" reduced my position " ....say it ain't so .
The run up today was because of the court docs filed by AZN in their effort to
launch Epanova ....looks to me that they are in trouble as they infringe on Amarins patents for lowering TG's without raising LDL by more then 20 %
Right now they (AZN) seem to be trying to steam roller over AMRN , but I don't think it will work unless they can find a flaw in Amarins patent.
The main act ...FDA decision , is yet to occur ....I rate it at 70/30 in favor of Amarin ....so I'm not selling
But if you already have a profit ....well done
Suspect they will push the 2gm version as an add on to Statins as a low cost way to reduce CV risk
It 88% EPA ...regulated by the FDA as a food ...not as a drug ...if you CAN NOT get V with insurance coverage or otherwise afford it ....it's worth considering .
I have used it , but prefer , and can pay for , Vascepa
I'm not Williams but the following info might help
AZN is claiming that Omethera does not infringe on Amarins patent that covers an up to 20% raise in LDL on treatment .
AZN claims that since Omethera increases LDL by about 20.5 % compared to baseline or placebo ( sorry forgot which one ) they dont infringe and thus can combine with Crestor if they wanted to
However ..when compared to baseline or placebo ( forgot which one ) Omthera only raises LDL by about 16% ...thus would infringe on Amarins patent .
Amarins patent is written to cover change from both placebo or baseline ...change has to be greater then 20% not to infringe
From HDGator on Ihub
Epanova increased LDL 15% relative to placebo and 26% relative to baseline arm
Amarin's patent is written to cover both placebo and baseline ....thus they infringe .
So unless they reformulate they may need Amarins patent to combine with Crestor
The PCSK9 is designed more for hetero familia hypercholestremia patients and those intolerant to Statins ...They do not directly compete with Vascepa
PCSK9 's dramatically reduce LDL cholesterol ...hetero FH paints have LDL levels anywhere between 180 to I think about 500 ...over that its more likely to be a #$%$ FH diagnosis
The drug will be expensive ..sub Q injection either every 2 or 4 weeks ...it won't be damaging to Anchor , Reduce it
JMO ( I have hetero FH and a Cardiologist and I did discuss my participating in Amgens trial ...but I dont like needles and would rather try and get my lipids in line with max dose Crestor and max dose Vascepa )
Some what OT ... Those with Hetero FH who are also Statin intolerant face an unmet medical need . Without aggressive treatment as many as 85% of these patients will have a CV event by age 65 ( Medscape )
PCSK9's will be targeted at this group IMHO
Everyone with hetero FH should also be on Vascepa .... to reduce chance of coronary artery plaque rupture.
Most patients with Hetero FH will likely have some amount of coronary artery plaque past age 40.
Hetero FH is about one in 350 in the US.
Build a home
I agree that OmegiaVia Via EPA is the best alternative for those that can't get insurance coverage for Vascepa .
Some patients using insurance co pays and Amarins coupon get a months supply of Vascepa for $19 ...OmegiaVia EPA will cost about $34 from Amazon including shipping for a months supply ....since it's 88% EPA you will actually need more of it to equal daily dose of Vascepa ....
OmegiaVia Via EPA is regulated as a food ...Vascepa as a drug ...Quality and quantity of EPA is higher in Vascepa
If you are getting OmegiaVia EPA delivered you will need to watch delivery times as the last thing you want is for it left out in the sun all afternoon . Vascepa I get from cold storage at Walgreens
Bottom line ....If you have great insurance copay and Amarins coupon you don't even consider dietary supplement alternative .
If your insurance declines coverage ...OmegiaVia EPA ..provides a lower cost , lower quality alternative
What insurance coverage do you have ?
Are you using Amarins coupon
What's your actual monthly cost ?
Agree that your MD will want the quantity and quality of EPA to be consistent especially at 4 gm dose and if you are considered high risk .....what's your lipid panel numbers and family CV history
IMHO ...Amarin will finish RI no matter what
They currently have funds to last to early 2016 when an interim analysis is expected .
I expect Vascepa's label to be expanded to include language that states that CV risk may be reduced by lowering high TG's using Vascepa in patients at high risk .
Wider approval contingent on positive Reduce It read put.
