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Futura Medical plc.: THE INVESTMENT CASE

Most doctors think Futura’s erectile dysfunction gel is an improvement on Viagra and Cialis

“We are delighted by the results of this new survey, which not only reinforce the potential of MED2002 identified in our two earlier surveys but provide some important additional insights”
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INVESTMENT OVERVIEW: FUM The Big Picture
A total of 200 doctors from the US, Germany and France took part in the research

Futura Medical PLC (LON:FUM) jumped on Monday after it told investors that the majority of physicians in the US think its erectile dysfunction gel is an improvement over current ED therapies.

The innovative healthcare group said the latest market research data found that 60% of doctors think MED2002 is a better treatment than the likes of Viagra and Cialis.

READ: Futura hails “excellent progress” in first half as erectile dysfunction gel moves closer to Phase III trial

The market research, carried out by Cello Health Consulting, also revealed that at least 10% of ED patients were contra-indicated – i.e. can’t be treated with – PDE5 inhibitors such as Viagra because of their existing medication. That’s higher than the 7.5% Futura believed it to be based on past research.

A total of 200 doctors – who have all been in general practice for at least five years and treated a minimum of 15 ED patients a month – took part in the survey.

Of those who took part, 64% of doctors in the US, 60% in Germany and 54% in France considered that MED2002 is an improvement over current therapies.

Futura added that the survey shows that its novel gel could capture between a quarter and a third of the current US market.

WATCH: Futura Medical pushing ahead with further CSD500 condom launches

MED2002’s rapid speed of onset (usually within five minutes) and the “spontaneity associated with the product” were given by doctors as key reasons for expected patient use.

“We are delighted by the results of this new survey, which not only reinforce the potential of MED2002 identified in our two earlier surveys but provide some important additional insights,” said chief executive James Barder.

“In particular, the number of ED patients contra-indicated to PDE5 inhibitors because of their existing nitrate medication is potentially much greater than we had previously thought.”

Phase III trial set for H1 2018

A mid-stage trial this time last year 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

Futura was dealt a blow by one its licensing partners, Church & Dwight Co Inc (NYSE:CHD), in August after it terminated its licensing agreement for CSD500 following a strange of strategy.

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.

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).

Shares jumped 6.6% in early deals to 25.1p.

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