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Auph is positioned well. But I would agree that it's time they flip the switch on and start to show significant increases in PSFs and Patient restarts. The one item that does concern me with Auph is that currently about 50% of SLE patients are not screened for LN. The new guidelines (Eular, ACR, and KDIGO) all now emphasis the importance of screening early and often for SLE patients. Also, all the guidelines also emphasize the need for early and aggressive treatment of LN with one of the newly recommended options. In the US, that boils down to either adding VOC/Lupkynis or Benlysta. Between those two, Voc is the only one to receive KDIGO's high certainty of evidence. Benlysta offers very little improvement over the prior SOC and thus only received KDIGO's medium and low certainty of evidence ratings. WT
Look. It's no secret that your talking about VERA. Vera paused as in stopped their LN trial. Don't hold your breath for Vera restarting the LN trial for Atacicept. The data they got for LN, IMO, was not that good as it offered very little improvement. My understanding is that they compared their results (showing that Atacicept barely works) to Benlysta (which barely works and offered very little improvement), and concluded that: if we combine two drugs, each that barely work or offer little improvement, we may have something. There is one reason that Benlysta was approved, and it's not because it offered any significant benefit. For more than 20 years, no one added anything to help LN patients. The LN indication was desperate for any hint of improvement. In most indications, the poor results that Benlysta offered would not support FDA approval. Vera is in a similar boat. Thus, IMHO, that trial is going nowhere. WT
That's funny!
SLE trial already underway: The P3 trial for a new treatment protocol for SLE is already underway and I would expect that trial to be completed in 2026 (but don't know). I believe it started shortly after the FDA approved Auph's treatment protocol (using VOC or Lupkynis). The trial costs Auph nothing because the NIH is paying for it ... but Auph's patents (i.e., the ones that provide protection to 2037) also cover the use of Voc for SLE (the treatment protocol) and so Auph would be the only entity that could market the use of VOC for the SLE indication. WT
Dear Mr. Watson,
Thanks for your posts, they are short, to the point and very persuasive (as simple, honest facts usually are!),
BTW, is your wife a nephrologist by any chance, and if not, maybe your cousin Winnie... anyone? (LOL!)
WT. from ChatGPT
Watson. If Lupy (not voc, because voc has just 3 years left on the patent, till 2027) is in the hands of a BP, it could go a long way than LN alone. BP has big pockets to go into different indications for trials( for Lupy, till 2037). They could probably explore SLE and they don’t have to go full monty (just p2 &p3) thus saving them a lot of money and time. Other indications also being treated by cyclosporine could be a target of Lupy since it is a knot or two better than cyclosporine…JMO.
It's a hot market, so you can always expect some entity will be chasing a solution that will likely be added to the graveyard of failures over the past 20 years. FWIW, the IgaN indication is not the same as LN. As far as the LN indication, my research says the only trial that seemed promising was the NVS trial, and of course that one failed. LN is a very tricky disease. Auph is protected with patents through 2037 and now the standards, including KDIGO now (in its recent 2024 clinical practice guidelines for treating LN) recommend VOC/Lupkynis for treating LN class III and IV.
What's important to understand about KDIGO guidelines is that they not only recommend VOC/Lupkynis, but my understanding is that the guidelines emphasize that VOC/Lupkynis is the only option that received KDIGO's a high certainty of evidence rating ... that is KDIGO finds high certainty of evidence that the the therapy that adds VOC to the baseline therapy is superior over the baseline therapy alone. The other options, not so good ... read for yourself at page S32 of KDIGO's practice guidelines. It seems pretty clear that this is a big step toward VOC becoming the new SOC. WT
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Scary! A third of patient with lupus nephritis who are considered complete respondues continue to aaccrue progressive renal damage - @Andreafava @rheumnow #RNL2024 pic.twitter.com/mhu3YoY3YV
— TheDaoIndex (@KDAO2011) January 27, 2024
Jess. My wife knows of 2 patients with LN on Lupy .
