-Amarin’s EPA medicine, Vascepa, recently showed a 25% relative risk reduction in newly announced data from the cardiovascular outcomes trial, REDUCE-IT.
Hey everybody and welcome to breaking biotech everybody’s favorite biotech podcast my name is matt thanks so much for coming in today if you like what i’m doing please like subscribe or leave me a comment and if you’re on youtube hit the notification bell so you know when i’m putting out videos and for anybody who’s just listening only you really missing out i
Get into a lot of stuff on the actual screen so i encourage you to switch over to youtube once in a while if you’re interested but yeah so today everybody i wanna talk about ameren and i it’s been a couple weeks almost a couple weeks since i put out a video but been busy but i managed to get some time yesterday to look into the details of their their latest cbot
Trial and i think it’s important that we talk about it because i was alluding to this with my experience a might have to do is cv ot as well so i think this is a good look into the process and it’s also relevant for our discussion on what actually leads to negative cardiovascular outcomes and ameren is one side of the puzzle that i’ve touched on a little bit with
I honest because they’ve looked at reducing triglycerides but mostly it’s through reducing ldl see that we talked about it in the context of improving major cardio at cardiovascular adverse events so yeah so gonna get into it not gonna do a roundup of my portfolio just haven’t had a chance but last week was pretty good and i’m recording this on early on monday and
You know things are going nothing too crazy to report anyway so let’s get into it so ameren for those who don’t know it was a before last monday before the data dropped i was trading around 3 bucks i had a 1 billion dollar market cap and then they released the data from their vicita cardiovascular outcome study called reduce it and stock shot up quickly to 12 and
Now as i’m recording this is trading at around 18 and the reason why is trading so highs because the results were extremely positive in this cardiovascular outcome study so what they saw was a was a 25% improvement in relative risk reduction so 25% relative risk reduction which is insanely high for some for some reference i’ll talk a little bit later but this is
A very very positive result for them it’s a it’s a larger risk reduction than any of the pcsk9 inhibitor cbot trials so it’s you know it planned it’s likely to generate a lot of revenue for the company so the drug itself is actually a concentrated amount of epa which is one of the fish oil fatty acids and the fish pellets have been studied but not to this extent so
Usually it’s been a combination of epa and dha or it’s been the lower dose of both and dha has been associated with increasing ldl-c cholesterol whereas epa doesn’t have that negative effect and it’s also involved or it’s been shown to lead to reduction in triglycerides so ameren has had the indication for people with triglycerides in the levels of 500 milligram per
Deciliter or higher for for quite some time now but the fda required them to do a large-scale cbot to see if it improved mace events major adverse cardiovascular events in people that had triglycerides between 150 and 500 milligram per deciliter so they underwent this trial it started in 2011 i believe and it’s just a huge study so over 8,000 patients that were on
Statins already this is who they looked into and then they you know they split the two groups into a treatment i’ll show it here and there and i think a treatment group and a control group that was taking four grams of asifa daily and then they followed up with them and and saw what was up and it looks like the viseu group had 25% reduction in the number of these
Mace events so pretty pretty substantial and it took five years to get all of these people followed up with so the follow-up time was five years after they started so pretty substantial and and the reason for this is because so many patients have are already on statins but they still have an increased risk of mace events even though they have normalized ldl-c so
That’s really the crux here when we’re when we’re trying to figure out you know what leads to these adverse events and they they break it down a little bit in their trial and they also allude to a paper a i don’t have it here i’ll link it in the in the notes below but they had a really good paper that summarizes what’s been going on was trying to really take that
Risk that’s associated with having high cholesterol and high triglycerides in your blood and trying to bring that to zero and so statins came along and they were able to reduce that by a significant amount and that and then there was some controversy and whether or not you needed to get your cholesterol to around like 50 milligram per deciliter or if it was okay
In the 70s or something so when the pcsk9 inhibitors came around the fda required them to do the cbot to see you know statins do okay they bring your cholesterol your ldl c to around you know 70 to 100 but if it goes down to like 50 do you get added risk reduction and the pcsk9 inhibitors did show in fact that you get a 15% improvement so but that’s not the same
As the normal healthy population right so there’s still some added risk associated with having these blood lipid profiles that are that are not normal and so it seems like reducing your cholesterol is also important in bringing your risk normal to in normalizing your risk to the normal population this has been relatively controversial though because a lot of trials
That looked at reducing triglycerides showed no added risk reduction so i wrote down a few here and if you look at the paper the review that i’m gonna link it goes into a lot of great detail but niacin and fino fibrates fino fibrate actually did not show an in an improvement in relative risk reduction but gem fibers all which is another type of fibrate did show an
Improvement in risk reduction so so it’s it’s a little controversial and some of the omega-3s were relatively controversial too and their data but i think what we’re starting to see here is that with this study now and there’s another study that was done in japan that showed that concentrated epa reduces triglycerides by about 30 percent i think so i think in 30%
With people with really really high triglycerides and then 20 percent in people that were were on statins so they had a relatively well controlled triglycerides so it between like 200 and 500 so relatively well controlled i don’t mean they’re that they’re normal but they had they weren’t above 500 so it seems like being able to reduce ldl c and reduce triglycerides
Is really the best that you can hope for when it comes to trying to improve your risk so when we look at the companies that i’ve been involved with that a lot of them only look at reducing ldl see so i honest and axia are a special case and they’re indication is only looking at patients that have above a triglyceride of above 500 milligram per deciliter so they’re
