Incorporation in Ireland is a hedge against no-deal Brexit issues relating to additional testing and packaging requirements for the importation of pharmaceuticals from non-EU countries. For example, the QP responsible for batch release has to be in an EU member state, packaging will need to carry new registration numbers.
More or less correct. It's an "informed consent" submission, meaning that it's made with the permission of the MAH, Recordati. It allows RP to submit EMA data under their own drug name/trademark where mutual recognition procedures are in place and to obtain a "certificate of pharmaceutical product" (a comfort factor for the importing country with respect to manufacture, drug strength, pharmaceutical form: CPP is a prerequisite for registration and not a substitute for a full dossier).
The Senstend trademark was granted back 2016. Fortacin is already claimed in China and several other non-Recordati countries and Plethora abandoned the US application a long time ago, and Senstend has been prosecuted in the US, China, Australia and other countries. The Fortacin trademark is registered to Plethora in Hong Kong (since 2018).
Nice to know that POM is still hoping that this dog will eventually have its day (if you are reading this, hope all is good with you). And, was I right or was I right about the rate of uptake in Europe?
Bothwell, yes, if you believe that Fortacin revenue is critical for RP's continued survival.
I can bang on about my rationale for this statement but instead I'll leave you with a quote which I've used for years when teaching pharma business development. Ironically, it's lifted from an analysis of Viagra market development:
"“The single most revealing measure of an innovation's economic value is the market's response to it.” (Alison Keith)
As usual, too little detail to divine the true state of affairs, but with only around 27,000 canisters sold in H1 of the second year of launch (in a territory now comprising six countries with a combined adult male population of over 106m), safe to say that wholesalers remain understandably indifferent to the “next big revolution after Viagra" (copyright MG Wyllie 2017). Wonder if he uses a Betamax recorder to catch up with The Great British Bake Off?
And what's with this "relaunch" malarkey? Certainly no evidence of new initiatives directed by the various national subsidiaries, unless you count an exclusive distribution agreement with a certain UK-based online pharmacy.
Having used Ipsos myself for market development support, I don't doubt the quality of the survey data but it's a very strange brief. Why focus on PE patients when it's prescriber perceptions that make or break a Rx product? As my dear old grey-haired grandma used to say "Punters don't prescribe. Prescribers prescribe. And you can't promote to punters".
I strongly suspect that very few of the interviewed sufferers had any experience of Fortacin, but, if the statement that only 40% of cats prefer Fortacin is to be believed, that makes it half as popular as Whiskas and suggests a higher early discontinuation rate than for SSRIs. This does not inspire confidence in a business plan which assumes chronic use and repeat scripts.
As for HK, the delay is possibly due to sprays not being terribly popular at the moment (thinking high pressure water, tear gas, pepper, dye....). And still no update on the TFDA bridging study submission.
It's generally Bunion's posts that make me laugh out loud, but this had me spraying Earl Grey all over my keyboard.
NDA submission (if at all) before the end of 2020 is, and remains, complete nonsense (and at odds with the estimate given in the PLE accounts signed off on 26th July, which at least recognises the time necessary for COA review). Is JG mistakenly referencing a typo in the RP release?
The statement regarding pivotal study size, if relative to the Phase II study, is equally nonsensical. However, allowing for JG's butterfingered grasp of all things study-related, it's possible that he means smaller than the two previous pivotal studies, not impossible since the expected delta between treatment and placebo groups and drop-out rate are predictable and power can be tweaked accordingly, although risky when you are dealing with multi-centre studies and multiple secondary endpoints.
As for "stock replenishment", canisters delivered to wholesalers at launch 18 months ago have now expired- wonder just how many thousands are sitting in recycling skips? And whatever happened to scale-up (no corresponding variation has been submitted)? Still unresolved "impurities" issues or simply not worth the faff for such low volumes?
All credit to Bignose for sharing, but the linked article dates from 2016, prior to the 21st Century Cures Act, and consequent changes in the FDA review process and a shift towards "patient-centric" drug development, with revision of the clinical outcomes assessment process being of obvious relevance.
