watching biotechs, gold & silver
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I think $3-$5B would be excellent.
$3B is too low.....should be worth $4B-$5B or more
Yeah, it's true......I argue with myself all the time
cheers
Wondering how much $$$ this gets sold for?
I think $3-$5B would be excellent.
Should we have a pool? We could all send $100 to Jess or is that not kosher per iHub rules?
GLTA
If you want to check the current PTAB status of the Aurinia-SUN dispute resolution,
here's a link:
https://portal.unifiedpatents.com/ptab/case/IPR2022-00617
The Patent Trial and Appeal Board (PTAB) is an adjudicative body within the U.S. Patent and Trademark Office (USPTO). The PTAB decides appeals from the decisions of patent examiners, and adjudicates the patentability of issued patents challenged by third parties in post-grant proceedings.
This is the Auph board.
It's way bigger than that........It's actually a Lupus Nephritis board with a primary emphasis on Aurinia.
Myopic is bad. If you're not interested in all possible medical breakthrough treatments that are underway in LN, it could hurt you.
I thought the early data I had seen from KZR was better then AUPH.......
Whala, would you post a link to that data? I would like to see it. It's been awhile, but I think I recall it was a just a few pts, and was not only a very small trial, but the results were also substantially inferior.
And they used high doses of steroids to boot.
So I'm curious why you're in love with KZR.
TIA
No BP will touch this pig
Clarity request:
Are you speaking about Greenleaf or Lupkynis?
Peter is AKA PiG
Lupkynis is clearly very valuable.
PiG- not so much
Hot dog cart?
H.C. Wainwright analyst Ed Arce reiterated a Buy rating on Aurinia Pharmaceuticals (AUPH – Research Report) today and set a price target of $14.00. The company’s shares closed last Friday at $5.15.
https://www.tipranks.com/news/blurbs/h-c-wainwright-sticks-to-its-buy-rating-for-aurinia-pharmaceuticals-auph-2?utm_source=stck.pro&utm_medium=referral
Aurinia's completed response to Sun's patent lawsuit is released
Read and/or download it here:
https://ptacts.uspto.gov/ptacts/public-informations/petitions/1549200/download-documents?artifactId=170313725
RMB: When I first heard about the 'Time is Nephrons' website/campaign etc., I assumed they were going to be very aggressively marketing Lupkysis as the way to stave off/delay the need for beginning dialysis.
I've been surprised they didn't do that and instead chose such a 'relaxed' sales campaign.
Hard to figure why they chose the course they did.
Aurinia launches 'uncomfortable' kidney health campaign as it details the realities of lupus nephritis
https://www.fiercepharma.com/marketing/aurinia-launches-uncomfortable-kidney-health-campaign-it-details-realities-lupus
rosemountbomber No real idea, but someone mentioned option expiration, and I thought that sounded plausible.
From SA: Aurinia announces resignations of medical chief and senior research executive
Aurinia defended at H.C. Wainwright after key resignations
Oct. 21, 2022 3:30 PM ET Aurinia Pharmaceuticals Inc. (AUPH)
By: Dulan Lokuwithana, SA News Editor
Just a day after a 13% rise, Canadian biotech Aurinia Pharmaceuticals (NASDAQ:AUPH) is back in the red even as H.C. Wainwright moved to address questions surrounding the departures of the company's Chief Medical Officer and Executive Vice President of Research.
The resignation of medical chief Neil Solomons and research EVP Robert Huizinga was not due to any disagreement with the company management, the analyst Ed Arce remarked, citing AUPH's Chief Executive Peter Greenleaf.
"After speaking with CEO Peter Greenleaf, we are confident that their leaving does not involve any disagreements with the company or management," the analyst wrote, reiterating the Buy rating and $26 per share target on the stock.
Noting "their extraordinarily long development stewardship of voclosporin from discovery to approvals," Arce rules out concerns over the timing of the resignation, which came after the European approval for the lupus nephritis therapy.
Citing its "long-tenured professionals, as well as a number of recent hires over the last couple of years," the analyst also pointed to the company's bench strength.
On Thursday, Aurinia (AUPH) shares spiked as investors highlighted the purported takeover approach made by pharma giant Bristol Myers (BMY) exactly a year ago.
