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Credit Evila on Stocktwits:
ITALY: Not sure if my interpretation of this document is correct, but VAZKEPA is on the “Agenda of reimbursement and pricing procedures at the Scientific-Economic Commission” being discussed this week (July 8th to 12th).
Negotiation type: Variations in the regime of reimbursement.
Duration process (provisional): 129 days.
https://www.aifa.gov.it/documents/20142/2468753/ODG_CSE_del_8-9-10-11-12_luglio_2024_HTA.pdf
Great find. Maybe they don’t want to affect the SP while undertaking share buyback, but if it’s material they only have a set number of days to announce. There haven’t been any SEC filings since approval. I presume there will be a milestone payment due which will be welcome in Q3.
Didn’t the PI or someone on the team say that the primary endpoints were not met after first review and there’s only a small possibility that this position would improve after analysing all the data? I’m not expecting anything impactful from BRAVE, unfortunately. Even if it’s trending positive I don’t think that will add any value or options for future development/investment. Hope I’m pleasantly surprised though.
Sleven, thanks for keeping us updated with the IPE shipments. It would be great if the generics viewed the recent opinion as potentially exposing them for inducement to infringe the CV patents, thereby dissuading the generics from purchasing and selling their generic version for CV.
Any triple damages would only apply to Hikma’s infringement I presume so there needs to be a big enough threat to stop the others from filling the gap. Let’s hope the generics’ lawyers see “clear expression or other affirmative steps” that foster infringement the same we some of us do.
It’s interesting to note too that the opinion specifically referred to Hikma’s position that “inferred infringement” is not a breach of the patent act, that Amarin had to prove active infringement. The generics are essentially saying, and I think the court recognises, that yes there is infringement but nothing to do with us. Let’s hope the balance of the Hatch Waxman act turns in our favour.
JRoon,
“If the other generics are NOT marketing their product in the same way, then no INDUCED infringement.”
I disagree.
(“[I]f an entity offers a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement, it is then liable for the resulting acts of infringement by third parties.” CAFC en banc, straight from the recent opinion.
They also confirmed this is a “run of the mill infringement case”. Nothing to do with a label or section viii carve out. They look at all actions taken by an alleged infringer to determine if they are inducing a third party to infringe. Entering into an exclusive contract with an insurer where the generic manufacturer is legally only permitted to sell to <25% of that contract is clearly inducing a third party to infringe on the CV patent.
There’s no mention of marketing. Generics are offering IPE for the clear objective of obtaining CV sales and they achieve this by undercutting Amarins prices to obtain exclusivity for all an insurer’s cover for IPE, regardless of the indication - thereby fostering infringement. JMO.
The court stated this is not a label case, it is a straight forward patent infringement case. Once generics conduct activities to foster inducement to infringe by a third party (ie by selling generic IPE to PBMs/Insurers in order to fill prescriptions for high trigs AND the CV indication), then they are guilty of infringement.
The generic label and AB reference protection is irrelevant now. It’s not just about inducing medical professionals to write and IPE script for CV indication. It’s about inducing the insurers & PBMs to infringe. The generics game is up. The court is finally aware that the balance of Hatch Waxman in Amarins case is out of whack - that if generics label only constitutes <25% of patients, then the manufacturers are inducing to infringe if generics end up with say 60% of the market. And it would have been more only Amarin had to slash prices to maintain sales.
Thanks. The headline says it all. Hikma does not have a CV drug.
Kiwi/RMB
I disagree that if Hikma left the market or were forced to leave that the generics would simply step in. This is not just about the fact that other generics did not conduct similar press releases or marketing like Himka’s that got them into trouble. It is also not just about the >500 trig label that generics are selling.
The CAFC’s opinion stated that induced infringement includes the following:
(“[I]f an entity offers a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement, it is then liable for the resulting acts of infringement by third parties.”).
All the generics who successfully competed with & caused Vascepa to either lose cover or be or at a higher cost than generics have offered PBMs/Insurance companies a lower price than Amarin. The industry (& the courts) know that >75% of IPE sales are for CV patented indication. Offering a lower price than Vascepa in a market where everyone knows the vast majority of sales goes to CV patients which generics do not have approval for would, in my opinion, meet the definition that the recent opinion outlined. The trig label really is irrelevant. Undercutting Amarin by offering a product which fosters infringement holds all generics liable. This is especially the case for whichever generic(s) are supplying CVS where Amarin has just lost 25% of sales, >75% (btw this 75% is what Hikma put forward, Amarin has pled, and has evidence that the rate is >90%). It’s up to the generics now to ensure that their product is only used for the HTG indication. They can undercut Amarin on that all they want, but can’t do it for the CV cover and it’s up to them to clarify any contracts with PBMs and insurers that the generic IPE can only be used for HTG.