The current FDA process should be viewed as a work in progress, with further major and minor revision anticipated as the 21st CCA is interpreted/reinterpreted and implemented over the next eight years.
All pharmaceuticals have, to a greater or lesser degree, safety concerns and Fortacin is of course no exception. Specific issues (drug interaction, age or disease-related hepatic impairment, potentially carcinogenic metabolite generation) and deficiencies in the safety data are clearly referenced in the EPAR.
The EMA took the reasonable and pragmatic view that outstanding concerns could be addressed through labeling and mandatory post-marketing studies. Recordati were able to wiggle out of the latter due to delays in marketing and absence of real life usage data.
The gamble is that the FDA (assuming "bother" is accepted in support of label claim) will also be pragmatic in consideration of a safety package comprising old and less than comprehensive data. Personal view is that, at the very least, it will require strong reassurance with respect to the metabolite questions and risk assessment around partner transfer. And let's not forget satisfaction of the crucial combination product rule.
I wouldn't read anything in to it- many clinical studies go months (or even years) without an update.
The rate-limiting factor is not "reluctance" per se, but the stringent subject selection criteria (limited to lifelong PE according to the ISSM definition, with a population prevalence of only a few percent, plus a raft of other exclusions), hence the need for a relatively large number of sites (18 listed) to recruit for what is after all a small (100 subject) pilot study.
Interims released this pm, bigs up the recent rare disease acquisitions and underscore the commitment to orphan/rare disease expansion (both by portfolio and geography).
Still apparent growth in Urorec revenue, although not clear whether this is through volume or price increase, but might mean that the urology field force in mature markets may not be wound down immediately.
That's a bit harsh- RP is equally inconsistent with inaccurate information.
I see that the famous Gibson time dilation effect is still in effect. Good show if the validation study will complete early, but since there is no fixed timeline for a full COA qualification package review (and with the current street estimate being 6-10 months), a Q1 2020 start for pivotal study work is pretty nigh impossible. And let's not dismiss the risk around submitting what is no more than a pilot study for an otherwise untested endpoint.
Assuming there's not a typo in the dates, you are looking at the shortest Phase III and NDA submission in history:again, pretty nigh impossible. RP have eluded to a single pivotal study, but outside of cancer and high need conditions, the FDA requires two studies (and historically, this has been the case for the few PE pivotal studies submitted in the last decade). And when are they planning to address the combination product rule question?
China timeline is close enough - 60 day IND review if nothing amiss with the submission, but there's no allowance for a pre-IND submission meeting, so add another 30-60 days and call it sometime late Q1 2020 until the NMPA response. Still no mention of the Taiwan FDA bridging study requirements.
As for the possible involvement in indigenous hemp/CBD production, hard to evaluate without more detail. Hemp production and CBD extraction are strictly regulated but there appears to be an increasing number of licences granted to Chinese companies. Hemp seek, oil and CBD are legal for use in cosmetics (but not ingestion), and not for medical use
The Chinese require animal testing for cosmetic approval (leading to a complex importation route for foreign cosmetics, although readily navigated by the majors) and no medical or wellness claims can be made that might assist with product differentiation. Chinese cosmetics do not meet EU or US conditions, so not possible to export finished product. So, all down to hemp/CBD export from China into increasingly competitive/self-sufficient markets?
All been written before, but Fortacin was acquired on the strength of being no more than a low-cost add-in to support an ageing urology franchise and perhaps squeeze a bit more out of an established field force.
Initial promotion was in line with what would you would expect for a minor product with well-recognized constraints on uptake: the early abandonment of active promotion may, in part, be due to realization of just how high the barriers are, but more likely reflects the bigger picture of abandonment of the urology franchise in developed markets (crucially, Italy, France and Spain) with the loss of Urorec exclusivity.
