Discussions with companies interested in licensing Futura Medical PLC’s (LON:FUM) breakthrough erectile dysfunction gel are ongoing, investors will be told at Monday’s annual meeting.
The company has already brokered deals covering China and south-east Asia for MED3000.
The product carries the CE mark, which means it can be marketed to users in the UK and EU. It also means approval can be fast-tracked in many other countries.
Its interactions with the US Food & Drug Administration, meanwhile, are 'on track', shareholders will be told. A confirmatory study of MED3000 will be carried out ahead of a regulatory submission to the American regulator with the first patient dosing expected to take place in the third quarter.
Chairman John Clarke will tell the meeting: “The team is laser-focused on preparation and execution of the confirmatory clinical study and the non-clinical study to finalise an OTC [over-the-counter] label for the regulatory submission for MED3000 in the US which the company aims to achieve in 2022."
MED3000 is built around a technology called DermaSys, which can deliver drug ‘payloads’ through the skin. Futura is also developing a pain relief gel.
"Futura has gained significant momentum this year with the EU approval of MED3000 and the recent fundraising providing it with plenty of firepower to execute the confirmatory US study and to negotiate meaningful outlicensing deals. On the latter point today’s update provides plenty of scope for optimism," analysts at house broker Liberum said.
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