Okay, this again. Maybe so. But try to find someone using Vascepa who isn't benefitting remarkably so, (I have personally documented over a hundred cases myself), then look at the hundreds or thousands of patients who now have afib due to using Lovaza. Look at the side effect profiles of fibrates and Niaspan and Lovaza vs. Vascepa. Look at JELIS. Look at the clean FDA 72 day letter. Look at the companies that benefit from the FDA's decision. I have a friend who will not be taking Vascepa simply due to the FDA's decision as will millions of others. The safest drug available that has a proven study showing great benefit, albeit for those alien Japanese folks, is being withheld simply because it does not benefit the right corporations. Be it greediness or whatever, trying to bring this great drug to the ANCHOR market with its track record seems to me the right thing to have tried to do. Like me, I believe AMRN's management figured on science to rule the day, but what they got were shells of human beings operating like gangsters.
Yes, by the measure of the stock price and wiping out many investors, yes AMRN was one huge flop. BUT, that flop was precipitated by an absolutely corrupt FDA. So, I would prefer if they just said, AMRN was one of biggest biotech FDA scandals of 2013. There is no other explanation, NONE.
If REDUCE-IT is allowed to finish, hopefully, then we have a light shined on the decisions made by the FDA in the present. If REDUCE-IT produces a 20% or greater reduction in adverse heart events then every single person involved in the decisions today has condemned hundreds of thousands of people to death or decreased life quality. And for what? I'm convinced the FDA would like to see REDUCE-IT stopped so they don't have to answer questions in 2015 or 2016 about their actions today. To deny the safest drug in its class, (maybe all classes), that demonstrably helps improve life quality is criminal. It appears simply that the FDA did this in order to make GSK an extra billion or two, which is like something out of COMA. Seriously. Now I can only hope R-IT is either stopped or fails, because if is a success I cannot let the folks that did this walk. I withhold judgment until that day.
A crime in this country is defined by the established norms. The FDA has control of the means of defining those norms. Yet logic suggests that yes, this is a crime, a bad crime.
The FDA thinks it has egg on its face because it approved drugs, (still being prescribed gleefully over Vascepa), because of failed trials, but that pales in comparison to the advent of the results from REDUCE-IT. The reasoning is they are using caution because they approved drugs due to their effects on lipid profiles and were wrong about the outcomes. That isn't caution, that's inanity. A drug with an already proven outcomes trail, used at more than twice the dosage, shown to be twice as effective, is very likely to produce the same results again but with better results. If REDUCE-IT fails, then you have patients who have less joint pain, a better mood, scores of other improvements in bodily function yet no reduction in heart events. That's somewhat better than what is going on now. The FDA has condemned many people to death, (certainly hemodialysis patients who were shown to have an 84% reduction in fatal heart attacks), and atrial fibrulation, along with strokes and many other maladies. The risk was not to approve Vascepa, not the other way around. Make no mistake about it, this was to make GSK an extra billion or two. When REDUCE-IT is successful, the members who voted no and the FDA geniuses who set this up should answer to the hundreds of thousands of adverse heart events and deaths that could have been prevented.
Well, according to the FDA panel, having a successful REDUCE-IT trial is unlikely. Fenofibrates already are approved for the 200-500 mg/DL indication yet they have not shown significant heart benefit in every study, so Vascepa is likely to do the same, or so the logic goes. V vs. fibrates is interesting in that V has fewer side effects and the only large long term scientific trial showing heart benefit with statins, (JELIS). The only reason Lovaza didn't get the 200-500 market was because of the raise in LDL-C on statins, and then a failed trial showing it actually can lead to atrial fibrulation. But L would have had the indication had it done what V does, and that is not raise LDL-C on statins, in fact, that WAS the requirement for ANCHOR until the FDA changed the goalposts at the last second. Niaspan is just a mess, but is still prescribed widely in the 200-500 mg/DL camp. Even Dr. Nissen still prescribes it to patients he thinks show some benefit, (although not to new patients). Forgotten in ALL of this is that Vascepa patients seem to enjoy their drug way more as opposed to all the others. Improved mood, reduction in joint pain, elimination of dry eye syndrome, and all manner of help for other inflammatory problems are things Vascepa does all the time. None of this helps investors who lost their life savings here, like me, but it does show that the FDA is not considering the bigger picture. The denial of Vascepa into ANCHOR was a disgraceful act, almost certainly brought on by pressure from BP and not the science or patients needs.
One thing the JELIS study showed was consistent improvement over time. The first patients would have shown the most benefit, adding in the latecomers would negate those early results a bit since results over the first 4-6 months are similar between both groups. And what is the purpose of denying those early results? If they show futility, then it's all a waste anyway and AMRN deserves their fate. If they show tremendous improvement, AMRN deserves at least the ANCHOR population and probably the REDUCE-IT population as well. This is all about saving lives isn't it, not destroying a company due to timing issues? The ADCOMM clearly has had a devastating effect on AMRN and regardless of what the FDA might do on Dec 20, the company clearly has been injured to date. They can ask for these results because the FDA has in effect broken their agreement with AMRN on how the study was to be run. The endpoints to be met were to lower triglycerides while not raising LDL-C, while not introducing any new safety concerns. That point seems to have been forgotten altogether by the FDA's damnable question. AMRN has a right to relief. If V does what I think it does, there should be no concern in looking at the results now.
