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Pomander, the 38m number is described as the "maximum patient population", which looks to be derived through the old nonsense of multiplying by lifetime prevalence (giving a 25-fold overestimate of the market-defining Tx-seeking population). There's no figure given for uptake, average Rx per patient or pricing, so I have no idea of the basis for European sales of USD 232 peak sales. The point I made in my last post is, that without knowing the base assumptions and inputs, it's futile trying to connect peak sales and the figure given for the total addressable population. The 7.5% figure in the US Potential Market slide for "treatment awareness" does look to mean "treatment-seeking". Like a French kiss at a family reunion, the US revenue projection is just wrong on so many levels. Winging back to Europe, my back of envelope figures give a snapshot of the actual market (at least as numbers under drug Tx, not value). This is the arena that Fortacin enters, and with national Tx populations in the low hundreds of thousands, it's not difficult to see the gap between feasible levels of uptake and the continued RP fantasy. As to expert input, again, without transparency around base assumptions and inputs, it's not possible to assess their competence. However, anyone that believes that you can use lifetime prevalence as the basis for a bottom-up model deserves a hard smack. The only thing I'm aware of close to an "independent" analysis is that made by Recordati, with their toppy but not outrageous Euro 20-25m peak estimate. The deal terms certainly reflect this view of potential. With respect to market dynamics, there's nothing in PE treatment-seeking (or across other conditions) that suggests that a patient-perceived lack of acceptable treatment options is a barrier. The 25-30% of PE patients that do not opt for medication either select behavioural or other non-med treatments, although about half refuse any form of Tx on the basis that it "medicalises" their condition. Psychotherapists have written reams on this. Fortacin certainly appears to be more patient-friendly than EMLA or gel formulations and, even with the constraint of out-of-pocket cost, should displace first line off-label topical Rx to some extent and certainly benefit from the high discontinuation rate associated with oral meds. However, beyond adverse events and meh efficacy, reasons for discontinuation of PE meds are complex, and until there are long term real life usage numbers available, the safety shot is to assume that new Rx will be balanced by discontinuation to give a steady state Tx population. You need to look at my model discontinuation rates again: they are actually 100% better than for SSRIs (might be overoptimistic, but I was interested in seeing the impact on sales).

Gents, In the absence of definition around the PLE/RP numbers, probably fruitless to try and reconcile patient and peak sales estimates. To repeat a point I've made before, sales projections are based on the total accessible market (Tx seekers), not the total addressable population (all men with PE). Allowing for differences in study methodology, % seeking Tx is pretty consistent across Europe at 10% or less of men who are bothered by their PE, as is the % opting for any form of drug treatment. I've posted estimates for the German and Italian populations (since I had reliable public domain and proprietary data to hand), but for back of envelope purposes, including other countries, take the age stratified male population (18-64 years) and multiply by 0.007 to give you a Tx (pharmacotherapy) estimate (1% of the male population are PE Tx seeking, with 0.7% on any PE medication). Disclosed wholesale (rounded up) pricing ranges from Euro 40 (Italy) to Euro 50 (Germany, France). Actual pricing is way lower than the PLE/RP estimate. Net return to Recordati will of course be lower than the wholesale price. The key variables are % uptake (as either first or second line therapy); discontinuation rate, and time between Rx. Again, you can find reliable comparators in the literature. I've taken a peak uptake of 15% (a 50% switch out for off-label topicals), a discontinuation rate of 50% at six months, 30% at nine months and 20% at 12 months (which is around half of that for SSRIs, and I'm ignoring the impact of lack of chronic dosing information) and coverage of two month and three months per scrip. Simple sensitivity analysis will show you how important adherence and time between Rx are to sales.

Heh, at least you were able to see the ball.... Larger batch size is to reduce transfer price in the longer term (and production scale-up won't commence until grant of variation, although, if RP are to be believed, this should be due anytime now). The current batch size is more than adequate to cover sampling requirements. The PR of the 14th Feb references launch as "by way of first sales" to wholesellers, although the next para starts "following the first commercial sale".....milestones will be due". Might just be JG's wording, but I still think it more likely that transfer was on a fee for service (pre-wholesale) basis and that commercial launch has still to be triggered by a commercial supply order. Should be clearer next week since, if first commercial supply was 9th Feb, milestone should be due within 30 days. Still no sign of promotional activity (or even listing) by the French, German or Portuguese subsidiaries, although Fortacin gets mentioned by several national pharma and health-focused news sites.

