Futura Medical PLC (LON:FUM) shares jumped higher on Thursday after the firm said it has held “positive initial discussions” with EU regulators as it confirmed it will seek to have its erectile dysfunction (ED) gel approved as a medical device rather than a drug.
The company has previously stated this approach should provide a simpler route to sign-off and also “represents a wider overall commercial opportunity”. Its decision to develop the “highly effective gel” as a device rather than drug follows the nuanced read-out from the FM57 phase III clinical trial.
READ: Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results
This showed the delivery technology for the active ingredient was just as effective in treating ED as the drug it was supposed to carry. This was more than simply a placebo effect noticeable when study participants in the control group receive medication with no supposed clinical benefit.
In the case of Futura’s phase III assessment, rather than an inert gel, the control received Dermasys, which was designed to deliver a pharmaceutical payload.
The company believes that DermaSys has an “evaporate mode of action” that stimulates nerve-endings. This made it a “clinically proven, highly effective” method of inducing an erection in its own right.
The pared-down formulation, called MED3000, was broadly as effective as a lower-dose pill such as Viagra or Cialis.
“In addition, the adverse events were substantially lower than seen with oral ED treatments,” said Futura.“This excellent safety profile, together with a rapid speed of onset and high efficacy creates a substantial and highly competitive product opportunity for MED3000.”
The firm reckons its technology may be suitable for men who currently can’t take oral medication, and it might also be used in combination with the current traditional product ranges.
Full clinical study in middle of the year
Following talks with the EU regulators, Futura expects to be able to submit the full clinical study report and other ancillary information in the middle of the year.
Meanwhile, a face-to-face meeting with the US Food & Drug Administration is expected to take place in the current quarter.
In a note to clients, analysts at Liberum Capital - which have Futura's rating and target price currently 'under review' - said: "This work will allow Futura to submit its technical file for review by the Notified Body in mid-2020 which we believe allows for potential approval within 6-12 months thereafter."
They added: "Importantly the feedback the company has received has not just given it the confidence to start the proceedings to file for approval but also indicated that MED3000 may be applicable to a very wide range of ED patients including those contraindicated from using existing medications such as nitrates, anti-hypertensives, and alpha blockers. It may also be used in combination with existing oral therapies.
In afternoon trading, Futura shares were 8.6% higher at 11.625p.
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