Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce positive data from its pharmacokinetic (“PK”) study FM58 of MED2002, the Company’s topical gel for erectile dysfunction (“ED”). MED2002 contains glyceryl trinitrate (“GTN”) as its active ingredient.
The PK study, which commenced in November 2017, evaluated the doses of 0.2%, 0.4%, 0.6% and 0.8% GTN to assess their suitability for maximising efficacy in the treatment of ED ahead of the two Phase III studies being planned by the Company for MED2002.
Prime People Plc (“Prime People” or the “Group”), the global specialist recruitment business for professional and technical staff working in the Real Estate & Built Environment, Energy & Environmental and Technology, Digital & Data Analytics sectors, announces its unaudited interim results for the six months ended 30 September 2019.
I am pleased to report the results for Prime People Plc for the half-year ended 30 September 2019.
The Group recorded a profit before tax for the period of £1.73m (H1 2019: £1.59m) on revenue of £13.17m
(H1 2019: £12.57m).
Group revenue of £13.17m was 4.72% higher than the same period last year (H1 2019: £12.57m).
Group Net Fee Income (“NFI”) was £8.80m (H1 2019: £7.99m). Our overseas business showed strong performance, with NFI for Asia increasing to £4.83m (H1 2019: £3.87m) and contributing 57.90% of Group permanent NFI (H1 2019: 52.16%). NFI recorded during the period by our Hong Kong subsidiary, Command Recruitment Group (HK) Ltd (“CMD”), was £2.28m (H1 2019: £1.68m), detailed in Note 3(a) within the NFI for the Group’s Asia regional performance. NFI for the UK business was £3.71m (H1 2019: £3.86m) and Rest of World was £0.26m (H1 2019: £0.27m).
Contract NFI represented 5.17% of Group NFI against 7.21% in H1 2019.
Administrative costs for the Group were £7.07m (H1 2019: £6.40m) during the period which included planned expenditure for enhancing technology to drive efficiencies across our business, greater advertising spend, and higher professional costs associated with our continued focus on organic growth.
In the UK, profit before tax was £0.48m against £0.62m in H1 2019. Our Asia business, which covers the Group activities in Hong Kong and Singapore, generated a profit before tax before adjustment for minority interest of £1.24m for the period (H1 2019: £0.95m), of which £0.84m related to CMD (H1 2019: £0.58m).
Our newly established business in Germany, disclosed under Rest of the World, reported a small profit and is indicating good opportunities for growth.
The charge for Group taxation of £0.31m (H1 2019: £0.10m) is based on the expected annual effective tax rate of 19% in UK (H1 2019: 19%), 16.5% in Hong Kong (H1 2019: 16.50%), and 17% in Singapore (H1 2019: 17%).
Basic earnings per share for the period were 9.33p (H1 2019: 10.95p).
The Group continues to maintain a strong net cash position. At the start of the current financial year, the Group had cash of £2.31m, and at the period end, had cash of £3.04m (H1 2019: £1.79m).
The Board will be declaring an interim dividend of 1.80p per share (2019: 1.80p) payable on 6 December 2019 to those shareholders on the register on 22 November 2019.
The present focus for the Group is managing the business for increased productivity and profitability. Notwithstanding the mixed and uncertain economic picture of today’s markets, we continue to seek opportunities to create shareholder value though both organic and non-organic growth.
The highly encouraging results confirm that increasing the GTN dose beyond 0.2%, which was used in the successful Phase IIa study which reported top-line findings in September 2016, will result in broadly dose-related higher concentrations of GTN in the bloodstream. This supports the Company’s strong belief that the higher dose forms of MED 2002 should improve efficacy, particularly in the more severe cases of ED.
Strongly positive results were also seen in the other key objectives of the study. GTN demonstrated a rapid rate of absorption and was first detected in blood plasma in 4-5 minutes, reaching peak levels in the bloodstream within 10-12 minutes for all doses. These findings are important firstly as they underline the effectiveness of the DermaSys® transdermal technology, and also as they are consistent with a product that has shown a rapid onset of action in the Phase IIa study. This is a key differentiator to other ED products on the market as, when compared with PDE5 inhibitors such as Viagra® and Cialis® which are taken orally and do not take effect for at least 30 minutes and typically one hour or more1, MED2002 would allow far greater spontaneity between application and sexual intercourse.
In addition the study also measured the amount of GTN remaining after 5 minutes of the highest dose being applied to the penis. The study saw a rapid rate of absorption through the penis leaving a low GTN residue on the penis at 5 minutes. By applying a 0.8% dose, the study provides reassurance that there is likely to be minimal risk in transference of GTN to the sexual partner during intercourse, even at the higher doses. This finding also supports the side effect profile seen in the Phase IIa study where only four, mild side effects were seen in sexual partners out of 1,003 sexual intercourse attempts.
The PK study also demonstrated that the doses of GTN were well tolerated by the subjects. Adverse events reported were generally mild and at an acceptable level, even at the highest dose. Importantly, the incidence of headache, a known adverse event of GTN, did not increase significantly at the higher doses. This data compares favourably with the 0.2% dose where mild headaches reported previously had shown to occur in patients in less than 2% of intercourse attempts in the Phase IIa study.
Futura is pleased to confirm that it has demonstrated that the blood plasma concentrations of GTN of 0.2%, 0.4% and 0.6% fall within the plasma concentrations of the chosen US reference product, Nitrostat®, which is used to treat angina. The total amount of GTN appearing in the bloodstream was lower than Nitrostat® for 0.2%, 0.4% and broadly equivalent at 0.6%.
The Board is reviewing the implications of the detailed study data with regard to the planning of the Phase III studies for MED2002. Futura expects to make a further announcement on this shortly.
James Barder, Chief Executive of Futura Medical, said: “We are delighted to report the excellent data from our latest PK study for MED2002. The results show the effectiveness of our DermaSys® transdermal technology and demonstrate the potential of MED2002 as a rapid and safe treatment option for erectile dysfunction. We look forward to taking these excellent, supportive results into our future clinical programme.”
1. US patient information for Viagra® and Cialis®