Healthcare Industry News:  Janssen 


 News Release - October 7, 2008

Halcygen Successfully Completes First Pivotal Trial with SUBA-Itraconazole(tm)

Improved anti-fungal targeting $600m market

Melbourne, Australia, 7 October 2008--(HSMN NewsFeed)--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.

The registration strategy for SUBA®-itraconazole(TM) is designed to compare HalcyGen’s SUBA®-itraconazole(TM) 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®.

The current global market for itraconazole is in excess of US$600 million per annum – HalcyGen’s SUBA®-itraconazole(TM) 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.

Source: HalcyGen

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