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JRoon
It may have failed because serum EPA levels were too low. We don’t know for sure why it failed.
Rose
Yes, so far only Quebec has added V to their provincial formulary. Ontario should add it within a couple weeks. It is common for coverage to start at different times for each province and typically Quebec and Ontario are the first to add. BC will probably be next.
Capt
V is “approved” for diabetes and 1 additional risk factor (which almost every diabetic can qualify for) but reimbursement is only for Pts with “established cardiovascular disease“ which a large percentage will have but reimbursement is purely for secondary prevention.
$181/bottle is a major accomplishment considering how hard NICE fought.
Shadolane
Regardless of the effect on SP today (more likely influenced by inflation data’s effect on the overall market) the fact they got $181/bottle approved by UK is SIGNIFICANTLY more than they currently make per bottle in the US (roughly 33% more per bottle). That is a healthy boost to their margin and a very positive sign for the remaining ongoing negotiations.
Personally, I’m very impressed with these results. It shows the value V brings to Pts and the healthcare system.
I was REALLY hoping the MITIGATE trial would be presented at ESC but a search of the scheduled presentations did not show anything. I guess we wait till November and AHA.
2 insignificant posters (UK costs and REDUCE-IT Smokers) is all that is scheduled for ESC in August. Very disappointing for a drug being launched in the EU at the same time. Vascepa should have been everywhere and the hot topic but instead almost nothing. WTF!
Ok this is funny! At the upcoming ESC in August one (of only 2) IPE presentations (poster) is:
“Cost-effectiveness of icosapent ethyl for primary and secondary cardiovascular prevention in the UK”. I wonder if any of the NICE panel participants will be in attendance? I’m sure someone will be flying Steve out so he can have another moment in the spotlight.
https://digital-congress.escardio.org/esc-congress/sessions/4749-costs-and-cost-effectiveness
Icosapent ethyl was the ONLY drug specifically mentioned in the opening “Welcome” to the ESC.
It appears that TRIGLYCERIDES are a key focus to this years EAS!
Welcome to the 90th EAS Congress in Milan, Italy
“In 2019, the European Society of Cardiology/EAS Dyslipidaemia Guidelines recognised elevated TG levels as a cardiovascular risk factor.5 Lifestyle intervention (eat less, exercise more, drink less alcohol) is fundamental to the management of moderate hypertriglyceridaemia, with pharmacotherapeutic options (after high-intensity statin) including icosapent ethyl and fibrates. Driven by genetics, the last 10 years has prompted re-evaluation of the role of elevated TRL and remnant cholesterol in cardiovascular disease prevention. Novel TG-lowering agents are now in clinical development and will offer new options in the future.”
https://eas-congress.com/2022/2022/05/25/welcome-to-the-90th-eas-congress-in-milan-italy/
Joint European Society of Cardiology (ESC)/EAS Session: What’s new in global risk estimation, and primary and secondary prevention?
“In addition, there is a renewed focus on the management of elevated triglycerides, especially moderate levels, driven by the strength of evidence from epidemiologic and Mendelian randomization studies, as well results from REDUCE-IT with icosapent ethyl.5 Individualised combination lipid-modifying therapy is the future for dyslipidaemia management in high-risk patients.”
https://eas-congress.com/2022/2022/05/25/joint-european-society-of-cardiology-esc-eas-session-whats-new-in-global-risk-estimation-and-primary-and-secondary-prevention/
NS
In the Canadian guidelines the criteria for secondary prevention is any documented evidence of:
Atherosclerotic Cardiovascular Disease (ASCVD):
myocardial infarction (MI), acute coronary syndromes (ACS)
• stable angina, documented coronary artery disease by angiography
stroke, TIA, document carotid disease
peripheral arterial disease, claudication and/or ABI <0.9
Abdominal aortic aneurysm (AAA) -- abdominal aorta >3.0 cm or previous aneurysm surgery
NS
Thanks for the link. If anything I think V appears to have been somewhat beneficial. What did GILD do/say after the trial? Did they give up or say they would move on to a phase 3?
North/Capt/anyone
I have a faint memory of Capt posting data that the V arm of the NASH trial showed no benefits from adding V. If anyone has that data/info please post. Thanks
Dogn
Was there ever any clarity given on why the approval in China was delayed a year?
Lem
Interesting. At 10 PM last night my healthy 17 year old son and I both started intense vomiting and diarrhea. The sickest either of us have ever been. COVID negative, I assume was standard gastro but never experienced anything that severe. And if that isn’t bad enough, all endured with no water or power since a huge storm wiped out power in our area for 3 days (came back on an hour ago). Two people with gastro and no running water - it was brutal. I still can’t handle anything beyond small sips of water.
