Member Info for Alquemie

Recordati never disclose actual sales for anything other than their lead franchise (>5% of turnover) products so I would not hope for an update on Fortacin before the RP interim report.

Fortacin doesn't even get a mention in the last corporate presentation as a new product launch, although that's in keeping with past minor product launches (Vitaros/Virirec, for example), and there's a palpable shift in corporate emphasis towards the orphan and rare disease pipeline.

And, to repeat a point I've made before, the disclosed sales of 21.000 canisters or so is just that- bookable sales made to wholesalers and not an indicator of prescription volume. With such a small treatment population, it's going to take a while for wholesaler held inventory to find its way off the shelves, so don't be surprised if the number of canisters sold since launch does not change much in the next update.

Always difficult to predict the sales trajectory of a non-reimbursed product, the only certainty being that it's much flatter than for reimbursed products. The true story with respect to sales dynamics might not become clear until at least three years from launch. It's no coincidence that Recordati opted for the delta between RP's estimate and actual sales after three years as the trigger for the clawback arrangement.

I wouldn't be overly concerned- delay is not unusual, particularly with a small generalist CRO which is likely to be heavily reliant on contract staff and a network of local investigators to pick up the slack.

Having said that, I do get the sense that for such a mission critical study, it's been pared back to the bone with respect to subject numbers and the time on treatment. It's not a question of the drug not working, but that, since the outcome is based on subjective response, the numbers might be insufficient for validation. First to admit that that's opinion, not an expert commentary.

I wouldn't count on the DBC to save the day, but at least someone appears to be thinking about how to get into the game.

There's no compelling evidence for plantar compression as a means of reducing post-operative complications but it's a much easier indication with respect to data generation than diabetic ulcer. But still a long and steep path to meaningful usage and certainly no money fountain.

The US study remains marked as not open for recruitment, a bit puzzling given that it was submitted for registration back in mid-June and that it's a relatively simple study set up.

From experience, most single site delays are down to staffing shortages, followed by budget or contract issues. Drug or placebo supply might cause a hold up, although Catalent have produced PSD502 clinical trial material in the past (and the 20 dose "insurance" batch to avoid the EMA sunset clause) without problems.

Possibly only of passing interest, but there appears to be a bit of reinvention going on within the moribund DBC, with a switch in focus from diabetic ulcer towards post-surgical recovery/complication reduction in lower limb vascular surgery patients.

This makes some sense in that there's next to zero evidence that plantar compression is of benefit in diabetic ulcer (a problematic treatment group all round), but a bit more credibility surrounding post-surgical benefit. There's still the issue of having no clinical evidence that the PulseFlow device works in anyone, but a pitch to vascular surgeons might get a more open reception.

The Products page looks to have been recently update on the Recordati corporate site and Fortacin is no longer listed under Germany (Urology).

There are several other local market products missing so I'd put it down to error. It is listed on the Recordati.de website, although you will not be be able to access information without a DocCheck registration.

It's most definitely available in Germany (Euro 38.40 retail).

"Official" launch was 27th April (press conference in Munich) and there is a German language website similar in content to the Italian one. Recordati also sponsored the recent mini-symposium at the annual get-together for German cock docs.

Marketing has been devolved to the national subsidiaries, although the corporate website does list country-specific products. Germany is strict on disclosure of drug information to consumers, but you can access it through the DocCheck system (I'm registered, just need to find my password!).

@Italian,

Email the study centre, (may need to tell a little white lie regarding interest).

And to put it things in context, a month's delay is not unusual in study recruitment (it's taken the best part of five years even to get to this point).

Looking at the protocol, I'd be more concerned about it being a single centre study (this can slow recruitment since geographical "capture" is limited) and that it's woefully underpowered for a placebo controlled study, particularly for an untested PRO (I'm not an expert in trial design but I do know enough stats to be dangerous).

Can't help but wonder if this is being run on a shoestring.

Not according to the single study centre involved in the study.

You can contact them directly to verify:

https://www.smartpatients.com/trials/NCT03578783

Do I have to pay online or can I just slide the cash into his stocking top on the day?

Ah, yes...the glamorous lady aviator in "Goldfinger".

She was forced to give up stunt performing after flying upside down caused a crack up.

I'll get me coat.....

The skin graft (but not the minor burns) study is referenced in the full EMA EPAR, which suggests that data was never obtained.

But there is another no-PE study listed, conducted in Poland and evaluating pain reduction in woman undergoing visual examination of the uterus, and for which some data must exist. Who knew?

Ezzza, having re-read your post, I've realised these reference different studies, the EudraCT listed protocol being in subjects with acute minor burns, while the ISRCTN study (for which the pilot was completed) being in skin grafted subjects.

Pain reduction in acute minor burns would have been a simple study and would have (largely) minimised the risk of toxicity. This could have been done as an investigator-led study at minimal cost. Wonder why it was abandoned?

The study was definitely abandoned (the EudraCT entry has not been updated: I use the ISRCTN registry which is more current). Also the study protocol was later amended (multi-centre, larger number of subjects).

More than 12 years to complete a Phase II would be unusual, even by PLE/RP standards. I did notice that recruitment for the US validation study has yet to start.

