Member Info for Alquemie

Dougie999, every company, regardless of size, that is sponsoring clinical trials or waiting regulatory feedback or decisions is experiencing unpredictable degrees of delay.

I'd be more concerned about the manufacturing issues that were flagged in the AR. A circular from the Italian Medicines Agency (30th April) advises that Fortacin is unavailable, with the earliest date of availability provided by Recordati being 30th July 2020. I note that Doctors-4-U is now offering Fortacin at £9.99, well under the net transfer price (after a long period at £19.99), presumably to get rid of the many unsold cans due to expire within the next three months. And no resupply on the way.

So,not only months of lost sales (such as they were), but nothing available for HK launch and, if approval ever granted, possibly no clinical trial supply for Chinese and Taiwanese bioequivalence studies. Not to mention undoubted partner nervousness over future CMC issues.

Dearie, dearie me...

As always, I was looking forward to a good laugh from the Results, but this is truly a shocker with respect to its contempt for shareholders.

Perhaps, being likely that it's the last AR that RPG will ever produce, JG has aimed to outdo his already impressive history of crassly stupid statements?

There is one single piece of honest analysis- the independent auditor's doubt over RPG continuing as a going concern.

Bothwell, you need to re-read my post, which points out the coming impact of delay. CROs have been doing what they can for weeks to minimise the impact on ongoing studies (but there's at least six on my watchlist which have halted in the past week).

The US study might not be too badly affected if the study sites are community rather than hospital based, but since the study is still ongoing that means RP are months away from a COA submission and will still, like every other company, be caught up in the NMPA and TFDA slowdowns/redeployments/reprioritisations. There are infinitely more experienced and talented sponsors than RP trying to salvage clinical development programmes, knowing that some degree of disruption and derailment is a certainty.

Bothwell, can't help but admire your confidence, but pandemic delays aside (and the question mark over RP's survival), the weakness of the product and business case remains unchanged.

Fortacin has singularly failed to gain traction in the most developed PE market in the world, even with an experienced multi-national marketing company behind it. Sales and Recordati's survey data underscore the obvious- that Fortacin, like other PE treatments, is of mediocre efficacy with no compelling advantage over €5 knob sprays . OTC status, not that it will be granted, will not change this and, if new approvals are ever granted, it will enter competitive and cost-constrained markets with the same flaws. I'm lost as to why anyone would believe that Fortacin might do better in other territories- well, at least outside of Narnia.

It did. PRAC highlights were posted on the 13th, full minutes are published around three months later.

Recordati will obviously receive a formal notification (assuming there's anyone around to actually read it).

While in no way defending what's laughingly referred to as RP's "management", the pandemic is, and will continue to be, a brake on clinical study and regulatory activity for many months. Although not made public, the NMPM moved to an emergency footing at the end of January, with suspension of non-essential activities (guideline revision, legislation, regulatory review), moving all hands to the COVID pump.

The FDA has now cancelled all non-essential meetings and reviews for the next couple of months, and clinical trial recruitment is way down across the board (as is new study initiation). Even if the clowns had been able to get the dossier to the COA office before the shutdown, I suspect that a knob spray review would not be a priority (there's no statutory maximum timeline for COA review).

Tough times ahead for the sector small fry, but with the strong certainty of no NMPM, FDA (or TFDA) progress, the knock-on effect for non-priority product review and clinical study initiation, the cessation of field force promotion in Europe, the only question is "when" not "if" RP goes to the wall.

Under IFRS (which I think HK recognises), reduced valuation is considered an impairment and can be immediately written off to the P&L account if the carrying value is greater than the recoverable value (which I guess is the revised NPV based on revenue out to 2023 minus depreciation).

Might simply be to make the P&L look less disastrous or may have to do with regulatory compliance.

Prof, not quite. The fair value estimate simply settled on the EU marketing exclusivity period as the write-down period, and was not explicitly based on the licence value (which would have been worked over to death in order to determine an acceptable value split and terms, and hence a known factor at the time of the fair value announcement).