Sentiment: Strong Buy
I believe they said at the ADCOMM the REDUCE-IT trial would have an interim evaluation at 60% of the required events. Well, since the FDA has put a terrible burden on AMRN with this snub, perhaps AMRN should take the ultimate gamble and request the first 1000 patients be evaluated now since they have no way to support the trial beyond this point. Those first 1000 patients should already be exhibiting a tremendous reduction in adverse heart events right now since most of them have over 1 1/2 years on Vascepa. Take it or leave it they could say to the FDA. My research says they'll find a greater than 40% reduction in events if this was allowed to happen. And why not? GSK might say because it might cost BP some money if they found Vascepa does what every single study points to it doing, including real outcomes studies, (that unfortunately didn't have any dark skinned people), like JELIS. Considering the people in REDUCE-IT are a little worse off than the sub-group which showed a 53% reduction in adverse heart events over 4.6 years and a little better off than the hemodialysis study which showed a 69% reduction in adverse events in just 2 years, I think checking this group after 18-21 months should yield the necessary result. Especially since it's at more than twice the dosage of the JELIS and HD studies, AND ANCHOR SHOWED TWICE THE EFFECTIVENESS at 4G vs. 2G. AMRN should just go for the throat and ask the FDA to do this and accept whatever results they find. What have they got to lose?
Bleak is an understatement at this point, but AMRN must wait until Dec 20 to make sure the FDA is intent on carrying out the panel's wishes, (which is all but certain). They can try various avenues, like a new study with a different placebo or lobbying, yet that will all take time and they will likely run out of cash sometime late in 2014. Once the FDA completes their dirty deed on Dec 20th the company has some choices. One is to become a viable company by ridding themselves of Reduce-It and all other R&D and concentrate on sales to become self sustaining. Currently V is making inroads with little to no help from insurers. The only ability V has to enroll new patients is due to coverage being at the same level as Lovaza, very few patients are being asked to pay more for the product. In February, most insurers should be putting V on a level playing field with L which should lead to more sales. The outcomes for patients taking Vascepa will eventually show their own successes and many doctors will prefer this treatment route, (because of fewer side effects, better blood work, and people feel better). AMRN could become a viable company, yet it would be a lengthy process fraught will challenges. Or, they could partner with contingency values added in. ANCHOR will eventually be allowed with the proper persistence and REDUCE-IT has a great chance of being successful. So, the partner idea is likely the best route. With all that said, I still cannot believe what the FDA did. They are saying that because all the other trials in this space have failed, they will ignore the only study, JELIS, that has shown benefit and not give patients a fighting chance. What they have done is so nasty words don't do it justice. I don't think it will have a chilling impact on other bio's, it's just a message that little companies shouldn't mess with large BP when a fairly logical and totally beneficial, (from a patients standpoint), FDA decision will take money away from them.
Yeah. The lead in was misleading to say the least. Yet, the FDA has said nothing, this was just an advisory committee commissioned to voice opinion. The FDA can do the right thing still. When I think of the 53% improvement in JELIS and the 69% improvement in that dialysis study, plus an 84% reduction in fatal heart attacks, plus the huge advantages for diabetics in lower trigs, reduction in inflammation and no rise in LDL-C I wonder what is going on. They mentioned bleeding at the meeting. There was no increase in bleeding times, just the normal blood thinner characteristics of all omega-3's, not expressed as pervasively with Vascepa, while omega-3's have always been considered very safe. Water is more hazardous, what is the FDA risking by approving this?
Lost are the patients who will suffer as a result. What happened today was shameful. I didn't want to believe it, but obviously GSK pulled some strings. Dr. Hiatt would have voted for this if it was their drug and probably the other eight as well. They all became AF for a day. I cannot write anymore, I have too many things I shouldn't say. By the way, I'm sorry for all the enthusiasm, this was a blistering rebuke. Hopefully, when GSK buys this for a song they'll make it the $100B drug it truly is and everyone can enjoy what everyone who is currently taking Vascepa already knows. And I'm sure the panel members know it as well.
Swalchie and Kutz, you were both right and Adam Feuerstein was dead on. Congratulations on your insights. Tomorrow the unremitting massacre continues I suppose. And like I thought, the company thoroughly expected a thumbs up, they had every reason to. Their presenters knocked it out the park, and the panel acted the part of zombies, not hearing anything apparently. The FDA could still approve, but I'm not holding my breath now. 9-2 against? Let's see....Belviq causes cancer in rats, causes 5 times the amount of people to have suicidal thoughts over placebo, etc... Yep, deserves approval for sure. Safest drug on the planet that actually has a study showing benefit, nope.
