Golong ...see I was cut off
10g dose of ZS-9 lowered serum potassium levels from 5.3 to 4.6 in 48 hrs
QUOTE " The patients in the study of ZS-9 had few adverse events , but the study was short "
ZSPH is currently running an 11 month trial with these patients ,,,final data collected in July .
ZS-9 has far more clinical data , more patients with a variety of conditions . In addition they will have the longest data series on adverse events .
IF their 11 month trial reads out as " The patients had few adverse events " ...as is reported so far , then ZSPH will be the co to receive any buy out offers that may materialize.
Limited data makes RLYP to risky for me .
But good luck anyway ...you have had your home runs thats for sure .
Ever chk out ESPR ?....data in March
Appreciate your analysis ..encourages me to dig deeper .
I prefer to use published analysis in the NEJM rather then each individual companies spin on the data
So to NEJM article updated Jan 16th 2015 " New Era for the Treatment of Hyperkalemia "
First the good news
Conclusion " both agents ( ZSPH and RLYP ) appear to offer some promise for the treatment of hyperkalemia "
" In the study of patiromer ....107 entered a 8 wk placebo controlled randomized withdrawal phase ...the most common adverse event was constipation in 11% of the patients .
Whether constipation would be more troublesome with longer term treatment is unclear ..adverse effects appear mild ..but patients recieved the drug for no longer then 12 weeks ...Thus caution is required "
I read that as FDA will want more data on safety .
ZSPH 's ZS-9 has been studied more extensively .....they currently have an 11 month maintainance study running ...final data collection in July 2015
With ZS-9 you have a 2 phase , double blinded P 3 trial with 753 patients ...60% were diabetics, 40% had heart failure , 65% were recieving RAAS inhibitor therapy..
"The mean serum potassium decreased from 5.3 mmol to 4.6 mmol in the group that recieved 10g of the drug P value
Quick update ... ZSPH Extend Study ZS-004 ...11 mths on drug ...last data collection July 2015
FDA will get a lot more data on ZSPH's drug then they will get from RLYP
A tweet direct from my wife who is as I type , working in a dialysis clinic.
Re Insulin ..."Yes we use it but effect is only temporary until other interventions kick in ...it is used in ER or ICU"
Suggest you read " A New Era for the Treatment of Hyperkalemia ? " NEJM
quote " decrease in potassium with patiromer therapy appears to be gradual, so how well this agent would perform in the actue situation is unclear "
I read that as meaning unlikely to be used in Acute setting ...and I doubt if FDA will approve broad use for it in the Chronic setting without a LOT more safety data
JMO ..always interested to read yours
What info do you have on the extended trial with ZS-9 ...when will it end ?
Two things here as always ...efficacy and adverse events ....adverse events can kill any new drug
The longer the ZS-9 trial goes with no serious adverse events showing up the better .
Suggest you read the ZS data more carefully
" In the open label acute phase serum potassium levels declined from 5-6mg at baseline to 4.5 mg with 98 % of patients achieving normokalemia within 48 hrs of beginning treatment "
The idea is to get to these patients BEFORE they need insulin in ER .
The ER is one of the most expensive places to treat patients ....far better to get to them before they reach that phase
Yeah I'd appreciate your view on ESPR ...maybe on that board .
I'm fine with opposing views , in fact I seek out the well informed opposing views just to chk my analysis .
So feel free to shoot holes in my analysis.
Not saying you won't make $ ...you are more of a trader then myself so there may be a run up to Adcom .
At Adcom tho I think the FDA will severely limit use of the drug until they have more long term safety data .
Remember Omonty and AFFY
Well we agree to disagree re RLYP .
IF ZSPH completes its trial with no serious adverse events ,I think it becomes the go to drug in the field .
I wrote a post on ESPR MB the other night ...you may want to take a look at it .
Trial data is supposed to be presented March 14-16 ...subject close to my heart ...pun intended .
Key again will be great results with no adverse events
Its not a mix ...its 1.8gms of Edapel ..just as they used in JELIS
Because of their high fish diet the actual effect may be closer to 3gms of EPA and 1 gm of DHA per combination of 1.8gm of EPA plus fish diet ....per day
But here again ...very much like in JELIS in actual EPA and DHA intake.
What makes it different from JELIS and more like Reduce IT is
1) All patients have had angioplasty and / or stenting ...ie far higher risk then average in JELIS
2) Stronger Statins being used
3) Lower LDL levels to begin with
BioBill has some interesting links to the Volcano technology for accurate measurements of plaques ...on IHUB if you have access.
But remember ..only 200 in trial for only about a year I think ( HDGabor may be able to confirm actual length of trail )
If they show 8-12 % benefit its a big plus IMHO for RI ...as EPA dose is a lot higher in RI in a low fish diet population ...also for a far longer period
JMG ( Just my guess )
From reading old posts ( a humbling experience on my part ) ...you were very much against going it alone ..for all the right reasons ...difficult for a small cap to do.
I still thought a marketing deal could be done ,right up to the first week of Dec 2012 ..where after a meeting with my Cardiologist ...came away with a far more sobering analysis of Amarins chances ...both for the prospects of selling the Co and of competing against DS alternatives
Raf , Benny , Short et al ...we all make mistakes . To avoid repeating them its always wise to consider opinions , opposite to our own .
Hi Swalchie ....correct , I do not remember you as a pumper and you certainly weren't throwing out super high buy out prices
As some one diagnosed with Coronary Artery Disease ... I'm one in about 20 million or more in the US alone .
Statin drugs reduce cardiovascular events ( Heart attacks , strokes etc ) so all those at risk should be on Statins
But some quick facts
1) According to the Journal of the American College of Cardiology 2012 " about 50% of patients discontinue statin therapy within the first year ". this is largely because of problems with muscle cramping , concerns over memory loss and slight increased risk of diabetes..
