Life Science Capital earlier estimated HK in Chronic Kidney disease patients , as well as patients at risk of heart failure ....to be $3b-$5b
Acute care to be about $200-$250 m
They still see ZSPH submitting an NDA in the first half 2015 ...so within the next 10 wks
The view I get is that once ZS-9 is used in Acute care ( and it appears to be the go to drug for Acute care )...the same drug is likely to be used at a lower dose in Chronic care .
The only reason to switch to Patiromer is if patient have problems ZS-9 and /or Patiromer is cheaper and has locked in insurance coverage.
I wish I could feel the same way as you do about RLYP ...but I don't.
If ZSPH had not come along , RLYP would have been a great play . My wife tells me her patients absolutely hate the existing SOC ( standard of care ) for high potassium ..and RLYP will be a great improvement BUT ...if no major adverse events show up ...a some what better product, ZS-9 will be available about 6 mths later .
So make the case for anyone buying RLYP
I'm are retired CEO ...small sub chapt S corp in CA . I can tell you that I would not be buying a company if I thought a company with a better product was coming onto the market 6 mths later
The only reason I can see to buy RLYP is if Patimoer was equal to ZS-9 in Chronic care ...but at a significantly lower cost .
But anyway ...would be interested to read your case on why , if U were Big Pharma ...why you would buy RLYP.
Appreciate your opinions, as always
Oh no...both ou and Golong are buying ZSPH .
Come on guys ...I need some one to make the bear case .
Why the switch ...not the idea that ZS-9 has the fastest onset of action ( NEJM article /letters ) ...and that once MD's have lowered high potassium levels in about an hr and avoided the cost etc of insulin ...they may keep their patients on ZS-9 at lower doses for maintainence.
Can't be that ?
Couldn't be that all the ZS-9 trails are double blinded ie the gold standard ..with few adverse events and larger and longer then RLYP's ...so far more clinical data ...no it couldn't be that .
Well how about one of the Alta Partners being the chairman of the BOD . Alta is known for grooming companies for buyout ...nope couldn't be that.
Can anyone make the bear case ...seriously ...if so I's like to read it .
I look for informed opposing views ...so unfortunately ou and Golong are losing their value to me ...sorry guys.
Golong ..U bt ZSPH ? ..say it ain't so ...:-)
I need some one to poke holes in my bull thesis .
Please stop agreeing with me :-)...ok ...so now I'll have to write the bear thesis .
Listen Adverse events could show up , They aren't first to market ....forget the fact that their clinical trials are double blinded , they still don't have everything they need to file with the FDA and they are years away from making $ .....what were you thinking ?
Good luck with CLDN . I maintain a small long position ...mainly for a friend who is a prof at UCSF .
Personally I don't think the dose they were using, was strong enough
Data/ info from JUNO possible this weekend ...I maintain a position.
Markets likely to be volatile over next wks /month depending on what happens with Greece
Hey Golong ...well market is definitely more "risk off ". Chinese govt cooling the market down over there is IMHO a good thing ...Greece tho is a real wild card . A collapse in Greece will probably cause a flight to the US $. I'm not a great fan of the Greece minister of Finance or his ideas on "game theory ". At this pt I think the Germans just don't care.
Stronger US $ will hurt our exporters and tank our market ...no matter what you are in .
How big are U in CLDN ...? Not a trade for the feint of heart ...data out this month I think.
Are U in any larger Biotechs . I have larger positions in BLUE , RCPT, BMRN that have held up better
Well right now , the further you are away from FDA approval and actually selling the drug ....the more vulnerable you are to any sell off .
So some pain today in ZSPH and PRTO.....but I'll try and wait it out
Correction ..article is actually a letter reporting the analysis of a subgroup of patients with severe HK ( elevated potassium )
My conclusion is still the same ...ZS-9 will be the go to drug for Acute care
Posted on RLYP board .
IMHO ZS-9 will be the go to drug in acute care
1)Existing therapies in emergencies , insulin etc have uncertain short term efficacy , poor safety profiles , invasive and costly
2) This study looked at patients with severe HK...mean serum level was 6.3
With one 10g dose of ZS-9 dropped by .4m at 1 hr , .6 m at 2 hrs and .7 m at 4 hrs
3) No serious adverse events
"In patients with severe HK , a single dose of 10g ZS-9 resulted in a rapid and significant reduction in serum potassium as early as 1 hr .
These finding suggest ZS-9 may be a therapeutic option in the urgent treatment of patients with severe HK. "
My take ...ZS-9 ( ZSPH ) will be the go to drug in Acute care.
Coria ...re replacing Lipitor .
The only way I can see ECT1002 replacing Lipitor or any Statin ...is a head to head comparison in a CV Outcome trial .
Reduction in MACE ...heart attacks , strokes etc ...which lowers them the most, ECT 1002 OR Lipitor or Crestor
Otherwise its used instead of Statins for the truly Statin intolerant or as an add on to Statins to get LDL to tar
Maybe a $1B to $3b market
Coria ...Its Statin not stentin and Lipitor not Lipotor .
Yes Statins can hurt your Liver ...so can Alcohol and I believe Advil etc as well ....so don't do all 3 together .
Bottom line ...small % of people are taken off Statins due to liver problems . Not saying it doesn't happen ...depends on the AST and ALT enzyme test.
Statins are risk vs reward .
