AGI announces termination of agreement with Axcan for AGI-010
Dublin, Ireland, 14th August, 2009 - AGI Therapeutics plc ("AGI" or
the"Company") (AIM, IEX: AGI), a speciality pharmaceutical development
company, today announces that its co-development/co-fund and licensing
agreement for AGI-010 with Axcan Pharma Inc. ("Axcan"), a
privately-held, leading specialty pharmaceutical company in the field
of gastroenterology, has been terminated by mutual agreement. AGI-010
is the Company's bimodal modified release once-daily formulation of the
proton pump inhibitor drug (PPI) omeprazole for the treatment of
gastro-esophageal reflux disorder ("GERD"). AGI now regains full
control of AGI-010 and neither party has any outstanding or future
obligations to the other.
AGI and Axcan entered into a co-development/co-fund and license
agreement in September 2006 to jointly develop AGI-010 for North
American markets and the parties have worked together since then to
develop and optimise the formulation and conduct human clinical
testing. AGI announced last year that it had identified an optimised
formulation of AGI-010 omeprazole for once daily administration which,
the Company believes, can improve control of night-time acid, a
prevalent and unmet aspect of GERD. Recently, AGI met with the US Food
and Drug Administration ("FDA") who confirmed that AGI-010 can be
registered in the US under the NDA 505(b)2 regulatory pathway.
AGI has already completed a number of human clinical studies which
demonstrate that the optimised formulation of AGI-010 achieves:
- a bimodal plasma level profile through its combination of delayed
and controlled release beads
- an extended plasma level profile consistent with once-daily
administration
- matching AUC and overall 24-hour gastric pH compared to Prilosec®
- greater night-time control of acidity compared to Prilosec®
Commenting, Dr. John Devane, CEO, said ''We have had a productive
association with Axcan in developing the AGI-010 product to this
advanced stage. The return of all rights, without any further financial
obligations, is, we believe, consistent with the business strategy
review currently underway at AGI. We will now seek to license this
product to a new licensee who will complete the development and NDA
filing and ultimately the commercialisation of AGI-010.''
Contact Information:
AGI Therapeutics plc. Tel: +353 1 449 3254
David Kelly, Chief Financial Officer
FD - UK Tel: +44 (0) 20 7269 7205
Jonathan Birt/John Dineen
FD - Ireland Tel: +353 1 663 3607
Niamh Lyons
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 1 614 8761
John Frain
Axcan Pharma Inc.
Isabelle Adjahi, Senior Director, Tel: + 1 450-536-7696
Investor Relations and Communications
For further information please see www.agitherapeutics.com.
Notes to Editors:
About AGI-010 and GERD
AGI-010 is a modified bimodal release once-daily formulation of the
proton pump inhibitor drug (PPI) omeprazole based on AGI's CHRONAB
technology which the Company believes will be effective in controlling
night-time acid, a prevalent and unmet aspect of current PPI therapy of
GERD. GERD is the most prevalent of the major gastrointestinal
disorders and is most commonly treated with PPI drugs, which achieve
global annual sales in excess of USUSD20 billion. Night-time acid
breakthrough is estimated to occur in at least 50 per cent of GERD
patients on PPI therapy.
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.
About Axcan Pharma
Axcan Pharma is a privately-held, leading specialty pharmaceutical
company that develops and markets a wide range of products to treat
gastrointestinal diseases and disorders, such as inflammatory bowel
disease, cholestatic liver diseases, irritable bowel syndrome, and
complications related to pancreatic insufficiency. Axcan's products are
marketed by its own dedicated and specialized sales forces both
in North America and the European Union. The company also markets its
products in more than 40 countries through a global network of local
partners.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
Contact Information: Contacts: RNS Customer Services 0044-207797-4400 http://www.rns.com