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Otsuka Receives Approval in Japan for Lupkynis® as a Treatment for Lupus Nephritis
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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Lupkynis® (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease.
Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system.
In the U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. In September 2022 Otsuka received European Commission (EC) approval for Lupkynis as the treatment for active LN in EU member countries. Otsuka has subsequently received reimbursement in several EU countries as well as in the UK.
In December 2020, Otsuka and Aurinia announced that they entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan, the European Union (EU), and the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide, focusing on cardiovascular, renal and autoimmune diseases as one of which are among our priority areas.
About lupus nephritis
Lupus nephritis (LN) is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE). The kidneys are vital organs, and LN is an irreversible and progressive condition that puts them at risk for long-term complications. If left untreated, this kidney inflammation impairs kidney function and can lead to permanent kidney damage and even kidney failure, known as end-stage renal disease (ESRD). LN is one of the most serious complications of SLE.
In Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women accounting for 90% of cases. It is particularly prevalent among women aged 20 to 40.1 Asians have a higher incidence of renal involvement compared to Caucasians, with 21% to 65% of Asian patients (living in Asia) with SLE having developed LN by the time of diagnosis, and 40% to 82% developing it over time.2 The development of LN in SLE patients often occurs at a relatively young age and is believed to increase the risk of end-stage renal failure, leading to a deterioration in life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication.
About the clinical trials AURORA 1 and AURORA 23, 4
The MHLW approval is based on data from clinical trials, including AURORA 1 and AURORA 2.
The AURORA 1 international phase 3 trial was conducted with the primary endpoint of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled in the trial, of whom 179 patients and 178 patients were randomly assigned to the voclosporin and placebo groups, respectively.
Both the voclosporin group and the placebo group were co-administered with mycophenolic mofetil and oral steroids during the trial, with a regimen to reduce the dose of steroids. The proportion of patients achieving renal response at 52 weeks was significantly higher in the voclosporin group at 40.8% compared to 22.5% in the placebo group (p<0.001).
AURORA 2 evaluated the long-term safety, tolerability, and efficacy of voclosporin compared to placebo in 216 patients with LN (116 in the voclosporin group and 100 in the placebo group) who received an additional 2 years of treatment following completion of AURORA 1. The long-term safety and tolerability was assessed and no new or unexpected safety signals were observed.
Reference
1. Information Center for Rare Diseases https://www.nanbyou.or.jp/entry/53 (as of September 2024)
2. Jakes, RW. et al.:Arthritis Care Res. 2012; 64(2): 159-168
3. Brad H Rovin, Y K Onno Teng, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-bling, randomized, multicenter, placebo-controlled, phase 3 trial. Lancet 2021; 397: 2070-80
4. Amit Saxena, Ellen M. Ginzler, et al. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trial. Arthritis & Rheumatology Vol. 76, No. 1, January 2024, pp 59-67
Z. as U know ...Lupkynis targets T cells . AUPH has begun their own BAFF / APRIL program for treating LN ...just several years behind VERA
Inhibiting both BAFF and APRIL is thought to be ( based on the past several yrs of research ) , a more effective way of inhibiting B cell production which is a key factor in developing Lupus Nephritis
Thanks Kiwi. I feel your presence as I am sitting on a bench near pier 39 in Frisco, on the way south thru the Panama Canal. Good luck with Vera
and another 3 years to determine its sustainability.
RMB. Agree that Tang will be very proactive in getting a deal done . For one thing VERA is holding a KOL day on Oct 2nd where they may discuss their plans for advancing their P3 LN drug ( Baff /April combo ) which is expected to be better than AUPH's Lupkynis . So I'm sure Tang would want a deal done for AUPH before VERA's LN drug was approved . ( roughly 3 yrs out if they start their P 3 soon )
JMO
Kiwi
Thinking that with Tang getting involved here big time that big things might happen quickly. He does not appear to be someone with a long time horizon.
Thinking that with Tang getting involved here big time that big things might happen quickly. He does not appear to be someone with a long time horizon.
kiwi, I behave a faint memory of Tang(?) recently closing position in AMRN while others are piling in, something more to check out.
You shrink the size of the board to get better control to facilitate a sale ....this has Tangs MOA ( method of action ) all over it
https://www.insightia.com/tang-exits-la-jolla-in-buyout/
Kiwi
There is a pretty active discussion of AUPH on StockTwits.
I am inclined to agree with some of the posters there who think we will soon see Tang lead a "private equity take under" at a relatively low price. THis seems to have been his MO in the past.
If that happens I will be disappointed to get a far lower price than we had hoped for over the last several years, but I will also feel relief to get some closure and move on.
The fact that they released OUTSIDE directors suggests they are not overly concerned about corporate governance issues over the long term, which further suggests a resolution in the (relative) short term.
