Mayne applies to register Subacap in Europe

Mayne Pharma Group has applied for a marketing authorisation application (MAA) with the European Union (EU) for the sale and supply of its Subacap drug to treat fungal infections.

Subacap is described by the company as an improved version of the existing anti-fungal drug itraconazole, the global market for which is currently estimated at around $US600 million.

Mayne Pharma’s CEO, Dr Roger Aston said that th MAA application represented a significant milestone for the company and Australian biotechs in general, given that in the last few years only a handful have sought the registration of new drugs.

“This is a great result as the EU market for itraconazole is estimated at over US$120 million, being greater than that for the US,”Aston noted, adding that early EU registration would likely result in faster approval in Asian and South American countries.

Over the next few months Mayne Pharma said that it will set about establishing agreements for the marketing and distribution of Subacap in Europe and other markets.

Regarding the US market, the company has a meeting scheduled for early next year with the FDA to discuss the next steps required for registration. This follows a Phase II trial in the US which demonstrated, according to Mayne, that Subacap is safe low dose replacement to Sporanox, one of the top selling anti-fungal treatments.

The MAA has been submitted via the Decentralised Procedure, with the United Kingdom as the Reference Member State and France, Germany, Spain and Sweden as the Concerned Member States.

Mayne said that the approval process for Subacap is likely to take between nine and 12 months and that it expects to receive income from the first commercial sales of the drug in the 2012 calendar year via yet-to-be appointed marketing and distribution partner.