Member Info for Alquemie

@The Italian:

“Clinical hold”? Only occurs when there is something scary in the AE profile, such as unexpected safety signals or an increase in known AE prevalence- a complete non-issue for a simple knob spray containing generic APIs. Bizarre that JamieBot even mentioned it.

An IND has no formal time limit. It can be voluntarily inactivated by the sponsor if no clinical development for two years (but may be reactivated with a new study plan). The FDA can terminate if the IND is inactive for five years. Of no relevance here.

The “To SPA or not SPA” question is moot since the Phase II failed to show a significant difference between treatment and placebo in the Phase II study in key objective and subjective endpoints. No validation of “bother” as a co-primary endpoint means no basis for continued SPA discussion.

Proceeding in the absence of an SPA without a very high degree of confidence in a novel endpoint relevant to the label claim would require a very large two-part study (600+ subjects plus partners), with everything hinging on the mercy of an AdCom. The only unknown here is how long does RPG believe that it can keep up the pretence about US submission.

We’ve supported several royalty financings (working for both biotech and private equity). Put simply, it’s a secured loan where a lump sum is provided in return for a share of existing or future royalties and milestones payments (“synthetic royalty”). Popular with small biopharmas who need to get a late-stage asset over the line, and for companies with a marketed product who need non-dilutive pipeline development support.

Benefits are that the developer retains commercial rights and IP ownership, and no fixed payment to service. Agreement structure is obviously deal-specific, but generally involves payment of around 10% of net royalties, although some are in the 18 to 50% range. Most deals are capped. Over half are signed after NDA acceptance. Royalty agreements may be resold.

From a diligence perspective, RPG would not get past the first phone call, principally because they do not own the “asset” (robust, long-life IP is the singularly most important requirement), followed by zero experience in product development (and let’s not forget the going concern issue). the nature of the asset (no established regulatory path, non-reimbursed lifestyle product), no clear route to de novo market creation and revenue generation, and no barriers to competition. I could list a dozen further reasons, but you get the drift. Just like the whiff of desperation emanating from RPG…

Sounds like JamieBot 1.0 needs a complete rebuild…

Genetic were the named manufacturer for Senstend (the reference product for China). The EMA approval was withdrawn mid-2022, leaving only the MHRA authorisation (effective December 2021 after the Brexit reset), and which I believe may now have expired due to the sunset clause. Senstend has never been manufactured, meaning there is no CMC dossier for the reference product. Submission depends on the NMPA being willing to accept Fortacin CMC data as a surrogate. This in itself may not be complete (for example RT stability). Genetic must agree to be the manufacturer for the submission (NMPA inspection is required), but they do not need to sign up to product supply.

The bioequivalence and Phase III study were conducted with Oompa Loompa manufactured material with a different specification and enclosure. Batch specific CMC data is needed for the NMPA submission, and again this might not be complete (or forthcoming).

As an aside, no contract pDMI manufacturer will extend production capability due to the impact of REACH regulations and clarity around non-HFA substitution.

Reading "the response", I can't help but wonder whether Jamie has been replaced by ChatGPT, and set to "random irrelevancy" mode .

Perhaps a cunning ploy so that RPG can blame the AI when the they finally 'fess up to the US being dead? And the complete waffle around supply cerainly indicates that JamieBot 1.0 needs a better training set.

But if anyone has a mind to interrogate JamieBot , why not ask about the status of the reference product, feedback on the NMPA position on use of a historical clinical supply product and incomplete CMC data. Oh, and where's the "excellent" Phase III data, given that Fosun was quick enough to publish the bioequivalence studies?

All as predicted months ago...

Absence of supply agreement is just part of the CMC headache- expect continued submission delay, and if it ever gets that far, NMPA pushback on material differences between clinical trial supply and commercial product among other issues.

And still the pretence that there's the prospect of progress in the US, or for additional licensing deals...this pathological level of dishonesty/self-delusion suggests that RPG is bettered suited to pushing crypto investments.

Same "friend" that told you China and the US are "going to happen"? And is that friend in the room with you now?

Heh..that's "happy ex-investor" (admittedly a long time ago). And thank you for "erudite".

Graced with a quietly knowing smile, rather than a smirk, although with the occasional hint of smugness. I do look forward to a few hearty belly laughs on reading the next company update. Parrot-jiggling at its finest.

What the f**k happened to my capitalisation?

"sell the product outright"...might be difficult when rpg don't have anything to sell. as stated multoties ante, no licensable or transferable intellectual property or commercial protection exists anywhere in the world.

past licences have been simple grants of commercial rights to an approved product. recordati is the de facto mah in europe (and owner of the fortacin trademark), and manufacturing know-how, if any, belongs to them and/or their subcontractor. in the increasingly unlikely event of approval in china (submission stimmied by historical cmc issues, a phantom reference product, and perhaps iffy data and cold feet over market potential), fosun would be the domestic mah and own the registration package.

so, what is in the ple lucky bag? an ind and clinical data package kicked into the long grass by the fda nearly 15 years ago, phase ii pilot data which failed to show any difference between treatment and placebo, the *** end of the recordati agreement, oh, and the orient europharma agreement, although hard to expect a royalty when you can't supply product. and of course that well known senstend trademark...

"remarkable bird, the norwegian blue... beautiful plumage!!

Ordovician-silurian xxtinction: 440 million years ago

Devonian extinction: 365 million years ago

Permian-triassic extinction: 250 million years ago

Triassic-jurassic extinction: 210 million years ago

Cretaceous-tertiary extinction: 65 million Years Ago

RPG shareholder hopes & dreams extinction- Spring 2024...

FFS...how many more times?

Patent coverage expired in all territories in 2016 (and in the US in 2014). SPCs granted in a few European countries post-approval, all since expired.

