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Futura Medical looking ahead to completion of key phase III ED trial

Snapshot

  • Focus on MED2005 ED gel and TPR100 pain relief gel
  • Based on its DermaSys skin-based drug delivery system
  • MED2005 phase III trial results due by end of year
  • Seeking UK approval for TPR100
man with erectile dysfunction

Quick facts: Futura Medical PLC

Price: 31 GBX

AIM:FUM
Market: AIM
Market Cap: £63.44 m
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What it does

Futura Medical PLC (LON:FUM) is developing a portfolio of products for two large markets: sexual health and pain.

All of its products are based around its DermaSys skin-based drug delivery system.

Perhaps the most exciting product is MED2005, Futura’s erectile dysfunction gel which is designed for those men where the current pill-based treatments aren’t appropriate or carry significant side-effects.

It is currently undergoing a Phase III study in Europe, headline data from which is expected by the end of this year.

The company is also working on three pain relief gels: TPR100, TIB200 and SPR300. Each contains a different painkiller or anti-inflammatory.

TPR100, the most advanced gel, contains diclofenac, TIB200 contains ibuprofen and SPR300, which is a potential follow to those two, contains methyl salicylate.

Futura’s most developed product is CSD500, a condom that is coated in an erectogenic gel which helps men maintain firmer erection for longer.

The condoms were launched in Saudi Arabia last year and more than a million have been sold, but without a major commercial partner, Futura is not putting any more money into this.

How it’s doing

With the condom very much on the backburner, Futura is focusing on two things at the minute: its ED gel pain relief gels.

A phase III study of MED2005 kicked off last October and more than 450 patients have been enrolled. Top-line data is expected before the year-end.

“The study is going well and we’re looking forward to getting the results at the end of this year,” said chief executive James Barder.

As for TPR100, Futura’s partner Thornton & Ross applied for approval from UK regulators last summer. Discussions with officials are ongoing, but the company is hopeful of reaching a conclusion later this year.

Losses in the half-year to June rose to £5.26mln, while it had cash in the bank of £5.6mln.

In November, Futura presented new information it said adds to the growing body of safety and efficacy data supporting its ED gel.

MED2005 demonstrated a “dose-proportional” increases in penile blood flow, according to the abstracts presented to an industry conference that took place in Nashville.

"The data presented add to the growing body of data supporting the clinical and commercial potential of MED2005," said James Barder, Futura’s chief executive.

What the broker says

In a note in late-November, analysts at Futura’s house broker Liberum said the upcoming headline data for MED2005 could be “game-changing”.

The broker, which rates Futura at ‘buy’ and with a 60p target price, said the phase III clinical trial, which is expected to report by the middle of December, had been “significantly de-risked” and had an over 70% chance of delivering a positive outcome.

“We believe there are 20 feasible outcomes of which just 1 would represent failure and leave no chance of approval”, Liberum said, adding that if the treatment was approved it could achieve peak sales annually of up to £500mln.

Research house Trinity Delta has a 62p share price target.

“We believe the ED market is evolving, especially in the US, and a single, global partner is unlikely to be able to optimise MED2005’s potential income.

“We would expect European, and possibly select Asian, regions to be partnered first (markets that are relatively conventional), with a US deal later.”

Inflexion points

  • Data from phase 3 trial of MED2005 by end of 2019
  • Approval for TRP1000
  • Additional commercial partners for either product

Blue sky

Looking ahead, there are a couple of key inflexion points:

Headline results from the phase III trial of MED2005 which are due before the end of the year

A decision from UK regulators on TPR100, which Futura is hearing about later in 2019.

 

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

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