RE: master investo19 Mar 2018 12:20
I will do my best to transcribe the wall slides which may assist further and address any ambiguity (or maybe introduce some more!). This is obviously all public information and non-sensitive, available for all to see on the wall of the stand at Master Investor. Some words may get censored below due to their nature.
Slide 1
Fortacin (tm)
Plethora's lead asset is Fortacin (tm), a novel Rx topical treatment for premature ejaculation, with potential to capture a global market
Focus is on bringing Fortacin to market through strategic commercial partners
Marketing approval obtained from the European Medicines Agency (EMA) in November 2013
Fortacin is out-licensed to Recordati (REC IM) for Europe, Russia, CIS, Turkey and certain countries of North Africa
Fortacin is now available by way of prescription in Europe through our commercial partner Recordati
NDA filing process commenced with FDA, with approval targeted in Q4'19
Slide 2
Premature Ejaculation
"A male sexual dysfunction" characterized by ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration, the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy."
Primary Efficacy Measure Intravaginal Ejaculatory Time (IELT):
Normal 4-7 minutes. ISSM definition of PE < 1 minute
Premature ejaculation is possibly the most prevalent sexual dysfunction affecting 1 in 4 men:
Estimated to be greater than erectile dysfunction
Estimated at 30-45m men in EU and 50m in USA
No properly effective treatment is approved widely for this condition
Off-label use of antidepressants, topical anaesthetic creams, monograph
Priligy (SSRi) associated with 90% discontinuation; only approved in limited EU territories
Slide 3
Therapeutic:
Topical aerosol formulation of Lidocaine 7.5mg + Prilocaine 2.5mg
Restores ejaculatory reflex from 32-34 seconds pre-treatment to 3-4 minutes (normal) almost immediately and effects are maintained on long term treatment
Commercialisation:
Out licenced Fortacin to Recordati, a European pharmaceutical group, to commercialise Fortacin in Europe, Russia, CIS, Turkey and certain countries of North Africa
Fortacin is now on sale by way of prescription in Europe through our commercial partner Recordati
Regulatory:
EMA approval received in November 2013 - the first topical Rx apprived in the EU for PE
USA FDA filing process commenced with aim of submitting NDA during Q1/2 '19, followed by 10 month PDUFA with approval expected in Q4'19
Market Potential
Potential significant market opportunity of up to US$3 billion per annum peak sales for US and EU (based on internal modelling), Rx only
Currently the only approved competitor in Europe is Priligy - SSRi, with significant profile disadvantages as compared to Fortacin
Mo