A safe and innovative topical treatment for erectile dysfunction

MED2002 is a topical gel applied directly to the penis for the treatment of male erectile dysfunction ("ED"). MED2002's active compound is Glyceryl Trinitrate ("GTN") which is delivered using our patented transdermal delivery system, DermaSys®. GTN is a potent vasodilator which has been used for the treatment of angina for over 100 years. It is a safe and effective drug with a known side-effects profile.

MED2002 is applied to the glans area of the penis. DermaSys®, our skin delivery technology, enables the active dose to be delivered effectively and rapidly through the skin. This targeted local application translates into a fast onset of efficacy but with a low systemic uptake which limits side effects. This is a less invasive method of application compared with other local treatments and is consistent with sexual foreplay.

How MED2002 works

The GTN in MED2002 is absorbed into the penile blood system and is converted to nitric oxide, which has the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, a natural erection occurs.

Clinical trial programme under way

A pivotal clinical efficacy study is in progress and expected to provide headline data in Q3 2016. The primary outcome of this clinical trial in 192 patients with ED, which is a randomised, placebo-controlled, double blind, home use, crossover study, is to demonstrate statistically significant efficacy. Both David Ralph, current President of the European Society for Sexual Medicine, and Ian Eardley, past President and recognised key opinion leader in erectile dysfunction, have advised the Company on the development of MED2002.

Market opportunity

We have conducted external market research to understand the potential opportunity that MED2002 represents as both a prescription and non-prescription treatment for erectile dysfunction in order to optimise the commercial opportunity. This market research highlighted the potential benefits of MED2002 when compared with PDE5 inhibitors.

The potential benefits of MED2002 were shown to include: a faster onset of action, a favourable safety profile and the product's suitability for all men, including the estimated 7.5% of ED sufferers who would not be prescribed any of the PDE5 inhibitors due to contraindications with other medications taken by them. The research found that up to 68% of men are dissatisfied with their PDE5 inhibitors and that MED2002 could potentially capture as much as a 30% share of ED patients.

Commercialisation

We have out-licensed exclusive rights to Quantum Pharma plc for the manufacture and supply of MED2002 as an unlicensed medicine ("Special") in the UK. Quantum is the leading manufacturer and supplier of Specials to retail pharmacies and wholesalers in the UK. In return, Futura will receive undisclosed royalty payments from Quantum on the sale of the product.

Specials are medicines that have not been authorised and which are requested and prescribed for treatment on a named patient basis only, by appropriately qualified doctors under their own authority. Such requests can only be made subject to a number of conditions being met, including the absence of licensed alternatives.

MED2002 meets the UK regulatory criteria for a Special because of the estimated 7.5% of erectile dysfunction sufferers who cannot be prescribed PDE5 inhibitors, such as Viagra®, owing to contraindications with other medicines they take.