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According to an old mate who is a buyer for DocMorris, Fortacin pulled from sale in Germany the last month. Not his division so reason unknown. Supply issues again?
Caught up with an old colleague who was an early investor in the jolly old Diabetic Boot Company, informed that it went into administration sometime before Xmas- nice one, Mr Mellon, although I guess the £6m loss from the three loans won't shatter the piggy bank.
In a sense, as it's essentially a passive process. Citing from the last major revision: "according to Article 23 of the Revised Measures, after the application of clinical trial is accepted by the Center for Drug Evaluation (the “CDE”), the decision shall be made within 60 days3, otherwise, it shall be deemed as approval granted, and the applicant can conduct the clinical trial according to the clinical trial plan submitted".
Hmm...only 87 randomised out of the target 100 enrolment, itself being generally considered the bare minimum for PRO validation.
As I recall, the primary endpoint was fairly soft (something like a one point difference in "bother"), but at 1:1 randomisation, only a one month Tx period, and the low product satisfaction found in the Recordati survey, might be struggling to reach significance.
@Dougie999. Commercial rights were then owned by Shionogi (previously Sciele in the US), which part-funded the Phase III studies. My understanding is that, as with previous PE treatment submissions, the FDA advised at the end of study/pre-NDA submission meeting that it would not accept the study endpoints in support of label claims and that Shionogi balked at funding the necessary additional studies. Situation complicated by a chunk of any future revenue being due to the late, and deeply unlamented, Paul Capital.
Shionogi were persuaded to allow PLE to pursue European submission (hobbled by lack of cash and a rumoured dispute over use of the manufacturing process). Commercial rights and ownership were returned to PLE (as RPG) on a £15m settlement with Shionogi, PC and the original inventor.
Rolling forward 11 years, the objective of the ongoing Phase II is to validate an FDA-acceptable study measure to support the label claim.
Fortacin OTC launched in Germany today. Pricing varies between pharmacies, but roughly 30% discount to Rx pricing.
Conceptually, it's not difficult to grasp. Ageing is accompanied by many biological changes at cell and molecular level. The "deep ageing clock" hypothesis is that changes in certain markers (telomerase length, site-specific DNA methylation, DNA binding proteins) are absolute determinants of biological age, and as such, offer an objective means of assessing the impact of pharmacological or lifestyle interventions that might prolong longevity.
Clock development("biohorology") goes back a decade or more. Attempts at validation have mainly involved lots and lots of mice. Best "accuracy" in humans is about +/- five years compared to chronological age.
As it stands, DLI is not much more than someone's PhD thesis: lots of nice notions as to how to build an algorithm from multiple biological measurements, but at least an expensive decade or more away from demonstrable utility. "Ageing" is not a disease state in itself, so the value, if any, is as others have done, to look to application in specific conditions, such as neurodegenerative disease. However, adoption or approval of an intervention depends on demonstration of meaningful functional improvement and not change(s) in cellular or subcellular markers. Return, if ever and in common with other biomarker research, will be minimal. And out of the quarter million wellness apps out there, one requiring blood work and a subscription is not going to get much of a following.
But, I remain hopeful that RPG finally manage to get the spelling right on the legal work and conclude this deal. I've been vastly entertained by JG's inability to understand and explain the somewhat undemanding topic of knob spray, and am greatly looking forward to his pronouncements as to why elastic net aggregators are the dog's compared to tandem DNNs.
Should give Pingu stiff competition in the clarity stakes...
The ongoing Phase II is intended to validate the PEBEQ instrument used to capture "bother", and is not a critical path evaluation of drug efficacy or safety. The FDA COA process was running at 10 months for review of a full qualification package pre-COVID.
In theory, possible to commence a registration study before FDA COA acceptance, gambling that PEBEQ approval is on the cards, or alternatively, hope for mercy from an AdComm, should the PEBEQ prove inadequate. Long odds, given that it's taken years for the FDA to even countenance "bother" as a potential label claim.
I guess the confusion is all down to Jamie's chrono-dyslexia but with no pivotal study protocol registered, crystal clear that there is no "overlap".
@Keithbfk, apologies if I've made this point before, but Fortacin promotion was as for any minor speciality product, with responsibility devolved to national subsidiaries. The Italian, Spanish and Portuguese language websites were a decent enough blend of punter and HCP information, with Germany and France being HCP promotion only.
Pre and post-launch HCP promotion was conducted through conference presentations, paid for "expert" publication and prescriber panel surveys (Italy only). The lack of prescriber interest is down to the unremarkable nature of the product and the absence of differentiating clinical data. The expected return is too low to justify further clinical studies or, with the decline in the urology franchise, continued prescriber engagement. Move to OTC is just a last throw of the dice, in the hope that it might somehow rattle along with the other sub-€1m odds and sods in the consumer product bucket.
The free version has apparently been under beta test at RPG Central, but Jamie not happy with his results or that you can only register by friending Jim Mellon on Facebook:
Photo age and recommendations: Seventy-three. Get a decent haircut, oh and ditch that smirk
Behaviour age and recommendations: Nine, but no big deal in the current job. Play nicely with others and stop fibbing
Psychological age and recommendations: Fourteen. Hang on in there, the world will a less confusing place in a couple of years. And get out more
Anamnesis age: Sorry, what was the question again?
Blood age: Pisces
RP's announcements have always been good for a belly laugh, but this latest jolly wheeze made me ruin a perfectly good cushion cover. No comment necessary, believing that even the most ardent Mellonanist can see this for what it is.
Dear oh dear...So close to the Muppet Show that it's a wonder that they have not received a cease and desist letter from the Jim Henson estate.