Why PG stays on the board I don't know. If there are negotiations in flight, I can see the board saying "we need to keep PG as CEO and point person in those negotiations", but he doesn't need to be on the board for that. Now that I think of it, I imagine PG told the rest of the board "if you accept my resignation I will walk away and you will need to start over on making a deal" (out of vanity and to keep "was voted off the BoD off of his resume) and the board caved.
Certainly, the fact that PG was retained suggests a deal in the near term is the most likely end game, though probably not at the premium we would have liked.
What do you make of this ? Tang is now on the BOD and wants this company sold ...thats what I make of it .
They finally got around to a BAFF/ APRIL drug ...first person dosed ....just years behind VERA who already have the same drug P3 ready .
it's the peter principle.
the BoD obviously feels that no one can continue to do a worse job than pete and to replace him with a ceo that could turn the company profitable and provide shareholders with a roi would show those that have yet to realize just how worthless pettie is a wake up call, so go back to sleep peeps.
just like trump is fighting to give the country back to it's legal citizens, yet half of the country is too stupid to appreciate it.
What do you make of all this?
I'm somewhat baffled by the cryptic content of this press release.
Waiting for the wannabe board oracle, who fancies himself as "a very stable genius" to weigh in and enlighten us.
Hoping for the best here
GLTA
Well the “exceptional circumstances” peaks my interest. If they are in some position that might lead to say a sale of the company then this may make sense. Otherwise. ……. Waiting to see if we hear anything from Lucien.
It sounds like we r at then. He’s staying on the board I’m guessing to finish up the BO negotiations n finally sell AUPH so we all get out of this nightmare
yeah - frustrating. Even worse is that all the voters would have loved to vote him out as CEO as well.
Voted out but bod says he should stay. That's some corrupt sht right there. Unbelievable
8K out AH indicating that while 3 directors' resignations were accepted (and therefore they are gone), PG's resignation from the BoD was not accepted due to "exceptional circumstances (so PG stays on the BoD). Kevin Tang of Tang Investments now on BoD. Separately, Tang Capital filed a 13D indicating they own 5.1% of AUPH.
What do you make of all this?
https://archive.fast-edgar.com/20240912/AJ2ZE22C822272B2222K2242V8RTZ2228S62/
RMB. The LN video featuring a KOL using Lupkynis has been out for about 3 wks on the Healio Nephrology site ...a site my wife and other prescribers with CKD patients regularly visit. So I would expect an uptick in sales / scripts following this presentation.
Waiting in the wings tho are other drugs likely to enter P 3 trials and are probably more effective .
Chk this Sept 24 presentation from VERA
https://ir.veratx.com/static-files/469e722f-5da8-4dad-9a54-e52ba68596f7
VERA is currently focusing their efforts on IgAN with key data Q4 2024 ...see page 10 of their presentation re comparing to Benlysta
JMO
No position in AUPH ...altho I wouldn't sell it right now if I owned it . I'd like to see script data thru end of year
I do have a position in VERA
Kiwi
Could, Japan approval is a possibility, since the news of the dosing of the first patient in the AUR200 trial was yesterday so it shouldn't be that. Of course we are always last to know.
Maybe it is investors seeing the video that Kiwi posted about a few days ago?
Hope there is a "very good" reason for
the price & vole increase today. I figure
Japanese approval would only rate as a
good reason. Management here has
proved to be unethical if not also doing
things that are illegal. Hope the BOD
members who are obligated to leave do
just that without having to be forced out.
Maybe, just maybe that will be enough to
get them to a point where a BO would be
something that management actually would
work towards. Today's stock action at least
provides me with a scintilla of hope!
Making an exit at a loss. This was a disaster lol.
Sucking in more bagholders. This is and will always be AUPHUL
I'm still here. It's been seven and a half years, but I'm still here. Avg cost around $10
This is fairly new and an excellent video for Nephrologists treating LN .
Its a Healio video that I suggest those invested in AUPH try and access
Thank you Kiwi. In the middle of trying to book Covid shots and their site is overloaded and jammed (CVS).
RMB. Theres a new video out on Healio / Nephrology that prescribers in the field are probably aware of .
I can't seem to link it but maybe you can
Explains the decision tree and how they ended up using Lupkynis with good results
We’ll probably get a news soon. How impactful the news is, remains to be seen. Unfortunately, the ones responsible for moving the needle in the last few days may have friends in high places or dark places. I can’t fathom why this would stay low for a long time given it is the only medicine to treat this condition efficaciously and safely, jmo.
Just get the feeling that something is going on behind the scenes. The stock price would have normally been hammered back down by now (after the little pop over 6) but it seems to slowly be continuing the march upward. Time will tell, as we are always the last to know.
I sold all the AUPH in my IRA yesterday, you're welcome everyone haha
Trash but carefully manipulated trash so there is that.
