Member Info for Alquemie

Blimey, Bothwell...all a bit neg. Are you getting enough vitamin D?

Good that we agree on the US being dead, but don't be too quick to write off China. Could be worth, oh, possibly hundreds of dollars in royalties each year.

I sense your anguish with regards to the money fountain. Let's see...approval end 2013, licenced 2014 and total revenue to date around half of what Regent had to shell out to Shionogi and Paul Cap for access to intellectual property that had about 20 minutes left until expiry.

Masterly.

I sincerely hope that your "goodbye" is just a call for help- kick back and enjoy the slow motion (clown) car crash. There's bound to be more belly laughs on the horizon.

Care to apply your decades of industrial experience to an analysis of the data and offer a more nuanced perspective?

Thought not.

Dougie, not "musings", only a simple analysis of data in the public domain, and hence open to anyone looking to refute my conclusions. There are free statistical calculators on the web to enable comparison of means.

Now, inconclusive data does not necessarily put the kibosh on further development, but considered in the context of ERP's dire financial situation, no prospect of a development and commercialisation partner, and the risible revenue potential, but investment in an expanded "bother validation" Phase II, or a large two-part Phase III study with approval at the mercy of a sympathetic Adcom looks positively suicidal.

Think about it- if there was a sniff of positive feedback from the FDA, why keep shtum prior to a placing?

My current view is that the US is dead. Recordati OTC sales, when and if product is released, might bump along at €1m-ish, with only five years left until the royalty drops to peppercorn level. China is a wild card, but with recent high-quality surveys indicating that prevalence and treatment-seeking is even lower than in the West, price-sensitivity and low prescriber awareness when it comes to sexual dysfunction treatment, smart money is on very modest revenue at best. That's of course assuming the pivotal study data is way better than that reported for the US debacle.

Ah, of course...all down to the rights issue. Announced end September 2022, a fair while after submission of the response to the FDA comments and information request concerning the exit interviews (early June),for which reply would have been received early August.

What happened to the Type C meeting scheduled for September- did the FDA stop laughing long enough to say "no"? And what was it supposed to be about anyway- EOP2A, or simply chit-chat about the "adaptive" design and the RLD study?

So much going on that, according to an early investor with whom I still have the occasional jar, ex-director Wyllie now full-time with his side hustle.

Start of 2nd para should have read: "As ERP stated, the primary endpoint was met, although this does not mean that a one-point shift in response is meaningful"

The problem is in plain sight, namely the iffy Phase II results. ITT population was below target enrolment, being only 78 subjects (33 in Tx group, 45 in placebo group), on the cusp of uselessness.

As ERP stated, the primary endpoint was met, although this mean that a one-point shift in response is meaningful. The secondary outcomes of difference between Tx and placebo across IPE domains, global impression of severity and change in quickness also reached significance.

Different story for the other secondary endpoints. For both global impression of change and bother, around 70% of the Tx group gave positive responses, but so did around 50% of the placebo group- WTF?. Binary response ("yes/no") so I can't calculate p value, but neither looks to have reached significance. There was no significant difference at study end between between Tx and placebo groups with respect to global impression of change.

Change in IELT over baseline data is very strange- huge SDs and no significant difference between Tx and placebo group. This is the key objective indicator of efficacy- what happened?

In short, results are insufficient to validate "bother" as being important in perception of PE, and with no or marginal difference between Tx and placebo treatment with respect to key outcomes.

All in the public domain if you want to run your own analyses.

"up coming high demand in China and USA"...bless...perhaps Genetic spa not being in a position to sign off on commercial supply might be a less fantastical explanation?

Recordati's priority is get Fortacin back into the German online pharmacies. While there's a squeeze on transfer price, still possible to make a few hundred thousand for very little effort at sub €1m annual sales. Now that the Oompa-Loompas are out of the frame, Genetic is of course free to pick up ex- European commercial supply, subject to NMPA inspection (for mainland China) and acceptance of the July 2022 variation (as the MAH, Recordati needs to lead on this).

US is a wee bit more complicated, although it's increasingly unlikely that FDA approval will ever come to pass. Clinical trial supply (Catalent US) is "old recipe" 6.5ml Fortacin- Genetic could supply, subject to FDA approval and grant of variation (which might involve a bridging study), alternatively tech transfer of "new recipe" 5ml production to Catalent, and variation acceptance- not something you want to be doing when the clock is ticking on the three year exclusivity period, and with accelerating HFC-134a phasedown.

Availability of Fortacin to wholesalers now delayed until March 2023 at the earliest. Reason not given.