Pomander, you're reading too much into my post. An expectation of a near-term, lump payment of country-specific milestones has been mooted: my counter is that, for a new product with no convenient benchmark nor the comfort of guaranteed cash flow from healthcare reimbursement, wholesalers may hesitate before purchasing commercial quantities. Given that launch responsibilities have been devolved to each subsidiary (which appear to be in very different states of readiness) and that sampling has only just begun or is about to commence, it's possible that country-specific milestones will be triggered over a period of several months. As for the ISSM, I'm sure that Dr W took the opportunity to enjoy four days in balmy Lisbon (relative to the UK, anyway). His co-author is an academic urologist and Dr W may have elected not to represent neither RP or PLE to give the presentations the sheen of learned analysis, rather than obvious infomercial. Not that I have anything against blatant promotion at conference. But, if presenting as an individual/co-author, it's possible that JG might be unaware until he gets the expenses claim.

Certainly not disagreeing with your opinion of JG, but there may be no announcement to be made (yet). "Commercial launch" within a licence agreement is usually defined as on receipt of payment from the end user, occasionally defined as "supply to end user", the end user being a wholesaler. Since wholesalers actually purchase the drug (and manage cash flow between retail pharmacy and third-party payers), they generally will not shell out on a new drug at launch unless confident of supporting Rx volumes. It's more common to have a "pre-wholesale" agreement, where the pre-wholesaler manages sampling logistics and perhaps local labelling and packaging. Wholesaler orders, and the milestone triggers, could be weeks or months away. As for the ISSM, the good Dr W's presentations are two five minute podium session slots tomorrow, both revisits of old study data (abstracts 138 and 139, available on the ISSM website). He's registered as representing "GPC Ltd", his service company, and not RP or PLE, so JG might not even be aware that he's in Portugal.

French pricing in line with other disclosed wholesale pricing at Euro 49. Not stated for Spain and Portugal, might be waiting acknowledgement from AEMPS for former, latter will vary depending on wholesaler and pharmacy mark ups. While the launch was always going to be a franchise level, I'm surprised at the lack of co-ordination among the national subsidiaries, with no online presence other than in Italy, and listing so far confined to the Spanish subsidiary which also offers a rather spiffy prescriber monograph. There may be active mailshot and boots on the ground promotion (and it's still early days) but all a bit old skool.

Sounds like Dr W was paraphrasing- you can only offer "free supply" of an investigational agent in the context of a clinical study (the open label study protocol and results are easy enough to find on line). But, even for paid subjects, the drop-out rate is low, particularly as these guys (and their partners) were still doing the old stopwatch thing and keeping study diaries for nine months. As a benchmark, when reviewing study plans for project valuations, I look for accommodation of a minimum 15% attrition rate (historical dropout rate can be double this some indications). Interesting to see what the real life discontinuation rate looks like.

That's not actually the case. The European Phase III comprised a 3 month double-blind placebo-controlled study, followed by an open label study, where the participants in the initial study (regardless of whether they had previously received drug or placebo) were invited to continue or commence drug treatment for a further five months. Subjects were paid for their continued participation, so I'd be caution about mistaking avarice for enthusiasm. That said, open label participation was 265 out of 275 subjects, which is a very low drop out rate, with around 250 or so staying the course. At the end of study, all drugs would have been collected by the study team (and broached canisters weighed) to ensure compliance with protocol.

I have a strong suspicion that Recordati are drawing from the same sources as me. After all, several of their PE advisors have authored studies on epidemiology and treatment-seeking behaviour (mainly on behalf of Menarini). As for Dr Mike and PLE/RP in general, hard to tell where they get there numbers from since they've never bothered to show the workings for their sums....no extra marks for you, my lads.... Your point about "the past" is a good one, and it would be nonsensical to take Viagra or dapoxetine market development as established precedent. At the same time, it's improbable that the factors that influence drug market development in general (pricing, real world efficacy and usage data, prescriber characteristics) will not impact on Fortacin uptake to a greater or lesser extent. And while it's always fun to volunteer and debate numbers, we're probably two, possibly three, years away from being able to claim bragging rights over who made the right call on Fortacin.