I'm not neutral on Lupy ( the drug )
It works .....to rapidly lower high levels of proteinuria and allows aggressive lowering of Steriods . ( patients hate the Steriods )
I'm neutral on the long term business prospects of AUPH ...for reasons I've detailed before
JMO
Kiwi
Neutral? You’re already undermining Lupy (‘might be better than Lupy’) with another drug that still has to go on p3 trial. I think you should be comparing it right after the p3 trial is over. Even if p3 is over, it could still NOT be approved by the FDA.
And even if it’s approved, you don’t know yet if it will be effective in the long run(at the least, two years) like Lupy. I know it’s only your opinion but I’m also opining that you’re biased against Lupy from the get go…JMO.
Jess. I think I posted that the termination of NVS's trial with Cosenrtyx was a plus for AUPH ...removed near term potential competition .
Don't think I was a huge fan of Benlysta ...other being less expensive and insurers might want Nephrologist's to try first .
Lupy has 2 advantages ...rapid lowering of proteinuria and the ability to taper Steriods faster than other meds.
I'm not negative on AUPH ...I'm neutral due to the recent results for the other LN or LN related drugs in development.
Kiwi
Geez kiwi, you’re promoting another p3 drug? Isn’t that what you intimated on secikumumab p3 trial from Novartis that was discontinued just recently? You were so high up on that drug. Quite a while ago, you were also so high up on Benlysta. I’ll give you an A for effort though.
WT Suggest you chk the drugs in development for IgaN as at least one Co I know has a LN P 3 trial ready to go another is I think is in P2 trials.
The data so far may be better than Lupy's .
Probably at least 3 yrs until either of these has an approved new LN drug ....however AUPH won't de making a profit until 2nd half 2024 ......and then possible face competition from a new drug approved for both IgaN and LN two and a half years later .
If U want to know the others Co's ask me on another board
Good luck
Kiwi
Kiwi,
Fair points. That's why they call it a rare disease. About 400K with Lupus in US develop SLE. So your metrics line up with Auph's metrics, 80k to 100K develop LN. LN class 3 to 5 accounts for about 80% of that ... .
I agree that Auph has been presented with multiple hurdles ... . But evidence-based treatment seems to getting more traction and the trend to 3 years treatment period presents a nice star factor on the opportunity. Unless they regress in PSFs + restarts, then it seems to be a safe bet that Auph is good value here.
Good luck.
WT
Nice find WT. I better follow you...
WT I agree with a lot of what you post. I just don't think the market will be as large as you think .
CKD patients are usually dealing with multiple issues , diabetes , heart disease , high blood pressure , high potassium or phosphorous etc that reduces their life expectancy well before their need for dialysis
Kiwi,
As your spouse probably knows through experience, Insurance companies seem to use PAs (and make them confusing as hell) to delay and sometimes avoid paying for patient care. That's why congress is taking action.
https://www.ama-assn.org/practice-management/prior-authorization/big-step-forward-congress-fix-prior-authorization
In Dec of 2023, Lorddragon (who I understand is a nephrologist) published a "Notice of Approval for Medicare Prescription Drug Coverage" for use of Lupkynis for 15 months and the approval was open ended in that, effectively, if the doc continued to prescribe the Voc, the coverage would be extended beyond 15 months. Again, this is simple recognition that failure to treat in most cases results in a far greater cost to the insurance entities -- IMO, cost of Lupkynis is trivial compared to cost of dialysis, hospital stays, and transplant.
WT
Otsuka is not alone ... many other BP entities pass on EU or discontinued sales of life saving drugs for rare diseases. It's all part of price negotiation. drug saves insurance/health industries the burden of more patients on dialysis and transplants (500K to 1M per patient) and now they don't want to pay. Some think that that the move is all part of the on-going negotiations ... i.e., the EU rights under the K would revert back to Auph ... which gives Auph another asset to include in a sale. NVS would negotiate a much better deal.
