watching biotechs, gold & silver
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2 very short versions of the ICER Final Report
(both posted to twitter by Michel Nantel)
Here is a 5 page summary of the 166-page complete report:
https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/LN_RAAG.pdf
And here is the 10-page report of the Policy Recommendations by ICER:
https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Policy-Recommendations_041621.pdf
Much easier to wade through vs. the complete report.
I still recommend one of those airline barf bags while perusing ICER'S BS.
Curious as to if/when, what, how, etc. any fallout from this travesty by ICER materializes?
Wonder if the President of ICER (who claims to be an M.D.), has supplanted the Hippocratic oath of "Do no harm" with an oath of cold-blooded Hypocrisy as a substitute?
All in a world gone mad
Hallelujah anyway!
Don't let the bastards get you down
Cheers
Correction to prior msg- 2nd quote from ICER Final Report reads:
Finally, the majority of the Council judged belimumab to provide a “high” long-term value for money and voclosporin to provide an “intermediate” long-term value for money, at current pricing.
(p. 10-11 of 166 pgs.)
Now, just where are those seasick pills?
It's past time for ICER to drop any pretense about being concerned about the health of Lupus Nephritis patients.
This twisted report clearly shows they're in the tank for GSK and the insurance payers.
*Note that GSK has representation within ICER (Aurinia does not) and that GSK also "donates" money to ICER (Aurinia does not).
It's up to the expert doctors and the patients to right this ship.
What this country needs is a good de-ICER
ICER final report (Lupkynis vs. Benlysta) is out and Aurina got royally shafted (as anticipated).
https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Final-Evidence-Report_041621.pdf
Can't really say enough bad things about these ICER bums- dishonest, disingenuous, incompetent, etc.
The report is 166 pages, so thoroughly digesting it will be time-consuming.
Here are a just a few gag-worthy gems I've found fairly quickly; I'm sure there are many more:
With these uncertainties in view, our modeling suggests that belimumab’s estimated net price aligns well with its’ estimated long-term added benefits for patients. These findings do not include
consideration of potential broader benefits of belimumab on health for patients with LN. For voclosporin, its estimated net price produces a cost-effectiveness result at the upper end of commonly accepted ranges.
(p. 10 of 166 pgs.)
Finally, the majority of the Council judged belimumab to©Institute for Clinical and Economic Review, 2021 Page ES4 Evidence Report – Belimumab and Voclosporin for Lupus Nephritis provide a “high” long-term value for money and voclosporin to provide an “intermediate” longterm value for money, at current pricing.
(p. 10-11 of 166 pgs.)
At their net prices, approximately 80% (belimumab) and 35% (voclosporin) of eligible patients with LN could be treated in a given year before crossing the ICER potential budget impact threshold of $819 million per year. Testimony from clinical experts at the public meeting suggested that the uptake of these drugs would include the chance for nearly every patient to be on one drug or the other. Given that efforts to reach this clinical target would create a short-term potential budget impact that exceeds the threshold, ICER is issuing an access and affordability alert.
(pg. 11)
Manufacturers should not seek to use common sense dosing algorithms as a tool to gain prolongation of their patents, thereby adding to future health care affordability concerns and reducing the headroom for future innovative therapies.
(p.11)
There are several other important differences between the trials. The primary outcome for the AURORA trial was “complete response” (CR) at one year, while the primary outcome in the BLISS-LN trial was “primary efficacy renal response” (PERR) at two years. Apart from the time of assessment, the two outcomes differed in the degree of allowable proteinuria (CR UPCR ≤ 0.5; PERR UCPR ≤ 0.7) and CR required sustained, low dose or no corticosteroid use. Since the differences are small, it is reasonable to compare them at similar time points. There were also slight differences in the definitions used for complete response and partial response in the two trials (Supplement Section A1 describes the specifics for each definition). Lastly, the AURORA trial required a rapid taper of corticosteroids, which was not required in the BLISS-LN trial
(p. 16)
They never said it would be easy!
Cheers anyway
This article is a goldmine if you want to better understand Aurinia:
(Ignore the April 1 dateline- their story is no joke)
Against the Odds – Victoria’s Aurinia Pharmaceuticals is poised for rapid growth
https://www.douglasmagazine.com/against-the-odds-victorias-aurinia-pharmaceuticals-is-poised-for-rapid-growth/
(posted on twitter by Michel Nantel)
Yesterday's news seems like a pretty big deal:
Lupkynis treatment can improve kidney response regardless of disease progression at diagnosis.