Ezzza, looking back at my diligence notes, there was a indeed a small study in burns patients and a corresponding press release (August, 2006).

https://www.investegate.co.uk/article.aspx?id=200608080700363690H

According to the clinical trials registry archive, the intention was to conduct a Phase II study in two parts: an open-label pilot in 8 subjects (which I'm assuming was reported in the release), and a larger placebo-controlled study (up to 45 subjects). Listed as "abandoned" but no reason given.

The endpoint was reduction in morphine use.

Lord knows there's still a need for non-opioid pain control, but I suspect that, along with recruitment issues, there may have been concerns over prilocaine toxicity (also from lidocaine, although to a much lesser extent) when treating large areas of grafted skin for long periods.

Given the way he appears to have been sidelined by RP, a "Dr Mike" would contain a big measure of bitters....

You could try a "Jamie Gibson":

Mix four parts salary with one of bonus, leave completely unshaken by shareholder outrage, garnish with a sliver of Mellon.

More than welcome, although I'm sorry if it's spoiled your (or anyone else's) day.

After over 25 years in pharma valuation and licensing, I'm the first to admit that all valuations are wrong, but I'm very confident when it comes to placing error bars. I could be out by plus or minus 40% (the industry range), but not by an order of magnitude.

The "lifestyle" market is a bit of a myth and seems to be based on a complete misunderstanding of ED drug market development. True, four years from launch, a number of new prescriptions in the US were being issued to men who did not meet the strict criteria for ED drug use, but this constituted a very small proportion of overall sales.The picture was very different in Europe with health system rationing and no reimbursement.

You would need to be very strongly motivated to undergo (and in some countries, pay for) a urological assessment just to get access to a product almost identical to something you can get buy from any pharmacy or online for Euro 5.

Fortacin is a decent product in the context of other PE treatments and could find a solid niche as a second line treatment. I believe that Recordati will continue to market it as long as the larger urology franchise remains profitable, but with a minimum of prescriber-focused promotion.

And if you need to mix a Gibson to cheer yourself up, I'd recommend an "Old Tom" style gin (Jensen's is good)- big on botanicals and no sugar.

I'd go with "very minor".

Canisters, closures and valves are purchased from one of several bulk suppliers (such as Bespak or Presspart). Possibly just a change of supplier, although if the reported low yields are down to leakage (the reason canisters sit for 2 weeks post-fill), this might have prompted a change in closure or other part. Alternatively, change in canister volume to accommodate change in headspace.

@ The Italian - I believe the Gibson (not to be confused with the classic cocktail of the same name) is gaining international popularity among the megarich:

Mrs Oligarch: "Viktor, do you have any small change, I need to pay the milkman"?

Mr Oligarch: "Da. There are a couple of Gibsons on the dresser. Take what you need".

As for arithmetic, the fatal flaw in PLE/RP historical estimates is that they are based on lifetime prevalence ("have you ever experienced PE") rather than point prevalence ("do you currently suffer from PE?), and assume that all men with PE represent a treatment pool, when the reality is that not all men with PE are bothered by their condition and the number actually seeking and accepting treatment is very small (indicated in all PE/sexual dysfunction studies, regardless of country).

I've used Germany as an example as there is high-quality survey data available (almost 2,500 participants), which, importantly, used a broad PE definition to capture those bothered by their PE (14.5% of those surveyed) rather than the narrow clinical definition. Of those bothered by PE, only 10% sought medical advice and of those, 70% received medical treatment. You can download the publication here:

http://tinyurl.com/ya8oguh2

German male population (18-64 years) is 25.3m. If we assume uniform prevalence and treatment-seeking across age groups (it's not, but we can ignore the error):

25.3m (male adults) divided by PE point prevalence (14.5%) = 3.66m men "bothered" by their PE. Ten per cent seek treatment (366, 505 men), and 70% accept treatment (256,554 men). Adherence to PE treatments (and ED treatments) is low, so the treatment pool remains more or less the same size, with new treatment seekers replacing those falling out of treatment.

Of those under treatment, around a third will also have ED or other co-morbidity. I've assumed (perhaps generously) an even split between oral and topical medication for the remainder, with Fortacin taking 50% of all topical prescriptions or 15% of the entire treatment pool:

256,554 multiplied by peak uptake (15%) = 38,483 men on Fortacin, at Euro 24 per canister (wholesale price), with an average use of 3 canisters per patient per year, = Euro 2.77m, 15% royalty gives Euro 415, 617 (approximately 0.33 Gibsons, at USD 1.5m = Euro 1.27m).

The EU5 calculation is identical, except I've averaged out national PE point prevalence (12%).

Sensitivity analysis (number of scripts per year, second-line treatment capture) doesn't change the overall conclusion that, without a massive increase in treatment seeking (1000-2000%?), revenues cannot reach the giddy levels projected by RP. Given time, sales might be more or less in line with the value reflected in the Recordati deal.

Whoa,there- rogue line in my spreadsheet.

Should have read Euro 416,000 for Germany (0.33 Gibsons). and for the five core territories, Euro 1.19m (0.94 Gibsons) at 15% peak uptake and a 15% royalty.

Wholesale price of around Euro 24 is certainly much lower than I anticipated (although out of pocket cost will be significantly higher), particularly as in real life, 12 doses is a two month or more supply. Not reimbursed, so scope for future price increases.