Member Info for Alquemie

Hah, second para should read "spurred". Not suggesting for a moment that cat impersonations were involved, although that would be far more entertaining than most academic exchanges of view.

Pomander, This is the puff piece I referenced earlier (the advantage of a commissioned article being that you can reference the trade name with abandon, rather than being obliged to use the generic designation). Herr Prof Dr Porst has certainly earned his corn from Menarini as an enthusiastic exponent of dapoxetine (to the extent that, most unusually, his alleged lack of balance purred a published contretemps with another KOL). I'm sure that he's delighted to be waving the flag for Recordati. Am I right in thinking your other post cites the Recordati resuls telecon (back end 2016)? There's no detail around the Euro 20-30m peak sales estimate, so can't comment. Recordati did downgrade their estimate around mid-2017 due to the impact of having to roll with the 12 dose presentation. My interpretation with respect to the CNS reference is that she's saying that the difference in side effect profile over "Triligin" (= "Priligy") might offer an advantage. True, side effects from dapoxetine and off-label SSRIs certainly contribute to treatment discontinuation, although low efficacy, the necessity for chronic use and cost are consistently cited as the major reasons for abandonment. Fortacin shares two of the same defects, but lower pricing (relative to dapoxetine) could conceivably translate to better adherence. The difference between the Recordati and PLE/RP estimate is down to the latter's repeated schoolboy howlerish use of lifetime prevalence in their bottom-up calculation and not Tx-seeking or even self-reported concern over PE as inputs. All the more unfathomable seeing that there's no shortage of good quality, peer-reviewed community survey data to estimate Tx seeking or even the % under Tx, although with less consistent definition around specific Tx use, other than that the choice of first-line Tx varies between countries.

Pomander, Nothing against Dr Mike, only that, as is usual with product originator/licensor companies, there's generally very little they can contribute to marketing and promotion, particularly where there is no clinical data or experience to communicate. Potential prescribers don't give a flying one as to how drugs are made or approved. Apologies, but you've lost me with your comment on licensing- what part of the equation do you see as being missing? And what's "the dapoxetine effect"? Since the full royalty bearing term of the agreement runs until after the end of exclusivity, it's fair to say that Recordati are not obviously concerned. It is usual to hedge against generic entry in agreements where IP or exclusivity expires before term end, by either a proportional reduction in royalty based on the number of generic entrants, or on generic market share, so while there's an outside chance of royalty reduction after 2023, I see this as unlikely.

Pomander, With the transfer of the MA, Fortacin in now, de facto, a Recordati product, and other than picking up the bill for the development work and variation submission for the larger batch size, RP's involvement is at an end. As is usual following transfer, Recordati has no obligation to share anything with RP, other than sales data. And while I'm sure that the good Dr Mike gives an entertaining after dinner speech, he's neither prescriber or KOL and can add nothing to the promotional effort. Personal view, but if this was my campaign, last thing I'd want is a speaker reminding the world that the last clinical study was completed nine years ago and that no data had been generated during the wilderness years. Neither Dr Mike or PLE get an acknowledgement (or even a mention) in the commissioned Italian journal article. Recordati's annual pin the tale on the finance donkey presentation is next Thursday (8th), so perhaps there will finally be corroboration of RP's repeated shrill claims of a "March launch", although tangible evidence points towards a single country launch or a slo-mo' core territory roll-out. We've discussed where Fortacin might sit among dapoxetine and other treatments before. Fortacin in no better, nor worse than available PE treatments and until head to head or real life usage data is available, uptake will not be driven by "superiority" claims. On reflection, I think Recordati has probably got the pricing right at Euro 39.40, while being more than the minimum out of pocket cost to try dapoxetine, it's close to half the cost of a two month dapoxetine supply. I haven't checked but it's probably reasonably competitive with off-label PDE5s and SSRIs. It's accurate to say that Menarini's consumer-orientated campaign only served to displace off-label treatments, not expand the addressable population (that's the population on any form of pharmacotherapy, not the nonsensical 25-fold RP overestimate). Recordati's initial drive will be, by necessity to build professional awareness, part field force driven but with a parallel digital element. I seem to recall Menarini running ads in some of the pharma trade journals, so there might be the odd woodpulp Fortacin ad. Recordati have paid less to own Fortacin than they did for a couple of OTC laxatives (French market only) last year. They can delay or dump Fortacin tomorrow and it will have no effect on the share price or 2018 revenue estimate. It is, and always has been, a low-cost add-in to an existing (declining) franchise, as was Vitaros/Virirec (which, five years after licensing is still tripping around the Euro 1m mark). Exclusivity only matters if you have competition on your tail, not something that features in the PE treatment landscape. And while Fortacin is as low-tech as it gets and easy enough to bang out, any generic entrant would need to brand and promote, not something that's in their business model.

