Our lead product MED2005, is a breakthrough topical treatment for erectile dysfunction (ED) currently in Phase 3 clinical trials with potential peak sales of $1bn1. MED2005 is a topical glyceryl trinitrate (GTN) gel which has the potential to be a highly differentiated therapy, especially for mild to moderate ED. Thanks to our proprietary drug delivery technology platform DermaSys®, MED2005 will be a strongly differentiated and innovative product addressing unmet needs in the ED market. With a fast onset of action (5-10 minutes) and rapid clearance, MED2005 has the potential to be the fastest-acting ED treatment.
Compelling data generated in the Phase 2 clinical study has been published in the peer-reviewed Journal of Sexual Medicine in 2018. A European Phase 3 study, "FM57" is ongoing with headline data expected at the end of 2019. Our strategy is to develop MED2005 to late stage and then to license MED2005 to major pharmaceutical partners.
1 Based on external market assessments from market research conducted by Cello Heath Consulting as a prescription product and Ipsos Group as an over the counter product