RE: Fortacin in USA14 May 2020 17:05
Bothwell, good of him to take the time to answer, if only with the usual scripted waffle and with no relevance to the evolving US PE treatment market,
Out of pocket drug cost is everything in the US (lifestyle drugs are not covered by CMS and, if included on a health plan formularly, are top tiered). Romans and others flog monograph products and generic off-label SSRIs at low cost, no insurance hit and with minimum fuss. PE treatment acquisition cost is, de facto, now set at $3 a dose and may reduce on increasing competition. There's a crossover between consumer and professional channels in the US: monograph products such as Promescent and Pre-Boost, which needed only a few million dollars of investment to reach market, are already actively promoted to urologists.
RP's desperate gamble is that, on the strength of FDA approval, Senstend (or whatever the US name will be) can command a price high enough to leave a decent margin after DTC and professional promotion costs. Everything hangs on punters (who pick up the whole drug and consultation expense) being convinced that the premium over OTC knob sprays or cheap off-label SSRIs can be justified by it being labelled as reducing the "bother" of PE.
Point of correction, but US monograph product labelling can include treatment claims, specifically "helps in the prevention of premature ejaculation." Does anyone other than RP seriously believe that slapping "reduced bother" on the label will justify an 8 to 10-fold price premium? Just look what the absence of differentiation and comparator or post-market studies have done for European uptake and prescriber opinion. The continuing and meaningless comparison with the ED drug market is getting really old.
As to the defensive position, the PRO is copyrighted, but "validated" only in that the FDA have agreed that it can be used in a clinical study, which may or may not lead to submission of a full COA package. True, if accepted as a COA tool, it could be useful (although not essential) to a third party seeking approval for a PE treatment, but in reality provides no direct protection for Senstend/Fortacin US.
In the absence of patent protection, the product would have only three years market exclusivity on FDA approval, after which a generic version can be approved on the back of a single (say 20 volunteer) bioequivalence study, although the market, if there ever is one, is not likely to be big enough sufficient to tempt generics players.
But, nice that he's still on message when the reality is a stalled clinical study, no cash, major manufacturing problems, no sales in the most developed PE market in the world, and a disengaged marketing partner.
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