Member Info for Alquemie

I would imagine that the shareholder relations dept might be pretty busy right now...

http://tinyurl.com/y8vyrdhq

Fortacin product codes and wholesale prices have been listed on the Greek and Romanian national formularies for a while, although this does not necessarily mean that launch is imminent.

The value of Fortacin is in refreshing the existing urology franchise (a new detail gives reps an opportunity for more face to face sales time) and I'd be surprised if Recordati did not launch in countries where Urorec is currently promoted through a sales force.

Vitaros (Virirec) was predicted to bring in something north of Euro 10m within the first two years, but four years later, only bobs along at around Euro 2.5m. This hasn't deterred Recordati from launching it in all of the countries to which they have rights and where they have direct urology sales.

Impressive. Most impressive. Obi Wan has taught you well....

I ate his liver with some fava beans and a nice Chianti....

(there's a pharmacological joke in there- anyone spot it?)

Correction- Hind Wing do claim to service China, although looking at the product offerings, does not have the whiff of a major operation.

http://www.hindwing.com/eng/aboutus.php

@sldmr, you can already see the impact of the ongoing CFDA/CNDA reforms, although this is confined to high need (cancer, rare disease) drugs where there has already been a Chinese study prior to EU or US registration.

Timelines should eventually reduce across the board, but will still entail at least two studies (Pk, then pivotal, although the latter could be as small as 200 subjects depending on label claims).But I think you are still looking at five years from submission.

I can't see hordes of mainlanders pouring into HK and Macau for urologist appointments. According to the HK submission, Fortacin is a Part I (prescription only) medicine. I had thought that, as with other lidocaine-prilocaine products, it might have slipped by as a pharmacy only (no script required) medicine. The authorisation is held by a local distributor, Hind Wing Co, which serves HK and Macau (but not the mainland), largely minor products from foreign companies. Does not mean that they will be necessarily be the eventual distributor, only that they served as a flag of convenience for the application.

Apologies- I should have been clearer in my reply.

Since RP are apparently contemplating undertaking the IND submission, then it suggests understandable reluctance on the part of a prospective partner to take on any additional risk.

Alternatively, JG has finally realised that, in the absence of holding any licensable asset (no intellectual property or future market exclusivity), then future ownership of the marketing authorisation offers more scope for partnering than would a distribution deal.

That's "investigational "new drug application.

As a "foreign-developed" product, Fortacin (or however it's designated in the ex-Recordati territories) needs to go through the CFDA submission and review process before approval is granted for national clinical studies (mandatory for registration).

As to significance, it lays to rest the whimsical notion that there is any "backdoor" into China that does not entail working through the CFDA process, and secondly , if RP are in "advanced active discussion" with a Chinese partner, then they look to be unwilling to take on the heavy regulatory lifting.

I'm surprised he has the time.

I thought he would be hard at work in a warehouse in Aylesbury, sewing fake Nike swooshes onto surplus footwear.I I wonder if they'll use the RP company motto on the boxes- "Just Not Do It"?

MattD78, I can vouch for the email address being genuine and active a year ago.

Can't blame JM for going dark, probably has the press crawling all over him on the strength of his peripheral association with Mr Banks.

No problem. A CCG is a NHS (England) Clinical Commissioning Group.

CCG's decide which drugs should be included on regional formularlies and the conditions for use. In the case of Fortacin, CCGs have concluded that, in the absence of a national appraisal by the National Institute of Clinical Excellence (NICE), there is insufficient evidence to prescribe it and/or that it's not likely to be cost-effective.

CCG opinion is generally revisited every two years, but while the future cost of Fortacin may be lower than the £100 launch price, there's still not likely to be sufficient data, particularly comparison with other treatments, or long term chronic use data to satisfy NICE or individual CCGs.

The UK has never figured in Recordati's plans (there was not even a UK launch sales milestone in the agreement), so no real commercial impact.

???
The agreement with the PLE-appointed UK licence holder, JSS, was terminated last November with the transfer of markeing authorisation to Recordati.

Recordati have no sales operation in the UK and with every CCG blacklisting Fortacin, there's no incentive to introduce one. Technically, an internet pharmacy might still acquire product through parallel trade, but the volumes would hardly make it worthwhile.

