12th Mar 2007 07:00
AGI Therapeutics plc12 March 2007 AGI Therapeutics plc Strengthens management team Dublin, Ireland, 12 March 2007 - AGI Therapeutics plc ("AGI" or the "Company")(AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinaldrug products, today announces the appointment of two new Vice Presidents to itsmanagement team. Dr. Sian Bigora, Pharm D. joins AGI as Vice President, Regulatory Affairs. Mostrecently, Dr. Bigora served as an independent consultant to pharmaceuticalcompanies providing regulatory strategy for product development with an emphasison 505b2 New Drug Application (NDA) submissions. Prior to that she served asVice President, Regulatory Affairs with ICON Clinical Research (formerlyGlobomax), where she was responsible for the management and direction of ICON'sregulatory affairs function. Her experience includes application of her priorregulatory, clinical, pharmacokinetic and technology experience to developregulatory strategies to achieve FDA approvals including Known Medical Entity(KMETM) type programmes and 505b2 NDA submissions. She is also familiar withregulatory processes outside the US including Europe and Canada. She has led andworked on large programme teams in various therapeutic areas includinggastrointestinal (GI) disease. Dr Bigora received her Pharm.D degree fromUniversity of Maryland at Baltimore and was a Post-Doctoral Fellow at thePharmacokinetics and Biopharmaceutics Laboratory at the School of Pharmacy,University of Maryland, Baltimore. Dr Amir Shojaei, Pharm D. PhD. joins AGI as Vice President, PharmaceuticalDevelopment. For the past seven years, Dr Shojaei served in various managementpositions with Shire Pharmaceutical Group, plc's, U.S. divisions. Most recentlyhe was Senior Director, Pharmaceutical Sciences with Shire Development Inc. Inthese roles he was responsible for all aspects of formulation and analyticaldevelopment from pre-clinical through Phase III, process validation andtechnology transfer on a range of global (US, EU, and Japan) product developmentprogrammes in GI, CNS and renal therapeutic areas. He assumed primaryresponsibility and authorship of the Chemistry & Manufacturing Control, (CMC),sections of various 505b2 NDA as well as New Chemical Entity (NCE) typeregulatory filings. Prior to Shire, Dr Shojaei was Assistant Professor ofPharmaceutical Sciences at Texas Tech University, School of Pharmacy, Amarillo. Commenting on the appointments, Dr John Devane, CEO of AGI said: "We are delighted that Sian and Amir have agreed to join our management team.Both will bring their unique skills and experience to assist in the developmentof the business. We recently outlined to the market the clinical progress of ourproduct portfolio, 2007 promises to be a busy and exciting year for us. Theappointment of these two key individuals is an important enabling step inprogressing our products to regulatory submission and commercial success in boththe US and Europe." Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7831 3113Anna Keeble Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey For further information please see www.agitherapeutics.com About AGI Therapeutics plc AGI is a specialty 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 (KMETM) 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 has developed a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,ulcerative colitis and gastro-esophageal reflux disease (GERD). The Company istargeting areas of the GI therapeutic drug products market for its productcandidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has clinical stage product candidates which are either isomers ornew drug delivery formulations of existing approved drugs, and which haveestablished safety and tolerability profiles in their currently approvedclinical indications. 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. This announcement has been issued through the Companies Announcement Service of The Irish Stock Exchange. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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