Mayne clears hurdle to SUBACAP approval in EU

Mayne Pharma (ASX:MYX) is back on track to gaining marketing approval from the EMA for its SUBACAP fungal infection treatment, after its application was temporarily derailed by UK regulators.

The Australian specialist pharmaceutical company revealed Thursday that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has reversed its previous decision that its application is not approvable in the UK.

This will allow Mayne Pharma to reactivate the decentralised procedure to also seek approval in Germany, Spain and Sweden.

In December last year, the MHRA advised Mayne Pharma that it must respond to questions raised from a review of the SUBACAP application by the UK's Commission for Human Medicines.

The sticking point appeared to be that while clinical trial data backed up SUBACAP's superiority over a placebo, the reference drug did not outperform the placebo, so the MHRA felt that no conclusions could be made regarding SUBACAP's non-inferiority to this formulation.

But after consulting with the MHRA over a six-month period, the agency's concerns have been addressed, Mayne Pharma said.

If the MHRA had not been convinced, Mayne Pharma would have needed to withdraw its application and conduct more clinical work. But now no additional trials will be needed.

Mayne Pharma has also applied for a Special Protocol Assessment (SPA) declaration from the US FDA for a phase III trial of the product in onychomycosis. An SPA is a guarantee that the trial design and endpoints are suitable for an application for regulatory approval.

SUBACAP is a specialty generic version of fungal infection formulation itraconazole. Changes made to the formula promise reduced variability between patients or dosages, allowing a reduction of active drug quantity required.

Itraconazole was registered as Sporanox by Janssen Pharmaceutica in 1992. The first generic version was approved by the FDA in 2004. The global market for itraconazole formulations is worth an estimated $500 million per year.

Mayne Pharma (ASX:MYX) shares were trading 5.71 per cent higher at $0.37 as of 11am on Thursday.