Adam I listened to it as I'm sure ZSPH mgt did. I also commented on the ZSPH board
RLYP needs to get their drug to drug work done and submitted in the 1st Qt 2016
It will then take the FDA 6 mths to review and decide whether or not to allow a 3 hrs prescribing window ...so some time in the 3rd Qt 2016 .
I expect ZSPH will try and get all their drug to drug studies done asap and hope to have them submitted for a 3 hr prescribing window at the time of their date with the FDA in May 2016 .
So yes RLYP is the first to market , but they are also the trail blazers showing ZSPH what to expect and thus
ZSPH may end up actually being the first HK drug with a 3 hr prescribing window.
I was wondering how big this market is . After listening to Dr Weir I don't think its as big as some analysts think ...but still probably a $1.5 to $2 Billion a yr market in the US
Long both ZSPH and RLYP
I listened to it and I also have a long position in RLYP .
So my take away is this
Dr Weir is very reputable and worth listening to . But listening to him I'm questioning how fast the uptake of Veltassa will be . It doesn't sound as tho he's going to be prescribing it more then 2 to 3 times a week and he has a large practice. ...Note his answers to the analysts
To quote him " Don't expect a big jump overnight " .
He also said that only 10-20% in total of all the patients in a typical CKD practice would need Veltassa ( or I assume ZS-9 ) ...so exactly how big is this market for either drug ???
RLYP will be going thru a huge cash burn in the first 2 quarters of 2016 . Medicare decision is not due to March . Supplemental NDA takes about 6 mths so third Qt 2016 would be the earliest to change the prescribing window from 6 hrs to 3 hrs. 1st Qt 2016 earliest date for drug to drug binding study results
Also the presentation gave no details on rate of recurrence of HK . The lack of detail gives the impression that there's no recurrence where in fact we know there is about a 15% HK recurrence from their trial data.
Biggest concern I have is determining the size of the market
Any ideas ?
Suggest you read the HARMONIZE trial some time .
Some in the trial had serum K over 6.3.....98% of those in the trial achieved normokalemia within 48 hrs .
In other words ...from 6.3 down to under 5 within 48 hrs .
I don't have any data on any individual patient dropping from 6 to 4 .....but don't sell yourself short ...you might have a chance in the Olympic 100 meters after all ....:)
The placebo measured time was from Day 8 to day 29 and we don't know whether the patients started out with serum K at 3.5 or 4.5 or how many of these were on RASS inhibitors .
70% of those in the trial were on RAAS inhibitors , so if you were on placebo BUT not on a RAAS inhibitor , your serum K may have risen more slowly then some one on a RAAS inhibitor.
Anyway ...patience Fghton , patience . All will be revealed , good or bad , on Saturday .
Have you read the earnings report .
From a quick glance , they had $25.3 m in General admin expenses and $32.4 m in Research / new hires etc . Thats almost $58m spend in one Qt and they say they have only hired 1/4 of their intended sales force .
They are going to burn thru a lot of cash before they get to break even ...thus the shelf and the sell off
Lurker and Fghton
Understand that normalized serum K levels are between 3.5 and 5.0 .
So if those on placebo had first had their serum K levels dropped from 6.0 to 4.0 on ZS-9 .....and then placed on placebo for 28 days .....if their serum K levels drifted up to 4.9 during that time they would still be considered to have normalized serum K
Lurker ...ZS-9 has been reviewed in the New England Journal of Med plus other peer reviewed journals .
Suggest you read them some time .
Finally ...we will have a lot more info on Sat ( Kidney week conference ) whether good or bad .
Suggest you wait till then .
The trial data they will be presenting is from the ZS-004E ... extension study
Perhaps you could familiarize yourself with the details of this trial ,so that can make some informed comments
RLYP has first mover advantage and will definitely build a client /patient base..
As poster Adam has noted ...once patients are comfortable with a med they can be reluctant to change .
I've seen and experienced this myself with Statin drugs over the years..
I've also noticed that Cardiologists may prefer Veltassa while Nephrologists may prefer ZS-9 .
I still think the market is big enough for both drugs ...just like there are several different Statins drugs being prescribed for high LDL cholesterol...providing options for MD's and patients.
They are about to ramp up a major sales force and marketing campaign .
Do you know how many sales reps they are hiring and their salaries .
This is not the somewhat fixed expense of running a clinical trial .
You can't say they have 1.5 yrs worth of cash ...you have no idea of their 2016 cash needs for sales and marketing .
JMO ( and I'm a retired corporate CEO /CFO )
By the way ,I'm not worried about the shelf filing ...its expected and a wise move
Did a quick search
So there are up to 1,000 abstracts ( from memory ) being presented in some form or venue at Kidney Week.
Of those , 15 ( your figure ) are selected for a "high Impact clinical trial "oral session .
So yeah , I'll go with the idea that this is an important presentation of clinical trial results that may affect future treatment of HK patients .
I never said it was going to be earth shattering .
There will be a discussion session afterwards . I'm sure the idea that they have some how fudged the results will be thoroughly explored ....and they will be well prepared to defend their data.
The ZSPH team are top notch . Suggest you chk them out some time .
Yes Fghton ..if the data is really bad for ZS-9 they would have insisted on presenting that at a High Impact Clinical Trial oral session with a moderator and a discussion following ....rather then disclosing it on some poster abstract as a Hall presentation .
What do you think ?
Do you know of any drugs that have yet to be approved by the FDA ...repeat ...yet to be approved ...featured in a " High Impact Clinical Trial " session .....if their data stinks.
Obviously if their data stinks it will have NO impact in clinical practice .. its not an approved drug yet ...so why present it in that ( High Impact ) setting .
