Futura Medical PLC (AIM:FUM, OTC:FAMDF) has confirmed it is in advanced discussions ‘multiple interested parities’ to out-licence its erectile dysfunction (ED) in ‘major regions’.
New agreements would build on similar deals it already has in China and South-East Asia, Latin America and the Middle East.
Chief executive James Barder said Futura was ‘executing’ on its strategic plans “to leverage commercialisation globally with a network of licensing and distribution partners with brand building strength, healthcare credibility and regional infrastructure and marketing expertise”.
His comments accompanied an update on the progress of MED3000, the company’s lead product.
Having completed a short human factors study to assess the ability of users to self-diagnose for ED, the group is carrying out a six-month confirmatory assessment of its breakthrough gel that will be used as part of its regulatory submission.
So far, just over 100 patients have now been enrolled with a mix of mild, moderate and severe ED. The group is recruiting for a further 10 men to join the study.
Futura confirmed it remains on track to make a regulatory submission to the US Food & Drug Administration in the third quarter of this year.
It hopes then to secure approval for MED3000 as an over-the-counter product during the first quarter of 2023.
The gel is being assessed by the American drug regulator under the De Novo classification for brand new types of medical devices.
“2021 has been a year of transformational progress for Futura and we are excited to be bringing more patients across the globe an accessible, new treatment option for their ED. We look forward to further updates for shareholders during what we believe will be an exciting 2022 for Futura,” said CEO Barder.