You are right to be wary of the developing competitive market. China (after Japan and Korea) has been an important market for the high-end cosmetics companies for several years and they already have well-developed marketing channels which exploit social media.
In February, China banned cosmetics companies from making "medical" claims, so CBD facials, shampoos etc will, as in other countries, be promoted as luxury products, with perhaps a nod to "natural" ingredients, through existing tried and tested channels. While a social media/infomercial approach is the way to go, I'm skeptical about early-mover advantage claims, since"early" was years ago for the big brands.
A major brake on the Chinese, and other, markets is regulation (or the current lack of it). The FDA are still in the process of developing guidelines for CBD consumer product safety assessment and evidence in support of wellness claims; other, less resourced, regulatory agencies have not even reached the roadmap stage. It's a far from static situation, but from past involvement in establishing OTC product and dietary supplement claims, it's going to be a long haul to regulatory clarity.
Small fry like RP might find eventually find a niche in the Asian CBD market, but the safety shot is to assume a long timeline and modest turnover (and not to forget RP's track record with regard to market predictions).
@the_italian- cannabinoid investment overview from Edison in my mailbox this morning (CBD gets a mention, but largely covers psychoactive products).
Own experience of CBD is confined to investment for medical development (cancer, cognitive function) although I have reviewed several consumer product (cosmetic/wellness) investor pitches for non-Asian businesses and have a passing interest in the bigger picture.
Ironically, while, along with Canada, being the world's largest producer of cannabis (as hemp) and with hemp seed and extracts being traditional medical ingredients for tens of centuries, China is still a long way from liberalizing CBD use (although legal in Japan and Korea). A usually reliable investment bank source estimates annual sales of CBD consumer products in China to be under $140 million.
US consumer CBD brands are busily looking for new markets ("wellness" and cosmetic claims are regulated in Europe and need to be backed with solid data, making Asia more attractive. US legislation is a work in progress, with federal law at odds with state law. The FDA has still to produce guidelines for ingested CBD products).
Product awareness is currently very low in China, and it's entirely credible that market development will be heavily reliant on social media. As a B2C/B2B operation, Yooya might pick up a portfolio of brands, although social media promotion is highly competitive and revenues would likely be modest and slow to develop (possibly more lucrative in other Asian countries?).
The few sanctioned Chinese CDB producers are understandably focused on the US as their main market, and personal view is that it will be years before there is a domestic market for locally-produced CBD consumer products. This might change as the 2018 Farm Bill will result in more US-produced hemp, in turn reducing export opportunities.
For what it’s worth, the HK marketing authorization was transferred to OEP last week. While this does not signal imminent launch, at least the process is ongoing. I’d expect to see something on the Taiwan registration process and bridging study timeline by mid-year.
If the PRC approval timeline in the recent presentation is to be believed, the next milestone payment will not be made until sometime in Q1, possibly Q2, 2020 (“late” 2019 submission, 90 day NMPA review). RP might see the full whack, but also possible that, with the conditions around the IND/CTA acceptance, it could be as low as $1m (refundable upfront, with 50% reduction in milestone).
No mention whatsoever of Fortacin in the Recordati Capital Markets Day presentation this morning. However, there is some detail on the future of Urorec which will have direct consequences for the urology franchise.
Generic competition will cause sales to fall off a cliff over the next two years and Recordati will only continue direct detailing in promotion sensitive markets (essentially developing markets).Since the other urology products contribute buttons to overall franchise sales, there’s bound to be a reduction or redeployment of sales teams, meaning that Fortacin promotion will remain essentially passive.
Dear old Bunion...allow me to address your understandable befuddlement.
CCGs use a "traffic light" system to provide guidance on the appropriate prescribing of products in primary and secondary care: Red, Amber and Green coding is joined by Grey and Black, the former indicating that a product may only be prescribed "in exceptional circumstances”, the latter "not recommended for use". Coding does not mean that a product is necessarily included in a local formulary.
