watching biotechs, gold & silver
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Department of Defense Announces Lupus Research Program Awardees
https://www.lupus.org/general-news/entry/department-of-defense-announces-lupus-research-program-awardees?utm_source=LO&utm_medium=email&utm_campaign=DOD_Lupus_Research_Program
OT Thanks for all the compliments- much appreciated.
Only negative is my hat doesn't fit anymore- need 2-3 sizes larger now.
cheers and GLTA
I hear you LTD, but I think someone will jump because VCS for LN is a special case- way more derisked than the rank and file.
"The biggest risk is not taking any risk... In a world that changing really quickly, the only strategy that is guaranteed to fail is not taking risks."
Mark Zuckerberg
"I don’t think BP will ever let us see that daylight" Me neither. I wonder how many billions BP and smalls spent over 50 years trying unsuccessfully to find something effective for LN.
I also think about the billions BP has (even more due to new tax laws) to spend to boost their product portfolios.
I think the potential usefulness of VCS for SLE just serves to boost the BO price.
Even if Aurinia leaves a couple billion on the table due to an early BO, the share price will still be considerable multiples from where it is today.
Just Musing- Will Docs prescribe VCS for SLE?
This scenario assumes P3 equals P2 results and that VCS would be prescribed off label:
Aurinia estimates there are 500K with SLE in the USA (300K just SLE + 200K with LN).
Benlysta sells for $37K annually, and is not very effective, and currently is generating approximately $500M/year, which is projected by some to grow to a $1B number by 2020.
Based on the SLEDAI scores from AURA (P2), VCS is a superior drug. I don't know if it's possible to directly compare VCS results to Benlysta, since the latter uses the composite SLE Responder Index (SRI), which "comprises criteria from three different, internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG)"
But assuming VCS is equal or superior if Aurinia did have an SRI measure, and 20% of the total SLE market could be captured at a reduced price (compared to Benlysta) of $35K annually, that would generate $3.5B in annual VCS sales.
20% of just the 200K LN group at $50K annually would generate $2B annually.
If Aurinia's estimated diagnosed population numbers are way off (very unlikely) and there are only a total of combined 300K SLE and LN patients, 20% of that number at $35K annually is $2.1B, a definite blockbuster number.
"Are you a beginning investor?" Nope, seasoned pro. I've got almost 2 months experience.
What's your native language? It can't be English.
Isn't 3 a lucky number? Today's Volume 3,331,333
Snap, Crackle, Pop!
Seven 3's would be even luckier.
Share Volume 3,331,333
50 Day Avg. Daily Volume 566,441
Confirmed breakout! Getting interesting
cheers
Dang it! They revised it:
Share Volume 3,332,533
"Here's Why Aurinia Pharmaceuticals Inc. Is Surging Today"
https://www.fool.com/investing/2018/05/14/heres-why-aurinia-pharmaceuticals-inc-is-surging-t.aspx
Aurinia Pharma-Congrats to our CEO, Richard Glickman, on his nomination!
@AuriniaPharma
2h2 hours ago
https://www.businesswire.com/news/home/20180514005430/en/Finalists-Announced-2018-Bloom-Burton-Award … $AUPH @bloomburton
Luna recently said to enjoy the quiet time because the unstable would eventually show up here- I guess this is just the preliminary so we have to get used to it.
I'm picturing a room of drugged up primates furiously typing gibberish.
"It was a thumbs up"
They clearly have their thumbs up something.
"On May 11th, 2018, AUPH had a plunge in stock by 25% during the afternoon. It was one of the largest declines of the exchange for that day."
"On Friday[May 11], there was a decline in stock. To compensate, the company offered a 36% discount on all shares which were bought. This transformed the sale from $6 per share to the steep incline which is being seen today at over $10 per share."
Not sure what drugs they're experimenting with, but they're clearly potent.
Have you clicked on the link you posted? It's total hogwash- so false some might even call it deranged.
I guess this is what Luna recently referred to- a pop and it brings out the crazies.
Jess- You're right- Not Trump. Thought it was Friday since the whole sector seemed to pop around 2:30 PM or so.