Nice to know that farce did not die with Ben Travers- this is quality stuff indeed.
Perhaps a bit harsh to put Pharmaserve on the naughty step in "relation to unreliable lack of supply", when they've been highly dependable when it comes to not supplying product, being talented enough not to supply for over a year.
Now, PSNW are only a jobbing CMO, but after four years of tweaking (failed stability testing, quality spec revision, new enclosure to give additional headspace) and the history of failure with low volume presentation, I'd put the problem down to the limits of physical chemistry rather than rank incompetence.
Full of admiration for JG's big shiny brass ones, burying the company's most fundamental issue in a fog of COVID-related waffle.
No, it is just confused nonsense. I'm quietly impressed with JG, having thought that our very own Alexander Boris de Pfeffel Johnson to be the Zen master of complete and utter guff, but JG can teach him a thing or two. Even his grasp of dates is less firm than old Boris slack hands. Bigger salary too.
Given the number of study sites involved, and the short interventional nature of the study, even allowing for any impact of COVID, the recruitment rate is truly appalling. Wonder how much has been spaffed on this to date?
And still no reference to the continuing supply issue, with no new batches released in the past year (earliest availability in Italy still flagged as end July by Recordati). No reference to sales, of course, that being a tad difficult when nothing has actually been sold.
For some unfathomable reason, UK distribution is exclusive to Doctor-4-U (and their IMed) subsidiary.
But, with D4U reduced to flogging Fortacin at £1.99 for the past month in an attempt to shift June-expiry stock, following price cuts from £59.99 down to £9.99, I suspect that Numan does not feel that it's missing out on anything. Besides, they can pick up an established OEM knob spray (manufactured in Watford, with pan-European product authorisation) for less than 50p a can.
Bothwell, a sensible decision. This (three, five year old?) "report" is only of use if printed on Andrex.
Looking at the blurb, Bayer and Lilly are presumably mentioned on the basis of their respective ED drugs being used off label for PE treatment. Neither has ever dipped into PE research. No mention of Menarini, which markets the only near-globally approved PE treatment, dapoxetine, for over a decade (after J&J giving up on it).
GSK and Pfizer both had early oral drug programmes, both abandoned about 15 years back. An abandoned Pfizer candidate was resurrected by a UK start up, Ixchelsis (Dr W's ex-workmates), but bombed out in Phase II. The Dong A Pharma (no s******ing at the back) oral SSRI candidate was abandoned five years back. A Turkish generics company has trialled and published on a fixed dose sildenafil-dapoxetine tablet in concurrent ED and PE (now recruiting for Phase III studies).
Of the monograph desensitiser merchants, Absorption does about $3m in Promescent sales (and a bit from OEM), Pre-Boost wipes (branded and OEM) under a $1m, Stud 100 about $0.5m before rights were sold (as wholesale transfer price- 5-10 fold more as retail). A lidocaine-prilocaine spray was approved and launched in India almost 10 years ago (since discontinued). A Futura-developed spray was launched by Ansell in the US over six years with next to zero sales.
I wonder if RP has ever shelled out for a copy? This would go some way to explain the company's complete lack of understanding of the PE market.
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.
Bothwell, that was thoughtful of you. Not sure whether Numan ship to Hong Kong, but likely that they cover the Isle of Man.
Not good, and certainly old, news.
I posted on this over a year ago with reference to men's health-focused US companies offering online consultation and PE, ED products over a year ago- HIMS, Romans and others. HIMS UK currently offers only ED treatments. Numans was founded by Sokratis Papafloratos (a tech investor), looks to be closely modelled on Romans. At 15% lidocaine, the Numan spray is not Promescent but some other OEM product
Very low barrier to entry (wholesaler's licence, a couple of minimum wage GMC registered box-tickers sitting in Estonia or Romania, someone to knock up infomercial content, packing facilities. Oh, and a website...). Business model revolves around building confidence in the brand sufficient to justify the price hike over getting Viagra Connect from Tesco or saving yourself £13 by buying Stud 100.
Context of last year's post was how Romans and others make a nonsense of RP's fanciful pricing (and desperate hopes) for the US. Including consultation, you can have a PE treatment of your choice (spray, wipe, off label SSRI) delivered for around $3 a dose, no expensive medical consultation or hit on your high deductibles medical insurance.
Romans offers re-badged Promescent and Pre-Boost wipes (both are also promoted to urologists, the latter by Timm Medical, a Plethora subsidiary once upon a time).
Rules on distance prescribing vary in Europe, but there are a few currently offering Rx and OTC PE and Rx ED products in several countries (Doc Morris, Zava).
Meanwhile, in the real world...
Accessible 2019 adult male population in launch countries (18-65 years) = 107.76m
Recordati net sales (RPG revenue of $164,000 taken as 15% of net, with € conversion) = €1.09m
Cans placed with wholesalers (at €23.5 transfer price) = 43,090
Product availability per capita= 1 can per 2,500 adult males, or 0.04% uptake on a population basis, assuming all cans taken up on Rx.
2020 full year sales = zero?
An estimated thirty months from registration to last subject follow-up is pretty poor, although not completely unknown for a study sponsored and run by small fry.
Worth pointing out that the revision does not take account of COVID-19 related delay (still a a complete unknown, even for the big boys) and that this is only a 100-couple, one month treatment pilot study, whereas a registration study, if ever initiated, will be three months on treatment (5-6 months per subject couple with baseline and follow-up), with an as yet unknown total subject number (dependent on the pilot study outcome- 200 to 300 on 2:1 randomisation?).
Anyone up for a sweep on the next study starting date?- 30th February 2025, or perhaps the 12th of Never seem good bets.