1st Apr 2020 11:10
(Alliance News) - Pharmaceutical firm Futura Medical PLC on Wednesday reported a widened loss on higher development costs and added that talks with regulators over its erectile dysfunction treatment are "progressing well".
In 2019, Futura's pretax loss stretched to GBP11.1 million from GBP7.2 million. Research & development costs surged 66% to GBP10.1 million from GBP6.0 million.
The company generated nominal revenue of GBP31,778 in 2019, against none reported in 2018.
Futura is seeking regulatory approval for its MED3000 erectile dysfunction medication. A European Union filing is expected by the end of July, and "good dialogue" with the Food & Drug Administration in US means the company is confident about securing de novo approval by the end of third quarter of 2020.
The de novo regulatory pathway is used when a product is considered "novel" by the FDA, with no similar product already on the market.
Futura said that clinical data from the Phase 3 study showed MED3000 to be an "extremely effective and safe treatment" for erectile dysfunction.
Back in February, the company said over 60% of patients experienced results within 10 minutes of application.
"Overall the level of efficacy was broadly equivalent to lower doses of current oral erectile dysfunction treatments and substantially higher than placebo effects typically seen with erectile dysfunction treatments," Futura said at the time.
Focus, at least for the near-future, has shifted to the Covid-19 outbreak. Futura said it is now operating as a "virtual business".
Futura added: "We are currently not conducting any trials requiring the use of patients or healthy volunteers. All operational activities can be managed using existing internal resource combined with our extensive resource of external consultants and sub-contractors should any of our employees become ill. We therefore currently expect limited impact from Covid-19 during 2020."
Shares in the company were 2.1% lower at 8.71 pence each in London on Wednesday morning.
By Eric Cunha; [email protected]
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