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Futura Medical mulling fast-track European submission for lead drug candidate

Depending on the read-out from current study, it may opt to submit the results from just one phase III trial in Europe. But at this stage it is only considering this option

man with head in hands
The company's lead asset is MED2005, a fast acting alternative to the blue pills used to tread erectile dysfunction

Futura Medical PLC (LON:FUM) said it is considering filing for marketing approval for its fast-action erectile dysfunction gel with data from just one phase III clinical trial.

In a preview of his address to the company’s annual meeting, Futura acknowledged it is normal for packages from two final-stage studies to be submitted to regulators – and indeed the US watchdog has insisted this happens.

If the company does opt to submit the results from just a single phase III study of MED2005 it would speed up the process of getting the breakthrough product to the market.

Recruitment for the European leg is already complete. Headline data is expected by the end of the year, which would allow for a marketing submission sometime next year.

Futura stressed it is currently only “exploring” the possibility of a single trial in Europe and the decision would be dependent on the results garnered from the 1,000 men currently under observation.

In the meantime, preparations are being made for the second trial that will have a US patient component.

The company’s other major innovation is TPR100, a pain relief gel, which it has licenced to manufacturer Thornton & Ross.

Thornton, part of the Stada group of companies, filed for marketing approval just under a year ago and was asked by the Medicines and Healthcare products Regulatory Agency to provide additional lab work.

Efforts in this regard are “well advanced”, with Thornton expected to submit its response in September, allowing for a regulatory opinion by the end of the year.

In the meantime, Futura has received “expressions of interest from a number of parties” from outside the UK.

Quick facts: Futura Medical PLC

Price: 34.9 GBX

AIM:FUM
Market: AIM
Market Cap: £71.43 m
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