Thanks North
Not to jump ahead of myself but regarding damages - does treble damages apply in this case & are they based on all generics’ infringement or is treble damages/collective liability reserved for ANDA lawsuits and section viii carve out cases?
If the panel determines that its decision will add significantly to a body of law, it issues a precedential opinion.
So they clearly wanted to issue new guidance on how patent law is applied.
This opinion could lead to all generics to reconsider their promotion of IPE and contracts. No question that particularly Hikma and also Dr Reddys are in a bind as it’s demonstrably provable that they have taken steps to foster infringement - ie persuade PBMs and Insurers to use their generic instead of Vascepa in a market where at least 75% is for the CV patented use.
Sleven, well spotted. I missed that.
Sleven,
Re the following:
DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1304 (Fed. Cir. 2006) (en banc in relevant part) (“[I]f an entity offers a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement, it is then liable for the resulting acts of infringement by third parties.”)
In all Amarins filings against Hikma & Healthnet, and in infringement articles and publications, I have never seen the above confirmation of what constitutes induced infringement. It seems apparent that if a generic manufacture offers a product to PBM/Insurer whose object is clearly to infringe & foster infringement (by offering a generic IPE whose use under a commercial contract will infringe a patented indication), then they are liable.
The more I read it it’s as if the CAFC is telling Amarin where to focus on meeting the induced infringement threshold.
And you can be sure that discovery will uncover internal Hikma presentations and sales force manuals, brochures to physicians and cardiologists promoting the generic for treatment of CV. That is, an overall strategy to get CV sales through the back door. After all, this is what generics use a skinny label for, and up to know they did it with impunity. Just my opinion & hopefully I’m not been overly optimistic.
The positives under this opinion is that Hikma’s intent and knowledge of infringement is settled. Hikma also shot themselves in the foot when they submitted to Nevada case that CV is at least 75%.
Sleven, yes that could be considered “obvious”🙈. I didn’t think of that point but exclusive contracts by their nature will undoubtedly infringe and the manufacturer really has no defence, they should be cornered in such a scenario.
If the evidence at trial supports the case that medical practitioners would view the Hikma label, together with the associated Full Prescribing Information (which outlines clinical trials experience & adverse events from Reduce IT) as promoting generic IPE for CV then that matter of fact finding would expose serious legal liability to all generics. As far as I am aware Hikma was the only one to blatantly promote CV. But if there is a finding that the label could in some way be seen by practitioners as promoting or instructing the CV indication then all generics are in trouble. I’m not a lawyer though, just my opinion.
Re settling Healthnet case. Your rationale is the only logical & plausible one I’ve heard. Assuming correct, Amarin & legal advisors clearly thought it more beneficial to go after the manufacturer rather than the PBMs.
(“[I]f an entity offers a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement, it is then liable for the resulting acts of infringement by third parties.”).
Could “other affirmative steps taken to foster acts of infringement” cover generic manufacturers where it is undisputed that the SHTG market is <25% yet they are selling such quantities as to reach >50/60%? More after losing CVS (? Can’t remember) recently.
Agree with what you say. But if the courts hold that ultimately it’s the generic manufacturer who is held liable for infringement then the generics will ensure that they don’t leave themselves open to costly damages and litigation and do whatever is needed so that PBMs don’t cause infringement of a patented indication. My opinion.
This could encompass the assertions that Hikma made in press releases and also conference calls where their CEO referred to the CV market and not simply SHTG which they were solely approved for - (clear expression promoting their product which will lead to third parties to infringe the CV indication).
Perhaps the Fed Circuit is saying hold on, if you express and make references to a market/indication which you do not have approval for then you are inducing infringement by third parties. And there are plenty of examples where Hikma engages openly about the size of the market for IPE. I think the Fed Circuit knows full well that Amarins CV patents are being openly infringed by medical practitioners, this is “undisputed” they say. And I think the wording of the opinion is narrowing who the culprit is for the infringement. I think & hope the Fed Circuit are trying to close the obvious loophole of section VIII carve outs.
It was noteworthy at the end of oral hearing that Chief Judge Moore couldn’t understand why the dosage was not direct infringement ie the 2g twice a day for both SHTG and HTG. This is where Hikma’s attorney messed up saying Hikma would have to promote & instruct all the complex steps to infringe, such as a medical practitioner having to go to the Drug Refence Manual. Amarins attorney highlighted that there was no step by step actions needed as the dosage was the exact same for both indications - all Hikma had to do was to promote the generics use for CV - and this is why I think the court kept referencing the significance of “generic equivalent of Vascepa” and the need for generic with a skinny label to be clear and concise in their communications.
