HalcyGen's SUBA-Itraconazole in commercial production

Melbourne, Australia-based HalcyGen Pharmaceuticals says that its lead product, the anti-fungal drug SUBA-Itraconazole) has been successfully manufactured at commercial scale in preparation for Phase III registration trials in the USA. The company specializes in what it calls "super generics" by improving variants of existing compounds, rather than in high-volume copy drugs.

The next major milestone for HalcyGen is the US Food and Drug Administration's approval of the Investigational New Drug application in the second quarter for the company's pivotal Phase III trial strategy.

HalcyGen says that its product is targeted to the $2.5-billion anti-fungals market, currently dominated by leading products such as Pfizer's Vfend (voricanazole) and Diflucan (fluconazole), Novartis' Lamisil (terbinaine) and Janssen Pharmaceutical's Sporanox (itraconazole). SUBA-Itraconazole, is expected to provide the same efficacy as Sporanox at half the oral dose. The Phase III trial is designed to determine non-inferiority against Sporanox and may provide an indication as to whether there is improved safety with HalcyGen's lower dosage form. Global sales of the anti-fungal drug itraconazole/Sporanox were in excess of $600.0 million last year.