HALCYGEN’S ½-DOSE SUPER GENERIC MATCHES MARKET LEADER
October 9th 2008 01:13
Tuesday October 7, 2008
Daily news on ASX-listed biotechnology companies
* ASX, UP, BIOTECHS DOWN: STARPHARMA UP 14%, PSIVIDA DOWN 21%
* HALCYGEN’S ½-DOSE SUPER GENERIC MATCHES MARKET LEADER
* AGENIX CONVERTIBLE NOTES, PLACEMENT TO RAISE $800k
* NOVOGEN VOTES ON CEO, DIRECTOR OPTIONS
* LIVING CELL VOTES ON 1.4m DIRECTOR OPTIONS
* BIOTA BUYS BACK 9.2m SHARES
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HALCYGEN
Halcygen says a US trial of its “half-dose” anti-fungal drug Suba-itraconazole has comparable pharmacokinetic levels to Sporanox, the itraconazole market leader.
Halcygen said it had completed the first of three pivotal pharmacokinetic studies of Suba-itraconazole under its investigational new drug application approved by the US Food and Drug Administration in June (see Biotech Daily June 17, 2008).
Halcygen said the study demonstrated that Suba-itraconazole in a half-dose format gave comparable pharmacokinetic levels to Sporanox.
The company said the registration strategy for its “super generic” Suba-itraconazole was designed to compare the Halcygen drug with Sporanox.
Halcygen’s chief executive officer Dr Roger Aston said the first [US] clinical trial of Suba-itraconazole showed 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,” Dr Aston said.
Halcygen said it had clinically evaluated Suba-itraconazole in five successful pharmacokinetic studies in Australia.
The company said the studies demonstrated that Halcygen’s formulation significantly improved bioavailability, or absorption by the gastrointestinal track, compared with the market leader, enabling the use of a lower dose of the drug.
Halcygen said its formulation provided for more stable blood levels compared to Sporanox which is owned by Janssen Pharmaceutical Products, part of Johnson & Johnson.
Halcygen was unchanged at 26 cents.
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