It's already fissile material Mark. When ANCHOR is approved what seems to be forgotten by everyone, even long timers here, is the insurance turnaround. If you have Medicare, many of the plans offer Lovaza at a lower tier than Vascepa. In almost no circumstance does V have any advantage, so patients pay less for L and doctors shy away because of the pre-auths and cost. That all changes with ANCHOR in the blink of an eye. What the market can expect going forward with DTC and insurance is mind blowing, (within a year). Lovaza's $1B in sales will go directly to V quickly, along with Niaspan's $800M and a huge amount of the several billion spent on fibrates, not to mention the people who aren't on any of them because they all raise LDL-C on statins, unlike the best of them all...Vascepa. It'll be nuclear.
Sentiment: Strong Buy
Announced May 30th at the National Lipid Association, three new studies:
1) Pharmacokinetic data showing the lack of drug-drug interaction when Vascepa was administered with atorvastatin, a commonly prescribed cholesterol lowering medication
2) Pharmacokinetic data showing the lack of drug-drug interaction when Vascepa was administered with warfarin, a commonly prescribed anticoagulant medication
3) Eicosapentaenoic acid (EPA) and its potential inhibition of the formation of membrane cholesterol crystalline domains
Sentiment: Strong Buy
Around noon tomorrow, seismic shock waves will be felt all around with no doubts about how this will turn out. Anyone listening will quickly learn that the knowledge they thought they had regarding pure EPA was tiny compared to the pure-EPA minded folks at AMRN. Anyone interested might want to check out the distinguished omega-3 executive team that has been working towards this exact moment in time for half a decade. And we have so much coming. Back in June they announced that the combo with rosuvastatin worked, but we didn't get the lipid numbers; we might tomorrow. Now, we have one, two, or possibly three more completed studies to report on. And there is no holding back tomorrow. AMRN hasn't said a peep about what they truly have in store, but tomorrow is their day to finally bust a can, they will destroy this cynicism. I have no sympathy at all for anyone caught up on the short side here, Friday's debacle and the preceding months have numbed me. The stock should rightly be sitting around $15-$20, yet we get some documents that knock the stock down 20% from near the lows already. And there was nothing in those documents to fear. AMRN themselves called them normal questions to be expected, they aren't afraid even a little. And they will be calling the shots tomorrow around 7 pm and nothing will be left on the table.
Sentiment: Strong Buy
Here it comes. AMRN didn't call a CC tomorrow to bemoan anything, they are the most knowledgeable folks on the planet about pure EPA. They also know their way around an FDA ADCOMM. First, the unbelievable clinical data to date, first hand accounts, massive amounts of study material showing all manner of benefits, and presenters who can deliver. Then the positive vote. THEN the nuclear bomb. I waited until after 8. Shorts deserve the entire enchilada. Enjoy the worst day of your lives.
Sentiment: Strong Buy
Instead of scaring shorts away, they've piled onto the stock even after recent PR's. They may pay a huge price this coming week. Back on Sept 25, AMRN made it a point for the first time to say, "An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident". Well, did you look over the briefing documents and find any new public health concerns? Nobody mentions that, only things like a mineral oil comment and outcomes being nice to have. What the FDA should be concerned about is not a problem and AMRN has made us completely aware of what the deal breaker would be, and it doesn't exist. It's all in the BD's.
Sentiment: Strong Buy
By the way, the REDUCE-IT population should be helped more than the sub-group since they are using 4G vs. the 1.8G used in JELIS. At 1 1/2 years, the divergence in the JELIS sub-group was about a 35% improvement in adverse heart events, (approx. the first 1000 patients in R-IT are at 1 1/2 years or more). If REDUCE-IT follows this at double the efficacy, AMRN may have received notice from the FDA that final information was being collected and would be released before the ADCOMM and currently it points to a 99% chance of success, barring any last minute findings. That is the type of thing that will get a CC scheduled after an ADCOMM while keeping the company mum, because of the 1% chance more time is needed. That is quite possibly why they said the final TG's will be above 200 mg/DL and why they announced a CC after the event. The market has taken everything to the negative and could just be slapped silly on October 16. AMRN's PR's have been unusual and I think quite telling.
Sentiment: Strong Buy
Just my 2 cents. The recent AMRN PR's have mentioned some incredible stuff. The REDUCE-IT study getting their 6000th patient was a PR with one of the most mind boggling pronouncements. They said, "Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL". The only way that happens is if the incoming patients recently added bring the total TG level over 200. Does that mean the trial is ending now? There is nothing in any literature prior to that PR stating anything of the sort, (and nobody has ever considered have TG levels finish above 200 mg/DL in 2016 is even remotely possible). I've read that PR tidbit and compared it to other statements and it makes little sense unless it's a tell, perhaps indicating that interim trial data is being collected and the results are in line with everything we know about the JELIS sub-group meaning the trial should be halted as a success. That was on September 25th. More recently they announced a CC will take place a couple hours after the finish of the ADCOMM. If they knew the committee would vote them down, they should have advised investors of the reason, it's material. If they thought the ADCOMM "might" be positive, why not wait for the final result and then put together a CC after completely digesting the committee's comments. That would certainly take more than 2 hours. It makes so little sense to have a CC if the event is in doubt. I tend to think there is no doubt with some great REDUCE-IT information to share to boot. Wednesday could be one for the books.
Sentiment: Strong Buy