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Kiwi-
Thanks. They Met the primary endpoint in dialysis and non dialysis patients but only met safety endpoint in dialysis patients.
Seems like it will be approved at least for that indication.
I’m just looking at it.
No position for me as of yet.
Thanks again
Sb
Kiwi-
Off topic
Any thoughts on AKBA?
Tia
Sb
Proof?
Eight,
Thanks for follow up.
That slide showed the moving average for V sales over a year. It seems Hikma was just stating a fact and not predicting their sales.
Even if they were predicting their sales, that number was prior to FDA approval for the R-IT indication. Doesn’t that make it hard to prove they intended to infringe on RIT patents when they can just say that was Marine type revenue (even though everyone knows it was off label R-IT revenue)?
Sb
Eight,
So how have generics infringed on Amarin patents without selling generic V yet?
Are you saying the slide in the Hikma presentation stating 700 million in sales was infringement or is there something else?
Thanks for the clarification
Sb
HK-
So what’s the issue with your specialty not prescribing V more often?
Cardiologists have been slow adopters of V in my opinion.
Sb
Hayward
I’ve found a few Amicus briefs from those entities but not many. What makes you so confident they will file?
Do you think AHA, ACC, and ADA even know of the ruling? Obviously individual physicians are aware but personally I would be surprised if we see briefs from these entities.
Sb
Zman
I believe those are numbers for patients CAD (and risk factors such as DM) and not the number of patients with elevated TGs on top of a statin.
Sb
Venus-
I believe Covington tried to use the Reduce It study during the patent trial because although it was designed for patients with TGs below 500, some patients in the RIT trial had TGs above that value (as in the Marine trial). They wanted to use that data to back their case.
Unfortunately Judge Du denied its use because RIT wasn’t intended to be for patients above 500...or something along those lines. Others on the board certainly have more knowledge about it.
Sb
Jasbg-
I’m not a lawyer but the answers are somewhat straightforward (at least I think).
AMRN’s exclusivity granted by FDA for the Marine indication expired. Their patents were still valid til 2030 of thereabouts.
Generics filed ANDAs with the FDA bc the exclusivity had expired. This in turn required AMRN to sue for infringement on their Marine patents. Thus AMRN was the plaintiff and the generics were defendants.
AMRN’s exclusivity for RIT indication expires 3 years after its approval last fall which means generics could submit ANDAs for that indication as well. AMRN’s patents would have to hold up in court.
Sb
Dr Mehra-
He responded to my question. They didn’t have enough patients to examine the effects of V on Covid outcomes.
He did say their database has grown by 6000 patients to 15000 patients so that they hope to be able to examine that question soon.
Sb
Interesting article today in the NEJM. See the link below.
It is a review of nearly 9000 patients with Covid from several countries. About 1500 are from North America.
26% had hypertension
15% had DM
10% had CAD
>30 % had dyslipidemia
About 9-10% of patients were on statins and Ace inhibitors. Both of these seemed to be protective for survival (but not definitively).
Despite, 1500 patients from North America and the high rate of CAD, DM, and dyslipidemia, there is no mention of V is the article (or what percent might have been on V).
The author is a cardiologist at Brigham and Women’s (home of Dr. Bhatt for those that don’t know).
They must be able to find data from the North American patients on V.
I will be emailing the author to ask about it. If there are any other questions from the board, let me know.
Someone might want to use Twitter to ask as well...(I’m trying to avoid getting a twitter account).
https://www.nejm.org/doi/full/10.1056/NEJMoa2007621?query=RP
Sb
Postes-
And how would generics and Amrn get the CAFC decision to uphold Judge Du’s decision vacated?
I know Marjac posted about a possible means, but the Markman article argues that vacating a decision is difficult.
It would seem generics could still enter if AMRN settled with DRL and Hikma
Sb
Post-
Why would generics settle at that point?
The market is 600M now and growing. Even without AMRN promoting V, the market will continue to grow and eventually be 1-2B.