This is something else. Maybe Dr. Glickman's bullish comments re DES- "Sleeper" plus reference to Merck strong animal results with DES.
No real clue, but welcome. This stock's ability to jump up and down is impressive.
Maybe is Bob Duggan loading up- he certainly has the horsepower to move this single-handedly.
Way too dangerous to be out. Wonder how many penny flippers are wringing their hands hoping to get back in? That stress I don't want.
Luna- Thanks for that. Makes perfect sense while my human error theory is implausible considering the caliber of talent at Aurinia.
update- Ron Liu is correct that an October AUPH presentation for their upcoming FSGS trial showed that the CR Primary endpoint was a UPCR of equal or less than .5mg/gm, and in the latest April presentation the CR endpoint was portrayed as equal or less than .3 mg/mg.
But I don't think it's a cause for concern because I've read on multiple, credible gov't sources that the definition for CR in FSGS is a UPCR equal or less than .3mg.
Since the definition for CR in LN is a UPCR of .5mg/mg or less, I think that someone at Aurinia just goofed and somehow thought the numbers for FSGS and LN would be identical.
Thanks Jess-looking forward to Vid's return. EOM
Jess, it was most likely Trump drug price speech:
Entire sector jumped big due to relief rally
"Why Trump's Big Drug Price Speech Sent Health Care Stocks Soaring"
http://www.fortune.com/2018/05/11/trump-drug-pricing-proposal-health-stocks/
Maybe Duggan will become active after his AKAO rockets after FDA approval.
"Also why would the low dose work better in females and the high dose work better in males."
A puzzlement. When the stellar AURA results came out, there were skeptics raising a fuss over this "reverse dose response" (low dose outperformed high dose).
Aurinia offered the explanation that perhaps because VCS is so potent, the high dose was simply not tolerated as well.
Apparently not true for males, but as you said there were only 35 of them.
Jess, I'm wondering if Bob Duggan is buying again. Maybe he wants to replace the shares he sold last fall or maybe even add more.
I agree with you it's nice to see AUPH come out of it's coma every now and then.
Someday...........
cheers
For the Auphaholics- "48-Week Complete Remission By Ethnic, Sex and Age Subgroups in Patients with Active Lupus Nephritis Treated with Voclosporin"
Hadn't seen this before- nice easy to read chart. Looks like males need the higher dose.
http://acrabstracts.org/abstract/48-week-complete-remission-by-ethnic-sex-and-age-subgroups-in-patients-with-active-lupus-nephritis-treated-with-voclosporin/
Earnings call webcast just concluded. Dr. Glickman said he sees VOS program (DES) as a sleeper- suggested could add very significant corporate value. Said Merck animal data was very exciting but couldn't share it at this time.
LN trial going very well, and everything on track according to plan.
Surprisingly, only 2 analysts asked a couple questions each. Dr. Glickman expressed surprise.
This company is off the radar evidently....zzzzzzzzzzzzzzzzzzzzzz.....
https://www.investornetwork.com/company/23480
Biggest and Best Aurinia Presentation to date (163 pages)
This is from last October, but well worth downloading as a reference re all things AUPH.
Titled "Unlocking the value of Voclosporin"
Contains: Corporate history, strategy, vision, LN Program and opportunity, IP, Expanding Renal Franchise with new products.....and lots more.
https://d1io3yog0oux5.cloudfront.net/_81923a6a8325706e9f7c168a566d03fd/auriniapharma/db/239/935/presentation/R%26D+Day+Final.pdf
I'm baffled- what is the strategy behind dumping 4K shares in premarket at $5.08.
Is someone trying to flush weak hands or ???
I'm assuming you can't take out stops in premarket trades.