Sort of interesting that Debbie claims her posts are positive!!!
If she ever says she is depressed I hope someone calls 911
Newbie, re John (trading cyclist):
Ditto what Benny said- John doesn't seem to be real active; not sure if he's on Twitter.
https://stocktwits.com/TradingCyclist
https://investorshub.advfn.com/boards/profile.aspx?user=458710
Hope he's doing well- always liked that guy.
This article is a year old, but interesting
As GSK, Aurinia heat up the lupus nephritis category, analyst gauges doctors' first impressions
https://www.fiercepharma.com/manufacturing/as-gsk-and-aurinia-heat-up-lupus-nephritis-category-analyst-gauges-doctors-first
Here is Ed and Justin's record/rating over the last 12 months:
Ed Arce
H.C. Wainwright
Wall Street Analyst
Ranked #1,215 out of 7,991 Analysts on TipRanks (#2,134 out of 21,404 overall experts)
Success Rate 38%
148 out of 388 Profitable Transactions
Average Return 7.80%
Average return per transaction
Justin Kim
Oppenheimer
Wall Street Analyst
Ranked #700 out of 7,991 Analysts on TipRanks (#1,140 out of 21,404 overall experts)
Success Rate 54%
49 out of 90 Profitable Transactions
Average Return 18.50%
Average return per transaction
Splitting the difference (26+13 x .5) would bring AUPH to $19.50, which would be pretty good considering all the ongoing headwinds, etc.
HC Wainwright & Co. analyst Ed Arce maintains Aurinia Pharmaceuticals (NASDAQ:AUPH) with a Buy and lowers the price target from $30 to $26.
Tuesday, 9 Aug 2022, 6:32am ET Benzinga News
Oppenheimer analyst Justin Kim maintains Aurinia Pharmaceuticals (NASDAQ:AUPH) with a Outperform and lowers the price target from $15 to $13.
Monday, 8 Aug 2022, 5:50am ET Benzinga News
Per Webster's re Debbie Downer (noun):
Deb·bie Down·er | \ 'de-be-'dau-nr \
plural Debbie Downers
Definition of Debbie Downer
informal
: a negative or pessimistic person : a person who speaks only of the bad or depressing aspects of something and lessens the enthusiasm or pleasure of others
"OK, now I really don't want to sound like a Debbie Downer, but 2018 has not been an easy one, my friends."
— Valerie Mesa
"If this is all supposed to be a big joke perpetuated on residents, I expect they probably violated the law to pull it off," said [Barbara] Petersen, president of the First Amendment Foundation. "I hate to be a Debbie Downer, but seriously, I don't think they thought this through."
— Associated Press
"I'm always the Debbie Downer and I'm always Mr. Negative … I call it like I see it."
— Brent Venables
First Known Use of Debbie Downer
2005, in the meaning defined above
History and Etymology for Debbie Downer
alliterative combination of the personal name Debbie and DOWNER
NOTE: Name popularized, if not introduced, by a skit character Debbie Downer on the American television variety show Saturday Night Live; the character first appeared in the program for May 1, 2004.
3 recent patent applications by Aurinia:
2 are dated July 7, 2022 for voclosporin for kidney diseases
1 is dated November 11, 2021 for voclosporin for Covid treatment/prevention
posted at 10:05 AM on ST by Paperjam:
https://stocktwits.com/paperjam
I can think of an argument against a settlement.......
If they settle (which seems likely) other generic, freeloading, IP stealing pharma could attack a later date.
But if Aurina goes full-bore into a trial and wins decisively, I think no one would dare challenge them afterwards, because the IP verdict would essentially be set in stone.
...."there will be a settlement before this goes to litigation"....
I agree. The odds and common sense (too often uncommon) would seem to favor it.
Only 15% of petitions filed against Orange Book patents resulted in a final written decision holding all challenged claims unpatentable
https://www.finnegan.com/en/insights/articles/key-insights-from-the-ptabs-updated-orange-book-and-biologic-patent-study.html
Why Biotech and Pharma Patents Survive IPR
https://www.jdsupra.com/legalnews/why-biotech-and-pharma-patents-survive-41420/
I'm hoping our sometime poster north40000, who is a patent attorney, is reviewing and digesting every possible shred of info on the patent issue, and will give us his learned thoughts/views fairly soon.
