Smelly feet
lift biotech
Olga Galacho
Biotechnology
ALMOST a year to the day
since it listed, HalcyGen Pharmaceuticals
looks ready to
gain a toe-hold in the $600 million
market for fungal foot
infection drugs.
News the company had received a
regulatory nod from the US Food
and Drug Administration (FDA) also
propelled the shares to a unique
position for a biotech stock in the
battered sector.
Shares in the anti-fungal drug
developer jumped by a third on the
announcement that its trademarked
compound, Subazole, had moved
into its final testing phase ahead of
registration.
The company expects to present
test results to the FDA before the
end of the year.
Known as a supergeneric because
it is an improved version of an
existing drug, it is a type of medication
the FDA particularly likes, as its
efficacy is already proven.
Supergenerics such as Subazole,
however, are often administered in
lower doses than established drugs,
leading to fewer side-effects.
The drug, bought from Mayne
Pharma International in its preclinical
test stage, targets fungal
infections generally, but particularly
of toenails.
The global market is estimated to
be worth more than $600 million and
is dominated by Johnson & Johnson's
Sporanox.
Melbourne-based HalcyGen has a
Step up: better anti-fungal drug.
strategic licensing deal with Mayne's
new owner, global pharmaceutical
Hospira, that allows it to acquire,
develop and test compounds from
Mayne's portfolio. Once regulatory
obligations are met, Hospira is given
first right to market the drugs.
Recruitment for the final-stage
testing of Subazole, known as pivotal
studies, has begun in the US.
HalcyGen, which has pokies king
Bruce Mathieson on its board, has
already put Subazole through its
paces in Australia.
Clinical studies in Australia have
shown Subazole to be more readily
absorbed than the market leader,
according to HalcyGen chief executive
Roger Aston.
"Initiation of pivotal studies in the
US is one of HalcyGen's biggest
milestones," Dr Aston said.
"We expect to meet the FDA again
before the end of the year," he said.
HalcyGen shares closed 100 higher
at 400.
Ref: 37752299
Copyright Agency Limited (CAL) licenced copy
Herald Sun (Melbourne)
Wednesday 18/06/2008
Page: 28
Section: Business News
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