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.
Successful clinical efficacy trial completed
A clinical efficacy study was completed in September 2016. The study met its primary endpoint and MED2002 showed efficacy, safety and speed of onset.
The study comprised a total of 232 randomised males and it measured, as its primary endpoint, improvement in the erectile function ("EF") domain score of the International Index of Erectile Function ("IIEF"), the scoring system used for the approval of PDE5 inhibitors. The study, which used a single dosage of 0.2% w/w of glyceryl trinitrate in a gel, was of a placebo-controlled, double blind, home use, crossover design.
The study which included mild, moderate and severe ED patients, achieved its primary endpoint in demonstrating a statistically significant improvement in erectile function (p-value = < 0.0132) in the EF domain score, averaged across the entire patient set, when using MED2002 compared with placebo. The results were highly statistically significant for the mild patient sub-group.
The sub-analysis has also showed statistically significant results in the mild to moderate group and also suggests that an increased strength dose, 0.4% w/w of glyceryl trinitrate, may increase the gel's efficacy especially in the moderate and severe ED patient groups. The speed of onset of action of MED2002 was rapid, with 93% of responders1 having an onset of action within 10 minutes and 57% within 5 minutes, offering the potential for MED2002 to be the world's fastest-acting treatment for ED.
The side effects profile was very favourable with no serious adverse events or serious adverse reactions recorded and no drop-outs from the study owing to side-effects.
The study results give us great confidence in the future development of the product. Professor David Ralph (former President of the European Society for Sexual Medicine) stated "The positive data from this study provides an exciting new innovation with the potential to be a first line therapy in erectile dysfunction. MED2002 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product. MED2002, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients."
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 as a prescription product were shown to include: a faster onset of action, a favourable safety profile and the product's suitability for all men, including 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.
With a superior speed of onset and a compelling safety profile our external market assessment forecasts that MED2002 as a first line therapy could achieve peak annual sales in excess of US$550 million. In addition, MED2002 has the potential to switch to over the counter. The market research firm Ipsos used its validated healthcare forecasting model to forecast peak OTC annual sales for MED2002 in key countries worldwide of more than US$650 million. Importantly, Ipsos forecasts that 73% of these potential OTC sales would be incremental to the prescription category. The key findings of the market research showed that the respondents believed that the product, once approved, would be highly differentiated from existing products. MED2002's rapid onset of action and favourable safety profile were the key features that attracted respondents to the product.
Commercialisation and development completion
We have appointed advisers to assist in the out-licensing process of MED2002 and are encouraged by the high level of commercial interest from potential licensing partners. In parallel to our commercial out-licensing discussions and following the recent successful fundraising we are finalising the development and regulatory strategy for MED2002. This will involve:
- Consultations with the relevant regulatory authorities in both USA and EU to confirm the requirements for marketing authorisation
- Completion of the remaining Phase III clinical programme
- Completion of manufacturing scale up and stability in final packaging
- Completion of any remaining safety studies.
2017 2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 EU & USA REGULATORY MEETINGS PHASE III EFFICACY STUDY PHARMACOKINETIC SAFETY STUDY FINAL MANUFACTURING SCALE UP ONGOING MED2002 STABILITY EU & USA REGULATORY SUBMISSIONS
We have previously 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. It is intended that MED2002 will remain available as a special until it gains marketing authorisation in the UK.
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 it offers a treatment option to erectile dysfunction sufferers who cannot be prescribed PDE5 inhibitors, such as Viagra®, owing to contraindications with other medicines they take.
1Patients diagnosed as suffering from mild or mild to moderate erectile dysfunction in the clinical efficacy trial