Futura Medical PLC (LON:FUM) has said it is “actively engaged” in commercial discussions about its erectile dysfunction (ED) gel ahead of a key meeting with US regulators.
The company said it has hired corporate advisers to organise the interaction with potential licensing and marketing partners for MED3000. It believes there is scope for the new treatment to become an over the counter (OTC) product, tapping into a large unmet need.
It is estimated that at least half of men with ED do not consult a doctor and, therefore, are not prescribed treatment. At the same time, pills such as Viagra and Cialis are not widely available over the counter. The UK is one of the few exceptions with Viagra Connect.
"We are increasingly excited by the commercial potential for MED3000 as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset and may be available without the need of a doctor's prescription bringing accessibility to men throughout the EU and US,” Futura chief executive James Barder said in a statement.
“This sentiment is shared with a number of potential commercial partners with whom we are now actively engaged in discussions."
He added that a meeting has been arranged with the US Food & Drug Administration “before the end of October” at which the company expects to agree “the final outstanding data requirements” to gain regulatory approval for MED3000 as an OTC treatment in the United States.
Futura said it would update the market on the interaction with the regulator following the pre-submission meeting.
The progress report was provided as part of Futura’s interim results statement in which it was revealed the company had, as at June 30, 2020, cash reserves of £2.62mln. This is enough to see Futura through to the second quarter of 2021 under current plans.
As is the norm for companies investing heavily in research and development, Futura was loss-making in the first half. It made a net loss of just over £1mln.