Completely agree with you on this
PG and those directors have no shame so doubtful Selce’s letter spurs them to do anything, so I guess Selce has to rely on Iljin calling for an emergency meeting.
August 13, 2024
Aurinia Pharmaceuticals Shareholder Calls for CEO Peter Greenleaf, Dr. Brinda Balakrishnan, and Dr. Robert Foster to Resign from the Board
Highlights Damning Annual General Meeting Results, Which Show That Four of the Company’s Nine Directors Failed to Receive a Majority of the Votes
Calls on the Company to Appoint Two Shareholder Representatives to Bring Much-Needed Accountability to the Boardroom
August 13, 2024 08:00 AM Eastern Daylight Time
GENEVA--(BUSINESS WIRE)--Lucien Selce, who owns approximately 2.2% of the outstanding shares of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (“Aurinia” or the “Company”), today issued the below open letter to the Board of Directors (the “Board”) regarding the urgent need for accountability and boardroom changes.
***
August 13, 2024
Aurinia Pharmaceuticals Inc.
#140, 14315 – 118 Avenue
Edmonton, AB T5L 4S6
Canada
Attention: The Board of Directors
Members of the Board,
Over the past few months, I have expressed my concerns regarding the Company’s current strategy and trajectory due to the Board’s lack of appropriate oversight and relevant skillsets. Recent developments following the 2024 Annual General Meeting (the “AGM”) have made clear that current leadership has no interest in acting in shareholders’ best interests and in protecting the future of the Company.
The fact that four of the nine directors up for re-election at the 2024 AGM, including CEO Peter Greenleaf, failed to secure a majority of the votes speaks volumes about the need for boardroom change and a new strategy for value creation.1 The current state of affairs at Aurinia – marked by unchecked spending, ineffective leadership, and a clear lack of strategic direction – demands immediate and decisive action.
Aurinia Has Spent Excessive Capital Without Focusing on Research and Development (“R&D”)
The Company has recklessly spent $100 million in just six months, yet there has been little to no investment in R&D, which is the cornerstone of Aurinia’s future growth. This irresponsible financial management is unacceptable. Aurinia should be operated efficiently with a budget of $70 million – not $150 million. The current financial strategy is unsustainable and detrimental to shareholder value.
Management Continues to Pursue an Ineffective Strategy
In February 2024, the Company publicly announced the discontinuation of AUR200. Then, during the Q2 2024 earnings call, Mr. Greenleaf reversed this decision, stating that its development had resumed. This inconsistency not only undermines the credibility of the Company’s leadership, but also raises serious concerns about transparency with the market.
Moreover, during the same earnings call, it was openly acknowledged that the Company struggled to achieve the expected sales of LUPKYNIS. In addition, ADALVO (a generic drug manufacturer) has come up with a Voclosporin-based product, akin to a generic version of LUPKYNIS. This development, which could upset the Company’s competitive position, was not even discussed by management.
Leadership Has a Track Record of Ignoring Shareholders’ Interests
Despite announcing a $150 million share repurchase program in February 2024, only $18 million has been spent over the last six months, even as the Company continues to trade at rock bottom levels. This lack of action is a missed opportunity to support the share price and demonstrates poor judgment by leadership.
After being voted out at the recent AGM, Mr. Greenleaf and three other directors remain in their positions. The Board’s failure to accept conditional director resignations and Mr. Greenleaf’s avoidance of this topic during the latest earnings call demonstrate a blatant disregard for shareholders’ votes and sound governance.
The issues outlined above highlight the urgent need for effective oversight and changes to the composition of the Board. In my view, the only way the Company can improve its trajectory and begin creating value for shareholders is by taking the below steps:
Dr. Brinda Balakrishnan, Dr. Robert T. Foster, and Mr. Greenleaf should each submit their immediate firm (not provisional) resignations, as they have failed in their respective roles. At the 2024 AGM, 52.5% of shareholders withheld support for Dr. Balakrishnan, 51.8% withheld support for Mr. Greenleaf, and Dr. Foster was narrowly elected with just 51.4% support.2 These three directors should be held responsible for the lack of meaningful M&A activity, the absence of significant research initiatives, and the consistent failure to meet the Company’s objectives.
The Board should appoint two shareholder representatives: one from MKT Capital and one from ILJIN SNT Co., Ltd. (“ILJIN”). This will ensure that the interests of the Company’s owners are directly represented in all strategic decisions moving forward.
The Board should reduce its size to streamline decision-making and enhance accountability.
ILJIN, a significant shareholder of Aurinia, should call for an Extraordinary General Meeting as soon as possible. This meeting is essential to address the aforementioned urgent issues, execute necessary leadership changes, and realign the Company’s strategic direction with shareholders’ interests.
The time for change is now. Continued mismanagement of Aurinia threatens the future of our Company and the value we, as shareholders, have entrusted to you. I expect immediate action to rectify these issues.
