HalcyGen to begin Marketing Authorization Application in Europe

HalcyGen Pharmaceuticals has announced that preliminary results from its UK-based Pharmacokinetic (PK) study comparing a half-dose of anti-fungal drug Suba-Itraconazole with Sporanox, has shown clinical bioequivalence within EU guidelines.

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

The results of the completed study show that Suba-Itraconazole given at a half dose to Sporanox is clinically bioequivalent to the latter when given according to the prescribing information.

The company will seek further guidance from the Medicines and Healthcare Products Regulatory Agency (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.