I commented on related issues on the RYLP board
I do not have a fair price estimate yr end for ZSPH
Prices on all stocks can be affected by the risk on / risk off trade .
IF the IBB etf is being sold as part of a risk off trade ..say from a Greek default ...ZSPH is likely to be sold also .
Its had a tremendous run recently . Some traders will just trade out of it on high RSI numbers alone.
The key to watch IMHO is being able to maintain a lowered potassium level .
To date the data I've seen in Patirmoer ( RLYP ) is that about 20% revert to hyperkalemia over time .
This is important .
MD's will want the drug that acts the fastest with fewer side effects ...thats ZS-9 so far ....but also that maintains Potassium levels under 4.8 ( preferably ) in definitely....
That drug will dominate the market if reasonably priced
First some disclosure
1) I am not short RLYP . They have developed a useful drug that is far better then the Standard of Care and are very close to FDA approval . ZSPH has not completed all their long term trials yet so risks remain with ZSPH
2) I don't care whether you or anyone else on this board is investing in 100 shares or 100,000 shares .
I'm only interested in informed debate on the merits of both ZSPH and RLYP
3) My wife did Kidney disease research at Yale and works in a dialysis unit at a major hospital with patients who often have several disease at the same time ...HIV drug users , Diabetics , Heart failure patients etc ....so I get some "in the field , first hand " responses to my questions
4) These are only my opinions ...there is a certain degree of randomness in investing ...I can be wrong.
To your question ... IMHO when an MD treating these patients does a deep dive into the differences between Patiromer and ZS-9 ....based on the data available to date ....ZS-9 is the better drug because of faster onset of action . able to maintain lower Potassium levels better over time and at 10gm dose , fewer adverse events .
The data on Hyperkalemic patients with Chronic Kidney Disease on RAAS inhibitors is important .
RAAS inhibitors are used extensively with heart failure patients , however this often causes a rise in serum Potassium levels which may limit the use of these RAAS inhibitors.
Data presented by both ZSPH and RLYP at the recent conference indicates that ZS-9 is the better of the 2 drugs to use , to lower and then maintain a lower Potassium level ...so even if RLYP is used to begin with ZS-9 will be the go to drug , once approved ...at least in this patient population
So my read of the ASH posters is that for those on RASS inhibitors , ZS-9 ( ZSPH ) works faster , at 10mg dose maintains lower potassium levels better and with fewer adverse events , then Patiromer .
Market seems to agree
Commented on the ZSPH board ....side by side comparison for Heart Failure patients on RAAS inhibitors ( blood pressure meds ) , which can elevated potassium levels and increase risk of sudden cardiac death
So this afternoon both ZSPH and RLYP are presenting Late Breaking Posters at ASH explaining the benefits of both Patiromer and ZS-9 for those blood pressure meds for risk of heart failure , and the risk of elevated potassium levels these meds ( RAAS inhibitors ) often cause.
My reading of the data is that ZS-9 works faster , maintains lower potassium levels better and has fewer side effects ( adverse events ) ...and so will become the "go to " drug of choice for this population provided its reasonably priced
A few corrections to your post
1) Statins are not very effective at lowering TG's ...usually only by about 15-20 %
2) Fibrates are usually not prescribed to those on Statin therapy
3) Niacin ...risks outweigh rewards ...form recent trial data ...few prescribe it now
4) O'3's ... Generic Lovaza is the go to if patient is already on Statins or has low LDL to begin with . Increasingly Vascepa is seen as a better alternative to remove LDL elevation risk
Re dietary supplements vs Vascepa
Omegia Via EPA 500 is the best DS alternative BUT max suggested dose is 3gms a day and its 88% EPA ...vs 96% EPA for Vascepa .
So it comes down to cost , how much you need per day and medical condition
I'm diagnosed CAD ( coronary artery disease ) so I'm prescribed and take Vascepa 4 gms a day
My wife likes the 2gms a day of Omegia Via EPA for less joint pain and for mood elevation .
For those prescribed Vascepa at 4 gms a day ...extent of insurance coverage /co pay will be the deciding factor IMHO ...it needs to cost the patient less then $100 a month otherwise most will look elsewhere .
If Reduce It shows only 20% benefit ...it will still be a big deal ...for Amarin and your Omegia Via EPA 500
Come April 2016 they will either have won the 1st amendment lawsuit OR they will be planning an offering ( dilution ) .....its fun arguing with both the longs and shorts :-)
What ...can you edit yourself ..so much to say so little .