As for the bigger picture, Recordati are promoting in line with the product: national language websites, a presence at national cock doc get-togethers and the odd (paid for) puff piece in learned journals. As a prescription product, step one is to engage professionals, not the great unwashed.

Listing looks to be chronological rather by quantum, with Reaglla being the most recently launched.

Small comfort, but Urorec revenue is still increasing, and while this will change on loss of exclusivity, it's likely that the urology franchise will remain a significant contributor, so no obvious reason not to continue promoting the raft of small sale corporate and national products that make the best out of the call points.

Report posted ahead of conference call.

http://tinyurl.com/ycr3bret

As expected, no mention of Fortacin other than in the context of being part of the portfolio and that the Euro 4m milestone was paid in the period.

Well, the "disgruntled" part is spot on, although that's at life in general....but nothing that the hands reaching beer o'clock can't put right.

Of peripheral importance, the DBC accounts have finally been filed, making for very grim reading when considered in the light of Mr Mellon's bigging it up and related party transaction support. In fairness, he is, for once, using his own small change to keep the lights on.

http://tinyurl.com/y7dwu9hf

So would you if you found out you were no longer on Vlad P's Christmas card list.....

Prof, being worth around $1 billion a year in its heyday, My Little Pony certainly outshines Red Rum.

But, over the mile in heavy going, I know where I'd have put my money.

And rumour has it that you could always get a better price for "recovered meat products" from Findus than McDonald's.

As for the Board offering themselves up as los hermanos penitentes, I suspect that they are far too thick-skinned to feel the benefit.

Prof Z, you did make me laugh with your take on the equus moribundus metaphor, but certainly makes better sense that the BoD flog a live horse.

Trouble is, they promised the world the next Red Rum when it was actually my My Little Pony trotting around the paddock.

Sales milestones are not time-limited, but triggered when aggregate sales reach an agreed level. It's possible that there's a limit set by the term of the agreement (10 years), but more likely to be open-ended since there is scope for continuation beyond the term (with RP receiving a low royalty).

The original sales milestone triggers (at Euro 200m, then Euro 450m) were unobtainable and set ridiculously far apart. I'm assuming that even JG had the commonsense to renegotiate much earlier lower aggregate triggers in line with the overall reduced value of the deal, with the Euro 15.6m split over three or more milestones, say Euro 30m , Euro 60m, Euro 100m, Euro 150m aggregate sales.

This, plus lower tiered royalty triggers, would be far more valuable than a face-saving clawback, which, if I've read the restated agreement release correctly, if triggered, resets the sales milestone aggregates back to their previously unfeasible trigger levels, ditto the tiered royalty triggers.

Comedy gold.......

For what it's worth, I still think there will be further launches in countries where Recordati have a urology franchise (Vitaros was launched in several countries despite negligible sales), and while this will not add much to RP's cash flow, the news (if JG remembers to get a release out) might stop the SP slide.

You need to use the net wholesale price in your calculations (varies slightly between countries, but Euro 24 is close enough).

On the assumption that the restated agreement preserves the original value split, then the aggregate sales triggers would indeed have to be reduced, as would the annual sales figures for triggering an uplift in royalty rate.

Playing around with some simple licensing models, I'd expect the first aggregate trigger to be around Euro 25-30m, and, assuming the same structure as the original agreement, the second trigger around Euro 125m. I have to admit that I can't get my sums to add up to exactly Euro 15.6m without adding in additional triggers (which I would normally expect in a licensing deal where both peak sales and time to peak sales are difficult to predict, and would obviously be to RP's benefit).

The current licence terms suggest that Recordati's working peak sales expectation is somewhere between Euro 10m and Euro 15m: given the constraints on PE treatment uptake, I would not hold out much hope for the clawback.

As I previously posted, Fortacin is listed in both the Greek and Romanian national formularies, although this is not necessarily indicative of imminent launch (Fortacin was listed in Spain and other countries months before actual launch). However, at least it's ready to roll. I have,so far, not found formulary listings for Poland, Czech Republic or Slovakia, but will take another look when I get the chance.

Turkey, Russia and the North African countries (essentially Tunisia and Morocco- Algeria is more or less closed for anything other than essential drugs) all require individual marketing submissions to be made. Turkey accepts EMA dossiers, but is glacially slow (three years from submission), Russia would require an additional national clinical study, Tunisia might be possible within 12 months. Recordati has nothing like the sales presence in these countries that it has in the core EU states.