You give too much credit to AMRN reps for increasing market value. DTC certainly will make the market larger, faster but it will get there on its own as practitioners learn of V through the medical community.
IMO, generics won’t settle if they win at CAFC.
Sb
Marzan,
I know you like to dream, but did you even look at that clinical trial?
The V arm is for 6 weeks. There is no way in hell that V is going to help NASH in 6 weeks (above and beyond whatever response is seen by GILD’s meds).
Just to remind you that the Mochida study in NASH (albeit at 2.7 grams) over a full year did not reach its endpoint.
Also, there are 3 arms in the GILD study using fenofibrate (2 of which are for 24 weeks). It may turn out the fenofibrate is chosen as an add over V (although I doubt it).
Please stop thinking this a home rum trial and GIlD will swoop in and buy AMRN once the results are out.
Sb
Here is part of the GS note that was posted on StockTwits. Thanks to JB Biotech for posting it.
It doesn’t make much sense to me.
Sorry no link to the whole note.
——
Expedited ANDA appeal could yield decision by YE20/early 2021. AMRN pre-announced its 1Q20 revenue (link), thus we do not expect the strong quarter to impact stock performance today. Rather, the focus remains on the company's ongoing appeals process related to the recent patent litigation decision in favor of generic manufacturers. The company has successfully filed for an expedited process for this appeal, and now expects the brief in 2Q20, potentially followed by a hearing in 3Q20/4Q20 and a decision by YE20 or early 2021. Note that a positive result for AMRN will lead to a re-trial, but will not overturn the recent decision. At the same time, the company is in the process of exploring direct commercialization and distribution options in Europe where Vascepa remains patent protected with potential for extension through 2033E. The EMA recommendation for Vascepa is expected by YE20, and AMRN is evaluating whether to launch Vascepa alone in certain regions or to establish a pan-European partnership. We expect this decision in Europe to remain of significant interest to investors, as we believe the opportunity for Vascepa in Europe remains meaningful. Maintain Neutral rating..
Still don’t know why they chose 2 grams instead of something higher
Sb
Mayo Vs Prometheus won by Fish in the Supreme Court (and mentioned by singer in the posted video below)
Not a popular decision at least with this guy.
https://www.ipwatchdog.com/2017/01/23/mayo-v-prometheus-lawless-decision-wreaking-havoc-patents/id=77438/
It wouldn’t hurt GILD in any way (unless GILD bought AMRN).
The other drugs in that trial will have exclusivity if eventually approved. So it would only hurt AMRN.
Btw it is an 11 arm trial, only one of which contains V (and two arms contain fenofibrate). The Treatment is only for 6 weeks, so there is no chance for V to help NASH on its owns. V (and fenofibrate) is used to control the hypertriglyceridemia caused by their drugs.
SB
Please explain why the FDA would be motivated to do this?
The FDA did not see it that way with other similar decisions such as Vanda Pharm.
Also, if you were truly taking it for the Marine indication, would it be fair that you have to take Lovaza and not generic V?
Even if FDA did hold off an ANDA, it will definitely help Amarin’s bottom line but much less so the PPS (our bottom line), as this would presumably be done quietly thereby creating market uncertainty.
SB
Thanks for your input SA as well as the link to the new Markman article.
I see someone left a comment asking whether she also committed a factual error regarding the USPTO having reviewed Kurabayashi in its decision to grant the patent in the first place.
It will be interesting to see his response to that. What are your thoughts on that subject?
Finally, has anyone read the articles suggesting prior art (Grimsgaard and Nozaki) as cited in the article ?
Thanks
SB
Hamoa,
Thanks for conveying this so clearly to the Board.
SB
Why would generics settle for a sliver of the pie (1/100), when they are staring down at the whole damn thing with a big toothy grin?
He stated that DTC ads should get FDA approval by June.
He also stated that direct patient education spending will be reduced although he didn’t say exactly which exact forms of spending would be reduced....I took it to mean these ads would be rolled out minimally or not at all
Sb
Is a deal legal at this point?