Iwanderer
I completely agree. Same points struck me as I read the disappointing announcement.
NS
Although I have not had any direct information from anyone at Amarin about future trials looking at pancreatitis, I have had direct exchanges with Dr Bhatt about trials studying long COVID. Dr Bhatt said he contacted and discussed trials for long COVID with Amarin and he was told they were not interested “at the time” in undertaking any new studies on long COVID, a condition Dr Bhatt felt V has a good chance of showing positive results. I asked if this was because Amarin did not have patents to protect US sales to which he replied “possibly” but did not give details about why his proposals were declined. It may have been a cash flow decision as well.
BBI
Here is the problem that I keep running into:
Family doctor: when Pt comes in for an appointment they usually have 2,3 or 10 acute problems they want to talk about/deal with. Doc only has so much time. Optimizing CVD prevention and ensuring the Pt is treated according to latest guidelines (1 of dozens of guidelines for so many conditions) just doesn’t make it to the todo list. Also, when they refer the Pt to a cardiologist they assume the cardiologist will look after all the CVD meds and if the Pt comes back on the same low dose statin and no V then they assume it’s because the cardiologist assessed their lipids and decided they (the GPs) we’re doing a perfect job as is.
Cardiologist: Pt is referred by PCP to address a specific problem. The appointment is to address that problem. Optimizing CVD prevention by following a simple guideline is something any PCP can do and should do. The cardiologist has more important, more acute problems to deal with that needs the expertise of a cardiologist. Those get the priority. In fact the 2 main cardiologists in my small town both have default paragraphs at the end of their consults saying “I will live the lipid management to you with a target of keeping LDL-c under 1.8mmol”.
Both PCPs and cardiologists have openly admitted that CVD prevention falls between the cracks and gets ignored. They all say “I’ll admit, we need to do better, we need to spend an extra 2-3 minutes at the end of the appointment optimizing therapy” - but we all know they won’t.
When I’ve suggested that a pharmacist be used to fill the crack and highlight/flag Pts that aren’t getting treated according to “simple guidelines” they all got very nervous /defensive and said they didn’t think that was the answer. So instead, nothing changes including improvements to Pt care.
I have no solution after a year of trying my best to get doctors to treat according to the current Dyslipidemia guidelines that include V.
HDG
(Thanks for your very appreciated financial expertise and through DD and unbiased review. It has been missed.)
Those poor socialist sheep!
When will they realize they are slaves to “The Man” big bad government. They need to rise up and demand the FREEDOM to choose which capitalist/profit driven, private insurance will tell them which doctor to see, what that doctor is allowed to prescribe, which hospital to go to, which pharmacy they have to use. And if you feel like that private insurance is screwing you too much you have the freedom to chose any other insurance to screw you even worse the next year. THAT is FREEDOM only Americans can enjoy.
I’m sorry, I don’t mean to insult my southern neighbours, I just hope to open a few eyes and get people to think that just because they have “their” way of doing something doesn’t mean it’s the best or the only way. Sometimes change is good. If you keep blindly telling yourself you have the best system in the world often enough you actually believe it in spite of the facts and evidence (same as blind faith to any political party, any country). I realize it will give guys like Raf and Invest a heart attack to think poor people will get “more free stuff for doing nothing” but when society flourishes, everybody does better.
Just the opinion of 1 foreign socialist who, for whatever reason, would prefer everyone had better access to mental and physical healthcare.
NS
30,000 scripts per week at probably $75/Rx profit makes 2.25M/week. Minimal change to operating expenses. I’m sure they want more but I doubt they see their situation as a waste of time.
HDG
There is one potential positive catalyst that could happen at anytime. The RESPECT-EPA clinical trial
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051&msclkid=189f4f87bb5211ecb893fee108201831
This is 3,900 Japanese pts, open label CVOT that completed Jan 31/22. This is only secondary prevention Pts so reasonable to expect a better RRR than R-IT because it does not have the lower efficacy primary prevention Pts who had a lower RRR of 19% in R-IT. This could be the second R-IT trial but without MO that some payers are requesting to validate the R-IT results.
IMO the MO angle and the questioning of the efficacy is purely a negotiating argument to reduce costs and few true scientists doubt the R-IT results. A second, independent, MO-free trial with better RRR than R-IT would make it difficult for payers to question efficacy and force more US insurance companies to start covering and force EU governments (like NICE in UK) to abandon their false arguments against coverage.
The underlying problem of Amarin having a massive and growing inventory they can’t sell won’t change in the short term but positive RESPECT-EPA results should gradually increase sales. My GUESS is that they will present the data at ESC at the end of August.