Furthermore, I want to emphasize that under no circumstances should the Board proceed with acquiring additional assets that could jeopardize the Company's cash flow and financial stability. This reckless behavior must be halted to preserve the long-term health of Aurinia.
Sincerely,
Lucien Selce
***
________________________
1
Company’s Form 8-K dated June 14, 2024.
2 Company’s Form 8-K dated June 14, 2024.
Contacts
Lucien Selce
Lucienselce@gmail.com
I got a kick out of this line from PG re this earnings report:
“Additionally, achieving positive free cash flow ahead of our initial projections further strengthens our financial position and allows more flexibility to explore opportunities to diversify our portfolio," said Peter Greenleaf, President and Chief Executive Officer of Aurinia”
They can’t monetize their current assets, he thinks acquiring more assets is the answer. LOL.
pete has set the bar so low that he feels that the stock only being .15 cents lower than when he became ceo justifies his 1.7million dollar salary puss millions in free stock.
not only does he follow the Peter Principle but he gets his management advice from joe and cameltoe.
I understand how you cannot see another person as being successful seeing how you years of employment peaked when you finally learned how to say "would you like fries with that" so you could keep your job!
I never disclose holdings of stocks only ignorant investors would do that. suffice to say in the last 40 years I have never had a stock purchase of less than a block of 1000 shares. And if that was all I had it would tenfold your holdings here.
Dump it ( AUPH ) and buy ARDX ...if Co ( ARDX ) prevails against CMS via the Kidney Patient Act or their lawsuit ...far greater upside by end of year
JMO
Kiwi
He said he used to be a CEO. I wonder what kind of company he CEO’d. He was blaming his brother for blocking him from selling half his holdings (who knows, 750 shares?). We had one like him from another bought biotech who’s posting here but he’s a milder one. He’s the one referred to as Gadfly by zzzzzz.
I was wrong in my assumption.
I'm a charter member of the club that has been wrong about him. For years I thought his pointless, worthless posts were a cry for help, and that he must have someone who cares about him enough to get him some professional help.
But if that/those person(s) even existed, they have clearly failed so far. I say that because if he is institutionalized presently, he's somehow able to have internet access, which is most unfortunate.
I like to think that everyone has at least some value, but he's really demonstrating how wrong that assumption is.
He might be the dumbest investor in history; if the Olympics had such a competition, he deserves to be a world champion.
Still here holding my bags. This tunnel is long and dark, let there be light!
If the current price holds till 4 pm, yeah the shorts are worried that there may be a showstopper announcement tomorrow or there could be a good ER leak, JMHO.
I think they might be more worried that AUPH would finally announce management changes...
Everyone knows there aren't any earnings to speak of.
I think they might be more worried that AUPH would finally announce management changes...
Everyone knows there aren't any earnings to speak of.
Could it be shorts are worried about earnings tomorrow?
Candidate & Indication | Development Stage | ||||
---|---|---|---|---|---|
Preclinical | Phase 1 | Phase 2 | Phase 3 | Market | |
VOCLOSPORINLupus Nephritis (LN) | Preclinical Phase complete | Phase 1 Phase complete | Phase 2 Phase in progress | Phase 3 Phase not started | Market Phase not started |
Aurinia is committed to working in areas of high unmet medical need and is poised to deliver the first approved therapy in the U.S. and Europe for the treatment of lupus nephritis, or LN.
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in lupus nephritis (LN) when added to standard of care mycophenolate mofetil (MMF). It has been granted “fast track status” by the U.S. Food & Drug Administration (FDA).
Voclosporin has the potential to become a best in class medication and the first approved treatment for LN in the U.S. and Europe, effectively altering the current treatment paradigm for the disease.
Our clinical data suggests that adding voclosporin to the current SoC of MMF for the treatment of lupus nephritis (LN) will yield superior results to using the standard of care alone.
Additionally, voclosporin may prove to be an ideal therapy for lupus nephritis due to advantages such as:
In clinical trials, Voclosporin has been shown to be especially effective in the presence of low dose steroids with rapid reduction of LN inflammatory markers and overall improved renal stability.
The list of potential product benefits includes:
LN Critical Need | Voclosporin (based on AURA Results) | |
---|---|---|
Control of Active Disease | ||
Rapid Disease Control | ||
Lower Steroid Burden | ||
Impact on Extra-renal disease | ||
Convenient Treatment Regimen |
In previous studies, over 2000 patients have been treated with Voclosporin with no abnormal or unexpected SAE’s
Efficacy of calcineurin inhibition has already been established. Voclosporin has a well-characterized safety profile (over 2,000 patient exposures across multiple years) across indications.
No new safety signals were observed with the use of Voclosporin in LN patients; Voclosporin was well-tolerated and renal function remained stable in clinical studies. The overall safety profile is consistent with other immunosuppressive drugs.
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