If combo bioavailability results had been negative, then Vascepa might not be able to be combined with anything. Now it can possibly be combined with everything, certainly statins. There are executives in BP boardrooms all across the country and world scratching their heads and wondering why Amarin shares went down yesterday and didn't hit 20. The value of a company with V in 2017 is somewhere between $5B and $50B and that's conservative. If they fail Reduce-It it's still the best darn thing for severe hypertriglyceridemia and it helps joint pain and improves mood; that's a $1.5B a year drug for years. If they pass Reduce-It as seems nearly certain to me, $50B is tiny. Giving the company a little credit for possibly having a drug that recaptures the Lipitor market and Crestor market and the warfarin market and the anti-psychotic market and the diabetic pill market and the who knows whatever else market, well, the possibilities are staggering. Yesterday was the biggest news in biotech history, maybe in all of market history.
Sentiment: Strong Buy
I think you should stop injecting prescription meds that you obtain illegally. What you said is complete mumbo jumbo cr@p. Do you even know what bioavailability is?
First of all, Vascepa is just a purified EPA capsule. You can get purified EPA capsules anywhere. High quality, prescription grade purified EPA has been around for decades and are available without prescription. Today, we have Vascepa as the most recent name brand selling pharmaceutical grade purified epa.
Second, anybody who wants to take a combo can. Just buy your pharmaceutical grade pure EPA and then buy your generic (much cheaper) form of your favorite name brand statin or whatever other medication or supplement you want. This isn't new. IN the United States, physicians have been prescribing combos of statins (and other medications) and EPA or EPA/DHA capsules for decades. Combo meal? Just order the exact burger and fries you want.
Finally, Vascepa is an ethyl ester of EPA. Ethyl esters are the #$%$ cousin of the natural free form fatty acid. Who on earth would settle for an ethyl ester form of EPA when an all natural triglyceride form of EPA is readily available to everyone? Are you going to cut corners when it comes to your health? I don't know anybody that would sacrifice their health for a very small savings of money.
There are plenty of pharmaceutical grade purifiend EPA supplements in the natural triglyceride form today. There are even more natural triglyceride form EPA supplements being developed as we speak! We will soon have other FDA approved options too like the natural free form of krill oil EPA in addition to new brands of tree form fatty acid versions of fish oil EPA. You can get pharmaceutical grade purified prescription EPA or over the counter pharmaceutical grade purified EPA.
BAD NEWS FOR ETHYL ESTERS
The patents protecting the ethyl ester based Vascepa will fail to stop any of these superior all natural triglyceride forms of purified pharmaceutical grade EPA products.
You are using pharmaceutical grade and prescription grade labels for the same products. Is that just an error on your part? She used bioavailability correctly, she knows what it is, most on this board do. What evidence do you have for the useless patents, most believe pretty solid. Just took my Vascepa, no fishy taste or smell like the clerk at the health food store described when I asked about dietary supplement fish oils.
It's from June 21st headlines:
In the multiple-dose study of 48 healthy volunteers, AMR-102 (the fixed-dose combination of icosapent ethyl and rosuvastatin, a leading statin) was assessed versus simultaneous administration of the individual agents, as well as versus rosuvastatin monotherapy, on pharmacokinetic measurements in order to show feasibility of the fixed-dose combination. The results proved promising, as there was no inhibition of either the rosuvastatin bioavailability, or of the bioavailability of the active metabolite EPA from Vascepa, observed with the fixed-dose combination product compared to the other arms of the trial.
The AMR-102 test formulation was well tolerated. No serious adverse events were reported in the Phase 1 trial, nor was there an increase in reported side effects with either the fixed-dose combination, or the arm given co-administration of the two agents, versus those who received rosuvastatin alone.
Amarin plans to continue its development of AMR-102, which could become the first combination omega-3/statin product in the lipid lowering market. Amarin intends to launch this first-of-its-kind combination product around the same time that generic rosuvastatin is expected to be available in the United States, subject to further positive clinical development and regulatory approval of AMR-102.
Note that AMRN is planning to combine V + Lipitor too, which should also become available in 2016. Lipitor's just the biggest drug ever in history. If REDUCE-IT is successful then V + Lipitor, (atorvastatin), will become a combo that saves more lives than any drug in history and has a chance of being the best selling drug in history, while the Crestor, (rosuvastatin), combo will only be a huge seller. The chances of this happening are far better than the ISIS-APOCIIIRx drug ever hitting the market, yet, nyet on that June 21st headline generating any enthusiasm. But the June 24th ISIS headline vaulted ISIS about $1B in value.
Sentiment: Strong Buy
KK -- agree . I used to take Niacin and hated the stuff . Vascepa is a dream in comparison -certainly the most patient friendly CV drug I've ever taken .
So what would prevent or delay a switch over ? Some MD's still believing in Niacin benefits ? Doubts on the benefits of " fish oils" --as per Dr Topol ? Wanting Outcome data before prescribing ..as per Dr Nissen
of the Cleveland clinic
What do you think ?
Really! Still trying to pump this great savior of a drug? I am sure some will say it cures sin! I can't believe after losing a year and 1/2 it's value that people still believe this is a wonder drug that somebody gives a #$%$ about. This drug means nothing to nobody including doctors. We should have JOE Z eat them all!