Kiwi will argue that MITIGATE is the data that is needed but I have trouble believing a 1 year trial will be very convincing.
By my rough estimates they have 13M bottles in inventory and it’s growing by about 1M/month. They need to try something unprecedented like offering a new country 1/2M free bottles of V if they fast track approval and add a condition like they have to be dispensed within a year or they get returned. It would encourage fast uptake, get usage going strong without any barriers and when the year ends they would start with strong revenue. The first year is always insignificant anyway. HLS did an interesting program where the company reimbursed Pts 88% of the cost until their private insurance kicked in. Had they done it for government insurance it would have been great. There is a new psoriasis cream on the market in Canada that is literally free for anyone right now. Pharmacies bill the cost to an insurance plan owned by the manufacturer and the Pt automatically gets 100% coverage until the cream is added to the government and private plans. It gets docs prescribing it, Pts using it and builds up the usage for once coverage starts. Imagine if reps were going around and telling docs there is a free drug that reduces heart attacks by 31%? Every doctor would listen and start using it.
Kiwi
V has 8 years regulatory exclusivity of which 2 years have passed. No generics, no Lovaza, no gL.
Wow. Absolutely nothing that could be viewed as even slightly positive or optimistic.
I will keep an eye open for RESPECT-EPA results (and half an eye open for MITIGATE) but otherwise I’m putting this stock on ignore till late August.
GL all, enjoy the summer
Iryokabu
Quote
“statins were associated with 63% increased T2D risk via HMGCR-predicted LDL-C lowering (IVW MR= 1·63, 95% CI= 1·44, 1·85; P= 7·2 × 10-15). After accounting for other lipids in the MVMR analysis, the increased T2D risk associated with HMGCR-predicted LDL-C lowering was attenuated and less precise (MVMR= 1·36, 95% CI= 0·82, 2·26; P = 0·36; physical activity adjusted MVMR= 0·85, 95% CI= 0·43, 1·68, P=0·72).”
Maybe the statin increase in risk of 63% was attenuated by the 53% reduction by IPE but the statin only group should still have had a 63% increased risk leading to a relative increase in new onset DM2 compared to the IPE arm. ?
RESPECT-EPA would be a beautiful black swan. Started in 2013 (enrolling might have begun in 2014) means they should have some solid data from 3900 pts. All Pts are secondary prevention so it won’t have diluted efficacy from the lower RRR DM2 population. Serum EPA levels being equal, their data may be stronger than R-IT.
Maybe RESPECT EPA presents at ESC in August and MITIGATE presents at AHA in November.
Kiwi
Just because the lines separate by 1 year does not mean they achieve stat sig p less than 0.05. Without a solid p value the data will be ignored just like PI2 which had a 22% reduction in hospitalizations but the p value was 0.18. FLU-PRO score improvement had a p of 0.06.
Rose
You are correct. I also expected some benefits from V on improving HgA1C but R-IT did not show benefits which is why I read the previous article with significant scepticism.
R-IT showed a lower 19% RRR in CVD but IMO that lower RRR is because DM2 Pts are CVD Pts on a waiting list. They are just flagged as being at a much higher risk of a CVD event, earlier on in the disease progression. It makes sense therefore that their RRR will be lower but IMO equally important- slow the progression, and like LDL, the earlier the better. Unfortunately the people paying for the V (eg: governments in a single payer system like Canada or UK) will say the lower RRR means it’s not worth covering because of the higher QALY dollar value. I think Amarin would have been better off seeking coverage INITIALLY only for secondary prevention and could have removed all the lower efficacy DM2 data and had an even stronger data set with higher benefits and better QALY values. They could have applied a year or 2 later for DM2 coverage. In the UK they went for the home run and are sitting with 2 strikes.
Dogn/Iryokabu
Before anybody gets too excited about the headlines of reducing DM2 with IPE it is important to acknowledge the following statement in the paper:
“In REDUCE-IT, among patients without T2D at baseline, no effect was observed for IPE compared to placebo for new onset T2D (HR= 1¢04; 95% CI= 0¢73, 1¢47).”
Don’t be expecting a Monday morning PR touting this article from the Lancet (partially because Amarin doesn’t believe in touting positive journal articles and partly because it isn’t that black and white)
Over 3,000 pts (40%) in R-IT did not have DM2 at the start of the trial and after 4.9 years they did not find a stat sig reduction in new onset DM2. Given these facts I lean towards the theory that the gene expression markers for increased DM2 risk aren’t very specific.
HDG
Great to have you back!!!!
You didn’t miss anything (or at least anything good).
