Another interesting thing about this deal is that Eddingphram went with Vascepa instead of Epadel .
Epadel is OTC in Japan .. ( has about 2% DHA vs 0% DHA for Vascepa ).
Its going to be very interesting to see how they market this ....ie as a US FDA approved product that they will sell to anyone concerned about heart disease ?
I was concerned about the push back from some healthcare providers in the US , re coverage ..UHC/CVS for example . This deal helps alleviate that concern
The $15m up front payment may remove risk of dilution pre Interim analysis .
Eddingpharm may market more openly to the Anchor ( TG 200-500 ) patient also .
There are wealthy Chinese who will pay for high quality and safe products ..so there is a market
Speculation is that Merck would be the most motivated as their cardio drugs come off patent
Believe PFE already own 4.8% of ESPR .
I can't believe they would walk away from this IF the 009 trial shows that ECT and a Statin combo can compete with the PCSK9's for LDL reduction ...in all but the extremely high risk and very high LDL hetero FH patient
With Crestor max dose ,you can get up to a 60% reduction in LDL...so Crestor plus ECT 1002 for those who are not Statin intolerant plus Zetia if needed , should get you close to the PSCK9 's ability to drop LDL , for far lower cost .
Hope they had a lot in the 09 trial on max Crestor
Using your math ..we now have 653 events if V has no benefits end of 2014
With 7,000 patients in the trial for 2015 at a 5% event rate , we have an additional 350 events by year end ...a total of 1,003 events .
Interim analysis is required once we hit 967 events ...so by your math , if V is NOT working we will know roughly by year end ... correct ?.
In fact if the event rate is 5.2% ( as they calculate ) , using your math ...we will definitely hit 967 events by end of year.
Regarding your calculations
7,000 patients for 1 yr half on Vascepa half on placebo ... 5% event rate
No benefit from Vascepa = 7,000 x 5% = 350 events
now with 40 % benefit from Vascepa
Half ( placebo arm ) is still at 5 % = 3,500x 5% = 175
Half on V at 40 % benefit ..event rate drops to 3% ( ie a 40% improvement over the placebo rate ) = 105
So for the 7000 in the trial in 2015 you would have a total of only 280 events
You are already calculating 563 events with V 40% efficacy to yr end 2014 ..so we will be at 843 events by end of year ....( 563 plus 280 )
Since the trial is blinded and all we have to go on is the numbers enrolled and the number of total events ..we should know if V is NOT working before we know how well its working
While I agree that this is a bet on RI being stopped at Interim or before ...if it is stopped , it will be huge news .
Nothing except Zetia has proven of benefit when added to Statin therapy ...and then only very modest benefit .
If RI is stopped for 20% or better efficacy , it will create huge demand for V .
Omegia Via EPA is about 88% EPA vs Vascepa at 96% EPA . It has a small amount of DHA
Its FDA regulated as a food NOT as a drug ...so quality control is not as stringent .
Max dose reccomended is 3gms vs 4 gms for Vascepa .
Vascepa is the gold standard ...HOWEVER ...IMHO Omegia Via EPA is an alternative for those denied insurance coverage for Vascepa .
Omegia Via EPA does appear to have good quality standards and testing of their product vs some "fish oils " on the market
OT Brad Loncar ( Twitter ) also likes AERI ...posted a video blog on the co over the weekend ..data out in next few months
I've followed some of your other posts .
Suggest you take a look at ZSPH ...Alta Partners are big holders .
They reduced their position some what in ESPR last week
Gabor ..you are far to polite and patient . Suggest you don't waste your time
I have a position in ISIS mainly due to their anti coagulant drug ...so thanks for the FYI .
Re APOC3 ...Vascepa lower it by about 20% I recall .
Re clinical trails ...been in one years ago ..done my time as a " lab rat "..at this pt I'm not interested in a chance of being in the placebo group .