Lupkynis nominated for 'Best Pharmaceutical Agent':
"Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors," said Dr. Sue Desmond-Hellmann, Chair of the Prix Galien USA and Prix Galien International Award Committees and former CEO of the Bill & Melinda Gates Foundation. "The commitment and dedication of the innovators who develop these products never cease to amaze the awards committee, and we are excited to announce the 2022 nominations."
https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2022-prix-galien-usa-nominees-in-best-biotechnology-product-best-pharmaceutical-agent-and-best-medical-technology-categories-301593193.html
Interesting ST post re current mess:
LongTimer2003
Bullish
AUPH
In many ways PG not to blame for situation...who is to blame?
#1 Robbie Foster - he was CEO of Isotechnika which launched VOC. He mismanaged VOC for 12 years before his ineptitude put VOC at brink of extinction. He even had positive results for psoriasis and renal transplant but decided not to pursue them. He wasted 12 of 20 years of patent life. Glickman saved the molecule but it took another 6+ years to get the company cleaned up and the LN treatment thru CT3. So PG took over a molecule with an expiring initial patent and did a good job in IMO to get an approved Process Patent in place to carry the LN application to 2037.
#2 US Patent Office - To grant a Process Patent for a product which a company then makes significant investments in based on the duration and then, early on in the term, the USPO agrees to review the patent and change terms is, for lack of a better word, disgusting! And, the review request is from a foreign parasitic vulture with ulterior motives.
Adding insult to injury-this seems criminal:
FDA Approves Belimumab for Pediatric Patients with Lupus Nephritis
July 27, 2022
https://www.rheumatologynetwork.com/view/fda-approves-belimumab-for-pediatric-patients-with-lupus-nephritis
Let's damage some poor kid's kidneys with crap drug Benlysta
Those bastards should be ashamed of themselves.
All in a world gone mad!
rosemount- I think so but not sure what the amount would be- details are kind of fuzzy from the PR:
As part of the agreement, Aurinia will receive an upfront cash payment of $50 million U.S. and has the potential to receive up to $50 million U.S. in regulatory and reimbursement milestone payments. Aurinia will receive tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka.
https://ir.auriniapharma.com/press-releases/detail/208/aurinia-announces-collaboration-and-licensing-agreement
Otsuka receives positive CHMP opinion for LupkynisTM (voclosporin)
for the treatment of active lupus nephritis
https://www.otsuka.co.jp/en/company/newsreleases/2022/20220722_1.html
Voclosporin (Lupkynis) on EMA agenda July 20
2.1.2. voclosporin - EMEA/H/C/005256
indicated in combination with background immunosuppressive therapies for the treatment
of adult patients with class III, IV or V (including mixed class III/V and IV/V) lupus nephritis
(LN).
Scope: Possible oral explanation
Action: Oral explanation to be held on 20 July 2022 at 15:30
List of Outstanding Issues adopted on 19.05.2022. List of Questions adopted on
11.11.2021.
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-18-21-july-2022-meeting_en.pdf
Max relates the cancer fight his son Jacob is undergoing:
https://twitter.com/Sue_S_E_N/status/1547685405381632007/photo/1
Extremely tough situation. I'm sure we all wish Max and family the very best outcome possible.
Interesting post re Lupkynis vs Benlysta:
Benlysta is actually 10X more expensive than $AUPH's Lupkynis when comparing equivalent efficacy times.