Rose
Another step in the process, long overdue. This group negotiates on behalf of all provinces so the dollar values are set. Now each individual province has to assess how it will cover it (primary prevention is unlikely IMO but secondary prevention is for sure). They will likely put a minor requirement similar to a PA which in Ontario is called a Limited Use Code. When they assign a LU code it means the prescriber has to write “LU 123” on the Rx which is the equivalent of the prescriber saying “I am aware it can only be prescribed to Pts who meet the listed criteria of … and writing this code is my guarantee they do”. It is instantly covered, no application forms or delays.
My sources tell me it could take a couple months before Ontario agrees on what the LU code criteria are and officially adds it to the formulary.
Retired
Question: Considered the enormous impact the tripling of production of gV would have on the cash flow of Amarin, have they had someone go in person and assess the status of the previously announced expansion of the generic’s production facility?
New data analysis of post MI Pts
https://www.sciencedirect.com/science/article/pii/S0735109722005538
Great job Capt! Appreciate the ability to visually analyze the data quickly and see trends.
IMO this weeks data shows more evidence that the ONLY thing holding back gV is supply. The news on insurance plans moving toward V is encouraging but there are so many plans that it will take a long time before it starts to affect Rx numbers. Automatic substitution, especially in state mandated systems, will always be a problem.
When script vol goes down while gV goes up it tells me that generics continue to have the ability to sell as much as they can supply. Last week gV was down a bit and this week they are up supports that their supply appears to be maxed out around 30-31,000/week. Holiday or not their production doesn’t change.
The other thing that your charts make easy to see is that it appears Apotex has out competed Hikma at the manufacturer level for the limited API.
The big unknown is whether or not the tripling of gV production with the new plant is happening or not. IIRC they expected the facility to be completed about this time with FDA approval at the end of the year. If, by year end, generics are producing 90,000 bottles a week and scripts remain stuck at 100,000/week (zero sign of any growth for 2 years now) then Amarin will start to hemorrhage cash while rolling out in EU and continuing to amass a bloated inventory (10M bottles at the end of 2021 IIRC). I would guess at least 2 years in EU to hit break even.
For the people who are more concerned with the day-to-day stock price I continue to believe that is dictated entirely by XBI. Every time Fox or CNN talks about inflation or rising interest rates you can expect the algorithms to kick in and sell off biotech dragging Amarin down further regardless of the fact they have no debt. Those two topics are going to continue to come up frequently for the next several months so I do not see a significant change in the stock price for months to come.
Long road ahead
Funnygi2
In general Lp(a) scores don’t change much but there are some clinical trials going on with some novel therapeutics. There is also a form of “blood filtering” that you can do to lower it if it is really high.
Here is a good diagram to explain a new therapeutic:
https://docs.google.com/file/d/1_n1zRTs4nXAk522DTfi_KNP08-xZCL18/edit?usp=docslist_api&filetype=mspresentation
Here is a picture of Lp(a) aka apo(a)
https://drive.google.com/file/d/1ZIBlnWfvQ0Lon-etZJr_Bizn8BImgBW0/view?usp=drivesdk
Rose
A CAC is not invasive at all. 10 minutes lying on your back in a CT scanner. It’s just a high speed (because a moving, beating heart is hard to get a good picture of) CT scan with a computer algorithm to take pictures of your heart as it beats to detect any calcium in your arteries.
In Montreal I can book one within a week for $250 if needed but I was able to get a free one through public health coverage.
Calcium deposits in your arteries is only something you need to check every 5 years or so, depending on your risk factors (much less often if your score is zero). If you can prevent further deposits your chance of an MI goes right down to normal.
Quick explanation: plaque builds up in your arteries. It’s not supposed to be there so your immune system tries to destroy it with inflammation. If successful at removing the plaque then it breaks off and goes downstream and you have an MI (the soft vulnerable plaque from the EVAPORATE TRIAL that is prone to rupture). To protect yourself your body tries to secure the plaque by building a coating of calcium (bone) over top so it doesn’t break of. Once the calcium secures the plaque that calcium generally doesn’t change.
Rose
Totally agree. Great discussion. IMO every person should have an Lp(a) test done once in their life and anyone with questionable risk (ie: low to moderate risk like some family history but no obvious risk factors) should get a coronary artery calcium scan done in their 50’s.
I had minimal risk factors: don’t smoke, don’t drink, eat healthy, exercise regularly, good BMI, no HTN or DM2 BUT I had high TG’s and low HDL (which my doctors blew off as meaningless) and my uncle died of an MI at 42, my father had CABG x3 in his mid 60’s. Had to fight to get a CAC. Cardiologist “guaranteed” me a score of zero. I was in the 80th percentile for my age, gender, race. Fired that cardiologist and then had an Lp(a) test to confirm the obvious genetic predisposition to CVD.