Lupkynis Shows Further Efficacy as Treatment for Lupus Nephritis Regardless of Disease Stage
https://www.lupus.org/news/lupkynis-shows-further-efficacy-as-treatment-for-lupus-nephritis-regardless-of-disease-stage?utm_source=TW&utm_medium=social
H.C. Wainwright & Co. continues to like it (from twitter):
Tom Silver
@TomSilver39
HCW:” $AUPH LUPKYNIS Improves Renal Response in LN Patients of Various Disease States in Post-hoc Analysis; Affirm Buy, TP=$35.”
Belimumab and Voclosporin for Lupus Nephritis: Effectiveness and Value
Public Meeting — March 26, 2021
https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Evidence-Presentation_032621.pdf
ICER evidence presentation re Lupkynis vs. Benlysta due tomorrow. It will be interesting to see if the final report (April) will still say Lupkynis is more cost effective than Benlysta
https://icer.org/assessment/lupus-nephritis-2021/#timeline
Short interest has nearly doubled since the year began
SETTLEMENT DATE-SHORT INTEREST-AVG. DAILY SHARE VOLUME-DAYS TO COVER
03/15/2021 8,175,109 3,361,332 2.432104
02/26/2021 5,953,855 3,226,622 1.845229
02/12/2021 5,442,521 4,199,973 1.295847
01/29/2021 5,396,860 10,218,667 1
01/15/2021 4,469,752 2,885,938 1.548804
Very interesting post from yesterday evening:
Fugitive447
Bullish
3/24/21, 09:47 PM
AUPH
This is getting depressing. To cure myself I listened in once again to Dr James Tumblin who was the guest speaker tonight as part of the Attend the speaker series: Introduction to LUPKYNIS.
Couple highlights
He sees Lupkynis as an easy to administer maintenance medication. He strongly believes that Lupkynis is less nephrotoxic than other CNIs paving the way to replace those medications in other indications. Test are now in process to attempt to validate that. He took many questions from other nephrologist's and rheumatologists . One question concerned Lupkynis being used for other indications. He emphatically stated yes and those diseases would be GN disease related or Glomerulonephritis one such disease is FSGS there are others. He personally believed Lupkynis could play a role in diabetes treatment!
He took a question about MMF and Benlysta. He commented he was always concerned with the trial results and the fact after 6 months Benlysta flat lined on protenuria reduction.
Aurinia Should Be A Long-Term Winner With Lupkynis Now On The Market
Article released today to public at SA. Released privately to subscribers of 'Biotech Value Investing' 30 days ago.
Definitely worth a read.
https://seekingalpha.com/article/4415783-aurinia-should-be-long-term-winner-lupkynis-now-on-market
Was Bernie "Mittens" Sanders responsible for today's carnage?
Saw the rumour somewhere earlier today.
XBI crushed as well.
Makes little sense.
In 2018 (can't find 2019 or 2020 info), there were only 46 drugs in the world that had USA revenues of $1B or more
Aurinia is going to be among very exclusive company someday
Fidelity recently bought 1,377,90 AUPH shares for FBTAX fund.
https://fintel.io/so/us/auph
Reported yesterday, so of course we tank today.
Another justifiable reason to drink
Yesterday's reason was St. Patrick's Day
cheers
Ganz, re your 'boost' comment:
....the boost will follow a solid earnings report from VOC sales or a BO.......even some guidance would help regarding some sales numbers.
Assuming no early BO, another bump could come when the final Aurora 2 readout happens.
No one truly knows yet how long these patients should be on the drug (Aurora 2 is blinded with a DSMB).
The readout might cause the analysts who are now around $30 to raise that number.
Patiently waiting here doing nothing might ultimately turn into a major win.
cheers
The Webcasts are great!
A wealth of info.
Unfortunately, no more are scheduled at present.
I wish we could see/hear them more often.
Does anyone know of a way to record them from a PC?
TIA for any help/info on that
cheers
PG definitely is confident.
Nice that he's been to a bunch of rodeos.
Still wondering when/where is lift off for us?
Some Leprechaun magic wouldn't hurt
cheers
Happy St Patrick's Day! AUPH Webcast also:
Oppenheimer’s 31st Annual Healthcare Conference
MAR 17, 2021 • 10:40AM EDT
https://ir.auriniapharma.com/ir-calendar/detail/1420/oppenheimers-31st-annual-healthcare-conference
Thanks Jess. You have a gift for going to the heart of the matter.
Lupkynis is far and way superior to anything out there.
It's only a matter of time before it becomes the SOC.
Thanks for reminding us/keeping us on an even keel.
cheers
Northern, thanks for your expressing your view re ICER
I think most here are 'moving targets' in a sense. I know I am as I'm trying to fathom complexities re the science, how things work in the real world of medical care, etc. I don't claim any special expertise/knowledge either.