Value of Fortacin as an intangible asset was based on the EMA 10 year market exclusivity which expired November 2023, along with some made-up fluff about revenue in other territories.

With no existent IP or other commercial protection in any territory, no need for amortization charge. Carrying value negligible, since only basis can be the NPV of the tail end of the Recordati agreement (less than four years away), Orient Europharma sales (if they ever get product- last imported batch expired Jan 2023), and risk-adjusted NPV for China (which I would not count on...).

Bothwell, thank you for this piece of entertainment.

According to Wilde, "“Sarcasm is the lowest form of wit, but the highest form of intelligence”, and your effort did produce a hearty belly laugh.

Have a "recommend"!

Have to disagree with you there, Dougie. I think the majority of discussions have been pretty damn short, and on the wild premise that there's actually been any recent BD activity, becoming a deal shorter:

"Intellectual property, market exclusivity"?- "Uh, none"

"Reliable 3rd party manufacture, with security of supply"?- "Uh, no..."

"Planning in place for the HFA phasedown"?- "Eh, what's that?"

"Potential supported by historical sales"?- "Sheepish look..."

"Post approval study data or other marketing collateral?"- "Looks out of window..."

"FDA acceptable co-primary endpoint defined and validated"?- "Mumble, mumble..."

Ironically, all over in a minute...

Au contraire, Keithbfk.

While there's nothing more refreshing than a deep draught of schadenfreude, any pleasure is solely down to the smug satisfaction of seeing my predictions hold firm. Not that it requires Holmesian powers of deduction to twig Recordati's indifference to Fortacin; that the American dream, always the remotest of possibilities, has been completely scuppered by "strongly positive" (= truly appalling) Ph II results, and that NMPA submission is impacted by an extraordinary history of CMC issues, but let's not dismiss the possibility of iffy study data.

What might 2024 hold for RPG, besides the inevitable going concern warning? Pushing my neck out, let's go with an end to the pretence that there's any meaningful dialogue still to be had with the FDA, a re-tabling of the China timeline, with the definite prospect of Fosun shelving launch as the company restructures and focuses on more lucrative opportunities than offered by a run of the mill knob spray. That said, Zezheng Biotech now has two bioequivalence studies of its Fortacin generic underway, although it's hard to envisage a shoal of little fishes chasing what is a very modest market, even by Chinese standards.

On the bright side, no need to worry about RPG having to raise cash to cover a Phase III study or a continuing regulatory consultancy bill, so only a few measly millions needed to cover salaries.

You might be right, Bothwell. The chatter is that Mr Mellon has tired of vulgar pursuit of the money fountain. Heart and soul now dedicated to becoming a renowned children's author and poster child for the compassionate farming movement "Save The Moo Moo".

https://www.alumni.oriel.ox.ac.uk/news/honorary-fellow-jim-mellon-publishes-his-first-childrens-book-junos-ark/

Heart-warming....And let's not forget his past contributions to animal welfare. Indeed, in RPG, he's managed to put together a first-class donkey sanctuary.

I did give a heads up months ago that the China submission would be delayed, a safe prediction considering Fortacin's manufacturing history and consequent gaps in the CMC section. Hard to make a call on this, but could be end Q1 at earliest, and potentially much, much longer to answer the necessaries. And, given RPG's historical interpretation of "excellent", I would not rule out other issues (how's that placebo response looking?), including supply (neither Recordati or Genetic willing to invest, and pace of HFA phasedown accelerating in Europe).

Looking to the bigger picture, Fosun, suffering from heavy debt and structural complexity now has different priorities and along with a better grasp of the very modest PE market potential, no reimbursement and decline in consumer spending, not unrealistic to suppose that Fortacin/Senstend might never be launched. That said, at least one Chinese company has disclosed development of a generic version (Zezheng Biotech).

Once more from the top, US is dead, killed by the self-inflicted headshot of the Phase II data, although progress was always the remotest of possibilities even before suicide by PEBEQ.

Recordati royalty might just about cover the Xmas party, but interesting times ahead- all down to DLI and its speak your age wizardry - what can possibly go wrong?

Ten years since EMA centralized approval- oh dearie, dearie me...

Time from approval to commercial launch- 52 months (let's draw a veil over the sunset clause-dodging 2016 UK launch...), no product availability for half the time since February 2018 (and supply still limited).

Accrued European royalties- c. €472,000 to mid-2023; revenue from wholesalers- c. €3,137,000 to mid-2023, units placed with wholesalers- less than 170,000 to mid-2023

Let's not forget the distinction of being the fastest Rx to OTC conversion on record in addition to being possibly the most overhyped drug product in history.

Sadly, no money fountain ahead. Marketing approval recently renewed with expectation of Fortacin bumping along at around €1m net each year, but with the royalty dropping to 3% or less in just over four years, RPG, if still existent, will need to find something else to cover the 'leccy bill.

Any hope?

None whatsoever...but take some comfort from Sartre: "Life begins on the other side of despair".

Just got to love the Chinese pharma industry- NDA not even filed for the imported drug and bioequivalence study for home-grown generic already registered, using Fortacin as the reference product CTR20232999.

Kilsyth, you mean apart from winding up the few poor wandered souls who believe that RPG has some sort of future?

"Not dead in the water"... Never underestimate the power of self-delusion...

For those not hard of thinking-Take.A.Look.At.The.Data.

https://classic.clinicaltrials.gov/ct2/history/NCT03578783?V_29&embedded=true

No need to worry about "the patent"- actually two, both expired 2014 in the US. Even the few SPCs granted in Europe post-approval have long since expired. Exclusivity, not that it means anything, will be lost in two months' time.

Do try and keep up.