They lower LDL more then ECT 1002 ..and probably hs CRP more as well .....but they have issue with muscle cramping for many and liver damage , memory loss and diabetes risk for a very small number
Its not replacing generic Lipitor any time soon ...except for the very few who have liver issues or who are otherwise Statin intolerant......but it will be added to Lipitor for the hetero FH who are not at LDL target.
My guess its that traders are on edge over the upcoming judges decision on the NCE .
My sense that whatever the decision is , the Judge is taking the time to thoroughly research all aspects of the case to limit the possibility of his decision being overturned in a higher court.
HDGabor , whose views I respect , thinks AMRN will prevail .
I don't think the 5.25 % event rate holds pre mid 2013....one of the reasons they upped the TG min to 200 and limited enrollment to more high risk patients .
Post mid 2013 a look at event rates in diabetes trials may be helpful as I believe a lot more diabetics were enrolled post mid 2013
JZ had to get Reduce It substantually enrolled to submit for Anchor ...so in those days it was more about getting the numbers . Once submitted I suspect Dr Bhatt ( lead investigator for Reduce It ) was seeing event numbers coming in under the planned 5.2% rate and stepped in..
You may have Nov 2015 as the 967th event if V is same as placebo ...I'm guessing more like Feb 2016....and mid 2016 for V to be 20% more effective then placebo.
Right now it seems all about NCE ...to be or not to be
Well when you do , maybe we'll move the discussion to the PRTO board .
I'm not trying to sell everyone on it . I'm just looking for informed investors to poke holes in my investment thesis .
So if you do any DD on PRTO ...appreciate a critical analysis .
Re RLYP ...you did notice that a director unloaded a lot of shares recently . He still owns a lot of options tho .
Seen any insider selling in ZSPH so far this year ?
OT ...Quick follow up re PRTO
One of the key data pts that came out April 2nd ...on the 3 yr follow up ( so Novartis didnt have this data a yr ago ) .... The preferred method to connect to a dialysis machine is by Radiocephaloic AVF's .
The 3 yr data ,showed use of PRTO's drug during Radio AVF's, lead to a 64% reduction in risk of loss of patency ( blood flow ) at 30 mcg dose ...P value of .02 ( very stat sig )
Thats a big deal in dialysis
You read it here first :-)
brian / Golong ...from my reading re PRTO ...mgt wanted to keep some role in the drug development , they and Novartis couldn't agree on that . But probably more importantly was the " mixed " P2 data which included both primary fistulas ( first time above the wrist ) and the secondary fistulas higher up the lower arm once the primary failed .
The 3 yr follow up data released earlier this month separated out the data between primary and secondary ....and found a 60% reduction in need for corrective procedures when PRTO's product was applied during the primary procedure ( less benefit in the secondary procedure )....going from memory ..Poster presented at recent confab.
We spend $2b a yr ( in the US ) on this procedure ( fistulas ) ...and about 50% of them fail ( clog ) in the first year .
A 60% reduction in this failure rate is a huge cost savings .
Anyway ...just thought I would pass it by you guys ....its had a big run and will likely pull back ...IPO lock up expires next week
.Thanks for the feedback
OT Re PRTO
Understand wanting to wait for a pullback and that its not your core area of investing interest .
I'll just try and pt out a few things you may be missing .
1) re competition ...Bard etc try to correct the problem after its occurred. PRTO's solution is to reduce the chances of the problem ( fistula blocking ) from occurring to begin with ...and according to Stifel ...could become the standard of care in the $2.5 billion spent on dialysis vascular access in the US each year.
2) Novartis originally had an option to buy this company for around $550m ...its now trading with a market cap of around $270m. The Novartis deal fell thru because they could not agree to terms and there was some questions on their earlier data
The update data released April 2 /2015 ... largely answered the Novartis data questions ....best improvement seen at 30mcg dose and when used with first fistula procedure ...and thats what hopefully the P3 will confirm .
Bottom line ....good chance of becoming standard of care and still a buyout target but at a lot higher price
Statins increase the life expectancy of millions of people , especially those with hetero FH ( myself included ).
Thats not to say they don't have issues ...muscle cramps etc ...but the scientific evidence of their benefit for those at risk has been well documented in multiple studies.....Look at the West of Scotland outcome trial for instance or the Jupiter trial .
So until you have an Outcome trial proving ECT 1002 lowers CV events more then say Lipitor or Crestor ( Statins ) ....MD's will not be switching except for those who are truly Statin intolerant .
They may add ECT 1002 for those that can not get their LDL to goal on Statins alone .
ECT1002 is an important advance ...I just don't think its the next Lipitor.
My wife works in a dialysis clinic .
One of her most frequent comments on the problems she and her patients face is the problem of the fistulas clogging ( or other wise failing ) ...Fistulas connect the blood vessels usually just about the wrist to the dialysis machine ..
About 50% of them fail within the first year of use requiring new surgery to recreate another fistula further up the lower arm .
Proteons PRT-201 is having measurable benefit in reducing this failure rate and thus "could reduce the $2.5 billion spent each year on dialysis vascular access" ...Stifel comments
Proteon's PRT -201 ( Vonapanitase ) acts as a vasodialtor in the immediate area its applied , increasing blood flow and reducing clotting .
Currently they are in P3 trials , FDA fast tracked and Orphan drug designation and may have application in PAD ( peripheral artery disease )