CCGs (NHS England) have concluded that there is insufficient clinical evidence to recommend Fortacin over licensed or off-label alternatives. There is of course no NICE or SMC guidance on Fortacin and no submission has been made in Wales.A quick search will retrieve dozens of relevant CCG reviews or you can look up your local CCG’s decision.
For example, to cite the Greater Manchester CCG "black spot" decision of February this year:
“The clinical importance of the evidence for Fortacin spray is not clear, and there is potential for adverse effects for men and their partners. There is not sufficient evidence to support use of off-label use of other products over the licensed product. Over-the-counter options are available”
In short, there are too many unknowns around Fortacin's relative efficacy and safety, too few potential prescribers and a very low level of treatment-seeking to warrant the expense of a marketing campaign for what is, after all, a minor product.
Professional indifference means that Fortacin distribution in the UK is essentially limited to online pharmacies offering remote consultation, with promotion being subject to the same restrictions as for any prescription medicine. I suggest that you track down a copy of the MHRA Blue Guide.
Sales, at least to end 2018, are no great mystery.
RP declared royalties of Euro 120,000, being 15% of net sales (Euro 800,000). Average wholesale price is Euro 23.5 per canister, so that's a smidgen over 34,000 canisters from February through December 2018.
The unknown of course is how many Fortacin canisters are still taking up space in wholesalers'' warehouses, although, being a non-reimbursed product, Recordati is probably as much in the dark as anyone, but not something that's likely to keep its Board awake at nights.
With the adult male population of the five core territories being around 83.5 million (with, according to RP's play skool riffmatick, over 20 million men a weepin' and a wailin' over the demon PE), it's safe to say that wholesalers are not exactly caught up in the excitement. And this in the most developed market in the world for PE pharmacotherapy.
As to UK PR, why would you even bother? Fortacin is uniformly black or grey listed by NHS CCGs, with insufficient clinical evidence to change this collective decision, or otherwise make any impression on the minority of urologists in full time private practice.
Add in the Blue Guide limitations, and apart from largely useless infomercials, there's little you can do to get Joe Punter (or even Mrs Punter) kicking off their carpet slippers and racing to the GP.
I appreciate that the office junior has been really busy of late, what with the Financial Results release, Annual Report and all, but long past time that a designated grown-up was made responsible for checking his or her copy/paste efforts.
Too many chestnuts in this laugh-a-slide presentation to count, although it's astonishing that a year after launch, they can't even get the European out of pocket cost right.
I do wonder about the purpose of these "presentations"- some sort of corporate psychological reinforcement (does the fantasy become real if you set it down in PowerPoint), or perhaps a manifestation of the Dunning-Kruger effect?
Or is JG confusing "institutional investor" with "institutionalized investor"?
In all seriousness, does anyone with English as a first language ever proofread these reports?
Still the same howler regarding US submission timelines, although no reference to PRC and Taiwan timelines (I'd have expected feedback on the TFDA bridging study requirements by now, and as of three days ago, the HK MA has still to be transferred to OEP). And what ever happened to the all important scale-up from current cottage industry batch sizes?
Operations Update on p9 is not strictly accurate (Fortacin adverse events have been listed in the EudraVigilance database, although given how common Fortacin-related AEs are, it would be amazing if it was otherwise).
Reassuring that Recordati is so engaged that it's "considering" pilot (!) market research, only about two years too late to assist in launch planning (and after ducking out of a far more informative drug utilisation study). I don't expect Fortacin to get a mention at the 9th May analyst/investor presentation, but there might be more clarity around the future of the urology franchise, with the planned managed decline in Urorec sales.
Current exchange rate: 383,000 Fortacin canisters = 1 Gibson.
I wouldn't get overly excited.
Bunion's "recollection", (nice to know that he's still doing OK on his MMSE score) refers to the SimplyWall website, an Australian startup that uses autobot generated company profiles to drag in punters.
The "street" part is the .st domain name.....a small, but important detail and, granted, certainly enough to confuse the hard of thinking.
So much for the popular misconception that the internet is a more of a danger to young people....