Pomander, I sincerely doubt that RP has much of a clue as to Recordati's activities or intentions, let alone influence. As to manufacturing logistics, bear in mind that the initial requirement is only for sampling, with mandatory limits on the quantity and frequency of sampling, with promotion directed at the modest (secondary care) existing prescriber base, so an initial single 100l batch is more than adequate. Since the small batch cost is relatively high and Fortacin has a short shelf life, it's unlikely that Recordati will have commissioned more than is needed. A limited launch makes sense for a product for which there is no professional awareness (the commissioned article at the turn of the year was the first to link the Fortacin brand name with the historical PSD 502 study data) or post-approval "real use" data with which to gauge positioning and likely acceptance. There's no pressure on Recordati to build Fortacin, so a local roll-out to test the appetite, followed by marketing in selected European territories where a higher unit cost might be acceptable is a sensible low-cost way to go. I'm the first to admit that my view is coloured by my own experience of European product launches, and I'm keeping an open mind as to other scenarios and will continue to sniff for signs of ex-Italian registration.

Assuming that launch is only a month away, it's still remarkably quiet on the Western Front. I won't bore you with national "blue box" requirements, but so far, Fortacin is only registered in Italy, at a wholesale price of Euro 39.40 (5ml presentation). As expected, it's a Class C (non-reimbursed) product. Pricing struck me as low, but once you add in wholesaler and retail pharmacy mark-ups (the latter is not capped for Class C products), VAT and the Euro 36 co-payment for consultation, the out of pocket cost is close to Euro 100. On a dose for dose basis, pricing is roughly half of that of dapoxetine. Neither of the health professional only websites are yet live and the only obvious promotion is a puff piece (paid for by Recordati) in one of the minor Italian urology journals and credited to two of the speakers at last year's European Urology Association conference. In keeping with Recordati's historical treatment of in-licensed products, all mention of Plethora has, Beria-like, been airbrushed from the article. I still expect a launch announcement to be made at the ISSM next month, but I'm now leaning more towards initial marketing being confined to a pilot launch in Italy, with possibly a second territory (most likely Germany) being added in the autumn. Italy makes sense in that Recordati have a home advantage with respect to field force and Menarini have helped create a more aware PE prescriber base than in most other countries (although off-label prescribing is dominant). I'll keep checking the various national registries, but right now, available evidence points to an initial modest roll out.

Pomander, apologies for not responding, but a zombie client suddenly sprung back to (quasi-) life, arms outstretched on the sniff of investment, although, more likely, it's back to the grave by sunup Monday. But as long as they are covering my hours.... First, the PEBEQ is not necessarily flawed, only that the FDA does not currently agree that it's suited to measure subjective endpoints in the context of a pivotal study, almost certainly because there's insufficient background data to support utility. As to impact, further delay is inevitable, if not a complete impasse. In theory, RP could crack on without agreement on the PRO and hope for mercy from an AdCom, but history suggests that this is what might be termed the "Lord Cardigan Gambit". Au contraire, but placing the PEBEQ in the public domain makes good sense in that, through curiosity if nothing else, it could attract academic interest, which in turn would assist in building a case for its eventual (re)consideration as a study PRO. Normally, release of a new PRO instrument would be through peer reviewed publication: "web sales", without a sniff of supporting data, is a very strange way to go, even at only $5 per instruction sheet. You make a good point regarding "over-engineering", and, having been through it with other products (migraine, IBS, medical foods), I couldn't agree more that there is an infuriating disconnect between demonstrated product efficacy/safety and what's demanded in support of simple label claim. But, as a wise man once said, there are two things certain in this world: death, and the FDA effing up your day. Trademarks are easy (dozens of dedicated search engines). PLE, (not Recordati, the trademark owner) tried to register Fortacin in the US but failed to respond in sufficient time to complete the process, hence the less than memorable "SENSTEND".

Pomander, the 008 protocol is the pivotal study protocol already agreed with the FDA and hinges on successful clinical validation of the PEBEQ. A point of clarification, but the FDA (or other regulators) do not oversee PRO or screening questionnaire contents, but only consider their appropriateness when used to support product labelling claims. Circling back to my original point, why bother quietly promoting a PRO to a narrow audience of academic PE researchers before clinical validation has been undertaken? Researchers are already spoiled for choice, with a multitude of long-established screening questionnaires and PROs available for the purposes of patient stratification or treatment comparison. Prescribers don't use PROs, as perception of treatment benefit is, de facto, subjective: moreover, assessment is not reimbursed. If the rationale is to raise general awareness in the US, why not simply announce material progress with the PEBEQ (and the consequent green light for US study initiation ) through a press release for maximum benefit? And agreed, the trademark related activities are of no significance, simply part of process. Incidentally, the registered ex-Recordati territory trademark is "SENSTEND", apparently devised by Dr W while waiting at an East Anglian airport.