I like to see different/opposing views as long as they are authentic/honest.
My objection to the report is that I believe both Lupkynis and Benlysta received the same overall rating when clearly Lupkynis is far superior in its ability to rapidly bring a complete or partial response to patients.
I don't want doctors to think they're similar re efficacy, as that means a high likelihood that some MD's will prescribe Benlysta in error.
The net result of that would be that patients suffer, just as they will if the ICER report were used to by payers to deny patient access to Lupkynis.
Since GSK is represented within ICER (and Aurinia is not), I suspect they have a hand in getting a higher rating than deserved.
All above is simply my opinion as well.
BTW, VOS is Aurinia's DES drug, VCS is Aurinia's term for voclosporin, although most refer to it as VOC
cheers
sommer, another great link-Thanks
The Enron connection makes sense. It takes brass cajones on the part of ICER to claim to be 'independent and 'non-profit'.
Very misleading.
The final report re Lupkynis vs. Benlysta on March 26 is going to be more than interesting.
Thanks again
The most important comparison to me was based on price.
I'm very confident you would feel differently if you suffered from LN.
How effective the drug is (efficacy) is the most important factor.
Lupkynis blows Benlysta out of the water in terms of its ability to save people from diabetes, dialysis, kidney transplant, etc.
You admit you didn't read the report.
I suggest you should and would be amazed if you are not struck by its glaring flaws.
That Benlysta is rated as effective as Lupkynis is a gross misrepresentation bordering on fraud.
The final report will tell the story, but right now it looks like GSK has either bamboozled ICER or worse.
Somer, the STAT ICER article was excellent
Thanks for posting the link to it:
https://www.statnews.com/2019/11/14/working-with-icer-or-around-it-on-cost-effectiveness-estimates/
Very revealing re what they're all about.
Really liked the author's conclusion of that piece:
As Patricia Goldsmith and Carole Florman of CancerCare recently pointed out in STAT, ICER’s latest framework “will continue to exclude disease-specific experts, patients, and caregivers from voting panels; and will maintain review schedules that signal a greater commitment to speed than accuracy.”
I believe that ICER poses a threat to patient access to new therapies. Its cost-effectiveness determinations have been so reliably friendly to insurers that CVS announced late last year a plan that would allow its pharmacy benefit manager, Caremark, to refuse to cover drugs that don’t pass ICER review. That’s a terrifying proposition for drug makers that have invested more than a decade of research and billions of dollars to earn FDA approval and bring products to market and the patients who are desperate to access those treatments.
It will be very interesting to see the final draft of this report on March 26th.
The current draft of this ICER report emphatically sacrifices accuracy over speed in spades.
So far PG and the team at Aurinia deserve very high marks for their ability to navigate the clearly treacherous, ICER infested waters of drug pricing.
Either someone has undue influence over ICER or they're truly incompetent.
I don't see how it's possible they could have failed so dismally if they are truly trying to help people.
Before today, I assumed they were professional (competent) and honest and were trying to provide excellence to better serve the entire medical community- doctors, patients, the general public, etc.
I no longer believe that.
ICER failed here.
The above is an opinion and should not be considered as evidence of proof.
I see GSK playing hardball. Lawsuits to follow
Re "proof" of GSK influence on ICER
"Proof" and "opinion" are very different.
Note my GSK comment raises a question that may not even rise to 'opinon' status.
If you read the report, please offer your view regarding it's credibility re the relative merits of Benlysta vs. Lupkynis.
I'm curious
My opinion/view is the report is tainted, creating a false impression.
Lupkynis is clearly far superior to Benlysta for LN.
Somewhat surprised that apparently, you are unaware of that.
A positive from ICER report- Lupkynis is less expensive than Benlysta
6. Now that voclosporin has been approved by the FDA, its
actual list price and reported net revenue per patient
have been reported. The estimated revenue of $65,000
per year to the company (which we assume is equivalent
to the net price since it is much lower than the reported
list price of $144,175 based on $3,950 for a ten-day
supply at full dosage), represents a cost per QALY that –
according to our analysis of the information ICER
included in the draft report – is approximately 25% less
than the cost per QALY for belimumab.
Given that the definition of value is benefits (which could
include clinical, patient, health system, and society
benefits) divided by cost, the company’s reported pricing
for voclosporin seems to be completely appropriate, and
since it is orally administered, an even higher net price
could be justified. That is, the company’s pricing for
voclosporin reflects the clinical and other benefits it
provides.
Above found on pages 22-23:
https://icer.org/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Public-Comment-Grid_031221.pdf
QUALY = quality-adjusted life-year
The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number.