Pomander, My bad- Germany is 256,000 under Tx. And the "lifetime prevalence" error is PLE's and goes way back to before Kevin and his mates at MME were engaged (their exercise was pricing and price sensitivity only). The 256,000 and 141,000 figures are for the total treatment population, of which only a % will receive Fortacin or another topical. Let's be bullish and assume that the discontinuation rate is substantially less than oral meds, to give 6, 9, and 12 month retention of 50%, 30% and 20%. A 15% market share (at current wholesale pricing) would be Euro 7.5 m and Euro 3.3 m Italy (RP royalty is 15%: Euro 1.62 m). I confess to using proprietary prescribing/urology workload data to give 15% uptake (broadly, a third of PE patients opt for no drug treatment, another third have co-morbid ED, leaving around a third for PE pharmacotherapy. I've bullishly split this between oral meds and Fortacin). Eight years to peak for a non-reimbursed medication, particularly with such a small initial Tx population is probably too optimistic. PE treatment seeking behaviour has been studied to death, and there's nothing to indicate that a perceived lack of treatment options is responsible for the low presentation rate. Reasons for discontinuation are also well understood, with, in order, low efficacy, need for chronic use, pricing and side effects the main reasons. Fortacin shares the same faults, but pricing is moderate enough to believe that it's likely to get a share of second-line Rx. As to "dodgy sprays", perhaps partly true in the context of self-treatment, but off-label Rx topicals are regulated products (generic or branded EMLA, lidocaine gel, benzocaine spray and gels). Even good old STUD 100 is manufactured under GMP (and, like other medications, has to have a kosher product licence).

Recordati release from last week, on corporate site but Italian only. http://www.recordati.com/resources/Pubblicazione/___eefcd96f0dda4d30a97824fc82fd4ebf_/comunicato-stampa-fortacin.pdf

Pomander, Your addressable market estimate propagates the PLE/RP error of being based on lifetime prevalence ("have you ever suffered from PE"?) and prevalence ("do you suffer from PE"?). Sales forecasts are based on accessible market (in this case, the % PE treatment seekers receiving pharmacotherapy). There is reliable high-quality/high-resolution epidemiologcal data available for Germany and Italy, not so much for the other core countries. The % of men that admit to being bothered by their PE is 14.5% and 11.3% (higher in younger men, lower in older men) for Germany and Italy, respectively, or 3.67m and 2m individuals. While these might seem decent sized pools to fish in, only 10% of "bothered" men actually seek treatment, and of these, around 70% end up with some form of drug treatment. That's less than 230,000 men in Germany and around 141,000 in Italy. Estimating market share is unashamedly guesswork. Topicals make up 10-20% of first line prescribing and Fortacin is likely to displace off-label products to some extent. It's no better (or worse) than other PE treatments and as you rightly say, given the high discontinuation rate for oral meds, it should also pick up a share of second line prescribing. If I was knocking up an estimate for a client, I'd anchor my sensitivity analysis at around a 15% peak uptake, 8 full years to peak. The obvious wild cards are ramp up (not reimbursed, so promotion sensitive and historically slow and no comparator study data to draw from), price sensitivity, time between scripts (will "not less than 12 doses" translate to two or three months usage?), and retention rates. The last two have a profound impact on return. On the plus side, Fortacin, as the first approved PE treatment to hit the European market in almost a decade might get some attention on novelty value alone and, in the longer term, should be safe from direct Rx competion. Wholesale prices are Euro 49.94 and Euro 39.40 in Germany and Italy, respectively, should you want to play around with your own sales projections. As to a "lifestyle" market, with the tight restrictions around DTC promotion in Europe, no internet prescribing permitted in the core territories, and a very narrow, predominantly secondary care prescriber base, what's the rationale for anticipated Rx expansion?

Prof Z. There was a low-key clinician-focused launch event in Milan yesterday, with opinion from a couple of tame experts, some coverage in the pharma-orientated news and health pages. Easy enough to find online.

Prego.

Italian only website now live, consumer-orientated "infomercial" (as per EU law, cannot state trade names), with secure registration for interested healthcare professionals (Italy only). Professional-only websites not yet active. https://ep-eiaculazioneprecoce.it

If you can stand the tedium of trawling my old posts, I did opt for Germany and/or Italy, on the basis of field force presence and potential prescriber base, and I still see these as being the main focus for promotional efforts. Musing on the shotgun launch, I think the rationale is that, since topicals are already in use in PE treatment and there's no mystery around the mechanism of action, why not see if you can displace off-label topicals with a specifically indicated product and go for early traction. Italian and German out of pocket costs are high but not outrageous. Urologists get very few new medicines to play with, so the curiosity factor might help drive some early volume. On the other hand, oral med prescribing is heavily entrenched and more data will be needed to drive conversion and market expansion, but this might not particularly bother Recordati, Agreed, prescribing delay should have no impact on the anticipated rise in share price (and Lord knows, you remaining shareholders have waited long enough). I wouldn't get all unnecessary over prescription volume. The vast majority of prescribers will not even know that Fortacin is available in their country until Recordati kicks off its promotional efforts (non-reimbursed product, so no national or regional health system heads-up) and overall PE prescribing volumes are minute, dictating a slow ramp up for any new product. I'd sit back and ignore the first year numbers: it might be two to three years before Recordati can tell which way the wind is blowing.