The reason for the change ....recent research in the New England Journal of Med identifying high TG's as a risk factor ....And .....probably over 30,000 patients now on V for over a year and no adverse events
I try an answer to that
Did not pay for doctor visit ....he emailed in request
Blood draw did cost me about $30
No charge for lipid panel ....guess my insurance covers that.
No doctor visit following ...email discussion on results / review ....no cost.
Yes , did get a prescription
Do not have extremely high TGs but do have a lipid disorder and a family history of heart disease .....so on risk reward basis Cardiologist felt it was worth trying
Well full disclosure ...I thought 70/30 in favor of approval at Adcom ...based on risk / benefit analysis ....potential for benefit with almost 0 risk .....so I was wrong there.
If expanded label ... An immediate jump to at least 3 ....then the debate will begin on whether or not the Corscia group might convert some of their debt to equity which might involve diluting the stock ...
I'm also wondering if the FDA may loosen their language on all RX fish oils ....so we might see more competition from generic Lovaza.
Thanks for that PS on low dose Statins
JELIS was mostly medium dose of a medium strength Statin ...Simavastsin
Most in Reduce it are on Lipitor or the strongest Statin, Crestor ...at a strong enough dose to get their LDL below 100 to even qualify for Reduce it.
The risk profile in Reduce it is similar to the high risk sub group in Jelis ...However I think the % still smoking was a lot higher in this JELIS sub group then in RI..
In effect ..you have twice the dose of EPA with twice the dose of Statin in Reduce IT vs JELIS.
Be happy if you just see the dramatic drop in CV events in those that have high TG's and low HDL profile in both trials ...I know I will be ..thats my lipid profile :)
Re FDA terminating clinical trials ......this is a cardio vascular Outcome trial ...NOT a cancer trial with some experimental drug .
Fish oils and fish , have been around , and eaten ..since who knows when.
"excessive deaths " WILL NOT be caused by Vascepa as a reason to terminate the trial ...neither will the placebo or the statin used
NONE of them will cause excessive deaths ...the question will be whether Vascepa added to Statins is better then Statin and placebo.
There are some good things to say about Omegia Via EPA ...but unfortunately you dont seem to know what they are....most importantly it offers a lower cost /lower quality option for those that can not get insurance coverage for Vascepa .
Almost everyone I know on Vascepa has an off label prescription that is covered by their insurance co ...particularly if they are on some Federal employee health plan .
Vascepa is subject to FDA drug regulations , OmegVia EPA is subject to FDA food regulations ...apparently you dont know the difference
Re reading your calculations ...thanks for posting by the way .
I'm more of the idea that because most in Reduce It are on Lipitor or Crestor ( the Statins used ) ...and these Statins are known since Dec 2011 ( ie after the FDA guidelines /estimate of event rate of 5.2% in RI population ) ..as being capable of causing in a regression of coronary atherosclerosis ( as opposed to slowing progression ) ... the event rate will be slower .
So I dont see an interim analysis in late 2015 .
Can you run your calcs on a 4.9% event rate
As some one who has swallowed more OmagiaVia EPA and Vascepa then most on this board ...I'll offer the following
OmegiaVia EPA is about 88% EPA , Vascepa about 96% EPA . Both will lower your triglycerides dramatically ...in my case by about 30%
Vascepa is regulated by the FDA as a drug , OmegiaVia EPA as a food ....so most pharmacists consider OmegiaVia EPA lower quality and quantity EPA
That being said tho ...OmegiaVia is a lower cost alternative to Vascepa for those that can't get insurance coverage for Vascepa .
Using Amarins coupon , but no insurance coverage , Vascepa currently costs me about $5 a day for 4 gms
OmegiaVia EPA would cost me about half that for 4 gms
Why not use OmegiaVia EPA ....well I often had trouble with the delivery ...left by UPS on my driveway all afternoon in full sun . With Vascepa I can pick it up from Walgreens knowing it is in perfect condition ....and since I'm high risk , I need my meds in perfect condition
Those that have great insurance coverage get Vascepa for less then $40 a month ....no need to even consider OmegiaVia EPA
As a follow up
Vascepa does not need the enteric coating ...it's at least 96% pure EPA . Those fish oils of lower quality or containing DHA use the enteric coating to reduce fishy burps