Also, Benlysta doesn't meet the 50% reduction in UPCR by 6 months per the EULAR/ERA recommendation while Lupkynis does.
https://twitter.com/Sue_S_E_N/status/1547438318106943489
Jess, I believe these are the 2 patents that Aurinia claims that SUN infringed upon with their DES drug Cequa:
https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=10&f=G&l=50&co1=AND&d=PTXT&s1=Aurinia&OS=Aurinia&RS=Aurinia
https://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN/10973871
The 2 patent lawsuit by Aurinia against SUN can't be about voclosporin since Cequa is just a different formulation of cyclosporine:
The active drug ingredient in both Cequa and Restasis is cyclosporine. Cequa comes as a liquid solution in a strength of 0.09%. Restasis comes as an emulsion (an oily liquid mixture) in a strength of 0.05%. Both Cequa and Restasis belong to a class of drugs called calcineurin inhibitor immunosuppressants
https://www.google.com/search?q=cequa+vs+restasis&rlz=1C1RXMK_enUS975US975&oq=cequa&aqs=chrome.3.69i57j0i512j0i131i433i512j0i512l7.4870j0j15&sourceid=chrome&ie=UTF-8
Info on all the approved DES drugs: https://eyesoneyecare.com/resources/medications-for-dry-eye-disease/
Wish we knew more about these lawsuit issues, but not much seems to be out there about them.
Jess, my take is that Aurinia stuck first by filing the lawsuit against SUN claiming their DES drug Cequa violates 2 of Aurinia's patents for their DES drug VOS.
Some time after SUN filed against Aurinia (retaliation perhaps?) by claiming Aurinian's 2037 dosing patent is invalid.
I don't think the DES lawsuit claiming violation by SUN is about dosing, but I'm not certain.
Unfortunately, that's all I know (or think I know)
Best,
Jess, I'm not sure that I understand your post.....
I believe there are 2 separate lawsuits, one involving the 2037 patent for Lupkynis and the other involving 2 patents for VOS, their DES drug.
However, Aurinia is suing Sun and its Cequa dry eye medicine approved in 2018 over two patents from its voclosporin ophthalmic solution. Aurinia revealed the suit in December 2020 claims Sun’s dry eye med Cequa, or cyclosporine, infringes on two of its patents and is asking for an injunction to stop Sun from selling Cequa and monetary relief including cost. Sun has denied the charges and said the two patents at issue are invalid. That case is expected to go to trial in March 2023.
https://endpts.com/aurinia-faces-choppy-waters-amid-lower-than-expected-2022-guidance-and-patent-challenge-on-lupkynis/
Jess, re Sun patent infringement, etc.:
It seems clear they are guilty as hell, and I've seen it said by some that Sun's challenge to the 036 patent 2037 expiration is due to spite.
I haven't really made a study of Sun, but some claim they are always being sued and fined; ie., that they are simply 'bad apples' in the Pharma world.
In light of all the market turmoil, etc. it's looking to me like it would be worthwhile to try to take a closer look at them, how they operate, etc.
cheers
You're welcome- Here's a little more clarity from a relevant excerpt from the more recent May Earnings Transcript:
Aurinia Pharmaceuticals (AUPH) 10 May 22, 2022 Q1 Earnings call transcript
Unidentified Analyst
Hi, all this is Bill on for Joe, and thank you for taking your questions today. Congrats on the recent progress.
So one for us, can you just remind us on the on-going litigation with Sun pharmaceuticals? And has the company filed its response to the IPR? And when should we expect an update here and kind of how does this process unfold? Thank you.
Peter Greenleaf
Okay, thanks. And that was Joe Schwartz team over at SVB Leerink, sorry a little choppy coming in.
So let me repeat the question for everybody on the call. It related to on any updates on the Sun pharmaceutical litigation, the IPR process, and have we actually submitted our response to the IPR submitted by Sun to the U.S. Patent and Trade Office.
So to start with the Sun Pharma litigation, there's really no news there. The most recent update we'll have for us probably sometime in 2023 is that that litigation is on-going. We're calling that that is the litigation where we are suing Sun for patent infringement on our ophthalmic solution that we believe their product CEQUA infringes upon our patents for voclosporin's ophthalmic solution.
So no new news there, Joe, and wouldn't look for any until 2023.
On the IPR process, so officially, the patent office recognize the application, the date for response, so our response back to them is in late June. And then the PTAC [Ph] has, I believe, three months to review the initial filing alongside of our response.
So I would look for something in the in the back half of the year, call it late 3Q, early 4Q but nothing new.
We have not submitted our response as of yet because we're still formulating it. And we have until the latter part of June to get that submission in.
Unidentified Analyst
Great, thank you.
Operator
Thank you, Mr. Schwartz.