Pomander, be fair...I did say it would be Italy first..... I did notice yesterday that the Fortacin entry had been updated on the German and Spanish national registries, with 15th given as "commercial availability". French and Portuguese registries are less forthcoming on non-reimbursed products. German wholesale pricing is Euro 49.98, more or less the same out of pocket cost as Italy once you add in pharmacy and wholesale markups and VAT. Spanish price not listed. No corresponding announcement from Recordati, nor are any of the healthcare professional only resources online active, so I'm guessing that they will hold off with a release until the ISSM conference. And without wishing to micturate on anyone's French fries, delivery to wholesalers does not mean immediate prescribing so expect a lag until Recordati's promotion efforts kick in. The RP release appears to confuse availability with sales- you don't "sell" to wholesalers, they distribute and process invoicing on your behalf (and charge for the privilege). "Commercial sale", and the milestone trigger, is usually on supply (or invoicing) by the wholesaler to the end user (retail pharmacy).

Hah, never write and conduct a phone conversation at the same time...edited out the repeats. A perspective. The Recordati presentation was intended to reassure institutional investors and analysts, several of which have understandable doubts around the potential of the two most recently acquired franchises, along with concerns over the rate of generic erosion. Yesterday's message had to be "steady as she goes", albeit at a modest pace, with emphasis on the key franchises. I'd have expected more on the imminent Reagila launch, and was surprised that they buried projected revenue in the total 2018 estimate. True, the pipeline has got a mention in past revenue estimate presentations but since none of these, including Fortacin, will have any material impact on 2018 earnings, why have the distraction of extra slides? As to the March launch of Fortacin, this never been corroborated by Recordati, with the only tangible evidence being its current availability and pricing in Italy. Recordati operates through largely autonomous subsidiaries in the larger European markets, all with different degree of engagement in the urology franchise (and different blue box and national registry requirements). For a product with no professional awareness or as yet compliant and authoritative support through prescriber-orientated websites, a home turf pilot launch makes sense, with a country by country roll-out when and if justified by prescriber interest and scrip volume. However, with a nominal three weeks to go, it's still possible that Fortacin could still pop up on other national formularies and disprove my current "Italy first" view.

A perspective. The Recordati presentation was intended to reassure institutional investors and analysts, several of which have understandable doubts around the potential of the two most recently acquired franchises, along with concerns over the rate of generic erosion. Yesterday's message had to be "steady as she goes", albeit at a modest pace, with emphasis on the key franchises. I'd have expected more on the imminent Reagila launch, and was surprised that they buried projected revenue in the total 2018 estimate. True, the pipeline has got a mention in past revenue estimate presentations but since none of these, including Fortacin, will have any material impact on 2018 earnings, why have the distraction of extra slides? As to the March launch of Fortacin, this never been corroborated by Recordati, with the only tangible evidence being its current availability and pricing in Italy. Recordati operates through largely autonomous subsidiaries in the larger European markets, all with different degree of engagement in the urology franchise (and specific blue box and national registration requirement). As to the March launch of Fortacin, this never been corroborated by Recordati, with the only tangible evidence being its availability and pricing in Italy. Recordati operates through largely autonomous subsidiaries in the larger European markets, all with different degree of engagement in the urology franchise (and different blue box and national registry requirements). For a product with no professional awareness or as yet compliant and authoritative support through prescriber-orientated websites, a home turf pilot launch makes sense, with a country by country roll-out when and if justified by prescriber interest and scrip volume. However, with a nominal three weeks to go, it's still possible that Fortacin could still pop up on other national formularies and disprove my current "Italy first" view.

Pomander, The good Prof's enthusiasm is certainly remarkable, given that he's probably never seen a tin of Fortacin, let alone treated anyone. And it's only taken him eight years to appreciate the benefits. KOLS....bless 'em.... Fortacin roll out might get a mention during the Recordati financial call this afternoon, although national registration/availability still appears to be confined to Italy.