There in kind of a special group and i don’t know if it’s worth considering them to be a competitor to ameren necessarily because they’ve already been kind of competitors but experian on the news of the reducer trial that came out last monday and they’ve recovered a lot since then but i almost think they’re in different leagues because they they’re really competing
With things like pcsk9 inhibitors to get their patients to have well controlled ldl c’s like well below 70 whereas ameren is already looking at patients that have a controlled ldl-c so the median baseline of their patients was 75 milligrams per deciliter so not not bad really and so they’re seeing whether or not the the triglyceride reduction is really what’s going
To move the needle forward so i don’t think they’re direct competitors but i do see that ameren has a crazy amount of potential moving forward so i just want to make sure i covered everything yeah so i mentioned already that the the pcsk9 inhibitor cvo tees they they had a relative reduction of 15% so with the spiri on there their target group really is a lot of
Patients that are on maximally tolerated statins and who are statin resistant so they they don’t respond statins very well so in these patients they need a lot they’re they’re trying to look for other ways to get that ldl see lowered because that’s still the the gold standard in terms of trying to reduce your risk of cardiovascular events although with this new
Data there might be a frameshift a little bit with cardiologists because that just because of how good the result is so when it comes to expiry on they’re trying to get their patients much lower in in ldl c and they’re not really looking at triglycerides as much so you know moving forward we need to think about how how the doctor is really going to consider this
And they’re also going to look at the cost so the the cost of this epa of asifa is very it’s really inexpensive and because it’s been on the market for so long they they probably they they know what to expect in terms of the side-effects and the risks associated with it and it’s not very significant so i think it’s gonna be easy for doctors to prescribe this so i
Really think that ameren has a really bright future ahead given given this amazing data so what else yeah so if we look at their their price so people are a lot of people on twitter at least where it were a little bit nervous because they had bought in in the threes and you know in the middle of last week it was trading around 14 so they’re already like almost 5x
Their their money and you know should they sure they hold or should they get out but i did some quick of a we’ll say back of the napkin math here to figure out whether or not it’s a justified price and so if we just look at prescriptions and so in 2017 they had 1.5 million prescriptions which was almost two hundred million in revenue and their market cap was about
1 billion so based on their their closing price on friday it was about sixteen point three they’re trading now almost at eighteen which i’m not surprised by but market cap of almost five billion and so if if they anticipate to double that prescription to three million they they’ll generate around three hundred and sixty million revenue and that’s where at today
But you know the the price of this closing on last friday is based on the anticipated amount of new prescriptions that they’re gonna have in 2019 moving forward so if they generate enough revenue that will cover half of the staten patients so the number of patients that are on statins right now is thirty eight million and if they reach half of those patients we’re
Looking at around 19 million prescriptions that’s probably two and a quarter billion worth of revenue and i come up with a share price at about forty four with a market cap of thirteen billion and of course if if you look at all the patients that are that have a triglyceride level of between of over 150 milligrams per deciliter you’re looking at around fifteen
Million prescriptions and share price of maybe around a hundred so this is like a pipe dream right it’s a super far down the road there there’s a lot of things that need to happen that’s right with ameren but you know there’s a lot of patients that could take this drug and see a benefit from it so i think as the the rollout goes forward and on their presentation
They talked about some some near-term catalysts i think in early 2019 they’re gonna apply it for the supplemental nda yes right here so there’s gonna be new results that come out at the november aah a meeting so you can look for that and we’re gonna see really how much of an effect the the cepa had on lowering triglycerides which are super important so this might –
Another move in the stock yeah so and then the publication so if they’re able to publish it before the end of the year we’ll be able to see some more details there and yeah so the nda is really what we care about in terms of how quickly they can do that because there is a competitor to them which is a astrazeneca product and i think they’re going to get a readout of
Their data in 2019 so that that’s gonna be something to to look out for if they see competition they’re obviously not gonna get anywhere near this amount of prescriptions so this match revenue is really like a very very very much a pipe dream but you know if they can reach half’s and patients i don’t that there’s a there’s a a world in which that is true whether
It happens in 2019 or you know it takes a few years that might be true as well but there’s no doubt that this kid could really be a blockbuster so yeah so other than that i hope like progression that’s uh that’s interesting that’ll be pretty cool to to see had if it actually has an effect on shrinking the size of atherosclerosis and in people but yeah so these
Are the catalysts that i’m gonna be looking for i i don’t have a position i haven’t bought any yet you know i’m looking at it because it’s it’s obviously got a ton of potential and it’s a it’s a pretty pretty substantial result that they got here so we’ll see i’ll post on twitter if i if i do buy any but yeah that’s it and so i’m not i’m not changing my spirit
On position i think they’re still a solid like i’m still holding them i think they still are their prices hammered down more than it should given the given the news that we’ve seen but yeah ameren pretty pretty cool so otherwise i didn’t do too many trades last week i i bought some viking i scaled it a little more when it went into the 17s i think on friday i i
Haven’t spent too much time looking at the charts this morning but yeah so i want to thank you guys all for watching please leave me a comment let me know what you think and let me review anywhere itunes or youtube and gonna wrap it up and we’ll talk to you next time
Transcribed from video
021 – Amarin's Vascepa Success By Breaking Biotech
