27th Sep 2006 07:03
AGI Therapeutics plc27 September 2006 AGI Therapeutics plc signs $19 million exclusive license agreement with Axcan Pharma for delayed/controlled release omeprazole Dublin, Ireland, 27th September 2006 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces that it has entered into anexclusive license agreement with Axcan Pharma, Inc. ("Axcan") (NASDAQ: AXCA,TSX: AXP) for North American rights to AGI's delayed/controlled releaseomeprazole formulation, AGI-010. Axcan is a leading marketer of pharmaceuticalproducts for gastrointestinal diseases and disorders in North America andEurope, with revenues in 2005 of over US $250 million. Under the terms of the agreement, Axcan has been granted exclusive marketingrights to AGI-010 in the US and Canada in return for an initial license fee ofUS $1.5 million, further payments of US $17.5 million on the achievement ofspecified milestones, and royalties on product sales. The parties will bejointly responsible for and share certain development costs of AGI-010 up to andincluding its regulatory approval in the US. Axcan will be responsible forcommercializing AGI-010 in the US and Canadian markets, while AGI will have anoption to co-promote the product in the US. Axcan has been granted an optionto license AGI-010 for markets outside North America and additional milestonepayments could become payable to AGI in the event that Axcan exercises thisoption. In addition to today's agreement, Axcan may elect to license rights from AGI todevelop other controlled release PPI products using AGI's CHRONAB technology andintellectual property under a similar commercial structure. AGI is developing AGI-010, a delayed/controlled release formulation of theproton pump inhibitor drug (PPI) omeprazole, based on its CHRONAB technologywhich it believes will optimize the treatment of nocturnal acid breakthrough(NAB), a common symptom of gastroesophegeal reflux disease (GERD). GERD is themost prevalent of the major gastrointestinal disorders and is most commonlytreated with PPI drugs which achieve global annual sales in excess of US $20billion. NAB is estimated to occur in at least 50 per cent of GERD patients onPPI therapy. In March 2006, AGI announced the preliminary outcome of a combined humanpharmacokinetics and pharmacodynamics study designed to characterize the in-vivodrug release profile, pharmacokinetics and the intra-gastric pH profiles ofdelayed release/controlled release formulations of omeprazole (AGI-010).Preliminary data from the study demonstrated that delayed/controlled releasecharacteristics were clearly achieved. AGI has subsequently conducted aprogramme of formulation optimization to further enhance the drug releaseprofile of AGI-010 and further studies will now be conducted on the optimizedproduct in the course of the co-development to be undertaken by AGI and Axcan. Commenting on the agreement, Dr John Devane, Chief Executive of AGI said: "We are delighted to announce our first partnership agreement with Axcan. Itfits very well with our business model of entering into development andcommercialisation agreements for products that address larger, establishedmarkets. Axcan is an excellent choice of partner for our delayed/controlledrelease omeprazole formulation and we are confident that their extensiveknowledge of developing and marketing products for the gastrointestinal marketwill contribute to commercial success. Nocturnal acid breakthrough continues tobe a significant shortcoming of current PPI therapy for GERD patients and withAGI-010 we look forward to being able to better address the needs of thesepatients with a more effective and improved therapy." Frank Verwiel, M.D., President and Chief Executive Officer of Axcan, added: "We are pleased to combine AGI's expertise in product discovery with Axcan'scapability in development and as a result be able to bring to thegastrointestinal market an innovative controlled release version of omeprazole,and are looking forward to our partnership. We are currently in the process offinalizing our development strategy and one of the alternatives we areevaluating is the option of qualifying for bioequivalence development under theUS FDA regulations. Should the product qualify, this strategy could lead toaccelerated development and launch of this innovative product." Contact Information: AGI Therapeutics plcTel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UKTel: +44 (0) 20 7831 3113Sarah MacLeod Financial Dynamics - IrelandTel: +353 1 663 3607Aisling Garvey For further information please see www.agitherapeutics.com About GERD and NAB GERD results in the reflux of gastric contents into the esophagus, causingsymptoms (e.g. heartburn or acid regurgitation) that are sufficient to interferewith quality of life. NAB is defined as the presence of at least 60 continuousminutes of intragastric pH < 4 during the overnight period (10pm - 6am) inpatients taking a PPI drug twice daily before meals. GERD is the most common of the major gastrointestinal disorders and itsprevalence in the general population is estimated to range from 20 to 40 percent. Proton pump inhibitors are commonly used drugs in the treatment of GERDand are one of the largest selling drug classes with global annual sales inexcess of US$20 billion. NAB is estimated to occur in more than 70 per cent ofh.pylori-negative and in up to 50 per cent of h.pylori-positive patients on PPItherapy and modification of the dosage regime of existing PPI drugs has only hadlimited success in controlling the symptoms of NAB despite improving acidsuppression. 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 IrishEnterprise Exchange of the Irish Stock Market ("IEX") as "AGI". The Company has a portfolio of product candidates derived from the KnownMolecular Entity (''KME'') approach to drug re-profiling and development. KME isa re-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 has developed a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), functionaldyspepsia, ulcerative colitis and gastro-esophageal reflux disease (GERD). 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 six clinical stage product candidates which are either isomersor new drug delivery formulations of existing approved drugs, and which haveestablished safety and tolerability profiles in their currently approvedclinical 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 theresults of these trials, the Company will initiate late stage clinicaldevelopment of lead product candidates and will also seek to enter intolicensing and development agreements with pharmaceutical companies so as toenhance the global market reach for its products and achieve optimal revenue andvalue opportunities for the Company. About Axcan Pharma, Inc. Axcan is a leading multinational specialty pharmaceutical company focused ongastroenterology. The company develops and markets a broad line of prescriptionproducts to treat a range of gastrointestinal diseases and disorders such asinflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseasesand complications related to pancreatic insufficiency. Axcan's products aremarketed by its own specialized sales forces in North America and Europe. Itscommon shares are listed on the NASDAQ Global Market under the symbol "AXCA" andon the Toronto Stock Exchange under the symbol "AXP". 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 ExchangeRelated Shares:
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