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AGI Therapeutics plc - Strengthens
management team
Dublin, Ireland, 12th March
2007 - AGI Therapeutics plc ("AGI" or the
"Company") (AIM, IEX: AGI), a speciality pharmaceutical
company focused on gastrointestinal drug products,
today announces the appointment of two new Vice
Presidents to its management team.
Dr. Sian Bigora, Pharm D. joins AGI as Vice President,
Regulatory Affairs. Most recently, Dr. Bigora served
as an independent consultant to pharmaceutical companies
providing regulatory strategy for product development
with an emphasis on 505b2 New Drug Application (NDA)
submissions. Prior to that she served as Vice President,
Regulatory Affairs with ICON Clinical Research (formerly
Globomax), where she was responsible for the management
and direction of ICON's regulatory affairs function.
Her experience includes application of her prior
regulatory, clinical, pharmacokinetic and technology
experience to develop regulatory strategies to achieve
FDA approvals including Known Medical Entity (KME)
type programmes and 505b2 NDA submissions. She is
also familiar with regulatory processes outside
the US including Europe and Canada. She has led
and worked on large programme teams in various therapeutic
areas including gastrointestinal (GI) disease. Dr
Bigora received her Pharm.D degree from University
of Maryland at Baltimore and was a Post-Doctoral
Fellow at the Pharmacokinetics and Biopharmaceutics
Laboratory at the School of Pharmacy, University
of Maryland, Baltimore.
Dr Amir Shojaei, Pharm D. PhD. joins AGI as Vice
President, Pharmaceutical Development. For the past
seven years, Dr Shojaei served in various management
positions with Shire Pharmaceutical Group, plc's,
U.S. divisions. Most recently he was Senior Director,
Pharmaceutical Sciences with Shire Development Inc.
In these roles he was responsible for all aspects
of formulation and analytical development from pre-clinical
through Phase III, process validation and technology
transfer on a range of global (US, EU, and Japan)
product development programmes in GI, CNS and renal
therapeutic areas. He assumed primary responsibility
and authorship of the Chemistry & Manufacturing
Control, (CMC), sections of various 505b2 NDA as
well as New Chemical Entity (NCE) type regulatory
filings. Prior to Shire, Dr Shojaei was Assistant
Professor of Pharmaceutical Sciences at Texas Tech
University, School of Pharmacy, Amarillo.
Commenting on the appointments, Dr John Devane,
CEO of AGI said:
"We are delighted that Sian and Amir have
agreed to join our management team. Both will bring
their unique skills and experience to assist in
the development of the business. We recently outlined
to the market the clinical progress of our product
portfolio, 2007 promises to be a busy and exciting
year for us. The appointment of these two key individuals
is an important enabling step in progressing our
products to regulatory submission and commercial
success in both the US and Europe."
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
Anna Keeble
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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 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.
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