DUBLIN, IRELAND--(Marketwire - April 01, 2009) -
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AGI Therapeutics, plc
Financial results for the 12 months ended 31 December 2008
Dublin, Ireland, 1st April 2009 - 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 USD577,000 (2007: USD577,000)
- Cash and short-term deposits at 31 December 2008 of USD23.6 million,
(2007: USD45.5 million)
- R&D spend of USD15.9 million (2007:USD19.4 million)
- Net loss of USD18.2 million (2007: USD20.7 million)
- Loss per ordinary share of 27.0 cents (2007: 30.7 cents)
Operational highlights
RezularTM - 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 RezularTM'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 RezularTM 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."
Click on, or paste the following link into your web browser, to view
the Financial results for the 12 months ended 31 December 2008
http://www.rns-pdf.londonstockexchange.com/rns/8774P_1-2009-3-31.pdf
This information is provided by RNS
The company news service from the London Stock Exchange
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