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AGI Therapeutics plc signs $19
million exclusive license agreement with Axcan Pharma
for delayed/controlled release omeprazole.
Dublin, Ireland, 27th September
2006 - AGI Therapeutics plc ("AGI" or the
"Company") (AIM, IEX: AGI), a speciality pharmaceutical
company focused on gastrointestinal drug products,
today announces that it has entered into an exclusive
license agreement with Axcan Pharma, Inc. ("Axcan")
(NASDAQ: AXCA, TSX: AXP) for North American rights
to AGI's delayed/controlled release omeprazole formulation,
AGI-010. Axcan is a leading marketer of pharmaceutical
products for gastrointestinal diseases and disorders
in North America and Europe, with revenues in 2005
of over US $250 million.
Under the terms of the agreement, Axcan has been
granted exclusive marketing rights to AGI-010 in
the US and Canada in return for an initial license
fee of US $1.5 million, further payments of US $17.5
million on the achievement of specified milestones,
and royalties on product sales. The parties will
be jointly responsible for and share certain development
costs of AGI-010 up to and including its regulatory
approval in the US. Axcan will be responsible for
commercializing AGI-010 in the US and Canadian markets,
while AGI will have an option to co-promote the
product in the US. Axcan has been granted an option
to license AGI-010 for markets outside North America
and additional milestone payments could become payable
to AGI in the event that Axcan exercises this option.
In addition to today's agreement, Axcan may elect
to license rights from AGI to develop other controlled
release PPI products using AGI's CHRONAB technology
and intellectual property under a similar commercial
structure.
AGI is developing AGI-010, a delayed/controlled
release formulation of the proton pump inhibitor
drug (PPI) omeprazole, based on its CHRONAB technology
which it believes will optimize the treatment of
nocturnal acid breakthrough (NAB), a common symptom
of gastroesophegeal reflux disease (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 US $20 billion. NAB is estimated to occur in
at least 50 per cent of GERD patients on PPI therapy.
In March 2006, AGI announced the preliminary outcome
of a combined human pharmacokinetics and pharmacodynamics
study designed to characterize the in-vivo drug
release profile, pharmacokinetics and the intra-gastric
pH profiles of delayed release/controlled release
formulations of omeprazole (AGI-010). Preliminary
data from the study demonstrated that delayed/controlled
release characteristics were clearly achieved. AGI
has subsequently conducted a programme of formulation
optimization to further enhance the drug release
profile of AGI-010 and further studies will now
be conducted on the optimized product in the course
of the co-development to be undertaken by AGI and
Axcan.
Commenting on the agreement,
Dr John Devane, Chief Executive of AGI said:
"We are delighted to announce our first partnership
agreement with Axcan. It fits very well with our
business model of entering into development and
commercialisation agreements for products that address
larger, established markets. Axcan is an excellent
choice of partner for our delayed/controlled release
omeprazole formulation and we are confident that
their extensive knowledge of developing and marketing
products for the gastrointestinal market will contribute
to commercial success. Nocturnal acid breakthrough
continues to be a significant shortcoming of current
PPI therapy for GERD patients and with AGI-010 we
look forward to being able to better address the
needs of these patients with a more effective and
improved therapy."
Frank Verwiel, M.D., President
and Chief Executive Officer of Axcan, added:
"We are pleased to combine AGI's expertise
in product discovery with Axcan's capability in
development and as a result be able to bring to
the gastrointestinal market an innovative controlled
release version of omeprazole, and are looking forward
to our partnership. We are currently in the process
of finalizing our development strategy and one of
the alternatives we are evaluating is the option
of qualifying for bioequivalence development under
the US FDA regulations. Should the product qualify,
this strategy could lead to accelerated development
and launch of this innovative product."
Contact Information
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AGI Therapeutics
David Kelly, Chief Financial Officer
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Tel:
+353 1 449 3254 |
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Financial Dynamics
- UK
Sarah MacLeod
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Tel:
+44 (0) 20 7831 3113 |
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Financial Dynamics
- Ireland
Aisling Garvey
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Tel:
+353 1 663 3607 |
For further information please see www.agitherapeutics.com
About GERD and NAB
GERD results in the reflux of gastric contents
into the esophagus, causing symptoms (e.g. heartburn
or acid regurgitation) that are sufficient to interfere
with quality of life. NAB is defined as the presence
of at least 60 continuous minutes of intragastric
pH < 4 during the overnight period (10pm - 6am)
in patients taking a PPI drug twice daily before
meals.
GERD is the most common of the major gastrointestinal
disorders and its prevalence in the general population
is estimated to range from 20 to 40 per cent. Proton
pump inhibitors are commonly used drugs in the treatment
of GERD and are one of the largest selling drug
classes with global annual sales in excess of US$20
billion. NAB is estimated to occur in more than
70 per cent of h.pylori-negative and in up to 50
per cent of h.pylori-positive patients on PPI therapy
and modification of the dosage regime of existing
PPI drugs has only had limited success in controlling
the symptoms of NAB despite improving acid suppression.
About AGI Therapeutics plc
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 "AG1".
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 has developed a range of product candidates
to treat a variety of prevalent GI diseases and
disorders, including irritable bowel syndrome (IBS),
functional dyspepsia, ulcerative colitis and gastro-esophageal
reflux disease (GERD). 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 clinical development
of lead product candidates 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.
About Axcan Pharma, Inc.
Axcan is a leading multinational specialty pharmaceutical
company focused on gastroenterology. The company
develops and markets a broad line of prescription
products to treat a range of gastrointestinal diseases
and disorders such as inflammatory bowel disease,
irritable bowel syndrome, cholestatic liver diseases
and complications related to pancreatic insufficiency.
Axcan's products are marketed by its own specialized
sales forces in North America and Europe. Its common
shares are listed on the NASDAQ Global Market under
the symbol "AXCA" and on the Toronto Stock
Exchange under the symbol "AXP" .
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.
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