The Reduce It trial will cost about $120m to run ...maybe thats small change for you ...but most companies will not take on such an under taking unless they really believe in the science.
As regards to the IHUB folks ...consider me one ...and I am certainly not telling you or anyone else to "buy all you can "
AMRN is a high risk investment ...invest only what you can afford to lose , as part of a diversified portfolio.
Down ...yes IF you can lower them with diet and exercise ..no need for Vascepa .
Fact is that some patients , despite max dose Lipitor , BMI ( body mass index ) under 25 and a Mediterrean type diet , still run TG's over 200 ...and combined with HDL under 40 ...have elevated risk of a Cardiovascular event ....I was one of them , which is why I'm prescribed Vascepa
OK Raf ....Lets just have you , RD , JL and James at over 40% efficacy . I think HDGabor is at about 30% efficacy and I'm down to about 20% efficacy .
20% efficacy is probably not enough to stop the trial at Interim ..so hopefully I'm wrong and you and the others are right !
In the 1st Qt they spent $14.5m in sales and marketing ...yet revenue was only $15.6m
1st qt they had a nett loss of $26m and ended the Qt with 161m in cash ......so the risk is that they lose another $100m over the next 12 mths and we end up April 1 2016 with $60m cash ..which would force them into raising funds .
They need to cut expenses and raise scripts #'s....enough to get to interim analysis without the need to raise
JMO ...always interested to read yours
I'm not bearish or bullish ...rather I'm neutral . Love the drug , believe it works , but not being able to market to the high TG market ( 200-500 TG ) really hurts the companies finances .
Re the 895 patients in JELIS with prior coronary intervention ...the incidence of MCE in the EPA group was 14.7% and significantly lower then the control group of 22% ....so whats that about a 33% benefit
But I'll put you down for 50% benefit ...Think Raf still holds the top spot with 53-55 % benefit.
Thanks for the note on the EVOLVE trial ...will chk it out
CY Thanks for posting the script #'s
Can you comment on the effect of the rebates in driving these numbers ...and will the script #'s decline or flatten out when the coupon program ends Dec 31 /15
Currently Vascepa costs me about $160 a month with no insurance .
That will jump to about $240 a month when the coupon plan ends ...and be 3 to 4 times the cost Omegia Via EPA.
Vascepa is definitely better then Omegia Via EPA ... but not 3 to 4 times better to justify the cost difference for those whose insurance will not cover Vascepa .
Kaiser refuses to cover Vascepa as well as some other major health care organisations.
Raf ...Reduce It is a trial enrolling patients at high risk of a CV event , who are on optimal Statin therapy to maintain their LDL levels below 100.
The reason for this is that at the time they designed the trial ,they believed that once LDL cholesterol levels are below 100 , they ( LDL levels ) are not a major risk factor.
Therefore they isolate TG's over 200 as the major risk factor .....and seek to see if by lowering those ( TG's ) using 4 gms of Vascepa ...they lower the # of CV events .
This is a simplified explanation ...TG levels alone will not be modified by 4 gms of Vascepa ....hsCRP , the EPA/AA ratio etc will also change ...BUT there will probably be little change in LDL levels between the 2 groups if the LDL levels are below 100 to begin with
RI has higher risk of CV event then JELIS...but probably less then the JELIS subgroup ( 53% reduction ) you are referring to .
The low HDL / high TG SUBGROUP has shown benefit in all the TG lowering trials ( ACCORD , THRIVE etc )...as well as JELIS ...but this is a subgroup.
IF RI was only diabetics with established CAD ( coronary artery disease ) with prior intervention ...then we might see the benefit you and JL expect ...but its not , so I don't think we will
#2 ..LDL under 100 ..its in the clinical trial description ...chk clinical trail .gov ..I applied to be in the trial ...even tho my TG was over 200 with family history , LDL was not under 100 so I was not accepted.
#3... Higher doses of Statins ..you need to read up on Statins and CV event reduction ...start with JUPITER Trial or the West of Scotland trial ...or read ESPR's docs on LDL levels and CV events ...note Alt's post on IHUB
The placebo rate in JELIS may be 5% ....so what does the Vascepa rate have to be to show your 50% benefit ...2.5% ? Sorry , do not think that will happen ...but if it did it would rock the world of Cardiology
AK / Kiwi