Futura Medical Share News (FUM)

(Sharecast News) - Futura Medical updated the market on Wednesday, reporting that the impact of the Covid-19 pandemic on the company had been "limited" to date.
The AIM-traded firm said its virtual model had enabled a "smooth and effective transition" to home-working for all staff, and all of its external suppliers, including regulatory agencies and laboratories, continued to operate in line with expectations and timelines.

Looking at 'MED3000', a topical treatment for erectile dysfunction (ED), Futura noted that in December, headline data from the FM57 clinical study demonstrated that it had the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction, with a rapid onset of action and excellent safety profile in a $5bn (£4bn) market.

A new patent application was filed in December around the novel effects of the MED3000 formulation shown in FM57, to potentially provide patent protection until 2040.

Regulatory submissions for MED3000 in both Europe and the United States were on track, with initial documentation already provided to the applicable EU notified body.

The company said it was also targeting submission of the regulatory dossier to the FDA by the end of the third quarter for the United States.

Looking at its US regulatory activity, Futura said the initial presentation of existing clinical evidence from the MED3000 FM57 phase 3 study was made at an FDA pre-submission meeting on 24 February.

As ot disclosed on 6 April, following receipt of the formal FDA meeting minutes from February, the FDA agreed to a 'De Novo' medical device application for MED3000, and invited Futura to pursue another pre-submission meeting once the company was in receipt of the final clinical study report for FM57.

On 20 April, it was announced that the company had filed for a further pre-submission meeting with the FDA in the coming months.

That meeting date had now been set, and the board said it would be used to further discuss clinical sufficiency following completion of FM57's clinical study report.

If successful, that could lead to a US submission filing by the end of the third quarter, to enable FDA review for pre-marketing clearance.

On its European regulatory activity, Futura noted that in February it began formal proceedings for MED3000 to be approved as a medical device and clinically proven treatment for ED in Europe by an EU notified body.

In order to obtain pre-marketing clearance within the EU, two requirements needed to be met - a technical dossier including sufficient efficacy, safety and quality data, and demonstration that the company can operate to a high standard of quality through a quality management system (QMS).

The relevant EU notified body had already started its review of documentation relating to Futura's quality management system, the board said, adding that the technical dossier was nearing completion, and would be submitted when requested by the notified body.

It said that to date, it had not experienced any delays with its chosen EU notified body as a result of the introduction of the new European medical device regulation nor Covid-19, although that was being kept under "close review".

In May, the company received research and development tax credits of £2.22m from HMRC for the year ending 2019.

The firm said it still had sufficient cash resources through to the second quarter of 2021.

"We have continued to make good progress with MED3000 regulatory submissions in both Europe and the US, despite the coronavirus pandemic," said chairman John Clarke.

"Futura's board and executive team want to thank our employees for their resilience and adaptability as we have all adjusted to a virtual working environment to ensure everyone's health and safety.

"As a breakthrough treatment for ED, we remain confident that we will receive MED3000 approval as a medical device and look forward to updating the market on Futura's developments during the remainder of 2020."

At 1100 BST, shares in Futura Medical were up 0.27% at 18.3p.