of Phase III programme, including current primary endpoint. - FDA confirmed RezularTM’s eligibility and associated requirements to qualify for 5 year market exclusivity in US - Completion of patient enrolment for ARDIS-1 announced January 2009; 711 patients randomised in 123 clinical centres in U.S., Europe, South America; top-line data from ARDIS-1 anticipated by end Q2, making RezularTM the most advanced product in development for IBS-D - Today, we are pleased to announce that enrolment into ARDIS-3 is now closed and AGI expects that the exposure target of 100 patients for 1 year will be achieved in Q3 2009 and data will be reported in Q1 2010 AGI-004 - A once-daily controlled release transdermal mecamylamine patch being developed for the treatment of chemotherapy-induced diarrhoea (CID) in cancer patients: - Commencement of patient enrolment in a proof-of-concept Phase II clinical study announced February 2008. - Preliminary results demonstrating AGI-004 is a promising new therapy for this potentially debilitating side-effect of cancer chemotherapy announced March 2009. AGI-010 - AGI’s modified release formulation of the proton pump inhibitor drug (“PPI”) omeprazole which utilizes AGI’s CHRONAB technology: - Completion of optimisation phase of development of AGI-010, co-developed with Axcan Pharma Inc., (“Axcan”) for treatment of night-time acid breakthrough (NAB) in gastro-esophageal reflux disease (GERD) patients announced March 2008. Other Projects: - Continued work on AGI-022 for the treatment of ulcerative colitis and investigated potential to further develop AGI-006 as a novel treatment in a number of clinical indications including gastroparesis, GERD refactory to PPI therapy and chemotherapy-induced nausea and vomiting (CINV). In keeping with our policy of carefully managing financial resources and prioritizing investment in our most advanced programme, Rezular, we have not committed further expenditure to these projects at this time. Commenting on the results, Dr. John Devane, CEO of AGI, said:"In 2008 Rezular dominated our activities. We are very pleased that in the initial weeks of 2009 we completed patient enrollment into ARDIS-1 and we now look forward to reporting top-line data later this year. Through our interaction with the FDA and contact with potential partners, we believe we have the ability to introduce the first new therapy for the treatment of IBS-D in the US in almost 10 years. This is a disease which seriously affects the quality of life of millions of patients and for which there are few effective therapeutic options available.” Click on, or paste the following link into your web browser, to view the Financial results for the 12 months ended 31 December 2008 http://www.rns-pdf.londonstockexchange.com/rns/8774P_1-2009-3-31.pdf This information is provided by RNS The company news service from the London Stock Exchange END