Overall once Amarin obtains discovery of emails and meetings where Hikma executives refer to the CV market and their aim to capture that market, then their press releases, website and label become a smoking gun for a deliberate infringement on a massive scale. And the Federal Circuit is on to this scam. Here’s hoping anyway. The more I read the opinion the more confident I am that finally some sort of recompense will come Amarins way. They better not settle like they diid with Healthnet which didn’t achieve anything. This is all or nothing and we need a court to uphold our rights to our CV patents.
The fact it was dismissed previously doesn’t necessarily concern me. The Fed Circuit opined it was incorrectly dismissed as the law was not correctly applied. In addition, the opinion was a reversal, so the case progresses to the discovery phase. It was not remanded back to Judge Andrew’s for reconsideration.
The Federal Circuit concluded Judge Andrew’s incorrectly applied the law. He is obligated to adhere to the inferences and conclusions the Fed Circuit came to and apply them appropriately. He slow walked Amarins ability to appeal his dismissal and he got it wrong. He delayed Amarins ability to get justice by around 3 years. You would hope he may have some level of bias in favour of Amarin for this egregious error on his part.
One of the significant benefits of this opinion is it gives our legal team the key signposts and angles upon which to focus the complaint against Hikma’s induced infringement. The Federal Circuit in many ways laid out the requirements needed to achieve a successful lawsuit. And it should be easy to convince a jury that the infringement & significant lost sales and promotional/marketing investment led directly to excess deaths and MACE.
Thanks Sleven. I’m encouraged by the following:
For purposes of this appeal, it is undisputed that Amarin’s complaint sufficiently alleges (1) that healthcare providers directly infringe the asserted patents by prescribing Hikma’s generic icosapent ethyl product for the off-label CV indication, and (2) that Hikma had the requisite intent and knowledge to induce that infringement.
And:
We continue to acknowledge, as we did in GSK, that there is a “careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs.” 7 F.4th at 1326. That balance benefits both brand manufacturers and generic manufacturers alike.
References to the generic label would appear to indicate they aren’t fully protected and there could be some level of exposure there.
It appears the Federal Circuit is well aware that generics are circumventing the skinny label laws and essentially stealing patent protected sales Hopefully judge Andrew’s takes note of the Fed Circuits opinions in these regards. To be fair, he seemed to be aware someone was infringing on Amarins CV sales but seemed to absolve the generic manufacturer, let’s hope that viewpoint changes.
Tom Lynch died in 2020.
I’d say the milestone is only payable upon NMPA approval of a new indication (for CVD) rather than simply submission.
Laurent, APOE4 gene is a characteristic of subjects recruited according to Uni of Wisconsin:
“The proposed proof-of-concept study will use an 18-month randomized, placebo-controlled, double-blind, parallel-group clinical trial design to investigate the effects of IPE (available as Vascepa® in the United States) on rCBF, CSF AD biomarkers, and cognition in 150 cognitively-healthy Veterans ages 50-75 years at increased risk for AD due to their combined independent risk factors of parental history of AD, increased APOE4 prevalence, and Veteran-related risk factors including high vascular risk profiles, TBI, and PTSD.”
Brave is a phase 3 study
I’m slightly confused. These results indicated that “higher concentrations of EPA were associated with a decreased risk for all-cause and AD dementia among APOE e4 non-carriers but not among APOE e4 carriers."
However, according to Bhatt et als publication re possible other uses of EPA states:
“The e4 variant of the Apolipoprotein E gene, for example, has long been known to increase risk for AD.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537800/
And the Brave trial design includes subjects with increased APOE4 prevalence:
https://radiology.wisc.edu/research-projects/brave-epa-brain-amyloid-and-vascular-effects-of-eicosapentaenoic-acid-epa-in-adults-at-risk-for-alzheimers-disease/
So the German study concluded that EPA did not benefit those that carry the APOE4 gene, but Bhatts review and the Brave study hypothesises that APOE4 increases AD risk and the study patients carry this gene. Hope they didn’t recruit the wrong subjects! I’m sure Carlson did her research but this study appears contradictory or else I’m just misunderstanding things.
The Brave trial was designed and commenced before the new FDA guidelines on approving preclinical AD drugs were published. Regardless of what the purpose of the trial is, if the new guidelines allow for approval based off specific biomarkers then Amarin are eligible to submit, and subject to statistical significance, safety & other relevant requirements, be reviewed for approval. This is the reverse of what happened with Anchor when the FDA changed their guidelines after signing an SPA with Amarin that biomarkers would no longer be acceptable to approve reduction in MACE events.
Also - p values are a scientific benchmark for assurance on the probability as to the accuracy of the results. Whether N is 131 or 2,000, what matters is the p value when using biomarkers as the outcome. So IF the p value is statistically significant in Brave, doing another larger trial would be largely pointless, otherwise why have p values if you don’t rely on them.