Your an idiot jmdiego64. Im doctor and over the last 2 months. My patients(or should i say patience) are asking about Vascepa. This drug will be huge in years to come,and my partners are already prescribing it to their patients.
Your comment " this drug means nothing to no one " is flat out wrong .
I take Vascepa . It's the most patient friendly CV drug I've ever taken ..and I've taken most of those prescribed over the past 25 yrs ( almost every version of the statins , early Fibrates , Niacin etc ....I was refused Lovaza for the reasons you probably know ".
The question is .." How effective it will be in reducing heart attacks "..., and that we won't know until the Reduce it trial outcome .
So let me ask you ....if you were at high risk of a heart attack due to an inherited lipid disorder ...would you take Vascepa now based on Jelis and the Anchor trial ....or would you wait for the Reduce it trial data .....that's what CAD patients and MD's are wrestling with
What would you do ?
Delusional people are delusional.
This stock just hit it's lowest price since 2010 yesterday and you all are talking about $40-$60 per share and the "biggest news in the history of biotech". LOL...just plain wow.
"Not a penny under $30!" mantra isn't working out too well for ya.
Who's delusional? The twisted Summer Street article, citing Dr. Brinton saying no reason to allow ANCHOR until Reduce-It is complete, crushed the stock price and it's held here due to a lie. Those comments still sit unchallenged in many minds because the response disputing the claims was slow in coming. The market is so "worried" about ANCHOR now even though every analysis; however slanted, says it will likely get approved. And why not, V has exceeded every endpoint and is as safe as water. The advisory committee gives V a chance for accelerated approval for crying out loud; a chance not available without it. That same doctor made the following comments recently, (note he's the President of the American Board of Clinical Lipidology, so his words carry more weight say than Adam Feuerstein in most universes):
"For key first-in-class indications, an FDA advisory committee meeting is expected, and this public forum will be an important opportunity to discuss the ANCHOR data, which demonstrated Vascepa's unique potential as an adjunct to diet in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) and mixed dyslipidemia," said Eliot A. Brinton, MD, FAHA, FNLA, Director of Atherometabolic Research, Utah Foundation for Biomedical Research, and President, American Board of Clinical Lipidology. "Currently, many of these patients are receiving another prescription omega-3 which is not indicated for this disorder. Having instead an omega-3 product which lowers LDL-cholesterol in addition to triglycerides, has tolerability comparable to placebo, and is FDA-approved for use on top of statin therapy would be a welcome addition to the physician's armamentarium for comprehensive lipid management."
Sentiment: Strong Buy
I think some of these analysts will be coming out to revise price targets in the next couple of weeks. While PT's usually extend for a 12 month window, some of their forecast assumptions will probably be modified. There was note by Oppenheimer (which I posted this week) that stated peak Vascepa sales (all indications) will peak at $1.9 billion in 2022. Obviously the analyst needs to do his homework. The more I think of it, the more I believe Joe is following the best path for shareholders. There's been a lot of pressure - especially by the retail investment community - to sell at 18-20. If all the dominos fall into place (Reduce It is the key) this company could possibly be sold for 40-50 per share by 2016.
Thanks for posting that Oppenheimer note .
If Vascepa is as successful as you and others hope ( I'm long by the way ) ...expect a ton of competition by 2016 by a combo drug from AZN and high quality DS 90% EPA from BASF ....BASF now owns Pronova's production facilities as I' m sure you know .
PS to Fremzy .
I'm told by someone working on the reduce it trial that they intend to run it as long as possible to try and avoid some of the criticism leveled at AZN re the Jupiter trial with Crestor . Kaylawa I think worked put that there had to be at least about 1600 " events "
Nice insight. I think if BP allows the company to get to Reduce-It and it's successful they won't be able to pay enough. If you follow the history of Lipitor you find it was almost scrapped because the market was already flooded with statins. They saw that Lipitor reduced cholesterol more than any other drug so decided to give it a go and it became the most successful drug in history, by many billions. Improving greatly on that drug in one convenient pill could yield similar results. A $10B a year drug with just this one combo. Also note that the major Reduce-It divergences occurred right at this point in JELIS. Even though they don't have the incidents they might have enough divergence to stop it now. That means ANCHOR approval immediately, Reduce-IT approval immediately, combo pill accelerated approval and no BP can afford what AMRN becomes overnight. All this angst over the failures of so many other promising treatments is the only hold up now. Niaspan is the strangest failure, but closer examination shows it doesn't reduce ApoB and ApoC-III or many of the particulates scientists now say are more important than sheer triglyceride reduction and things like increasing good cholesterol. Vascepa hits the targets that no other drug can while also reducing triglycerides with a vengeance and helping any statin perform way better to reduce cholesterol more. The time to buy AMRN is right now, BP has very little time IMO. Also, the fact scripts are tracking better than Lovaza at this point, (a $1.5 billion drug in worldwide sales at one point), shouldn't be discounted either. Note that regardless of current stock price, it takes only one day to erase the disparity. Everything is in place now. The non-reaction to news yesterday will not last. PFE, AZN, JNJ, GSK, AMGN, etc... all noticed and are having their scientists examine JELIS now, (the most successful heart health study ever).
Sentiment: Strong Buy