You have odd logic on your Icer point. I am also on Vascepa (not for high triG but for other issue -- got a PA exception). I was also an investor. Bought at 3 sold 1/2 at 12. Sold other 1/2 at 18. Amrn would have sales and would have been IMO bought out at 25 to 30ish. But mgnt had a big FU. The story is simple. don't file your pharma suit to defend your patent in Nevada. For that, AMRN deserved to lose. It's the area I work in and it seemed odd as hell. After that loss the sales went to generics. It's well known that Delaware is where you should defend a pharma patent. Icer has nothing to do with it. WT
WT. You make some good pts.
AUPH seems active in attracting a BO offer . So since Otsuka has EU rights and Germany ( the largest market there ) won't pay for Lupy, NVS ( big in the EU ) wouldn't be interested .
So who do you see ( if anyone ) buying this Co.
I'm familiar with ICER . Shows Vascepa ( which I'm prescribed ) to be very cost effective ...doesnt mean they are selling a lot of it ( brand or generic ) in the US or EU .
Re ARDX ...keep an eye on UNCY . Wife already prescribes Fosrenol ...UNCY's version has advantages of a drug she already prescribes ...so easy for patient transition if their pivotal trial reads out positive , mid year 2024 .
If you have time , chk it out and let me know what U think . A lot of smart bio hedge funds now own about a 1/3rd of the Co .
Thx for the detailed , informed , debate
Kiwi
That's the knee jerk reaction by many. But it's short-sited in my view. This is the nature of a rare disease indication (meaning there are few patients in the TAM) ... such drugs would never be developed for the rare diseases if the price was not reflective of some ability to recoup development cost. Look at what's going in in Germany -- Otsuka pays a small fortune to acquire the rights ... but Germany sets a price so low that it makes no sense to even offer Voc in Germany. Thus, Otsuka shut down its sales operation in Germany and rumor has it they may do so for all of EU.
What's interesting is that ICER played a roll in arriving at this price ... in that they gave a favorable rating to Auph's price, concluding that it would save the health/ins industry significant $ as it was the first contribution in over 20 years to the LN indication and the only contribution that actually works.
WT
Those are current numbers ... keep in mind that when Lupkynis was launched, the expectation is that the period of treatment would be 6 months to 1 year. And revenue estimates were based on those numbers. Now, nearly 50% of those patients continue to be on therapy past 18 months. That's huge.
- In fact, since launch, the persistency and length of treatment has gone up each Q. And now they are seeing patient restarts (recognizing that it was a mistake to discontinue therapy). This is all having a material impact on revenue estimates. Currently they have about 2100 patients on therapy, but because period of treatment is trending toward 3 years, they have a annual rev run rate of about $200M.
WT
Yep ...ripping off the dialysis patient ...sorry but thats how they see it .
If they priced at same rate / unit as IBSRELLA , at lot more patients could afford the copay
Kiwi
Thx ...but as you post
Kiwi
- the guidelines (EULAR and ACR) each recommend using Voc for at least 3 years. ISN/KDIGO says up to 3 years.
- Since 3 year study (and the EULAR guidelines) the length of treatment is trending toward 3 years
- current persistency metrics are as follows.
- at 1 year 54% remain on therapy
- at 15 months 48%
- at 18 months 43%
- and, due to the new 2023 guidelines, Auph is starting to see significant number patient restarts, i.e., patients that stop treatment and due to flare up or other issues are coming back to treatment and staying on a maintenance plan for 3 years ... I expect that trend to continue. Why? Docs that don't follow the clinical practice guidelines open themselves up to liability. And given that LN destroys the kidneys in a very short period of time, the liability ramps up fast ...
- bottom line: after therapy starts: I would expect most patients to say on Lupkynis (Voc treatment protocol) for at least 3 years.
WT
WT. All good pts . I may come back to them later if I have time .
Have you checked how many stay on Lupy once proteinuria levels have been corrected ?
Kiwi
WT excellent DD
What is the copay for Lupy , once prescribed ? AUPH won't subsidize ( via coupons or whatever they do ) for ever.
