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ABBV’s neurotoxin, AGN-151607 misses primary endpoint in prevention of PAOF (PostOperative Atrial Fibrillation) in cardiac-surgery patients:
https://finance.yahoo.com/news/abbvie-announces-breaking-results-phase-173100778.html
AGN-151607 is a Type-A botulinum toxin that, unlike Botox, is intended for cardiology indications.
Why does ABBV show up as delisted?
Impetus for ABBV selloff today:
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022
Imbruvica (ibrutinib) Pharmacyclics (AbbVie)
2021 Sales $9,777,000,000.00
Data was excellent. Doubled CR of (ABBV) ibrutinib alone in MCL
Data in P53 mutant CCL is game changing
ABBV Let this sink in on how valuable this combo is $$$ for ABBV
Two ROR1 acquisitions Merck acquired early clinical data VelsoBio.. for $2.8 Billion & Boehringer buys NBE Therapeutics $1.5Billion ROR1 deal last year.
$ONCT
Great informant video of ABBV & ONCT combos in the clinic (cancer stem cells)
ABBV 2 trials one with ibrutinib & the other zilovertamab with Oncternal Therapeutics ROR1 molecule the data speaks for itself. This is going to be huge for ABBV bottom line.
ABBV with Oncternal Therapeutics Presents Updated Interim Data for Zilovertamab in Combination with Ibrutinib at ASCO 2022 Phase 3 starts in a few weeks in ths usa.
May 26, 2022 at 5:15 PM EDT
Updated MCL and CLL data from the CIRLL study are encouraging and continue to improve
ORR of 85% (23 of 27 evaluable patients) and CR rate of 41% (11 of 27 evaluable patients) for patients with MCL treated with zilovertamab plus ibrutinib compare favorably to historical ORR of 66% and CR of 20% for ibrutinib monotherapy
Data from p53-mutated MCL and CLL patients show encouraging response rates in sub-group analyses. Landmark PFS was over 80% at 15 months for MCL and 100% at 36 months for CLL in p53-mutated patients treated with zilovertamab plus ibrutinib
The combination of zilovertamab and ibrutinib continued to be well tolerated, with an adverse event profile consistent or improved compared with historical data for ibrutinib monotherapy.
ONCT is going to help ABBV with ibrutinib sales & with investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC).
I think ABBV buys ONCT sooner than later 10 drugs in their pipeline.
ZILO-301: Phase III study of zilovertamab + ibrutinib vs ibrutinib in R/R MCL
(VIDEO 2 min)
ABBV 2Q22 results:
https://investors.abbvie.com/news-releases/news-release-details/abbvie-reports-second-quarter-2022-financial-results
2022 non-GAAP EPS guidance is unchanged at $13.78-13.98, including a $0.23 charge for in-process R&D during 1H22, but no IPR&D charge relating to 2H22 insofar as M&A activity during 1H22 is not yet known
ABBV set aside $2B to settle opioid litigation (https://finance.yahoo.com/news/1-abbvie-sets-aside-2-121111751.html ), but this charge is excluded from the non-GAAP results are guidance.
ABBV submits NDA/MAA for Rinvoq in Crohn’s disease:
https://finance.yahoo.com/news/abbvie-submits-regulatory-applications-fda-124500484.html
ABBV submits Qulipta sNDA for prevention of chronic migraine:
https://finance.yahoo.com/news/abbvie-submits-supplemental-drug-application-120000934.html
The FDA approved Qulipta for prevention of episodic migraine in Oct 2021 (#msg-166135709).
FDA approves Skyrizi for Crohn’s disease:
https://finance.yahoo.com/news/skyrizi-risankizumab-rzaa-receives-fda-120000225.html
Didn't expect that. Bailed and wiped out most of last months ABBV flip gains. That's how it goes sometimes. :)
ABBV 1Q22 results:
https://news.abbvie.com/news/press-releases/abbvie-reports-first-quarter-2022-financial-results.htm
Non-GAAP EPS has been lowered by $0.08 due to a FASB accounting change re in-process R&D (i.e. accounting for acquisitions). The new range is $13.92-14.12.