Amusing, but a bit sad, that the hoary old misconceptions regarding market drivers still persist in the face of real life events, as does the magical thinking that somehow prescriber/punter perception of a run of the mill knob spray is going to be somehow different in other territories.

And perhaps best not to get all unnecessary over FDA progress- those of you with of a statistical bent might care to take a gander at the data in the study report, specifically ITT population breakdown, placebo response rate and spread around the means. Hardly confidence-inspiring...

https://find-and-update.company-information.service.gov.uk/company/04977609/filing-history
No longer a happy camper?

He has a reputation for being barking, even among fellow longevity zealots. In Silico no longer, if it ever really was, longevity focused, hence the affirmation of personal commitment to "the cause".

Pledge quote: "I will not marry until I meet someone as dedicated to the cause as I am. Also, if I ever reproduce, I pledge to train my kids to excel in biology, chemistry, computer science, and medicine and motivate them to prioritize extending healthy human longevity above all other values".

Not yer Friday night pints after work, hoping to get lucky kinda guy. And any future family life likely to feature regular visits from social services.

Tangentially connected, no offerings from DLI at ARDD 2022, although Horvath and other clock advocates featured. ERP probably not able to afford the registration and flight costs.

FFS...this is simply a response to the results submission- the QC element relates to conformity with NIH database reporting standards, comments relate to shortcomings in clarity. Sod all to do with regulatory filings.

You've just reminded me of that classic ripsnorter from dear old Dr W as reported by Bloomberg back in November 2014:

"Plethora in License Talks For Drug to Rival Viagra Sales"
Plethora Solutions Holdings Plc (PLE) expects offers from at least six pharmaceutical companies to license a drug in the U.S. for premature ejaculation, according to the company founder, who helped develop and market Pfizer Inc.’s Viagra.
Discussions are approaching term-sheet stage with three of the international drugmakers, which sell sexual health or testosterone-replacement products, said Michael Wyllie, the company’s chief scientific officer. A licensing agreement will probably be reached before the company submits the drug, called Fortacin, to U.S. regulators late next year, he said.
“This could be as big as Viagra,” Wyllie said in an interview in London today. “I’d be surprised if we hadn’t decided on an agreement by this time next year.” Plethora is also open to offers to acquire the company outright, he said.

PLE market cap at the time was around £45m- what's ERP at now? Half of that?

I appreciate that you poor old LTHs haven't had any good news in a while, so just to lighten those Friday blues, all applied for variations granted this week, future supplies to be knocked up by Genetic SpA, a generics/OEM manufacturer with a couple of pMDI lines. An old mate at Chiesi has had past dealings with them, no negatives. Like Recordati, owned by CVC. Official company line is back on the shelf in some territories by February 2023.

I'm with you, Keith. The ramblings of Statler and Waldorf never fail to entertain, and I have greatly enjoyed their musings over deal structure and the phantom $17m.

Basis in another of Dr Wyllie's senior moments, or simply Jamie's fevered wet dream? Or, and I can't possibly know this, perhaps just the wild guess of a consultant, shaped by "internal modelling" and the haruspicy of Kevin and his mates?

As with all things ERP, unlikely the real story will ever be known. By most, anyway.

Do try and keep up, Bothwell.

US patents expired 2014, ROW 2016. The SPCs granted in some EU countries expired 2021, as did EU data exclusivity, with market exclusivity expiring 2023. They don't even own the Fortacin trademark.

If by some miracle product is ever approved in the US, de facto exclusivity term is a commercially useless three years. Generic challenge hardly an issue in a market already stuffed with essentially identical non-proprietary and non-prescription knob numbing products.

Bothwell, sorry to hear about your prostate trouble. Have you tried an alpha-blocker?

Bothwell, I'm sure that most readers are familiar with the concept of "magical thinking", but thank you for providing such a clear example.

Dougie, of course you may. No need for me to devalue anything, since ERP continues to do such a splendid job without assistance. Sad, I know, but I do find the whimsy and self-delusion wafting from this board vastly entertaining. Well, that and the magical thinking.

How does it go again? Ah, "if we all believe hard enough, a product established as a complete and abject failure in the least demanding of markets, will be absolutely massive in even harder markets".

Anyways, thanks for taking an interest. Have a "recommend" on me.

Chopping through the verbiage, earliest availability in Europe remains in line with Recordati's own estimate of Feb 2023.

Don't get teary-eyed over "commitment"- Fortacin is, and will remain, a low volume OTC novelty, transfer to an EU based supplier simplifies batch release and logistics, giving better margin and more flexibility around wholesaler pricing. Recordati must be delighted to ditch the Oompa-Loompas.