Agree that Lupy is better than SOC but the feed back I get re prescribing is major PA ( prior approval ) hurdles put up by the insurers .
Co is making $ tho.. but this is not the next GLP-1
Good luck
Have you looked at EWTX and ( further behind ) TNYA in the Cardiac space ?
Kiwi
Kiwi,
I read the ISN guidelines. Keep in mind, those are international standards. If read thru the US market lens, there is no question in my view that Lupkynis will become SOC for LN class III-V. Look at the "graded recommendations" in conjunction with the "certainty of evidence."
In the US the recommended added immunosuppressive agent will either be Lupkynis (VOC) or Benlysta.
For Lupkynis (VOC), there is high certainly of evidence that adding VOC gets results that are superior to the current SOC (with the added benefit that VOC allows the rapid tapering of steroids). Here's the quote.
WT. maybe Class 3,4 CKD with eGFR greater than 45
Wife only knows of 2 patients on Lupy....to try and rapidly reduce levels of proteinuria as well as taper steroid use.
Major insurance push back re prior approvals ( document patient failed on all other available meds etc ) ...due to cost of Lupy.
OT. chk out EWTX ...recent find and medically relevant to me
Good luck
Kiwi
Kiwi,
Thanks for the information. Be curious to know your spouse's view on the US metrics for LN: (1) estimate of US population that gets LN each year (I have seen estimates from 80K to 200K, noting that many never get diagnosed or treated); (2) estimate number of patients that get diagnosed with LN each year (this number is apparently increasing significantly each year); and (3) I would think that most LN patients when they initially get diagnose (assuming it was caught early enough) would have an eGFR that is greater than 45. Particularly now that we have guidelines preaching screening all SLE patients early and often. My understanding is that about 80% of LN patients fall under the Class 3, 4, 5 LN category and ... very few would have an eGFR under 45 and thus be excluded under the ISN guidelines. Does you spouse agree with that?
WT
Kiwi,
you can ignore my question ... I see the reference to ISN.
WT
Kiwi,
Which guidelines are you quoting from: EULAR? ISN? Or ASR (which I recall was in the draft stage ... but was told it will be very close to EULAR which would be good). ISN is good as well as I recall it was fussy on the other CNIs like TAC ... i.e., it did not provide the clear differentiator that EULAR provided for VOC.
WT
Moose. I think this why they are limiting Lupy to the higher eGFR range .
Moose. I think it means they are recommending Lupkynis only for those that match the eGFR levels used in the pivotal trial.
Some Nephrologist might be using it " off label " as a last ditch effort for a patient with rapidly declining eGFR due to high levels of proteinuria .
eGFR is a measure of kidney function
Re 'The limitation that surprised me was the recommendation for only those with a eGFR over 45.'
It appears that they are saying no need for voc with moderate CKD.
Is that likely a cost saving measure?
Seems like they're saying "wait until your kidneys are in severe trouble ;i.e.. ready to go on dialysis before spending the $$$ for voc?
If not, what else could it mean?
TIA
Nephrologists will follow these guidelines
There are some positives here for Voc ( Lupkynis ) but these guidelines also limit the population likely to be prescribed Voc
.....which means the "Black Box" should be eliminated?
It's all a question of focus:
Correction not recommended for patients baseline < eGFR 45
https://www.kidney-international.org/article/S0085-2538(23)00627-0/fulltext
This 2024 update guideline will be used by prescribers . Has some positive mentions of Voc ( Lupkynis )
Kiwi
2024 guidelines
Voclosporin is an analog of cyclosporine that exhibits enhanced potency in calcineurin inhibition. Voclosporin was noninferior to tacrolimus in the prevention of biopsy-proven acute rejection in a 6-month multicenter open-label phase 2b trial that involved 334 low-risk kidney transplant recipients.164 Voclosporin for the treatment of active biopsy-proven Class III, IV, and V LN was investigated in the AURA-LV trial,107 a phase 2 RCT of 265 subjects and the AURORA 1 trial,108,165 a phase 3 RCT of 357 subjects. Both trials included patients of diverse ancestry. Voclosporin was compared to placebo, and all patients received glucocorticoids and MMF (target dose: 2 g/d) as background therapy. The rapidly tapered corticosteroid regimen used was novel. All patients received 2 doses of i.v. methylprednisolone (500 mg/dose) followed by 20–25 mg prednisone that was rapidly tapered to 2.5 mg/d by 16 weeks. The primary endpoint of these trials was renal response (RR), defined as urine PCR =0.5 mg/mg [50 mg/mmol], eGFR =60 ml/min per 1.73 m2, or no decline of >20% from baseline, and prednisone dose of <10 mg/d for the 8 weeks prior to endpoint measurement.
