Dublin, Ireland, 1st April 2009
AGI Therapeutics, plc Financial results for the
12 months ended 31 December 2008
AGI Therapeutics plc ("AGI" or the "Company"), a speciality pharmaceutical company focused on gastrointestinal drug products, today reports audited financial results for the 12 months ended 31 December 2008.
Financial highlights
•Revenue of $577,000 (2007: $577,000)
•Cash and short-term deposits at 31 December 2008 of $23.6 million,
(2007: $45.5 million)
•R&D spend of $15.9 million (2007:$19.4 million)
•Net loss of $18.2 million (2007: $20.7 million)
•Loss per ordinary share of 27.0 cents (2007: 30.7 cents )
Operational highlights
Rezular™ - AGI's lead product for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D), a chronic, relapsing condition that affects millions of people.
•Primary focus on ARDIS, our Phase III programme, comprising of
ARDIS-1(efficacy) and ARDIS-3 (safety), both studies to be included in
future New Drug Application to US FDA
•Key findings of study to assess pharmacokinetic profile announced
in February; possible MoA and further analysis of Phase II data presented
at DDW in May
•FDA agreed on the statistical approach for analysis of ARDIS-1 in
June and reaffirmed the key parameters of Phase III programme, including
current primary endpoint.
•FDA confirmed Rezular™'s eligibility and associated requirements
to qualify for 5 year market exclusivity in US
•Completion of patient enrolment for ARDIS-1 announced January 2009;
711 patients randomised in 123 clinical centres in U.S., Europe, South
America; top-line data from ARDIS-1 anticipated by end Q2, making Rezular™
the most advanced product in development for IBS-D
•Today, we are pleased to announce that enrolment into ARDIS-3 is
now closed and AGI expects that the exposure target of 100 patients for
1 year will be achieved in Q3 2009 and data will be reported in Q1 2010
AGI-004 - A once-daily controlled release transdermal mecamylamine patch being developed for the treatment of chemotherapy-induced diarrhoea (CID) in cancer patients:
•Commencement of patient enrolment in a proof-of-concept Phase II
clinical study announced February 2008.
•Preliminary results demonstrating AGI-004 is a promising new therapy
for this potentially debilitating side-effect of cancer chemotherapy announced
March 2009.
AGI-010 - AGI's modified release formulation of the proton pump inhibitor drug ("PPI") omeprazole which utilizes AGI's CHRONAB technology:
•Completion of optimisation phase of development of AGI-010, co-developed with Axcan Pharma Inc., ("Axcan") for treatment of night-time acid breakthrough (NAB) in gastro-esophageal reflux disease (GERD) patients announced March 2008.
Other Projects:
•Continued work on AGI-022 for the treatment of ulcerative colitis and investigated potential to further develop AGI-006 as a novel treatment in a number of clinical indications including gastroparesis, GERD refactory to PPI therapy and chemotherapy-induced nausea and vomiting (CINV). In keeping with our policy of carefully managing financial resources and prioritizing investment in our most advanced programme, Rezular, we have not committed further expenditure to these projects at this time.
Commenting on the results, Dr. John Devane, CEO of AGI, said:
"In 2008 Rezular dominated our activities. We are very pleased that in the initial weeks of 2009 we completed patient enrollment into ARDIS-1 and we now look forward to reporting top-line data later this year. Through our interaction with the FDA and contact with potential partners, we believe we have the ability to introduce the first new therapy for the treatment of IBS-D in the US in almost 10 years. This is a disease which seriously affects the quality of life of millions of patients and for which there are few effective therapeutic options available."
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Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Jonathan Birt/John Dineen
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Niamh Lyons
Tel: +353 1 663 3602
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
For further information please see www.agitherapeutics.com.
Notes to Editors:
About AGI-004 and chemotherapy-induced diarrheoa (CID)
AGI-004, a controlled release form of mecamylamine, is a potent, non-competitive specific antagonist at nicotinic acetylcholine receptors (nAChR). More specifically, AGI-004 has been shown to be selectively active on certain nAChR sub-types which are the predominant form found on enteric neurons, where nAChR is known to regulate a range of gut functions, including modulation of secretory and motility effects. AGI-004 is formulated in a proprietary controlled release transdermal patch which is applied once-daily.
CID is a prevalent and severe side-effect associated with cancer chemotherapy treatment which occurs in up to 50% of patients receiving chemotherapy and can affect up to 80% of patients receiving certain chemotherapy regimens. CID may range from troublesome (NCI grade 1) to life-threatening (NCI grade 4). CID can negatively impact a patient's health to the point that they are unable to tolerate their prescribed chemotherapy, commonly leading to delay or reduction in treatment which may diminish the effect of treatment. Loperamide is the current drug of choice for the management of mild to moderate CID, but is limited in terms of its effectiveness and dosing flexibility, and there are currently few effective alternative therapies available.
Clinical Trial Design and Conduct
The Phase II study was a randomised, double-blind, placebo-controlled, balanced, parallel-group trial in 64 cancer patients across 7 sites in Europe. The study evaluated the efficacy of two doses of AGI-004 in controlling diarrhoea resulting from the administration of 5-Fluourouracil, including capecitabine and/or irinotecan or cisplatin, compared with placebo, in patients with NCI grade 1 or 2 CID. Patients were randomly allocated to active treatment or placebo. Treatment was initiated 24 hours prior to chemotherapy and patients continued to self-administer AGI-004 or placebo patches once daily during and after chemotherapy for the duration of the cycle of chemotherapy. Patients were allowed free access to loperamide or other appropriate medications on a rescue basis to treat any active episodes of diarrhoea. Treatment with AGI-004 or placebo was for two consecutive cycles of chemotherapy. The dose of mecamylamine was escalated over the two cycles from the lower dose in the first cycle to the higher dose in the second cycle.m
About AGI Therapeutics plc
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
multiple mechanism 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, 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 novel 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.