So there's a huge population who have not been able to lower their LDL cholesterol by diet and exercise alone AND will not take Statin drugs.
2) Some can tolerate low dose Statins like simavastatin but can not take strong enough doses to get their LDL low enough ...diabetics need to be under LDL 70 for instance
3) One in about 300 in the US have hetero familia hypercholesterolemia ( my lipid disorder ) and many of us never reach our LDL targets on Statins alone even if we can tolerate Statins at the strongest dose.
So there are multiple markets for a safe , effective alternative ,or add on ,to Statin drugs
Trial data ...009 due in March will tell us if ECT at max dose , combined with max dose Statins will come close to the PCSK9's ability to lower LDL .
Safety data for ECT-1002 will be critical
JMO ...do your own DD
Swalchie ...we go back several years ... back to that time in 2012 when ( if my memory is correct ) you thought a buyout was about to happen and I argued that I wasn't that convinced .
OT ..in case you are still interested in CV drugs ...my largest position is ESPR.
I'm about write a New Topic post on that board in case you are interested
Raf ...Swalchie posted big time back in 2012 so he has a lot of history with the stock and this message board.
Suggest we welcome anyone that has a reasonably informed pt of view ( whether short , long or neutral ) ...if they can present their opinion , without a string of insults attached
Golong ..still long and strong ?
These small caps are not without risk ...note ARDX ...which I unfortunately had a position in ....any jump in adverse events can kill these stocks .
I have never been a great fan of Amarin Mgt ( although feel better about JT now )
A little history ...several yrs ago JZ persuaded the board to accelerate the time period for where mgt options could vest ....allowing him to cash out about $14m and JT about $5 m right after FDA approved Vascepa for the Marine indication.... Mid 2012......
JT then blustered on hinting a deal was in the works ....even tho he was selling ....so as the months went on and nothing happened ...I sold also.
After the Adcom ambush ( I was long again going into Adcom ) the board had to do something to retain key mgt ( after firing JZ but allowing him to stay on the board ) ....and this I believe is their incentive package
What the board and we investors want is a steady ship to Interim . No MGT departures to seek " other opportunities " , controlled cash burn ( which JT is doing a good job at ) , hopefully steady script growth and no dilution
What the dates on the package tell me is ....No one leaves until we see RI results
Hi Shortfish ...I suspect that they will use it to help their sales in Japan .
Going from memory . They are using 1.8gms of Epadel added to their Statin . Not sure who owns Epadel now ( Nissin ? ) ...but Epadel is almost identical to Vascepa except it may contain 2% DHA
So the info I have on it .....HDGabor and DEN may have more
Patients with stable angina or acute coronary syndrome...received PCI ( percutaneous coronary intervention ---which I assume to mean either angioplasty or stenting ) and whose LDL is above 140 .
Aim is to find out if the coronary plaque regression and stabilization achieved by strong Statin dose ...are reinforced when EPA is added. ( sounds like Reduce It )
Remember tho ...small study of 200 , EPA dose is 1.8gms , not the 4 gms used in RI
Primary Outcome ...Change of tissue characteristic in coronary plaque
Secondary Outcome ...many including change in % stenosis , incidence of MACE etc
Most of the negative posts on this board have to do with TG's ...
The reason I take Vascepa is from everything I've read ..its helps to strengthen the cap covering the coronary plaques making them less likely to rupture...thus reducing chance of a heart attack .
Anyone diagnosed with CAD with have some degree of plaque buildup
Follow up from USA Today 2/2/15
Pfizer retains 4.5% stake in Esperion as part of deal in transferring intellectual property to Roger Newton ( who developed Lipitor for Pfizer )
"Company has received considerable "inbound interest " from prospective Pharma partners .
Co to keep options open ...an acquisition is possible at some pt "
Kowa's CHERRY study should end around the end of March 2015 and readout soon after .
It's the closest trial to Reduce It that I am aware of and should give some indication of likely RI interim results .
If those results are positive then Reduce It Interim results showing 20% or greater efficacy with a P value of .001....,, should be enough to stop RI .
The current view is that there is no proven value in adding any Omega 3 to Statin therapy ...in a US population ...thus Reduce It will fail ...thus AMRN trades at $1
Anyone buying AMRN at these levels is making a bet based on recent research that shows that lower levels of TG's and APOC3 equal lower CV events .....thus Reduce It should show benefit since Vascepa lowers both more then Statins alone
The risk is asymmetric......downside you lose a $1 per share ...Upside ? certainly a lot more then $1 a share
Rocket. ..no near term catalysts that I'm aware of .
RLYP will be first to market , ZSPH awaits final data in 3rd Qt .....ZSPH is a better drug IMHO especially in the acute setting ...but still 6-9 mths behind ...as long as no serious adverse events appear
There are major differences between JELIS and Amarins Reduce It trial
In JELIS ..69% of the patients were postmenopausal Japanese women ...a group known for long life expectancy . In JELIS itself only 15% had diabetes and 20% had coronary artery disease
These , by and large , were not high risk patients
When you dig into the study you find areas that may be applicable to Reduce It ...as example the results from the 3,664 patients with a history of Coronary Artery disease ... 19% significant reduction in major coronary events using EPA , compared to control .
And for further detailed analysis of the patients in JELIS that are most like the patients in Reduce It ..of course you'll read " Secondary Prevention Analysis from JELIS " and report back ...followed by an analysis of the benefit in the sub group with high TG and low HDL ( typical of diabetics )
JELIS was NOT a study of high risk people ...only 20% had CAD
Reduce It IS a study of high risk patients , likely to have a CV event with 5 yrs...thus its is the high risk sub groups within JELIS that offer indications on what to expect in Reduce It