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HalcyGen Pharmaceuticals Limited
(ASX: HGN) has successfully completed the first of three pivotal
pharmacokinetic* studies scheduled under its
Investigational New Drug application (IND)
recently approved by the FDA (announcement 17
June 2008). The study has demonstrated that SUBA®-itraconazole
in a “half-dose” format gives comparable
pharmacokinetic levels to Sporanox®,
the current itraconazole market leader.
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The registration strategy for SUBA®-itraconazoleTM
is
designed to compare HalcyGen’s SUBA®-itraconazoleTM
and the market’s leading product
Sporanox®**.
HalcyGen’s CEO, Dr Roger Aston said,
“This is a very pleasing result from our
first clinical trial, our SUBA®-itraconazole
shows promise as a half-dose alternative
to the higher dose Sporanox®.
We expect to have all three
pharmacokinetic studies completed by
Christmas prior to seeking further
guidance from the FDA”
HalcyGen has clinically evaluated SUBA®-itraconazole,
a patented formulation, in five
successful
pharmacokinetic studies in Australia.
These studies have demonstrated
that HalcyGen’s formulation has
significantly improved bioavailability
(absorption by the gastrointestinal
track) compared with the market leader,
enabling the use of a lower dose of the
drug.
HalcyGen’s formulation also
provides for more stable blood levels
compared to Sporanox®.
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The current global market for itraconazole is in
excess of US$600 million per annum – HalcyGen’s
SUBA®-itraconazoleTM
is targeting this market.
*Pharmacokinetic Studies: Clinical
pharmacokinetic studies are performed to examine
the absorption, distribution, metabolism and
excretion of a drug under investigation
(investigational drug and approved drug) in
healthy volunteers and/or patients.
Pivotal pharmacokinetic studies are
studies that form part of the registration
dossier for a new drug application (NDA).
**Sporanox®
is the market leading form of itraconazole and
is owned by Janssen Pharmaceutical Products LP –
part of the Johnson & Johnson Group.
Enquiries:
Dr Roger Aston
Craig Bottomley
0402 762 204
03 8614 7777
Rudi Michelson
Monsoon Communications
0411 402 737
Background on HalcyGen:
HalcyGen has been founded to bridge the gap
between mainline pharmaceutical companies and
high volume generics companies through the
development and licensing of new improved
proprietary generic formulations known as "Super
Generics" or "High Functionality Generics".
HalcyGen's strategy is to capitalise on the
value associated with the development and
commercialisation of novel, improved variants of
existing proprietary pharmaceuticals known as
Super Generics.
The basis of the HalcyGen's strategy is a
strategic licensing partnership with Hospira,
Inc. The Company will initially develop and
market two products in partnership with Hospira.
Subject to performance and meeting certain other
criteria, the Company has the opportunity to
develop further products with Hospira.
Through the global exclusive license granted to
HalcyGen by Hospira, Inc., for the
commercialisation of SUBA™-Itraconazole, Hospira
has a first right of refusal to manufacture
SUBA™-Itraconazole to support sales. Hospira is
a global specialty pharmaceutical and medication
delivery company.
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