Dublin, Ireland, 18th September 2007
AGI Therapeutics, plc reports Interim financial
results for the six months ended 30 June, 2007 and Commencement of enrolment
into Phase III study of arverapamil
Full
Report Here...
AGI Therapeutics plc ("AGI" or the "Company"), a speciality pharmaceutical
development company focused on gastrointestinal drug products, today reports
interim financial results for the six months ended 30 June, 2007. In addition,
today the Company is pleased to report that enrolment has opened into
ARDIS-1, the first of three pivotal Phase III studies of arverapamil,
(AGI-003), AGI's lead programme for the treatment of diarrhoea-predominant
irritable bowel syndrome, (IBS-D), a major unmet medical need.
Financial highlights:
- Revenues of €196,000 compared with no revenues in the same period of the previous year
- Cash and short term deposits at 30 June 2007 of €37.4 million (2006: €40.4 million)
- R & D spend of €4.8 million (2006: €1.7 million)
- Net loss of €5.2 million (2006: €2.3 million)
- Loss per ordinary share of €0.08 cent (2006: €0.04 cent)
Highlights of the first half of the year include:
- In June the Company filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for our lead development candidate, arverapamil (AGI-003), for the treatment of IBS-D.
- In 2006 and early 2007 we reported the Phase II proof-of-concept data for our arbaclofen (AGI-006), 4-ASA (AGI-022) and mecamylamine CR (AGI-004) product candidates. Since then we have focused on the development programmes for these products and we expect to initiate Phase II clinical studies in gastroparesis, ulcerative colitis and chemotherapy-induced diarrhoea respectively later this year or early in 2008.
- We continued to progress our co-development programme with Axcan Pharma Inc. for CHRONAB-omeprazole for the treatment of nocturnal acid breakthrough (NAB) in patients with gastro-esophageal reflux disease (GERD), and expect to provide a further update by year end.In anticipation of the increased level of development activity, particularly in our late-stage arverapamil programme, we further strengthened our management team with the addition of two experienced senior executives to our US group; Sian Bigora, Pharm D. as Vice President, Clinical Research & Regulatory Affairs and Amir Shojaei, Pharm D., Ph.D. as Vice President, Pharmaceutical Development.
- In anticipation of the increased level of development activity,
particularly in our late-stage arverapamil programme, we further
strengthened our management team with the addition of two experienced
senior executives to our US group; Sian Bigora, Pharm D. as Vice
President, Clinical Research & Regulatory Affairs and Amir Shojaei,
Pharm D., Ph.D. as Vice President, Pharmaceutical Development.
Since the period end:
- We expanded our early-stage development pipeline by signing an exclusive option agreement with US-based Williamsburg Holdings LLC to license certain intellectual property and know-how for a novel prodrug platform for the prokinetic/antiemetic agent, levosulpiride.
- Most recently the IND and associated clinical protocols for our ARDIS-1 and ARDIS-3 Phase III studies have been agreed with the FDA and we announce today that these two studies have now opened enrolment.
Commenting on the interim results, Dr John Devane, Chief Executive
of AGI, said:
"The first six months of 2007 were dominated by the substantial work required to meet our stated objective of advancing arverapamil, our lead programme, into Phase III. This has now been achieved and we are looking forward to the prospect of
developing this product for the treatment of IBS-D, a significant unmet medical need"
Outlook
Commenting further on the outlook for the remainder of 2007, Dr. Devane added:
"While keeping our primary focus on the progression of arverapamil in Phase III, we remain committed to moving forward our other programmes in GI-related disorders. We continue to progress CHRONAB-omeprazole under our co-development agreement with Axcan, and have now completed our plans for the further clinical development of three mid-stage products, where we will initiate Phase II trials across a range of indications in the coming months. Furthermore, we successfully expanded our early-stage pipeline and will look to add further new projects on an ongoing basis. We are on track to make 2007 another landmark year for AGI."
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
Notes to Editors:
About Arverapamil (AGI-003)
Arverapamil (AGI-003) is an orally administered triple-action intestinal regulator, a first-in-class mechanism for the treatment of IBS-D. Arverapamil is a single enantiomer moiety of the racemic drug verapamil. Unlike the currently available commercial forms of racemic verapamil (a mixture of two enantiomers), arverapamil shows a dominant activity in treating the symptoms of IBS-D without the traditional cardiovascular actions of the racemic drug. The efficacy and safety of arverapamil in IBS patients has already been established in a Phase II trial, the preliminary results of which were reported by the Company in 2006. The final results of this study will be presented by the Principal Investigator, Professor Eamonn Quigley on October 17th, 2007 at the American College of Gastroenterology's 72nd Annual Scientific Meeting to be held in Philadelphia, PA, USA.
About ARDIS
ARDIS represents AGI's Phase III programme for arverapamil (AGI-003)
in the treatment of IBS-D and consists of three pivotal studies.
ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel group,
Phase III study in IBS-D patients (both men and women). There are four
treatment arms (placebo and three dose levels of arverapamil) and patients
will be treated for 12 weeks of double-blind therapy. At the end of double-blind
therapy in ARDIS-1, patients will become eligible to enrol into ARDIS-3.
It is planned to randomise 1,200 patients into ARDIS-1.
ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted in IBS-D patients upon completion of ARDIS-1.
ARDIS-3 is an open-label safety study designed to capture 1 year extended safety in approximately 100 patients on continuous arverapamil therapy.
About IBS-D
Irritable bowel syndrome (IBS) is a functional disorder that comprises a cluster of gastrointestinal symptoms which are likely to be life long and which affect between 10% and 20% of the population in developed markets. IBS remains the most common diagnosis made by gastroenterologists and can lead to a substantial reduction in patients' quality of life, accompanied by considerable socio-economic and psychological consequences. Altered intestinal motility is a major component of IBS and patients are diagnosed and sub-typed according to their predominant symptom of bowel disturbance. Diarrhoea-predominant irritable bowel syndrome (IBS-D) is estimated to occur in one-third of all IBS patients. IBS-D represents a significant unmet medical need as there are currently few or no safe and effective therapeutic options available to these patients.
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.