Dublin, Ireland, 30th August 2007
AGI Therapeutics plc Enters into an exclusive option
agreement to license new pre-clinical compound
AGI Therapeutics plc ("AGI" or the "Company") (AIM,
IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal
drug products, today announces that it has signed an exclusive option
agreement to license certain intellectual property and know-how surrounding
a novel prodrug platform for the prokinetic/antiemetic agent, levosulpiride,
from Williamsburg Holdings, a US private drug development company.
Williamsburg Holdings owns intellectual property, invented by Donald L. Barbeau, around the chemical design and composition of a prodrug platform for levosulpiride and the therapeutic uses of these new compounds in certain gastrointestinal applications. Levosulpiride, a known molecular entity (KME) has already been marketed in various countries for the treatment of certain gastrointestinal conditions and an optimal prodrug form, to be developed by AGI and which AGI have designated with the project name AGI-025, is expected to have important therapeutic advantages over levosulpiride itself.
The financial details of the option agreement are not disclosed, however certain pre-agreed in-licensing fees, milestone payments and cost sharing arrangements will be triggered if AGI exercises its option and enters into a licensing agreement with Williamsburg Holdings. The option period is for twelve months and may be renewed by AGI under certain circumstances for a further 12 months. During the option period, AGI intends to conduct further research and development 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 prokinetic properties of levosulpiride and its possible applications in certain specialist GI-related applications, such as nausea and vomiting induced by chemotherapy (CINV), functional dyspepsia, gastric stasis including diabetic and post-operative gastroparesis and gastroesophageal reflux disease (GERD). We were impressed by the intellectual property developed by Williamsburg Holdings, and are pleased that we have been able to agree an exclusive option agreement with pre-defined future licensing terms. While still an early stage opportunity, we believe this could become an important area of interest for AGI and demonstrates our commitment to broaden our early stage portfolio.
"We continue to focus on progressing our later stage programmes, particularly arverapamil, (AGI-003), our treatment for diarrhoea-predominant irritable bowel syndrome (D-IBS), which is expected to enter pivotal Phase III studies in the US this year."
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
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.