That the "fair value" estimate was in gross excess of the licence value is a given, but hey, when you have just vastly overpaid for an asset, you are going to hit that pig with all the Maybelline lippie you can muster. And since the Fortacin carrying value is most of RPG's current worth, as both asset value and goodwill value, they have no choice but to roll with it being treated as "negative income".

And for shame, questioning Nostramellon's uncanny ability to pick, uh, winners..... We are all getting on, and I for one am sure that a man who can afford a daily rub down with a fistful of wet monkey glands and the odd top up with (ethically sourced) teenager blood is still playing with a full deck. As Carl Van Vechten might have said, "A thing of beauty is a Jim Mellon forever".

The term used in the fair value calculation was set by the EU market exclusivity period- ten years, running until November 2023. Struck me at the time as a strange choice, since the valuation included management revenue estimates for ex-EU territories, but with no other existent licences, patent protection or meaningful market exclusivity, I guess the bean counters needed something to hang a hat on.

Current asset value ("the carrying value") is the initial fair value (around $194m?) minus depreciation accumulated to date.

Biopharma has never been short of pirates (worked for more than a few of them over the years), but "Jammy" Gibson is indeed in a class of his own when it comes to rapacious trousering.

CEO cash compensation for the five largest US pharmas averages $2.4m (most under $2m). Total compensation (options etc) is in the $16m to $21m range. So poor old Jammy, if $1.5m is the limit of his plunder.

But wait....let's look at compensation relative to revenue. The big dogs average 0.0063% of revenue (cash) and 0.053% (as total compensation). Based on the last sales figures, Jammy is scooping over 833% of revenue.

Most impressive.....

1 Gibson = 387,234 cans of Fortacin at current exchange rates.

Being a centralised classification switch the EMA is responsible for the process, but requires input and acquiescence from each member state. There are significant national differences towards OTC classification and switching, which in part accounts for there only being four successful centralised applications in over ten years, all for products with five years or greater in the marketplace. Even Pfizer, with thousands of man-years worth of Viagra data could not get past the post.

If, as is likely given the paucity of safety data and post-marketing experience, reclassification is rejected, this will impact on any future national application. To repeat an earlier observation, this is desperate stuff, and, if any more evidence were needed, it simply underscores how peripheral Fortacin is to Recordati's business.

The clinical trials website is run by the NIH, not the FDA. Updates are the responsibility of the study sponsor. Status is usually updated by NIH within 2-3 days of receipt of the update.

It's not unusual for sponsors to be lax in submitting updates, and certainly possible that the study has, or is close to completion. On the other hand, recruitment is never easy to predict and a December finish may have been all too optimistic if recruitment rates declined in Fall/early winter.

Disclosure of study results is down to RP. A savvy small cap might push out a release to the effect that a study has been successfully completed with respect to meeting the primary endpoint, although it's the FDA COA decision on the full PEBEQ qualification package, some 6 to 10 months post study data submission that's critical.

Alternatively, forward the email to another account. If you can see the image, right click and copy the source address.

The "cid" prefix indicates that it's an email embedded image (in png format). You can't link directly to it.

Try opening the image in the email (use a browser) and forward the corresponding URL.

Dearie, dearie me....we are confused. You'll be sharing accommodation with Bunion next.

Allow me:

1) Recordati Ireland is a subsidiary. In Ireland. It handles the legal and commercial aspects of the European pharma business

2) "Centralised procedure" means the whole of the EU. You can find a list of member states on the internet. Ireland is a member state.

3) The reason that there are no launches scheduled is because, after 20 months, and in core territories with active field forces and national promotion efforts, they can't shift more than a large carrier bag's worth of wee cans. Fortacin is about as popular in Europe as the Black Death was in the 14th century.

Clear enough?

Bothwell, thanks for sharing.

So it's embarrassment that's the problem....That must be why Viagra sales were so constrained in Europe that Pfizer waited 20 years to go OTC. In just one country. And a switch to pharmacy only status still requires consultation (face to face for retail, although questionnaire sufficient for online purchase).

As to the benefits of DTC, true, you can (in contrast to Rx status), use the product name, but you can only make substantiated claims, and cannot make reference to other products or guarantee efficacy. Fortacin could reasonably be claimed to be "fast acting" but not a general PE treatment (since the label indication is lifelong PE), nor for all men (no over 65s in the pivotal studies).