Or perhaps we are done correcting? :) Earning coming soon.
Thanks DewDilligence, you are most likely right about Androgel, but I found it odd that they had a 48 month estimated completion for their trial though having 60 month time frame. At the very least the estimated completion date should have been June 2023. Though the time to Major Adverse Cardiac Event is the primary outcome and they are looking a cardiovascular a nd prostate cancer safety. The trial is also looking at other indications including: sexual activity, depression, bone fractures and anemia diabetes.
As for Libigel, there appears to be more to the story. As you stated it did fail to show efficacy for HSDD due to a large placebo effect. But the larger safety trial was also measuring efficacy and had a surgically menopausal population similar in size to the total of the two pivotal efficacy trials. They efficacy her was being measured in similar method used in the Intrinsa trials. The results form this trial have yet to be released. Secondary outcomes for this trial were never disclosed, as well.
It is true that ABBT/ABBV have never publicly owned or expressed an interest in female testosterone. However, I and a few others can attest to the fact that Dr. Michael Snabes' Linkedin profile, at one time, stated that he worked for AbbVie as early as January 2013 while working for Biosante at the same time. His linked in work history now reads as if there was no overlap, with him starting at AbbVie in April 2013.
Additionally up until, ATRS was issued a patent for using Testosterone to treat HSDD, ABBT was seeking a similar patent.
Dr. Snabes discovered that Libigel reduced Cardiovascular events over placebo ( never publicly disclosed). It appears that Libigel safety/efficacy trial or at least the observation of the 3,656 participants went beyond the December 2012 completion date. This became evident on December 19, 2015, when during the patent prosecution for reducing cardiovascular events (Dr. Snabes as inventor) they added the claim that restoring testosterone also reduced breast cancer events. In September 2012, the reduction in breast cancer events by restoring testosterone was not present. Interestingly, the support for the claim that it reduced cardiovascular events is well documented in the specifications of their patent application, but there is no such support for the breast cancer reduction claim. If ANIP had continued the work to make such a claim they would likely provided the supportive information to their claim in the specifications document accessible through the Public Pair. It also would have shown up in their R&D expenses as ANIP is a smaller company and it would be hard to hide the expenses related the follow-up of the participants.
According to the American Heart Journal article titled "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder" which also credits Dr Snabes.
Androgel is now available as a generic, so ABBV no longer has an incentive to promote it.
Libigel (which was never owned by ABT/ABBV) failed to show efficacy way back in 2011 (#msg-69947013, #msg-69947600).
Question for the board, is AbbVie interested in being the leader in male and female testosterone restoration and advancing the benefits beyond hypogonadism?
I see that AbbVie was the primary sponsor for the clinal trial titled A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE) which was estimated to have 6,000 participants and a study time frame to completion of approx. 60 months. However, when first posted they had an estimated completion of 48 month completion Start date May 2018 and completion June 2022. Additionally the stopped recruiting at with 5,246 participants.
It appears they were more concerned to meeting their original completion date of June 2022, than getting 6,000 participants.
Then I see that after 9 years of dormancy, the clinical trial titled Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM), involving 3,656 postmenopausal women at an elevated risk of cardiovascular events, was updated on October 27, 2021 by submitted a Certification/Extension request to delay submission of results. As it currently stands there us no obligation to submit results as the primary completion date was well before January 18, 2017 when the Final Rule for submitting results applied. It is more likely an NDA has been file or in the works, where a Certification request would be required. Arguably AbbVie would be best positioned to submit the NDA, as the Study Director, Dr Michael Snabes is now a Senior Medical Director , AbbVie Global Clinical Research and Development. In this trial he discover that restoring Testosterone reduced the risk of cardiovascular events by at least 70% over expected outcomes and by an undisclosed percentage over placebo. Additionally, by December 2015, it was discovered that it reduced breast cancer events over expected events and over placebo. None of this information has been made public other than in patent application and subsequent.
