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news.HalcyGen Pharma (HalcyGen) has reported that the preliminary results from its UK-based pharmacokinetic study (PK) comparing a half-dose of anti-fungal drug Suba-Itraconazole with Sporanox has shown clinical bioequivalence within EU guidelines.
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HalcyGen said that following a pre-registration meeting with the regulatory body it plans to file for registration in the UK in August 2010 as a first step towards registration in the various EU territories.
Earlier, on 28th August 2009, HalcyGen has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had guided it to undertake a single pharmacokinetic study in the EU to demonstrate that Suba-Itraconazole performs in a similar manner when compared to EU registered Sporanox as it does with US derived Sporanox. The advice concurred with guidance from the corresponding regulatory agency in Sweden (MPA, announced 22 June 2009)
The results of the recently completed study showed that Suba-Itraconazole given at a half dose to Sporanox is clinically bioequivalent to Sporanox when given according to the prescribing information. HalcyGen is expected to 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.
Furthermore, Suba-Itraconazole showed 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 said that its 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.
Roger Aston CEO of HalcyGen, 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.”