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09-28-2007, 03:42 PM
HalcyGen Pharmaceuticals Limited (ASX: HGN) lead product anti-fungal drug SUBA-Itraconazole has successfully been evaluated in the second of two pharmacokinetic studies in man. The next major milestone is the pivotal Phase III trial in early 2008 before product registration and sales.

The current trial demonstrated that HalcyGen's formulation of Itraconazole is absorbed twice as effectively as the lead marketed form of the drug, Sporanox* allowing the development of a half-dose format of the drug. The study also demonstrated that SUBA-Itraconazole was absorbed effectively in the fed and fasted states. Sporanox is recommended as "to be taken with a full meal". Global sales of the anti-fungal drug Itraconazole/Sporanox were in excess of US$600 million last year.

This trial confirms the results of three previous trials conducted by HalcyGen's license partner Mayne Pharma International and a trial conducted by HalcyGen in July 2007. Mayne and HalcyGen have now successfully evaluated SUBA-Itraconazole in five clinical trials. HalcyGen's formulation is intended to provide the physician with a drug with greater reliability in absorption and more reliable levels of the anti-fungal agent in patients' blood.

Dr Roger Aston, HalcyGen's CEO said, "Since our IPO at the end of June 2007, we have reported on the successful completion of two pharmacokinetic studies with our partner Mayne Pharma and our Contract Research Organisation CMAX, a division of Institute of Drug Technology Australia Limited. These clinical results continue to support our development and registration strategy for the Super-Bioavailable formulation of the drug Itraconazole developed by Mayne." "We will meet with the US FDA to discuss the regulatory framework for SUBA-Itraconazole with the aim of beginning the pivotal Phase III trial in early 2008."

The Clinical Study

The study was a single-dose, randomised, fed/fasted, balanced, open-label, four-treatment, four-way crossover study. Twelve subjects have been studied. All subjects participated in four treatment periods. In each treatment period, subjects resided at the CMAX Clinical Unit from Day -1 (the day before dosing) to Day 3 (48 hours post-dose). A post study assessment was performed 7 - 14 days after the fourth treatment period.

The subjects received four single oral doses of Itraconazole, twice as a test formulation (110mg) under both fed and fasted conditions and twice as a reference formulation, Sporanox (200 mg), under both fed and fasted conditions. A single dose was administered according to a treatment randomisation schedule with a minimum of seven days between doses.

*Sporanox is owned by Janssen Pharmaceutical Products LP-part of the Johnson & Johnson Group

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 global pharmaceutical company Mayne Pharma. The Company will initially develop and market two products in partnership with Mayne Pharma in anti-infectives. Subject to performance and meeting certain other criteria, the Company has the opportunity to develop further products with Mayne Pharma.

http://www.halcygen.com (http://www.halcygen.com/)