Latest News

Futura Medical up almost a fifth after it says it is making commercial and regulatory headway

0

Futura Medical PLC (LON:FUM) shares shot higher after it said it had made regulatory progress in the US and was garnering significant commercial interest for its erectile dysfunction (ED) gel.

In an update, investors were told discussions were taking place with a “growing number” of potential partners interested in helping Futura exploit the commercial potential of MED3000 as an over-the-counter treatment.

It said priority has been given to “certain negotiations for one specific region where discussions have advanced with parties for the exclusive marketing rights for MED3000”.

“The company has reasonable expectations that these negotiations will be satisfactorily concluded with one of several interested parties although no guarantees can be given at this stage that any of these negotiations will conclude successfully,” it added.

Chief executive James Barder said he was hopeful of signing at least one agreement.

In the same announcement, Futura confirmed it expects to carry out a “small supplementary study” of its erectile dysfunction gel after coming to a preliminary agreement with the US regulator.

The final protocol for the assessment of MED3000 will be agreed once Futura has received the final meeting minutes from the Food & Drug Administration.

However, it is expected to be a comparative, randomised, open-label, home use, parallel-group assessment of around 100 men with ED. About a fifth of the group will be drawn from the US to “provide reassurance that data generated outside the US is comparable to the US population”.

The main goal is to compare MED3000 against a pre-treatment baseline for efficacy for up to six months.

Barder hailed the “positive” regulatory momentum as the group said the EU approval process continued to “progress well”.

“We are increasingly excited at the prospects of bringing to market the first over the counter, topically applied clinically proven treatment for erectile dysfunction with a faster onset of action and enhanced safety profile compared to currently available oral, on-demand, drug treatments,” he added in the update.

Analysts at house broker Liberum estimate the follow-up study (FM71) to gain US approval will cost £2-3mln, which could be funded by an outlicensing deal in one specific region if completed in the near-term. 

Shares jumped 18% to 15.98p on Thursday afternoon.

–Adds analyst comment, shares–

Today’s Market View – Vast Resources, Serabi Gold, KEFI Gold and Copper and more…

Previous article

Small Cap Wrap – Crossword Cybersecurity, EKF Diagnostics, Alien Metals and more…

Next article

You may also like

Comments

Leave a reply

Your email address will not be published. Required fields are marked *

More in Latest News