Effective DTC is expensive and with OTC products being freely priced, retailers can set their own margins, and there will necessarily be a price reduction to bring it closer to the basket of existing OTC treatments. Sustained promotional spend, retail pharmacy training and significantly lower unit cost does not make for an easy return. On the other hand, it could bring more online distributors into play, although that also has pricing implications.

EMA timeline roughly correct if the amended RMP already submitted (runs about 70 working days from post validation of the application). But what was JG on when he wrote the rest of that paragraph?

But let's not forget the real story here. Projected Rx sales are so dire that Recordati is actively exploring a shift to a low margin/higher volume model at a ridiculously early point in the product lifecycle. Any guesses as to what's going to happen when they are forced to stick with an Rx label? And what does this tell you about Fortacin/Senstend's chances in other markets with significantly lower levels of Tx seeking and health professional to punter ratios?

More than welcome.

I was able to discuss this with regulatory colleague with past experience of Rx to OTC switching, and she too has never come across one contemplated so soon after launch (and in an indication with notoriously low levels of Tx seeking).

Her take that is that Recordati will be heavily reliant on historical safety data from lidocaine-prilocaine cream (EMLA), which is a pharmacy only medicine in several countries, and that a large body of product-specific safety data (from "real life" use) and large efficacy and safety datasets encompassing individuals not represented in the pivotal study are essential.

Recordati intends taking this through the centralised route, which involves submission of a Type II variation (covering non-clinical/clinical data, safety, efficacy, formulation, risk management plan). Timetable guidance is provided after the pre-submission scientific advisory meeting and will depend on the breadth and depth (or lack) of data.

As to "good news", you need to consider this development in context. An Rx to OTC switch generally occurs towards at the the end of the product lifecycle/close to loss of market exclusivity, where there is an extensive safety base and with a strong and established brand. For example,Pfizer took 10 years from launch to submit a Viagra switch, although this was quickly withdrawn when they could not satisfy EMEA concerns (even with a 35 million man safety database and data from 120 clinical studies). Almost another decade went by until "Viagra Connect" was accepted (via the national route) as a pharmacy only medicine.

That Recordati would contemplate a switch after less than 2 years after launch through a centralised procedure, with next to no post-marketing experience, and with none of the deficiencies identified in the EPAR addressed, is unprecedented (and unfathomable). While there was never any great expectation around Fortacin, it now appears to have been written off as a promotable Rx product, with classification switching being a last and desperate kick of the ball.

Ah, dear old Bunion- how's the Aricept working out for you?

And that's certainly no way to refer to Recordati's commercial director- I think his or her opinion to abandon Fortacin as a viable prescription product is perfectly valid, even if they are in for a frosty reception from the EMA with respect to the paucity of data, although a Pharmacy only designation might be achievable in some countries.

With the urology franchise winding down, makes sense to throw it in with the other small fry in the OTC portfolio, with the hope that it might bob along at €1m or so each year, with a hefty reduction in wholesale pricing necessary if they want to take this out through retail chains. Still, better than deep-sixing it entirely, although that might still be on the cards.

Possibly a world record in attempting an OTC switch within 21 month of launching as an Rx product. The other piece of record-breaking being that PLE/RP have managed to get every single prediction concerning the "value proposition"- pricing, uptake, KOL engagement, patient satisfaction- so utterly and completely wrong. Looking forward to RP's explanation of the Recordati decision.

From the EMA Pharmacovigilance Risk Assessment Committee Agenda this week:

Applicant: Recordati Ireland Ltd
PRAC Rapporteur: Maria del Pilar Rayon

Scope: Change in the legal status from ‘medicinal product subject to medical prescription’ to ‘medicinal product not subject to medical prescription’ in view of the safety profile of Fortacin (lidocaine/prilocaine), the post-marketing experience already available with other medicinal products containing amide local anaesthetics and in view of making the medicinal
product more accessible to the target population.

May not happen, given the lack of chronic toxicity data (and that other lidocaine-prilocaine products are all Rx), but looks like they've given up on getting traction among prescribers or trying to differentiate it from €5 knob sprays.