Dublin, Ireland, 3rd April 2008
AGI Therapeutics, plc Financial results for the
twelve months ended 31 December 2007
AGI Therapeutics plc ("AGI" or the "Company"), a speciality
pharmaceutical company focused on gastrointestinal drug products, today
reports audited financial results for the twelve months ended 31 December
2007.
The key findings were:
- · Revenue of €392,000 (2006: €196,000)
- · Cash and short term deposits at 31 December 2007 of €30.9 million, (2006: €40.0 million)
- · R & D spend of €13.2 million (2006: €3.5 million)
- · Net loss of €14.1 million (2006: €4.3 million)
- · Loss per ordinary share of 20.9 cent (2006: 6.9 cent)
Operational highlights
· Positive meeting with the US Food and Drug Administration (FDA) in relation to Rezular™ (arverapamil, AGI-003) resulting in guidance on the investigational new drug application (IND) requirements for further clinical and pre-clinical development, Phase III study design and NDA 505b2 submission requirements
· IND filed and ARDIS programme initiated for Rezular™ in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D)
· Characterised mechanism of action of Rezular™, a triple action intestinal modulator, which the Company believes to be a first-in-class compound offering a safe and effective treatment for IBS-D patients
· Identified target indications and developed Phase II programmes for arbaclofen (AGI-006), 4-ASA (AGI-022) and mecamylamine CR (AGI-004) in gastroparesis, ulcerative colitis and chemotherapy-induced diarrhoea, respectively
· Further strengthened the management team with the addition of
two experienced senior executives to the US group:
· Sian Bigora, Pharm D. - Vice President, Clinical Research &
Regulatory Affairs
· Amir Shojaei, Pharm D., Ph.D. - Vice President, Pharmaceutical
Development.
· Exclusive option agreement signed with US-based Williamsburg Holdings; an important first step in expanding AGI's early-stage development pipeline
Post year-end highlights:
· First patient dosed in a Phase II study of AGI-004 in the treatment
of chemotherapy-induced diarrhoea (CID)
· Completed optimisation phase of development of AGI-010, a modified
release formulation of the proton pump inhibitor drug ("PPI")
omeprazole which utilizes AGI's CHRONAB technology and which is being
co-developed with Axcan Pharma Inc. ("Axcan") for
the treatment of night-time acid breakthrough, (NAB), in gastro esophegeal
reflux disease (GERD)
· Positive pharmacokinetic data on Rezular™ which support its safety profile and development strategy for Rezular™ in the treatment of IBS-D
· Characterised the pharmacokinetic profile of arbaclofen (AGI-006) in healthy volunteers
Commenting on the results, Dr. John Devane, CEO of AGI, said:
"The successful filing of an IND application and the commencement of the ARDIS clinical programmme for RezularTM was our most significant achievement this year and we believe the continued development of this exciting IBS-D product will benefit patients in the future in this underserved marketplace. In addition, we substantially increased our investment in R&D in 2007 and have achieved strong progress across our development pipeline. We were particularly pleased to report the start of a new Phase II clinical study for mecamylamine (AGI-004), for the treatment of CID, in February 2008.
Overall, 2007 was a busy year for AGI and we look forward to continued progress in 2008. Our focus this year will be to further advance our clinical programmes which will allow us achieve our commercial goals."
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Deborah Scott/Lara Mott
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Aisling Garvey
Tel: +353 1 663 3607
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
Notes to Editors:
About the Study
The pharmacokinetic study was a single-dose, open-label, randomized, three-way crossover study in nine healthy subjects (4 males, 5 females). The treatments were arbaclofen/AGI-006 (5mg) administered under fasting and fed conditions and Lioresal® (10mg) administered under fasting conditions. Lioresal is an FDA-approved form of racemic baclofen which is used to treat CNS disorders. Blood samples were taken periodically up to 24 hours after each administration and there was also a cumulative 24 hour collection of urine. Plasma and urine concentrations of the R- and S-isomers of baclofen were measured using a validated Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) method. All treatments in the study were well tolerated.
About arbaclofen (AGI-006)
Arbaclofen is our product candidate for the treatment of gastroparesis and for dyspeptic conditions such as functional dyspepsia. Gastroparesis is a significant GI disorder among diabetic patients and affects up to 20% of Type I and 30% of Type II diabetics. Current drug therapy for gastroparesis is limited and there is a significant market opportunity for new safe and effective products. Arbaclofen is an oral dosage form of the predominant pharmacologically active r-isomer of baclofen.
About gastroparesis
Gastroparesis is a gastric motility disorder where there is delayed gastric emptying and the condition is usually chronic. The primary known cause of gastroparesis is diabetes and the condition is frequently referred to as 'diabetic gastroparesis'. In diabetic patients (both Types I and II), gastroparesis is caused by prolonged elevated serum glucose levels resulting in vagal nerve damage, which in turn leads to impaired gastric motility and emptying. Gastroparesis is estimated to affect up to 30% of Type I and 20% of Type II diabetics. There are an estimated 2.5 million diabetic gastroparesis patients in the US and 1.5 million in Europe, while the incidence is expected to rise as the diabetic population continues to increases across the globe.
About AGI
AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastro-intestinal (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 its Known
Molecular Entity (KME) approach to drug re-profiling and development.
The Company's lead product candidate, RezularTM, is an orally administered
triple-action intestinal regulator, a first-in-class mechanism for the
treatment of diarrhoea predominant Irritable Bowel Syndrome (IBS-D).
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 (IBS), dyspeptic symptoms, gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) and diarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). 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 five active 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.
For further information please see www.agitherapeutics.com
Statements contained within this press release may contain forward-looking comments which 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.