ICER independent? I don't think so.
Was the report edited by GSK? Looks like maybe it was.
The recent AUPH price decline might be due to this report leaking early.
Doesn't seem to pass the smell test.
Avoiding diabetes, kidney dialysis, kidney transplant, reduced life quality and expectancy, etc. only considered a "small net health benefit"???
What utter BS!!!
The author(s) should be nominated for the Hall of Shame.
Did someone pay off Spherix to write this swill?
If you didn't know the truth, you probably would think Benlysta is superior to Lupkynis after reading this garbage:
https://www.prnewswire.com/news-releases/on-the-heels-of-recent-fda-approvals-glaxosmithklines-benlysta-belimumab-and-aurinia-pharmaceuticals-lupkynis-voclosporin-emerge-as-practical-and-effective-tools-in-the-treatment-of-lupus-nephritis-301246136.html
BOSTON, March 12, 2021 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of belimumab (Benlysta®, GlaxoSmithKline) and voclosporin (Lupkynis™, Aurinia) for the treatment of lupus nephritis (LN).
https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-therapies-for-lupus-nephritis/
https://icer.org/assessment/lupus-nephritis-2021/#related
https://icer.org/assessment/lupus-nephritis-2021/#timeline
https://icer.org/assessment/lupus-nephritis-2021/#overview
Nice story about Aurinia yesterday from a Canadian Business publication :
Saw this on ST- the article is fairly short so complete story follows:
The Innovators: Aurinia Pharmaceuticals is improving the treatments for rare diseases
Nick Rockel Mar 11, 2021
With FDA approval in hand, the Victoria company plans to bring its drug to market
In the U.S. alone, as many as 135,000 people suffer from lupus nephritis (LN), a complication of the autoimmune disease lupus. Helping that group manage LN, which leads to chronic and potentially life-threatening inflammation of the kidneys, could be just the start for Aurinia Pharmaceuticals.
Victoria-based Aurinia got some good news in late January when the U.S. Food and Drug Administration approved its medication Lupyknis (voclosporin) for adult patients. In the first successful global Phase 3 clinical trials for a new LN drug, this oral treatment proved significantly more effective than mycophenolate, or CellCept, the unapproved U.S. standard of care.
“We recently joined the rarefied ranks of Canadian companies who have successfully ushered a drug from the lab through to a U.S. FDA approval, ultimately into the hands of patients,” says co-founder and chief business officer Michael Martin. “Our company’s future rests on the foundation that this team has built over the last decade in Victoria. We have the tools and resources in place to continue to bring meaningful treatments to people living with serious autoimmune diseases, and we have no plans of slowing down.”
Martin and chief medical officer Neil Solomons previously worked at Victoria’s Aspreva Pharmaceuticals, where they played a role in developing CellCept. In 2012, four years after Swiss pharma giant Galenica bought Aspreva for $915 million, they and colleague Larry Mandt spun off Aurinia. “We saw an opportunity to find a drug that we could layer on top of that therapy,” Martin recalls. Their addition: voclosporin, commonly used in renal transplants.
Through a reverse merger with Edmonton-based Isotechnika Pharma the following year, Aurinia secured the worldwide rights to voclosporin and a listing on the Toronto Stock Exchange. Since that deal, the company, which now trades on the Nasdaq Stock Exchange as well as the TSX, has raised about US$640 million.
LN is called an orphan disease because it affects fewer than 200,000 Americans. Aurinia president and CEO Peter Greenleaf, a pharmaceuticals industry veteran who took the helm in early 2019 and usually splits his time between Victoria and Maryland, says the company plans to start with the U.S. market.
To that end, Aurinia has been hiring stateside as it makes the Washington, D.C., area its commercial hub. In December, it announced an agreement with Tokyo-headquartered Otsuka Pharmaceutical Co. to bring voclosporin to Japan and Europe. But as Greenleaf stresses, 265-employee Aurinia is still very much a Canadian business, with its entire R&D team in Victoria.
As part of its mission to combat autoimmune disease, the company also launched trials of a voclosporin ophthalmic solution for dry eye, which afflicts millions of people worldwide. After suspending work on that treatment last fall, though, Aurinia is focused on lupus nephritis. “Our goal is going to be to get this drug launched successfully, become a fully integrated pharma company, not just a development-stage pharma company, and then alongside of that, to continue to build our pipeline,” Greenleaf says.
https://www.bcbusiness.ca/The-Innovators-Aurinia-Pharmaceuticals-is-improving-the-treatments-for-rare-diseases
BR, Rick, re 13D Filing today:
From Aurinia's website- the description of the SEC doc filed today:
Schedule filed to report acquisition of beneficial ownership of 5% or more of a class of equity securities
https://ir.auriniapharma.com/all-sec-filings#
I'm stumped.