In AURA-LV, 33% of patients treated with voclosporin 23.7 mg twice per day reached an RR at 24 weeks compared to 19% of placebo-treated patients (odds ratio [OR] 2.03, P <0.05).107 Similarly, in AURORA, 41% of voclosporin-treated patients achieved RR at 52 weeks, compared to 23% of placebo-treated patients (OR 2.65, P < 0.001).108,165 A pooled analysis of the 2 trials showed that patients treated with voclosporin added to standard therapy had an RR rate of 44% at 1 year, compared to 23% in placebo patients (P < 0.0001).166 The incidences of adverse events were similar between the placebo and voclosporin arms.
Compared to other CNIs, such as cyclosporine and tacrolimus, voclosporin has a more consistent pharmacokinetic–pharmacodynamic relationship due to enhanced binding of the voclosporin–cyclophilin complex to calcineurin and reduced drug and metabolite load. Preliminary evidence, based on data from the AURA-LV and AURORA trials, suggests that therapeutic drug monitoring is not necessary in the studied patient population.167 Note that there are no data on voclosporin given together with cyclophosphamide.
Results from the pivotal trials led to the U.S. FDA approval of voclosporin to treat adult patients with LN in January 2021. Of note, voclosporin is not recommended for patients with a baseline eGFR >45 ml/min per 1.73 m2, and these patients were excluded from the trials. ( my emphasis ) Similarly, significant impairment of kidney function is often an exclusion criterion in clinical trials of CNIs. The use of a CNI in patients with severe CKD requires careful individualized consideration of risk versus potential benefit, and should be done with caution and careful monitoring, and at reduced drug exposure.
The positive results of AURA-LV and AURORA coupled with those of the Asian studies of tacrolimus and cyclosporine suggest triple immunosuppressive therapy incorporating a CNI can be an effective treatment regimen for LN. An advantage of a CNI-based regimen is the more rapid reduction of proteinuria. However, outstanding issues on the duration of the CNI, its tapering and suspension, and the long-term efficacy and safety of CNI triple therapy regimens remain under study.
Kiwi
It appears to be just "trading range" trading that has been going on for a long time.
will somebody tell me whats going on with this stock?
My take is that with the SR not yet ended after more than 6 months,
either a potential deal is being worked on or else JPMorgan is just wasting
time. I would go with the former and not the later. "If" a deal is had I'd guess
it would be between $18-$22. However, did not our activist investor state that
AUPH was worth $28 in a BO? Perhaps that was just bluster. Much simply
depends on what BP believes they could get peak revenues to hit and for how
long...info we could only guess at. Then, if PG were to end the SR without a deal
after all the time & money placed in the SR, the shareholders would want his head.
The biotech sector is going to have a great year with many small and mid cap stocks like AUPH get taken out
This preliminary report is so bullish. The company with its hoard of cash and increasing revenue makes it so strong. Any offer less than $25 should be rejected.
Seems some uptick in M&A activity in the sector lately. Aurinia is mentioned recently as a takeout candidate.
Does anyone here subscribe to the FLY? they may have something.
Along with what Whalatane posted, it has been virtually 6 months since SR started. If this is to be sold, six months should be plenty.
We have seen this before, on any given day it will shoot up for no apparent reason and than retreat. But I think there may be something behind this. sure hope so
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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