HalcyGen sees success in SUBA-Itraconazole study

HalcyGen Pharmaceuticals Limited (ASX: HGN) is pleased to announce that preliminary results from its UK-based pharmacokinetic study (PK) comparing a half-dose of anti-fungal drug SUBA-Itraconazole with the market leader Sporanox, has shown clinical bioequivalence within EU guidelines.

Following a pre-registration meeting with the regulatory body, HalcyGen intends to file for registration in the UK in August 2010 as a first step towards registration in the various EU territories.

On 28th August 2009 HalcyGen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had guided HalcyGen to undertake a single pharmacokinetic study in the European Union to demonstrate that SUBA-Itraconazole performs in a similar manner when compared to EU registered Sporanox as it does with US derived Sporanox. This advice concurred with guidance from the corresponding regulatory agency in Sweden (MPA, announced 22 June 2009).

The results of the recently completed study show that SUBA-Itraconazole given at a half dose to Sporanox is clinically bioequivalent to Sporanox when given according to the prescribing information. HalcyGen will seek further guidance from the MHRA as to the sufficiency of the data for registration purposes with particular emphasis on what indications will be granted under the scope of a registration. Currently, Itraconazole is registered for use in indications including: onychomycosis candidosis, aspergillosis, histoplasmosis and cryptococcosis.

HalcyGen’s CEO Dr Roger Aston said, “I expect that the results of this study will allow us to file for registration of SUBA-Itraconazole in the UK this year, potentially allowing HalcyGen to receive income from first sales in 2011. This will be subject to regulatory authority review times and the appointment of an EU marketing and distribution partner’’. ”Licensing discussions to address marketing and distribution, whether regionally or globally, are currently under way with various partners”.

He further said, “This is a very pleasing result as the EU market for Itraconazole is estimated at over US$120M being greater than that for the USA. The Global market for Itraconazole products is in excess of US$610M.”

The clinical and commercial advantage offered by HalcyGen’s formulation (SUBA-Itraconazole) is the potentially greater safety of the drug as compared with Sporanox. Patients receiving SUBA-Itraconazole are administered only 50% of the drug received by patients on Sporanox. Furthermore, SUBA-Itraconazole shows lower inter-patient variability as compared to Sporanox resulting in more predictable blood levels. A further benefit of SUBA-Itraconazole is that it can be taken on an empty stomach, unlike Sporonox which is recommended to be taken after a full meal.

HalcyGen’s PK program enables a dual registration strategy to simultaneously seek approval in the USA through the FDA and in Europe with the UK as the Reference Member State.

One of the key advantages of achieving early EU registration is that the approved dossier may be used for faster approval in many Asian territories as well. Asia is an important market for Itraconazole. The annual sales in Japan and Korea alone are in excess of US$200 million.