I see Item #5 you refer to:
Interest in Securities of the Issuer.
Each of the Reporting Persons has ceased to own beneficially five percent or more of the Issuer’s Common Stock.
Beats me
13D filed today
03/11/21 SC 13D/A
Schedule filed to report acquisition of beneficial ownership of 5% or more of a class of equity securities
Louis S. Citron, Esq.
New Enterprise Associates
1954 Greenspring Drive, Suite 600, Timonium, MD 21093
Re NEA:
Scott Gottlieb, MD | NEA | New Enterprise Associateswww.nea.com › team ›
Scott Gottlieb is a Special Partner on the NEA healthcare investment team; he was Venture Partner at NEA from in 2007 to 2017 until being appointed the 23rd Commissioner of the U.S. Food and Drug Administration (FDA), where he served from 2017 to 2019.
The bar is probably conservative (low), but.......
hoping that their estimated $1.4B peak sales is equally low.
No one knows, as the numbers for SLE, LN, the % of LN vs. SLE, etc., are all over the place!
But, PG stating that the launch of Lupkynis is likely going to be in the top 10% of all new drug launches going back some years is kind of exciting.
Underpromise, overdeliver seems to be their mantra.
The stock price seems beyond stupid here.
Sage advice. Another day closer
Today's HC Wainwright Webcast- more excellence
The picture keeps becoming clearer.
The constant is that Aurinia is continuing to do very well at this early stage.
They are surpassing of all their internal expectations for the launch of Lupkynis, which is getting an enthusiastic response.
https://journey.ct.events/view/c2377400-b1ce-4fc0-846f-f7da5d7fb106
Me too. Fear does amazing things to markets.
I would love to know what effect (if any) the Korean guy and algorithmic trading software had on yesterday's market action in AUPH.
If you haven't already heard it, this weekend would be a great time to listen to the recent Cowen discussion.
I believe it's truly outstanding and gives justifiable high confidence in believing that this company will succeed.
They clearly believe in the mission to help LN patients live better.
https://wsw.com/webcast/cowen81/auph/1952646
Take out the cash and AUPH is below $9
KMPH has us beat, though. From $18 after FDA Approval 2 days ago to $8+ today!
Just amazing!
So FDA Approval is apparently a negative!
Very strange times indeed!
Worth noting:
re Max Calao, Chief Commercial Officer:
He's the guy playing a big role in making the launch of Lupkynis happen.
Appointed a year ago, he has decades of experience launching drugs, including 20 years at Amgen and a lengthy stint at Alexion.
Max recently stated that Lupkynis is his 13th drug launch, and 4th transformative drug in a rare disease.
He also stated this is the fastest drug launch he's ever witnessed, which is remarkable considering it's occurring during the Covid pandemic.
In just 4 weeks Aurinia has met with payers representing 190 million Americans, which is 75% of the nation's insured lives.
re Peter Greenleaf on being well capitalized for the launch:
Peter cited this as a big advantage over other companies trying to accomplish a launch with only $100M or so, as they have to make decisions based on trying to stretch their cash, which compromises their ability to make the best decisions.
Aurinia has the luxury of not needing any cash for 2 years without any revenues! A sizeable plus.
AUPH is $10 if you strip out the cash. When you consider everything they've accomplished that price seems absurd, almost unbelievable.
My 2 cents, all imo
Good luck to all
If the KOLs Cowen referenced in today's webcast are right, we're golden!
They are predicting a 50% participation rate of eligible patients for Lupkynis.
There are 80,000 to 120,000 estimated LN sufferers in the USA.
It's estimated that 80% are candidates for Lupkynis.
Using the lower number of 80K pts x 80% x 50% (per KOL's) x 65K cost =
$2,080,000,000 estimated revenues!
It would be $3B annually if the 120K number is used!
The entire group today sounded very positive/upbeat!
KOLs = 'Key Opinion Leaders'
GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3
Maybe this news helps us.
https://www.fiercebiotech.com/biotech/gsk-vir-hit-as-covid-drug-hopeful-halted-possible-weak-efficacy-key-nih-phase-3?mkt_tok=Mjk0LU1RRi0wNTYAAAF7l7_mxIgsC6bK6Y7O3H-Zi0C_RuU1cNxZB9roheb8EYxiW-BWyrzLwUkdIoCqSwde-E1MqFgXYrhO0OcIQscLWUAlnUODZV0nDD7NMK2ZBLlS_rnvOw&mrkid=51876159