We’ve apparently benefitted from changes to prior authorisation and preference over generic in NY and Texas healthcare systems yet these supposed achievements haven’t filtered through to scripts. Hopefully they will soon.
Yip, that pretty much sums it up! we’ve had nothing go our way for the past 3 1/2 years. We’re long overdue some crumbs
Especially when one set of management said FDC was a game changer and the current ones dropped it. And to be fair to Holt/Denner, they are focused on the lowest hanging fruit to increase value in the quickest time possible so they clearly didn’t think it worthwhile. All we’re left with now is
1. Brave (~50/50 IMO as if the results were not trending positive they would have stopped it given it’s very invasive with spinal taps)
2. Self emulsifying EPA (MND-2119)
3. Europe
The majority of Vascepa sales were off label prior to FDA approval of CVD, including the large ramp up from September 2018 to December 2019 so it doesn’t seem to be a major issue. Therein lies part of our sales problem - just as we received approval for an expanded label (and could look for insurance coverage) the generics won the patent suit so we didn’t get much of an expanded label with insurance so most pharmacy systems only had the v high trigs and so automatically switched to generic. I think Karim called this the compendium problem which was never fully fixed.
Wouldn’t the generics just eat our lunch on any uptick in sales as a result of positive Brave outcomes? And regarding huge opportunity with respect to preventing Alzheimer’s - we already have a drug that prevents debilitating strokes and heart attacks and guess what - nobody appears to want to pay for preventative drugs, unfortunately.
Wasn’t there a Data Monitoring Committee for BRAVE? Given the invasive nature of determining changes in the biomarkers and CSF (lumber puncture), if the data was sub-optimal the DMC would recommend a halt for futility. Given the study ran its course, this should give us at least a 50/50 chance for statistically significant results, I would think.
Can anyone give an opinion as to what the effect positive Brave results will have on the share price/co valuation? Most posters believe it will be significant. While I hope so too, Evaporate - confirming Vascepa as a liquid stent - didn’t have any impact at all. The Brave study is small & I just don’t see the FDA approving it for any AD indication. If another larger study is required then Brave would be of limited value. Also, off label scripts may rise but generics will take 40%, in the US anyway & there is zero promotion. Could Brave have an impact in EU? I’d like to hear what people think and their rationale.
Slightly sidetracking but the way Ozempic was touted as reducing heart attack and stroke by 20% as if this was exceptional is a sad indictment of the management of Vascepa. I’m convinced PCPs and a large number of Cardiologists aren’t even aware the 25% reduction in MACE is on top of statins. Boggles the mind that such a great, relatively inexpensive drug has so little traction and awareness.
KM had indicated that they would not comment on ongoing research & development for competitive reasons but there would be an announcement in H2 2023. So they are clearly working on something but not sure when it would be announced now with the new mgt. obviously they will keep their cards as close to their chest as possible and leave any announcement to the last minute.
The business is not in a viable state to sell. Who would want to buy it? The current management have to:
1. Maintain script level in US or even improve it while staying cash flow break even
2. Obtain reimbursements in key countries (France, Italy & if possible Germany);
3. Achieve script growth trend in UK and Spain; and
4. Have a viable plan for life cycle management in the US, presumably a self emulsifying capsule which could recapture market from generics & grow the market.
Then they can think about selling.
Let’s hope so. It’s the only rational way to regain any sort of a market/value in the US. Sarissa & Amarin R&D team are privy to all and more info that we have so you gotta think they would explore the self emulsifying capsule to generate an increase in value. We won’t know until they announce something & hopefully they will be some part down the road to commercialising it & that they won’t say it’ll be 3 years away.
You would certainly hope so. While the trials refer to 2019, and I can’t imagine there were too many PIII studies initiated during Covid - (a) the fact there are so few PIII studies in progress
(b) the fact FDA changed the criteria to allowing bio markers
(c) all the hoohaa over Leqembi
(d) the fact Vascepa is already on the market with an excellent safety profile
(e) the fact Vascepa is much cheaper & oral
Yet we languish at a $400m market cap. I know generics would take a chunk of the US market but potential for AD has to be worth something, even before readout. Shows no one has much interest in anything Amarin does. Zero faith in any management team to deliver anything. Sad!
Thanks. Do you think the study can deliver statistically significant results with ~135 patients?
Amarin needed the money badly in 2015 and Sofinnova had already participated in a prior private equity placement in 2009 and had preemption rights to the 2015 placement. The reason they were given warrants was a sweetener to participate. Investors weren’t exactly knocking down the door at that time. Amarin, at this moment, does not need to raise any finance.