That CAC changed my life. I started living even healthier and had a better appreciation for each day. I think I would have been that “healthy guy” who drops dead of an MI in his 50’s and everybody is shocked saying “but he looked so healthy”.
NS
My GUESS would be ESC 2022 August 26-29. They are going to want the attention of an international conference and that is the next big one.
Results would have to be pretty spectacular for them to publish without a conference to promote.
NS
I agree the product in the article is a mixture BUT at the end they discuss new EPA products coming this year.
“In 2022, the new EPA products of Guowei Pharmaceuticals that break through the international technical barriers are about to meet with you, and the vast Omega-3 industry chain layout belonging to Guowei Pharmaceuticals is also slowly unfolding in front of us.”
I still believe China will source, manufacture and produce their own V.
NS
They are doing this entirely internally. Their own API, manufacturing and production. China built a hospital in 2 weeks. They will expand as needed, and quickly. They have their own massive fishing fleet that will be able to meet the demand. There already exists a huge DS fish oil market which I expect will convert to the more profitable, low (no) competition, government endorsed CVD risk reduction with prescription EPA.
I do agree that it will make API supply problems bigger for gV and therefore help preserve the US market but the loss of China is huge (and complete IMO). If it costs Amarin $30 to produce a bottle of V the Chinese will do it for $20, sell it for $30 and be happy with a 50% profit. Volume play as JT like to say.
I don’t recall hearing anyone from Amarin mention revenue expectations for China at all in the last year. Amarin knew China was a dead market.
China is gone and nobody should really be surprised. Remember: Egypt already has at least 2 gV on the market. The US doesn’t even respect patents why should we expect areas known for ignoring patents to be any different.
NS
It would appear that, as many expected, China has come out with their own version of V and will be sourcing, manufacturing and producing their own pure EPA. It looks to me like we just 1) realized why approval of V was delayed a year 2) just lost the entire Chinese market. No way Amarin/Edding will be able to complete with Chinese made version.
It appears they are using the legal loophole of EPA for TG reduction which has no valid patents to produce Chinese version of Vascepa to sell for CVD treatment.
This is very bad news and something WS has surely known for a while.
“In 2022, the new EPA products of Guowei Pharmaceuticals that break through the international technical barriers are about to meet with you, and the vast Omega-3 industry chain layout belonging to Guowei Pharmaceuticals is also slowly unfolding in front of us.”
By “technical barriers” they mean “legal barriers”.
Good bye China revenue and Edding milestone payments.
Kiwi
One key aspect of the KP trial format is that it will (likely) use a computer algorithm to select the placebo group created to specifically match at a 10:1 ratio each variable in the active group. If they chose to increase the active arm it would take their tech savvy system less than a minute to send out 5,000 text/email notifications to eligible Pts to enquire if they would like to join a trial and get free meds for 6 months - meds already proven to reduce MACE but may also reduce the severity of COVID (which they should already be on anyway).
Question: do you think they went from 1,500 vs 15,000 to 1,500 vs 38,100 (an odd number to choose) or did they go to 3,600 vs 36,000 (nice round number) and maintain the stated ratio in the trial protocol. Option A would be a clear alteration of the protocol and would (I assume) be edited in the clinicaltrials.gov website. Yet, the stated ratio remains unedited while the number enrolled is edited.
Rose/Bolio
HK may not have been PR worthy because there is no plan to do a commercial launch in the near future and don’t want to highlight the financial conditions of Edding, unable to do an IPO to generate the cash needed for commercial launch.
As for MITIGATE, this explains why Amarin didn’t include MITIGATE in their PR listing the Vascepa related presentations. Amarin has known for a while apparently (in their defence, it wasn’t their trial and therefore not their right to publicly announce the withdrawal)
Note/open question:
Will Amarin be given access to the data or at least a summary of efficacy so that they can plan accordingly or share under NDA the results if entering BO negotiations??? Maybe in a month KM knows it works on COVID and/or has data supporting CVD efficacy without placebo BS
Kiwi
You better sit down for this: I have it from a reliable source that the MITIGATE presentation has been withdrawn from the ACC. Apparently they weren’t ready. I assume data analysis wasn’t complete. No idea what the next step is for KP and MITIGATE.
Study
The Chinese government is a very powerful negotiator, especially when it comes to drug pricing. They know they are a massive market with rich rewards so they demand a huge discount offering volume over margin.
https://www.gtlaw.com/en/insights/2022/2/china-on-the-move-lesson-from-chinas-national-negotiation-of-drug-prices-in-2021