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Re: Option Agreement

30th Aug 2007 07:01

AGI Therapeutics plc30 August 2007 AGI Therapeutics plc Enters into an exclusive option agreement to license new pre-clinical compound Dublin, Ireland, 30th August 2007 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces that it has signed an exclusiveoption agreement to license certain intellectual property and know-howsurrounding a novel prodrug platform for the prokinetic/antiemetic agent,levosulpiride, from Williamsburg Holdings, a US private drug developmentcompany. Williamsburg Holdings owns intellectual property, invented by Donald L. Barbeau,around the chemical design and composition of a prodrug platform forlevosulpiride and the therapeutic uses of these new compounds in certaingastrointestinal applications. Levosulpiride, a known molecular entity (KME) hasalready been marketed in various countries for the treatment of certaingastrointestinal conditions and an optimal prodrug form, to be developed by AGIand which AGI have designated with the project name AGI-025, is expected to haveimportant therapeutic advantages over levosulpiride itself. The financial details of the option agreement are not disclosed, however certainpre-agreed in-licensing fees, milestone payments and cost sharing arrangementswill be triggered if AGI exercises its option and enters into a licensingagreement with Williamsburg Holdings. The option period is for twelve months andmay be renewed by AGI under certain circumstances for a further 12 months.During the option period, AGI intends to conduct further research anddevelopment of AGI-025. Commenting on today's news, Dr. John Devane, CEO of AGI, said; "For some time we have been interested in the anti-emetic and prokineticproperties of levosulpiride and its possible applications in certain specialistGI-related applications, such as nausea and vomiting induced by chemotherapy(CINV), functional dyspepsia, gastric stasis including diabetic andpost-operative gastroparesis and gastroesophageal reflux disease (GERD). Wewere impressed by the intellectual property developed by Williamsburg Holdings,and are pleased that we have been able to agree an exclusive option agreementwith pre-defined future licensing terms. While still an early stage opportunity,we believe this could become an important area of interest for AGI anddemonstrates our commitment to broaden our early stage portfolio. "We continue to focus on progressing our later stage programmes, particularlyarverapamil, (AGI-003), our treatment for diarrhoea-predominant irritable bowelsyndrome (D-IBS), which is expected to enter pivotal Phase III studies in the USthis year." Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7269 7182Deborah Scott Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey For further information please see www.agitherapeutics.com Note to editors: About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (GI)diseases and disorders. AGI's common shares are listed on the AlternativeInvestment Market of the London Stock Exchange (AIM) and on the Irish EnterpriseExchange of the Irish Stock Market (IEX) as AGI. The Company has a portfolio of product candidates derived from its KnownMolecular Entity (KME) approach to drug re-profiling and development. KME is are-profiling methodology used by the Company to identify existing therapeuticdrugs which typically have been marketed for a number of years, have establishedsafety profiles and can be developed for new clinical indications or withimproved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) anddiarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). TheCompany is targeting areas of the GI therapeutic drug products market for itsproduct candidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has five active clinical stage product candidates which are eitherisomers or new drug delivery formulations of existing approved drugs, and whichhave established safety and tolerability profiles in their currently approvedclinical indications. Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock Exchange

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