Member Info for Alquemie

To paraphrase James Carville, "it's the Phase II results, stupid"...The only puzzlement is why request an SPA prior to EOP2- a desperate "keep it in play" gambit, or do they genuinely believe that communication to date is sufficient to give a full picture? Twenty months since initial data submission and five months since supposed SPA request submission with no response. Considering the nonsensical study outcomes, I'd think the strategy obvious.

Coming up for 10 years since EMA approval, sole revenue is from a single batch placed with wholesalers. I can confirm that another batch is available, although it will be interesting to see whether there's still an appetite among German (and perhaps Italian) wholesalers. No supply in Spain anticipated before November, no date for ex-Europe supply and, perhaps of more critical importance, no third-party supply agreements in place.

DLI continuing to defy the maxim that there's money to be made from woo-woo wellness...

I'm bemused that, with the disastrous Phase II results being in the public domain for so many months, that there can still be any expectation of regulatory progress in the US. There is no validated co-primary endpoint, or even a credible path towards one. To repeat a previous (rhetorical) question, "what part of no statistical significance do you not understand"?

No amount of re-reviewing of exit interviews or EOP2 meeting advocacy was ever going to change this and guff about Phase III study submission and subsequent pursuit of an SPA should be called out for what it is. That said, I am looking forward to the excuses- a big boy mixed up the test and placebo drugs and ran away, or perhaps the Gibson family dog chewed the data?

And I wouldn't get all unnecessary over China. Delay already flagged in the Plethora Limited July filing, which may or may not be related to CMC and manufacturing issues (currently no Fortacin supply even in Germany, continuing absence in Italy and Spain flagged by corresponding medicines agencies), or perhaps the same interpretation of "positive data" was used as for the US Phase II?

"Friend", eh. Bothwell- real, imaginary or did contact involve a Ouija board?

And if real, do you happen to be on the same medication?

Other than Bothwell's medication?

For those of you on the wardrobe side of the gate to Narnia and with a better grasp of numbers than a pre-schooler...

Fosun cites a PE prevalence of 2.3% in its recent Phase I study press release (from a large survey of urban Chinese men, 18-50 years, Niu et al 2023, which captures lifelong and acquired PE).

Let's extend the target population to 18-60 years, being around 455m men in 2023. Adjusting for prevalence and locale, that gives a total urban PE Tx population of 6.843m. Tx seeking is less well-defined but let's assume it's close to that for European and US populations at 10% (almost certainly a generous overestimate).

That brings the accessible population down to 0.639m. From Menarini AP's high-res study of real-life Tx practices, first-line topical Tx prescribing in andrology/sexual medicine centres averages 4%, equating to a current urban topical Tx population of just over 23,000.

You might want to take that 9m in the first year (over 80% uptake by the entire national population of PE sufferers) with a pinch of salt. Let's not forget that in the second full year of sales and with HCP promotion, Recordati could only offload 45,000 cans to wholesalers serving the most developed PE Rx market in the world.

Sexual dysfunction drugs are expressly excluded from the NRDL. Given the experiences of Menarini and Pfizer with regard to price sensitivity, I'd estimate a "viable" out of pocket price of Fortacin/Senstend to be around €30. Factor in the dominance of dapoxetine (alone and in combination with TCM), if ever launched, uptake will be near invisible and glacially slow.

And if you need a further sanity check, just work backwards from the deal terms.

"...the little information", Bothwell? No shortage of public domain information with respect to Recordati's opinion on value, and there's enough of the Phase II data published to determine that it was a complete train wreck.

In short, next to nothing to come from Europe (and to rub salt in, royalty drops to 3% or less in under five years, if product still on the market), US is dead, not that there was ever any real prospect of approval. As for China, there's sufficient recent and high resolution data from Menarini Asia Pacific to be able to rough out a prevalence based model which indicates just how low sales (if approved) might be.

I wouldn't get your hopes up about an SPA agreement, or indeed, any material progress.

Following the disastrous Phase II study, there's no support for the hypothesis that "bother" is a valid concept in the context of PE treatment, nor that it can be reliably measured. This is crucial, since the FDA has, in contrast to the EMA and NMPA,never accepted that "distress" is a valid and quantifiable PRO.

To quote ex-PLE director Homer Wyllie "...the data presented show that patients do not necessarily differentiate between distress and bother"...Doh! He didn't elaborate on the stonking placebo effect.

Without decent data to define a co-primary outcome, or means by which such an outcome might be validated, it's not possible to put together a credible study protocol for SPA consideration. And there is no decent data, nor a chance of generating any.

Lovely plumage, the Norwegian Blue...

Not so much clarification as utter wibble.

Tiered royalties are a means of adjusting the value split between licensor and licensee should revenues exceed the base case used in setting licence terms. The uplift is generally triggered by pre-agreed net annual sales figures. It's got sod all to do with intellectual property. In fact, for a product such as Fortacin which has no IP protection, the royalty can be reduced should a generic product enter the same market during the term of the agreement.

In the context of the China licence, "net receipts" mean revenue accruing from non-affiliated entities, that is the profit arising from supply of product to non-Fosun group companies. This is not additive to the royalty due under the licence agreement and is always very much smaller that the royalty on net sales.

Pricing of around $100 is complete tosh- just ask Menarini Pacific (sexual dysfunctions drugs are excluded by law from the NRDL). That's if Fosun even bother to launch at all- treatment seeking even lower that of Europe and the US, virtually no first-line topical prescribing, entrenched dapoxetine and TCM use, even allowing for a a larger population, return hardly likely to justify intensive promo.

