Dublin, Ireland, 12th March 2007
AGI Therapeutics plc - Strengthens management team
AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today announces the appointment of two new Vice Presidents to its management team.
Dr. Sian Bigora, Pharm D. joins AGI as Vice President, Regulatory Affairs. Most recently, Dr. Bigora served as an independent consultant to pharmaceutical companies providing regulatory strategy for product development with an emphasis on 505b2 New Drug Application (NDA) submissions. Prior to that she served as Vice President, Regulatory Affairs with ICON Clinical Research (formerly Globomax), where she was responsible for the management and direction of ICON's regulatory affairs function. Her experience includes application of her prior regulatory, clinical, pharmacokinetic and technology experience to develop regulatory strategies to achieve FDA approvals including Known Medical Entity (KME™) type programmes and 505b2 NDA submissions. She is also familiar with regulatory processes outside the US including Europe and Canada. She has led and worked on large programme teams in various therapeutic areas including gastrointestinal (GI) disease. Dr Bigora received her Pharm.D degree from University of Maryland at Baltimore and was a Post-Doctoral Fellow at the Pharmacokinetics and Biopharmaceutics Laboratory at the School of Pharmacy, University of Maryland, Baltimore.
Dr Amir Shojaei, Pharm D. PhD. joins AGI as Vice President, Pharmaceutical Development. For the past seven years, Dr Shojaei served in various management positions with Shire Pharmaceutical Group, plc's, U.S. divisions. Most recently he was Senior Director, Pharmaceutical Sciences with Shire Development Inc. In these roles he was responsible for all aspects of formulation and analytical development from pre-clinical through Phase III, process validation and technology transfer on a range of global (US, EU, and Japan) product development programmes in GI, CNS and renal therapeutic areas. He assumed primary responsibility and authorship of the Chemistry & Manufacturing Control, (CMC), sections of various 505b2 NDA as well as New Chemical Entity (NCE) type regulatory filings. Prior to Shire, Dr Shojaei was Assistant Professor of Pharmaceutical 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 development of the business. We recently outlined to the market the clinical progress of our product portfolio, 2007 promises to be a busy and exciting year for us. The appointment of these two key individuals is an important enabling step in progressing our products to regulatory submission and commercial success in both the US and Europe."
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Sarah MacLeod
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.