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Futura Medical hails positive regulatory momentum

Snapshot

  • Developing fast-acting gels for erectile dysfunction and pain relief
  • Seeking to gain regulatory approval as a medical device
  • Meetings with FDA and European regulators to discuss trial results

 

Futura Medical PLC -

Quick facts: Futura Medical PLC

Price: 15 GBX

AIM:FUM
Market: AIM
Market Cap: £36.84 m
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What it does

Futura Medical PLC (LON:FUM) has created a technology called DermaSys that delivers active pharmaceuticals through the skin barrier rapidly and effectively.

In the case of its lead product, MED2005, the payload was glyceryl trinitrate (GTN), normally used to treat heart failure and high blood pressure. Futura combined the two to create a rapid onset gel that tackled erectile dysfunction (ED).

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.

Medical device

Why as a medical device? Well, the results from DermaSys-only cohort showed the men involved responded to a mechanical and physical effect rather than to the chemical substance GTN.

That mechanical and physical effect on the body means DermaSys conforms to the definition of a medical device rather than a drug.

 

How it is doing

In October, Futura hailed the “positive” regulatory momentum as the group said the EU approval process continued to “progress well”.

It is also discussing 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”.

 

What the boss says: James Barder, chief executive

"We are happy to see continuing, positive regulatory progress for MED3000 in parallel with advancing commercial discussions and the board is hopeful of signing at least one agreement with a third party."

“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."

 

Video

 

Inflexion points

  • Submission of MED3000 for US approval
  • No delays in Europe
  • Potential partnerships in discussion
     

What the broker says

Liberum placed a ‘buy’ rating and 55p target price on Futura.

"Following a 3rd pre-submission meeting with the FDA, management believes it has a clear structure for a follow-up study (FM71), that we estimate will cost just £2-3mln, to gain US approval," analysts noted.

"In Europe the filing is under review by the regulator and management continues to expect approval in 2021."

"The company confirmed that partnership interest is growing with discussions having advanced for an outlicensing deal in one specific region which we believe could fund the FM71 study if completed in the near-term."

The broker previously predicted that with the right partner, MED3000 could take a “15% market share in the US and EU5, which at a slight price premium implies just over £300mln of peak sales”.

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Futura Medical kicks off work on Phase III trial for erectile dysfunction gel

James Barder, chief executive of Futura Medical PLC (LON:FUM), tells Proactive they've begun preparatory work on the first Phase III efficacy trial for MED2002 - their topical gel for erectile dysfunction (ED). The study will recruit approximately 1,000 patients with mild, moderate and...

on 27/4/18

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