Pomander, the content is very strange indeed if the purpose is simply to generate awareness. The PEBEQ is the proposed PRO instrument to be used under the 008 protocol (with the first part of the study being clinical validation of the PEBEQ). The wording in the RP presentation refers to past pivotal studies, which used an "off the shelf" PRO (developed by Pfizer) for subjective endpoint determination. The reported outcomes certainly did show statistically significant improvement in all subjective endpoints over placebo. Good enough for the EMA, but the FDA have never accepted the Pfizer-developed PRO (or any other established PE PRO) as being robust enough to support the desired label claims. Timeline has simply never been updated to reflect the delay (and probably uncertain start) of US studies, and I'd put it down to sloppiness rather than deliberate misrepresentation.

With the distraction of the festive season you may have missed PLE's launch of PEBEQ.com in December (https://www.pebeq.com). The purpose appears to be be to flog copies of the proposed PRO instrument to US prescribers and researchers, although the content is strangely muddled and incomplete for a website aimed at professionals. It states that "PEBEQ is the first validated premature ejaculation test to be developed in the United States and follow the FDA guidelines", although, tellingly, there's no reference to, or description of, validation methodology or data, while the cited "guidelines" are general to product labelling claims (and not in any way specific to PE). The only fathomable reason for this is that the FDA does not agree that there's insufficient evidence to support the use of the PEBEQ in the pivotal study and that PLE is hoping to drum up professional interest in the PEBQ to assist in convincing the FDA of its validity. It's approaching two years since PLE submitted the PEBEQ for FDA consideration without announcement or study registration, and in the absence of other obvious interpretation, I'll stick with my position that US development remains stalled by PRO problems.

Pomander, looks to be about right for a regional deal at Phase II and where the licensor is picking up development and regulatory costs. I wouldn't consider it to be a fast track to first approval. The Brazilian regulatory agency, ANVISA is not easy to deal with (although better than it used to be) and the Phase III, even if they only require demonstration of non-inferiority, will be fairly chunky. There' some harmonization among regulators in LA but they will each need individual dossier submissions. The bigger question mark is over uptake. As in developed markets, ridinilazole will face the same issue that has constrained fidaxomicin sales, namely preference for low-cost metronidazole and vancomycin as first-line treatments. But, overall, better than a poke in the eye with a sharp stick. And my old mate Dan should get his Xmas bonus.

Pomander, can't deny my job title.... RP have trotted out that pan-European launch line since long before Recordati even acknowledged that 12 doses was a viable presentation. And do you remember all of the bluster around a "full" UK launch and the false dawn of the post EAU workshop? Can't blame RP for being hopeful, but no pharma company invests time and resource on detailed roll-out planning until there's a degree of certainty around product availability and logistics. I do believe that there is now a plan in place and that launch will finally commence in March, but the first year objective is simply to gain traction in one or two key territories where there is some knowledge of the potential prescriber base and an existing sales force before taking the plunge into more challenging markets. But, if I do become aware of backroom activity suggestive of a different strategy, I'm happy to share.

Pomander, RP's line regarding initial launch has always included the words "in anticipation" and it's highly unlikely that Recordati have ever shared a launch plan. That a portion of the launch milestones was held back against progress on larger batch production indicates the importance of the latter to improving Recordati's gross margin: a couple of 100 litre batches would more than cover sampling and initial sales, Recordati need now only place a single large batch order, the cost being almost certainly less than that of two small batches. I'll stick to my prediction regarding the launch announcment being made at the ISSM conference in March (why would they waste the opportunity?), but there's nothing in Recordati's visible operational activities to make me change my view on active promotion being initially confined to Italy and Germany. Current company focus is on the all important Reagila® launch. if the picture changes in the New Year, happy to revise my opinion accordingly.

Near end of shelf life is certainly part of the reason for the reduction (60% since it's the 5ml presentation) but also last chance to get UK packaged product out before Recordati terminate the arrangement. As the MA holder, no point in continuing PV and risk management in a fringe territory and, as part of good marketing practice, Recordati will want to control and own all distribution channels. And as Pomander stated, nothing to get exercised over. The UK launch served a purpose and has never represented a viable Rx market.