Revised guess- maybe not. Here's what Aurinia said in December 2016:
"Renal Transplantation: A Phase 2b clinical trial in de novo renal transplant recipients was completed. Study ISA05-01, the PROMISE Study was a six month study with a six month extension comparing voclosporin directly against tacrolimus on a background of MMF and corticosteroids. Voclosporin was shown to be equivalent in efficacy, but superior to tacrolimus with respect to the incidence of new onset diabetes after transplantation. In 2010, tacrolimus lost its exclusivity in most world markets and as a result, the competitive pricing environment for voclosporin for this indication has come into question. Additionally, the more expensive development timelines for this indication has made it a less attractive business proposition as compared to the LN indication, even when considering the fact that a special protocol assessment has been agreed to by the FDA for this indication."
http://content.equisolve.net/sec/0001193125-17-075811/d313671dex991.htm
Guessing the next VCS use will be for kidney transplant recipients.
Tacrolimus annual sales are nearly $2B and Voclosporin looks as good or better.
A Phase 2 was completed in 2009 comparing VCS to tacrolimus.
Study (with results):
https://clinicaltrials.gov/ct2/show/study/NCT00270634?sect=X1256
For some reason they planned but did not start the P3.
"PROMISE was a 6-month Phase IIB multicenter, randomized, open-label clinical trial comparing three doses of VCS (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg) vs tacrolimus (0.05 mg/kg) in combination with a standard immunosuppression regimen (anti-CD25 antibody induction, mycophenolate mofetil, and corticosteroids) in 334 low-risk renal transplant recipients. Rejection rates, the primary end point for the study, for all three VCS doses were noninferior to tacrolimus (10.7%, 9.1%, and 2.3% vs 5.8%, respectively). Secondary objectives included renal function, new-onset diabetes after transplant, hyperlipidemia, hypertension, and pharmacokinetic–pharmacodynamic evaluation. Renal function was clinically similar (68–72 mL/min) at 6 months after transplantation among all groups. Compared to the tacrolimus group (16.4%), the incidence of new-onset diabetes after transplantation was significantly lower in the 0.4 mg/kg VCS group (1.6%), but not in the 0.6 mg/kg and 0.8 mg/kg VCS arms (5.7% and 17.7%, respectively). There were no clinically significant patterns of hyperlipidemia or hypertension development among the groups. There was exceptional correlation between trough and area under the curve for the VCS groups (r2=0.97), and there was no difference in mycophenolic acid exposure for the VCS groups compared to the tacrolimus group. The incidence of adverse events was similar among all four treatment groups, with no specific safety concerns raised. The major limitation of this trial was that only low-risk patients with immediate graft function were studied, but the results showed great promise for use of VCS for prevention of graft loss.15
INSPIRE was a Phase III randomized, multicenter, open-label, concentration-controlled safety and efficacy study to compare VCS and tacrolimus in renal transplant recipients. The trial was scheduled to begin in March 2013, with a plan for completion by December 2015 (NCT01586845). The primary end point for this noninferiority study was to assess efficacy failure at 12 months postrandomization; however, the study was withdrawn prior to enrollment for unclear reasons."
https://www.dovepress.com/drugs-in-development-for-prophylaxis-of-rejection-in-kidney-transplant-peer-reviewed-fulltext-article-TRRM
Apparently Ron goofed re FSGS trial change:
R @Lucy3370 57m57 minutes ago
$auph heard back from HR. (Nothing has changed in what’s been disseminated-this is from me) FSGS is open label study, while primary endpt is 6 month,Mgmt has indicated recruitment cud take 12 months, w/interim readings along the way.Same as b4-the sky is not falling
From Ron Liu on Twitter today:
https://twitter.com/RonaldLiu3
"FSGS trial pushed back and also harder CR endpoint to hit. Material info"
and another next to it:
"In order to complete the clinical dossier, we will also commence a confirmatory drug-drug interaction study between voclosporin and MMF in 2018. In addition, we will conduct a pediatric study post-approval. Why is the DDI study removed with no notice?"
Aurinia to Present at the Bloom Burton & Co. Healthcare Investor Conference on May 3, 2018
https://www.businesswire.com/news/home/20180425006469/en/
"They're getting lazy." Yup- Keith (author of latest swill) must get paid by the word.
Keith was very high on AUPH last summer and fall, but since then some of his picks (INCY CELG ABBV) have taken hits.
He may have lost his nerve and decided to pull in his horns a bit.
Any idea when the big money starts to flow into this in anticipation of P3 results?