Bothwell, I'm distressed that your future happiness relies on an event with such a vanishingly small chance of coming to pass. Perhaps taking up a hobby, or acquiring a pet, such as a famous Norwegian Blue, might prove a more realistic source of cheer?

As for those little Chinese nails, bear in mind that the US Phase II results were also proclaimed as "excellent" although the reality was no meaningful difference between study arms.

Never going to happen. Recordati has no interest in expanding sales, promotion or upping capacity .Fortacin has a carry value of around €2m- why waste another single Euro?. Company is content to shift a pallet's worth to wholesalers serving German online pharmacies (36 or more are offering Fortacin, almost all at discount) every now and again. Minimal effort and with a transfer price of close to €20, let's say net profit of around €15- easy money from low volume, although I do wonder how many of the 30,000 cans purchased by wholesalers will end up as landfill (again), even with the new recipe conferring an extra six months of shelf life.

Recordati not even bothered about supply to their subsidiaries- earliest availability in Italy is sometime in September. No supply to Orient although that's not a concern for Recordati. Neither is China, if ever approved and actually launched. With the looming HFA phasedown, Genetics and other CDMOs will be understandably nervous about committing to pMDI line expansion, at least until low GWP substitutes are approved.

As for the UK, Fortacin was so successful in the hands of Doctor-4-U that, despite their blatantly fake reviews, they ended up dumping stock at £1.99. Boots already sell Stud 100 at the price of a decent pint in London (and offered an own-branded OEM version once upon a time). Fortacin is an unestablished brand with no point of differentiation, so no appeal.

I wouldn't get all unnecessary. About five years back, we were involved in a bunch of financings for telemedicine companies offering kosher CBT (video and digital) and mental health wellbeing/digital Tx, all looking to expand into the workplace market. Almost all have since pulled out, since minimal employer uptake, even with the expected push from the pandemic.

And this was for clinically validated CBT services, not the DLI woo woo, although in fairness, there are a few woo woo companies (Calm, Headspace) which, decades on, are actually growing revenues.

Cheer up, Bothwell.

Just because the there's never been any US partnering interest or tangible FDA progress during the past 13 years, and ignoring the dogpile of a Phase II study, the absence of commercial protection, a history of prescriber and consumer disinterest, manufacturing change requirement and environmental (HFA phasedown) issues, no need to stop believing...

As my dear old grandma used to say "If the bottom has dropped out of your world, take a swig of syrup of figs, and the world will drop out of your bottom".

You might want to consider that from a different angle, Bothwell- what kind of a muppet keeps throwing money into an "investment" which has generated a negative return for over a decade, and with zero prospect of the situation changing?

Same guy who's still out more than £5m from another "investment" with nothing to show for it other than a lock-up full of soft shoes big on velcro and a few thousand pairs of assorted insoles...

And just in case there were any lingering doubts as to how unimportant Fortacin is to Recordati, have a look at the 2022 accounts: "Impairment mainly refers to the intangible asset Fortacin® (€ 2.2 million), following the decrease in
expected future cash flow"

Just me, or anyone else think that they've replaced the office junior with ChatGPT?

What's this with "our European partner"? I know ERP are not on Recordati's Christmas card list, and that Fortacin is de facto Recordati's product, but why the coyness? Bit of a tiff over third-party supply access perhaps?

Very strong whiff of decomposing Norwegian Blue coming from somewhere...

Sounds as though the consequences of the Phase II debacle have still to sink in...be guided by the Dead Parrot sketch...

Owner: There, he moved!
Mr.Praline: No, he didn't, that was you hitting the cage!

You have seen the "Dead Parrot Sketch", right?

Unscrupulous petshop owner, who previously nailed said parrot to its perch, jiggles the cage and claims that the parrot moved. Ring any bells?

Seriously, what part of "no significant difference between PSD502 and placebo" are you having difficulty in grasping?

Recordati, as the European MAH, allowed PLE to rebadge the Fortacin dossier and submit as Senstend for centralised approval in the EMA. This became the reference product for China.

Senstend approval was withdrawn in Europe but registration maintained in the UK. The Type II variation now needs to granted in the UK for the reference product and the updated dossier submitted to the NMPA for consideration of the significance of the variation and acceptance.

The Italian manufacturer, Genetic spa, will require NMPA inspection (usually at the end of NDA data review), with NMPA certification being a condition of imported drug approval, and of course a supply agreement. Manufacturing transfer is a possibility, decision would rest with Genetic.

C'est tres simple, non?

Not that it needed confirming, but crystal clear that the FDA does not like the Phase II data or protocol. Design flaw or sloppy execution?

And, you have to laugh, ERP now chasing a Special Protocol Assessment, when a SPA was agreed back in 2014, predicated on establishing reduction in bother as a co-primary endpoint. Back To The Future, eh...

Now, might just be Jamie not being the sharpest tool in the box, or sloppy copy and pasting, but SPA not usually considered before EOP2. Type C request not yet granted so I would take the SPA timeline with a very large pinch of salt.

Fortacin has been available from DocMorris and other German online pharmacies since last week, bigger operators discounting it to €39.99. Not yet on sale in Italy.

Dougie, just for sch*tz and giggles. And of course, the magical thinking.