IMHO neither Co will be sold until there is a lot more long term data ... some on safety but particularly on which normalizes serum Potassium levels the best for patients on RASS inhibitors
You have data on this group for only 306 patients for 52 wks AMETHYST-DN
and soon for about 200 patients on ZS-9 for 52 wks ( and eventually 750 patients late 2016 )
How do you value these companies without this data ?
Rereading these trials again
I'm guessing that 10-20% of those on Patiromer will revert to HK , depending on the severity of the HK to begin with .
Its whether ZS-9 can do better then that and the earliest we may know is late Nov 2015.
Ok Lurker ...we got the message RLYP in the 20's and ZSPH in the 30's is your prediction , recorded this 11th day of August 2015
Golong Always appreciated your due diligence
So ...the OPAL trial Poster # 240 presented at the Kidney Conference earlier this year .
Here we are looking at HK in advanced CKD patients on RASSI ....This is probably the money market for either of these drugs .
Anyway 106 patients with moderate to severe HK 5.5 to less then 6.5
Do a search for " Patiromer Reduced Recurrent Hyperkalemia in Advanced CKD Patients on RASSI "
I may have mis read the data but in the Withdrawal Phase .....all started on Patiromer for 4 wks .
After that half went on Placebo and half stayed on Patiromer for another 8 wks .
20% of those on Patiromer reverted to HK by wk 5
Again ..chk it to make sure I'm reading it right . It's shorter then the trial you cite and with moderate to severe patients.
ZSPH will have 12 mth data on ZS-9 late Nov 2015 ....200 patients ...to compare to the AMETHYST -DN trial
Well Lurker , best you move on and grace some other board with your due diligence.
Fact is there are about 1 million patients who are on less then optimal RASSI dosage right now because of elevated serum Potassium levels .
These patients ( Chronic care ) will be on Patirmoer or ZS-9 fairly soon after both drugs are approved.
The Co that will dominate will be the one with the best long term data on normalized Potassium levels and is the safest with the fewest side effects
We already have 52 wk data from 106 stage 4-5 CKD patients on Patiromer OPAL trial on RASSI
and will have 52 wk data on 200 patients on ZS-9 and RASS inhibitors I think in late Nov 2015 .
So chk back then ( ZS-9 data release late Nov ) and we'll see if either RLYP hit the low 20's and ZSPH dropped into the 30's.....as you are predicting tonight.
Well, will now fine tune this post having talked to some one far more knowledgeable then me ...my wife.
1) Need fastest acting and safest in Acute care ...period. There is no if's and but's about that.
2) Kayexelate is prescribed a lot in the out patient setting but only after patients have failed to lower their K on the correct diet. Real problem with binging on high potassium foods.
3) No one is buying either company until they see long term data for both ...which maintains normalized Potassium the best and is also the safest .
Good luck to all
Its been a tough day for both sides , ZSPH and RLYP.
I would just comment the following.
The first paragraph of Pharma's post lines up with what my wife says .
Most HK scripts ( currently Kayexelate ) start out in the hospital setting .
Most out patient HK control is directed to dietary restrictions of Potassium ( banana's etc ).
Patients hate Kayexelate and most won't stay on it in Chronic care ...just what I'm told.
Re labeling ...both will be instantly approved for Acute care. FDA may have some wording for both about Chronic care as there is limited long term data for the approx one million patients on RAAS inhibitor's ( Cardiology ) that have HK problems and who may eventually be on one or the other.
Near term catalysts ... About a month after the FDA approval for Patiromer , ZSPH may release some data on trial # NCT02107092. These are 200 patients on a long term open label extension study ZS-004E
There is also trial # NCT02163499 long term trial ( which may include the 200 above .. not sure ) is now fully enrolled with 750 patients but doesn't end to August 2016
Anyway , data on the first 200 in Nov 2015.
We know that 20% of those on Patiromer reverted to HK in their long term trial
Will ZS-9 do better . As you know I'm betting it will
I'm surprised by the extent of the sell off in RLYP.
Expected ZSPH to have some -ve reaction , but just not - 7.8%
I think you are right on re Sanofi.
I believe you have experience in the Pharma space . What do you think of RLYP fielding their own marketing team for the hospital / Acute market . Thats where I expect Patiromer to immediately replace Kayexelate...and ZS-9 to eventually replace Patiromer.
I'm surprised they are trying that market with their own team
Sanofi sells Kayexelate in the US and Patiromer will immediately replace Kayx in the Acute setting .
I don't think a lot is used in the more Chronic setting ( physican practices ) because of poor patient adherence and heavy emphasis on reducing dietary intake of Potassium in that setting .
Relypsa has no other drugs in the Acute setting correct ? So for an unknown company to come into a hospital setting ?.....would be a lot better if Fressenius was doing that for them . Fressenius are very established in Acute care
By the way ...that CEO sell about 10 days ago ...where I mentioned that you probably own more actual stock then the CEO now ....always a tell IMHO
Golong ...just some added info re the deal.
Fressenius is a major player ...but the marketing deal in the US was made with Sanofi who is I'm told more of a minor player and more in the Kidney transplant space.
IMHO if RLYP is down vs ZSPH at close today ...tells me the market is looking past this good partnering deal for RLYP and deciding that ZSPH will eventually dominate the HK market
Well you know my view.
If RLYP falls more then ZSPH today ( general market scare on Chinese devaluation ) , it tells me that the market is looking past this good news for RLYP, and deciding that ZSPH will eventually dominate.
Golong ...direct from the dialysis clinic ...
My wife texted " Fresenius is very big in the dialysis business " ...
Man , the connections you have : )
If RLYP does not jump on this then ...well ...lets see.
Golong Little follow up
Fresenius are the leading provider of dialysis products , at least in the US .
As I have said before ...Patiromer will immediately replace Kayexelate .
The question ,at least for me , is to what extent ZS-9 will replace Patiromer .
IMHO these are great deals for RLYP ...and deals they had to get done to hit the ground running .
If RLYP is not up at least 10 % tomorrow , it tells me that the market is looking further out and figures ZSPH may eventually dominate.
Golong Seriously Fresenius are big players ...at least at my wife's dialysis clinic.
Most of the stuff we pack into box's for storage are Freenius box's she brings home from work.
I believe they are big in private and out patient dialysis .
Sh#t ...as I look around my office , what do I see Fresenius Medical Care box's ...seriously
You would need to do a Google search to see if they have an established presence besides my office and wife's clinic : ) Pretty sure they do
Really . Their ( SAGE ) Chief Science Officer has been a big seller over the past month or so ...automatic sales .
Guess he's hedging his bet .
Let me know if you see the same thing in PRTA .
Those I know in the field are hopeful for SAGE but express more confidence about PRTA's program
Major news on RLYP tonight .
Marketing deal with Sanofi in the US and a deal with Fresenius for Europe .
I expect ZSPH to do similar deals but they may not be announced until there is more info on long term data ...expected late Nov 2015.
Anyway , there should be some happy faces on the RLYP board tonight
Deals with Sanofi and Fresenius .....major players in the CKD space .
Way to go guys ...with an up front payment to ?
I don't own the stock but those of you who do. should be feeling better to night