Yes , you convinced me that Veltassa would find a market . At $14 a share well worth the risk and so far its been a great run , so thanks
PS ...still think ZS-9 will eventually get the biggest market share tho
I've almost given up guessing what will happen with either ZSPH or RLYP on a day to day basis .
IMHO we will have two FDA approved drugs to treat or prevent hyperkalemia
The feedback I get is that Cardiologists may favor Veltassa and Nephrologists may favor ZS-9 ...for different reasons which I won't go into .....but those who follow this space should know what they are.
Re RLYP ..no one was talking about a black box 6 hr prescribing window for Veltassa pre approval . If you remember , those of us who suggested the possibility of some limitations on the label were scorned .
That possibility is priced in now on ZSPH ...most expect some limitations on the label.
The focus will shift in the next 2 days to RLYP's presentation on CKD patients 65 and older on RAAS inhibitors ...this is the market they will IMHO target ...presentation Nov 5 at 6pm ET.
So it would not surprise me if there was some softness in the PPS of ZSPH
But on Saturday we will have the " High Impact Clinical Trial " oral presentation by ZSPH on long term maintenance and safety data for ZS-9.. For a presentation to be accepted for the High Impact session ...the sponsor's ( ZSPH ) have to convince the conference organizers that their data may very well influence clinical practice. I doubt if their data will stink .
Good luck to U also .
Re Orbimed .....from memory their last major sale was in the low $30's ....so if you are following Orbimed , watch the SEC Form 4's
A 2 pt drop on ZSPH and you call that tanking ??
To some of your pts .
ZS-9 ( ZSPH ) will be approved IMHO. They will have more clinical trial data on ZS-9 by time of FDA decision then RLYP ever had on Patiromer ( now Veltassa ) and the data on balance shows ZS-9 at 10gm dose to be similar to placebo with more elevated risks at the 15gm dose.
So they will not need more trials ...poster greenforever ..
Re emergency use ...strong possiblity that ZS-9 will be use for serum K under 6 because of data showing significant drop in serum K after 1 hr and I don't think we will know for sure about a 6 hr (black box ) window until we see the drug to drug info.
Since I've been a long term holder of ZSPH and am obviously bullish on ZS-9 ...why was I buying RLYP at $14.
Because even I can some times recognize a deal . Veltassa will immediately replace Kayexelate .
It has first mover advantage . Many treating CHF patients like it because of concerns about a sodium load .
The market is probably big enough for both ZS-9 and Veltassa with Nephrologists preferring ZS-9 and Cardiologists perfering Veltassa .
The main thing that worries me about RLYP .....is that you all are so convinced its going to the moon.
Hi Pharma ( and Adam )
Pharma , I think its a little much to call Adam a quack . He 's certainly informed and probably sees mainly CHF patients on RAAS inhibitors .
My experience is at the other end . I've met dialysis patients at their annual patient Xmas party at the hospital . These folks were very high risk patients with many co-morbidities . Many barely getting by in terms of food and housing . It was a very sobering experience .
Yes #1 cause of death is heart failure / heart attack.
Wife's clinic had patient with serum K at 7 who had an MI ( heart attack ) recently , but survived .
I agree with your pt about Calcium . That is one concern mentioned by my wife as Cleveland Clinic reccommends Ca not exceed 2gms a day for CKD patients so they are concerned about long term exposure to Veltassa .....When I say concerned , I mean that they want long term follow up studies to chk for any signs of Ca load..
I do expect Veltassa to be used tho . Which is why I bt RLYP at $14 . I think it will immediately replace Kayexelate , which as you probably know, now has a 6 hr prescribing window ..
Assuming that response was directed at Adam .
What everyone needs to recognize is that patients with stage 4 CKD or ESRD ( dialysis ) usually have multiple risks .....its just not serum K at 6 in isolation.
60% of my wife's patients are diabetics
A large number are on high blood pressure meds ( sorry I don't have the % off hand ) .
In addition several of her patients are IV drug users and /or HIV positive
So with these patients the concern is that serum K once at 6 , could rapidly elevate to 7 and become life threatening.
Thats why they are interested in whether or not they will be able to use ZS-9 with these patients at serum K at 6 and then monitor them for the next hr or two to see if ZS-9 is lowering their serum K .
Clinical data to date shows ZS-9 significantly lowering serum K after the first hr.
I'm guessing those comments were being addressed to Adam .
Re Calcium in Veltassa . So far RLYP has not detected elevations in Serum Ca from its clinical trials but those in Renal ( CKD ) are concerned about potential Ca load and will want a calcium balance study to measure calcium deposits.
CKD patients are I think the majority of the HK cases , and the feedback I get from those in the CKD field is that they still prefer the clinical profile of ZS-9 , like its faster on set of action etc .
But all eyes will be on long term data this Sat ....can ZS-9 at 10 gms maintain normalized serum K better then Veltassa , and do so with a better safety profile ?
Some claim ZS-9 will not be used because its a "sodium bomb "
From Pharmactherapy 2015
" Altho higher doses of ZS-9 have been associated with modest increases in the rate of Edema and Hypokalemia , the over all adverse event rate is similar to placebo "
So far the data on use of 10gms of ZS-9 shows that the few patients who experienced Edema , ALL had the condition resolve without treatment .
We will find out a lot more on Nov 7th at the Kidney wk presentation .
I am long both ZSPH and RLYP
In your Oct 29th , 5.38pm post you wrote you would use Kayexelate with a patient serum K from 6.5 to 7.
Now you write " Kayexelate with bicarb and /or glucose /insulin "
No 2 patients are the same. The patient I was referring to had other diseases co occurring with with his Kidney disease.. My wife works mostly with dialysis patients at a large hospital . Most of the patients are low income , often minorities , some are also IV drug user's , HIV patients and of the prison population .
If you work with sicked patients ....you have my utmost respect.