My main concern is LDL cholesterol ...as high as 312 pre Statins ...only once under 100 with max dose Crestor , max dose Zetia and max dose Vascepa combined
Next step are the PCSK9's which I may have to consider .
I've had a large position in ESPR because of ECT 1002 ability to lower LDL and hsCrp without the side effects of Statins ...yes there are side effects for most on high dose.
Yes , have met patients with HoF . Most with diagnosed hetero FH in their 50's know that they have coronary artery plaques ..its how to prevent them or reduce the chance of them , rupturing in your 60's.
Appreciate your info tho
So much to say so little !
Amarin has already disclosed ...967th event expected to occur early / mid 2016
Polymer ...working up to your pitch for dietary supplements ?
I am one of about a million people in the US and Canada combined with hetero FH ...its about 1 in 300 ...so no so rare .
In addition there are the 20m odd diabetics and 23 m with mixed dyslipidemia .
So the numbers that can benefit from Vascepa are quite large ...plus the 4 m with very high TG's
Suggest you google " Stabilizing effects of combined eicosapentaenoic acid and statin therapy on coronary thin cap fibratheroma " to get up to speed..
The market is .....What can be added to Satins to further reduce CV risk ?
We know Zetia will some what ..maybe by 6%
Can Vascepa do more then that ?
Regarding your DHA/EPA supplements ...they never have and never will be approved for the 24m mixed dyslipidemia market because ......you know the answer right ? ...they raise LDL cholesterol.
Raf JL was never impressed by Jupiter . Some criticize the DMC for halting the trial to early ...but Dr Ridker ( Harvard ) was lead investigator and has defended the decision .
Dr Ballantyne ( Anchor trail ) is also a big fan of the Jupiter trial .
For myself ...I look at the body of evidence ...Jupiter , Prove It , West of Scotland ...and for me the evidence is overwhelming that Statin drugs can reduce CV risk , for those most at risk .
Polymer ..your first post ...not bad .
So are you now going to launch into a " you don't need Vascepa just increase the Statin dose ".
For the record
Lipitor lowers TG's by 19-37%
Livalo lowers TG's by 13-22%
Lovastatin by 6-27%
Crestor by 10-35%
I was on max dose Lipitor and still had TG's in the low 200's with HDL under 40 .....so for many , Statins alone do not remove all risk .
My main interest in Vascepa is to increase my serum EPA levels which research indicates may stabilize vulnerable plaques better then statin alone
The two most cited trials are the Jupiter Trial and the Prove it Trial
Best to google them for details .
Rouvastatin has been shown to reverse coronary plaque progression and is probably the Statin of choice for those most at risk .
By the way ...its the Statins effect on hsCRP ( inflammation ) as well as LDL cholesterol levels that supports their use . They usually only reduce TG's by about 20% ....so high TG's with low HDL still represent considerable risk even if the Statins have lowered LDL.
Vascepa lowers TG.s , hsCRP and APOC3 ....so a lot of potential for reducing risk thats not fully reduced by Statins
Good to have an MD on the board posting real life experiences.
The only patients I know getting Vascepa for less then $30 a month are govt or ex govt employees on BCBS , who also use Amarins coupon..
Amarins Coupon should be available thru their web site ...I use it.
Regarding cost ...There is not a huge incentive for payors to make Vascepa low cost until they see cardiovascular benefit ....ie Reduce it being stopped at interim with 20% or better efficacy
So in 2016 we will have generic Crestor ( we now have generic Lipitor ) ....so thats very low cost to patients .
If RI is stopped for efficacy I expect every effort by payors to make Vascepa affordable to patients at risk of a CV event ....especially those who meet the profile of those in the Reduce It Trial.
The very high TG market I expect to be dominated by generic Lovaza , for reason I've outlined before .
As an investment , I'm only interested in AMRN for the potential for RI to be stopped at Interim.
I believe Amarin has the funds to make it to interim analysis without a capital raise