This is interesting/different: ImmuPharma going to push for "conditional approval" from FDA. Says BP interest still high in Lupuzor.
http://www.proactiveinvestors.co.uk/companies/news/195553/immupharma-chairman-and-chief-executive-upbeat-on-lupuzor-industry-interest-remains-strong-195553.html
The P2 study for the Celgene Crohn's drug (mongersen) was loaded with red flags; far from "stunning". No one with any credibility expected a "slam dunk".
Here are some excerpts and links to the articles they come from:
"Previous mongersen trial results in treating Crohn's, released in 2016, were both unimpressive and difficult-to-interpret. Analysts have been walking down expectations for the medicine for some time now."
https://www.bloomberg.com/gadfly/articles/2017-10-20/celgene-stops-mongersen-trial-not-the-end-of-the-world
"However, the inclusion criteria used by Monteleone and colleagues were based on the CDAI score and did not include more objective criteria for active disease. Endoscopic confirmation of active Crohn's disease was not an inclusion criterion, so it is unclear what proportion of patients underwent randomization without actually having mucosal lesions."
http://www.nejm.org/doi/full/10.1056/NEJMe1415053
"In conclusion, the impressive clinical efficacy of mongersen still needs to be confirmed by future studies, and especially in CD patients with active endoscopic inflammation. The ongoing Mongersen phase III trial may provide an answer to this question."
https://onlinelibrary.wiley.com/doi/full/10.1111/apt.13563
"Analyst at Bernstein, in a detailed analysis of Celgene, forecast mongersen sales could approach $2 billion in a decade, but warned it was a "controversial asset" and that the study results were "hard to predict." Michael Yee, an analyst at Jefferies, said in a note that expectations for the drug among fund managers had been low."
https://www.forbes.com/sites/matthewherper/2017/10/19/drug-celgene-bought-for-710-million-fails/#60ed78bc2377
Additional red flags are:
a) The Celgene team that paid $700M for the drug were described as very inexperienced in that area and
b) They used a post hoc subgroup analysis to mine the P2 results.
c) The demographic chosen to participate was nearly all Italians, which seems a very unbalanced choice.
My view is the P2 results for mongersen are not at all comparable to the success of Voclosporin in P2.
Is the romance with AUPH over for MF?
Pretty negative article with some glaring flaws:
https://www.fool.com/investing/2018/04/22/dont-get-greedy-with-aurinia-pharmaceuticals-stock.aspx
What's up with this Indian Company offering Voclosporin?
They're offering it in bulk- how can that be since they say "We Don't BUY/SELL/MARKET/ consult any products covered under patent or are restricted."
http://www.avanscure.net/voclosporin-2697962.html#inq_pp
Aurinia's manufacturing contract for Voclosporin is with Swiss company Lonza:
https://ir.auriniapharma.com/press-releases/detail/65/aurinia-announces-long-term-manufacturing-collaboration
So could it be counterfeit or ???
"...explosive component to the manufacturing process..."
That's it- whether it's physically dangerous to be in the immediate vicinity where they make it. The workers must get combat pay for that and insurance must be steep.
I know it's super safe to take, as more than 2000 people have with no safety issues.
Will be nice when the price finally explodes higher.
Thanks Luna- I may have assumed "difficult" also meant expensive.
"Explosive" as in potentially causing physical injuries???
TIA
Luna, re "...price tag closer to $50k than $35k."
Probably so since Aurinia says the current annual financial cost to these patients is around $60K annually.
My $35K WAG was a) to be conservative re revenue estimates and b) figuring that leaves plenty of leeway for annual price hikes (which seem universal).
I know that it's expensive to manufacture Voclosporin- any idea how expensive?
TIA
ALLINforLupusNephritis.com, says 200K have LN in USA
https://www.allinforlupusnephritis.com/about-lupus-nephritis/prevalence
Estimating that only 20% will take VCS, that's 40,000 people at $35K per year would be $1.4B annually.
At $50K per year it's $2B annually for just LN.
Why isn't this a "table pounding buy"???
I know, "Patience is the key".
I need to learn how to do "patience"- it's foreign to me.