Pomander, yup, never been the same since they merged with B&Q. Mind you, would not be without my multi-speed Randy Rabbit with hammer setting in the tool box.Decent battery life, comes with assorted Phillips and Pozidriv heads. I also hear good things about the split crotch lace plumber's overalls. But, to echo your serious note, OTC conversion remains a possibility but given the safety data requirement,is probably at least decade away. Margin is lower than Rx, so you need to be assured of volume. Not a problem for Viagra, and allows Pfizer to milk what the brand past patent expiry. OTC conversion in Europe grants 12 month exclusivity, so they have time to secure arrangements with retail pharmacies before the multitude of generic sildenafil producers barrel up. As to your mild umbrage regarding other revenue streams, remember that my perspective is one of a potential buyer, and that RP is busy sitting with its collective abductor pollicis wedged firmly up its fundament when it comes to commercialisation. "Maybe" and "perhaps" don't cut it when developing a term sheet. Tangible progress in the US, or even a decent territorial deal could change this, but I'll stick with my valuation snapshot until if and when events change the picture.

I'm guessing you're over the moon with this, Nigie boy....no more faffing around with one-eighth dowel and gaffer tape, eh?

Just dropped into my mailbox https://finance.yahoo.com/news/uk-gives-pfizer-worlds-first-152143026.html Interesting in that Pfizer explored OTC sales in the UK (and I think NZ) years ago, but abandoned the experiment. "Pharmacy only" medication and still carries some significant drug interaction and safety issues, but clearly not enough to warrant restriction to POM status. Still years away (insufficient safety data) but on balance, I'd say that if the MHRA considers sildenafil to be safe enough to move to pharmacy only status, then Fortacin could go the same way someday.

Pomander, I consider the commercial potential as being commensurate with the constraints of the PE treatment market and the product characteristics. Same story for any wannabe PE treatment, unless it has a completely novel mode of action and an as unreached level of benefit. And, in my third decade as an advisor (and way longer if you count my whitecoat days), my primary concern is, as always, getting paid. Not that attention to the vulnerability of one's rear is not good practice. My post related to how I consider a perspective buyer (not a licensee, although there is a degree of shared perspective when it comes to valuation) would view the ex-PLE assets as they currently stand. No buyer will give a flying one as to whether the Recordati deal terms underestimate the opportunity, only that the agreement irrevocably sets the return. And any reasonably diligent bottom-up valuation will confirm that the terms are reasonable for what is after all a minor bag filler/conversation topic to support an existing franchise. In the absence of any other potential revenue stream, the future European royalty stream is the only tangible basis for valuation- the rest is just fluff until marketing approvals are in place. True, a buyer might assign a premium if there was potential to dominate a market, but there's nothing in Fortacin's performance to date that makes this probable. It's also true that "bad" (from a buyer's perspective) do get made, but they are a rarity among the mundane, everyday transactions that make up 99.99% of pharma and life science transactions. But if RP are counting on a "Friday afternoon eff up" to generate exceptional terms, I'd counsel that Plan B might be the better option. Desperation might force RP towards royalty monetization for chump change, but if divestment is the game plan, it makes more sense to hang on until there is evidence of European sales and study initiation in the US.

Pomander, I'll tip the BB the wink should we ever get asked to undertake a valuation. And it would take more than a few beers for me to warm to the arithmetically-challenged RP revenue projections... The only tangible cash flow is defined by the Recordati agreement. The terms indicate a modest sales expection, of which RP will receive less than a 20% split of value (dropping to a few percent after 10 years). There is no comprehensive PE treatment market data (script volumes or billing codes) to benchmark against but there's enough good quality epidemiological data (public domain and proprietary) to be able to quantify a Tx population and develop a sensible revenue estimate range. In the absence of ex-EMA regulatory approval, commercial agreements (other than Recordati) or patents, and with the sole asset being the clinical data package, it's unlikely a buyer would include potential future cash flow in the initial purchase price. Fair value would be a cash offer based on the NPV of the Recordati revenue stream, plus future milestones to an aggregate of 20-50% of the initial cash payment. RP could opt to sell the Recordati royalty stream to one of the many companies (Royalty Pharma, SWK, PDL, DRI Capital) which specialise in pharma royalty monetization. Historically, price would be around a 50% discount to the royalty NPV, although with a near-term product launch, RP might be able to talk the value up on lower risk.

Busted.. Or not. Ironically, if it had not been for the unlamented Urology Company, I'd never have bought into PLE, since the decision was made on a sure-fire takeover by a US company interested in using the UC to distribute its feminine hygiene product (Bignose knows....). On the other hand, I would never have made a few decent fistfuls of beer vouchers off the back of the European approval, so all in all a successful experiment. And certainly not one to be repeated.