Futura Medical PLC. (LON:FUM) shares rose today as the Innovative healthcare group hailed the “excellent progress” made in the opening six months of the year as its breakthrough erectile dysfunction gel moves closer to its Phase III study.
In early afternoon trading, Futura shares were up 2.5%, or 0.75p at 30.50p.
In a statement, the AIM-listed firm said a mid-stage trial last September showed that MED2002 – as the gel is formally known – gets to work quicker than its competitors and has a favourable safety profile.
Futura’s management received “constructive feedback” from US and UK regulators earlier this year regarding the further clinical development of the MED2002 ED gel.
A pharmacokinetic study is set to get underway in the fourth quarter of this year, with the results informing a large-scale Phase III trial in the first half of 2018.
Should the gel make it through unscathed, market research firm Ipsos recently forecasted peak over-the-counter (OTC) annual sales of US$650mln.
The AIM-quoted firm is currently in commercial discussions with potential licensing partners for MED2002 and said it expects to make an announcement on this front “in due course”.
‘Potential for significant prescription sales’
“Futura made excellent progress in the first half of 2017 with MED2002, our breakthrough erectile dysfunction gel, which is moving close to its phase III programme,” said chief executive James Barder.
“This exciting programme brings the potential for significant prescription sales and the prospect of an OTC switch in the future.
CSD500 condom set to launch in a number of EU counties
Futura also has its CSD500 erectogenic condom which was launched in Saudi Arabia at the beginning of the year.
More than half a million condoms have now been sold and that figure is set to rise, with more launches in the Middle East planned for as soon as necessary regulatory approvals are received.
READ: Futura Medical says Church & Dwight intends to terminate CSD500 erectogenic condom licensing agreement
The company said the termination was “disappointing” but added that it expects to get official approval for its brand names and pack designs by the end of this month which will allow other distributors to launch the condom in a number of European countries.
READ: Futura Medical chairman says there is “significant commercial interest” in its erectile dysfunction drug
Commercialisation of pain relief portfolio on track
Futura also told investors that the commercialisation of its pain relief portfolio of drugs continues “on track”.
The UK regulatory submission for its TPR100 topical pain relief gel is scheduled to take place in the first quarter of 2018.
Thornton & Ross holds the manufacturing, marketing and distribution rights to the gel in the UK for the lifetime of the patents which currently run until 2028.
As for taking the gel outside of the UK, Futura is in licensing discussions with potential overseas partners.
Discussions are also underway with regards to Futura’s ibuprofen-based drug, TIB200.
Strong cash position, losses narrowed
For the six months ended 30 June, Futura saw revenues rise to £363,000 (£67,000). Cash resources totalled £10.2mln as of the end of the period (30 June 2016: £2.9mln).
As is often the case for a company still very much in its growth phase, Futura recorded a loss for the period of £1.6mln (H1 2016: £1.89mln).
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