Can’t remember who posted the link, but paying off generics to delay launch is now illegal
(At least in CA)
Sorry, but that is not the case.
Patients who meet criteria for Marine, also take the medication indefinitely.
Sb
Amrn can’t sue generics. The manufacturers are not the ones infringing.
Also, How would AMRN know someone is getting a refill for more than 12 weeks?
It would require info from doctors, pharmacists, and insurers who will not be divulging that info to a third party.
Btw, despite AMRN’s Marine patent for 12 weeks, you should know that anyone with severe hypertriglyceridemia that poses a risk for pancreatitis, isn’t going to take V for 12 weeks and be done. It is life long therapy for those patients just as it is for R-IT type patients.
Believing that AMRN can salvage US without a reversal on appeal is wishful thinking.
Sb
TTE
What about the defendant’s expert witness Dr. Heinecke who swore under oath that the reduction of apo-b was significant?
How is that possible?
Best
SB
Eight,
Thanks for your insight.
I know you think the focus of AMRN’s appeal should be on Judge DU’s procedural error in determining obviousness.
The recent Markman report (thanks for posting Mike), suggested that AMRN May not be able to address the Kurabayashi error if they didn’t bring it up previously in court.
Is that true? No new arguments or no new evidence? It would seem that AMRN should be able to refute Judge Du’s conclusion in regards to this specific point since it was part of her decision making process (and she got it wrong due to a cropped table and lack of thoroughness).
It just doesn’t seem right that an error can’t be corrected because it was not initially realized.
TIA
SB
Prescriptions never have the indication
It’s not regulated.
Generics will be used almost exclusively
The reason Vascepa was a high tier for Marine wasn’t because of the Marine indication. It was because of the cost of Vascepa compared to drug rivals in the class such as generic fibrates.
Price will determine tier, not the indication (with rare exception as noted by PDude with Wellbutrin/Zyban).
It doesn’t mean that Amrn couldn’t litigate insurers and others for infringing patents but I’m not aware if that has been done.
Litigation of insurers/providers, of course, would be biting the hand that feeds you.
SB
Insurance companies mainly set drug tiers by price, not by indication.
US sales are lost without the decision being over turned
SB
The US accounts for 33% of all pharma revenue globally....
Western Europe -22%
China-10%
Japan—9%
Will some of the posters on the board with legal back grounds please comment on whether the errors that have been found and listed on the board (regarding Mori and Kurabayashi, not the prima facie issue), merit sending the case back to Judge Du for review herself? I read the success of this process is usually almost zero but if these mistakes were genuine, you never know what could happen.
Can AMRN send back to Judge Du and process appeal at same time (or only one or the other)?
At any rate, these errors should be sent to Judge Du via email for her to review and realize her mistake(s).
Thanks
SB
Some companies make both brand and generic (eg Wyeth with Protonix/pantoprazole).
The reason, i believe, is to capture both revenue streams.
Branded V (at higher price)
“Generic” V (at a lower price)
If Amarin just reduced their price, they could lose revenue compared to the above strategy
Anyways, Hopefully they will win an injunction and then on appeal.
Best
SB
I work in a medium to large medical group in California with about 250 providers including roughly 7 Endo providers and 15 or so cardiology providers. I have yet to see a patient on V that I did not start. Truly Shocking.
I’m disappointed in my colleagues but I assume this is the case around the country as well.
Thanks AVII
Very nice rebuttal. Everyone appreciates your expertise. Thanks again
Zip-
You know what it’s like to write a script and not have it covered. Doctors hate it. Amrn needs to deal with the insurance issue or in the meantime prescribers will be dissatisfied with all the extra paperwork for prior authorizations. You don’t want to have grumpy doctors getting frustrated by paperwork
Yes, all the scripts won’t matter if insurance coverage is for tier 3 or 4.
FWIW, BC of CA recently approved a script that they previously denied after submitting RiT data (just topline data).
Hopefully that will happen across the country.
Did anyone see, hear or calculate the NNH?
Would be nice to use that number along with NNT in promotion to docs.
TIA