If AbbVie were intent on advancing the benefits of testosterone restoration, there is a 700,000 participant trial titled Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes due to be completed in November 2022, which could drive interest in the potential benefit of testosterone restoration.
Wondering if it is another tool in countering LOE for Humira.
Good luck to all.
Up too fast perhaps. Maybe a new 120 base?
ABBV’s #2 executive, Mike Severino, is leaving to become CEO of a biotech startup:
https://www.sec.gov/ix?doc=/Archives/edgar/data/1551152/000110465922045308/tm2212581d1_8k.htm
Wow a $13 mil buy @ end of day. :)
FDA approves Rinvoq for second-line ulcerative colitis:
https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-fda-approval-212900389.html
The 45mg dose is approved for (8-week) UC induction therapy, and the 15mg dose is approved for UC maintenance, with 30mg allowed for those with severe disease.
Rinvoq is also FDA-approved for RA and psoriatic arthritis (15mg dose) and for atopic dermatitis (15mg and 30mg), all in the second-line setting.
Recent investor. Looks like a safer long term than most of my purchases. :) I usually do penny's.
ABBV reports positive Qulipta phase-3 in prevention of chronic migraine:
https://finance.yahoo.com/news/abbvie-announces-positive-phase-3-131500532.html
The current Qulipta label is for prevention of episodic migraine, a less severe form of the condition.
Alvotech settles Humira-US-patent litigation with ABBV:
https://finance.yahoo.com/news/abbvie-resolves-humira-adalimumab-u-213200516.html
Alvotech (which is trading as OACB until the SPAC merger closes) can launch its Humira biosimilar on 7/1/23 if it has received FDA approval by then.
ABBV has now settled its US patent litigation with all Humira-biosimilar companies, as far as I know.
Skyrizi PDUFA date for Crohn’s disease extended three months due to additional data submitted by ABBV during the BLA review:
https://finance.yahoo.com/news/abbvie-provides-regarding-skyrizi-risankizumab-211500107.html
Looking Great!
ABBV
FDA approves Rinvoq for second-line atopic dermatitis:
https://finance.yahoo.com/news/u-fda-approves-rinvoq-upadacitinib-181000896.html
The approval includes both dose strengths (15mg and 30mg qD).
ABBV JPM slide set:
https://investors.abbvie.com/static-files/6eaf137c-4bee-4a5d-8047-33b9f299382d
FDA approves Rinvoq for second-line psoriatic arthritis:
https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-u-fda-231800396.html
The second-line restriction (following TNF-a treatment in the first line) is a consequence of the label changes for JAK inhibitors generally in inflammatory diseases (#msg-167001417).
Summary of Rinvoq indications in US and EU:
Rinvoq hits_primary/secondary_endpoints_in phase-3 trial_in_second-line Crohn’s disease:
https://finance.yahoo.com/news/upadacitinib-rinvoq-achieved-primary-key-133000723.html
Detailed results will be presented at an unspecified medical conference. A second phase-3 Rinvoq trial in Crohn’s has yet to read out.
JAK inhibitors—including ABBV’s Rinvoq and PFE’s Xeljanz—have new FDA labels that relegate these agents to the second-line setting in RA (and other inflammatory diseases) following unsuccessful treatment with a TNFa agent (such as Humira); today’s label changes are in addition to the safety warnings added to the JAK labels three months ago (#msg-165728499).
ABBV’s PR:
https://finance.yahoo.com/news/abbvie-provides-rinvoq-upadacitinib-treatment-211500945.html
Please see #msg-165728499 for related info.
Note: BMY’s TYK2 inhibitor, Deucravacitinib is not affected by the above changes because the FDA considers TYK2 a different drug class from JAK.
Whatever happened to Michael Jordan drug free commercials?...Stop it...Get some Help!
ABBV
Also the confusion of what is a real 'chemical imbalance' vs normal adolescence= disconnect in families we see today... adds to the problem.. how are kids turning into hypochondriacs at 12?Whenever you see families let's say at a restaurant, or any public place where they have downtime, kids these days are all over their tablets, smart phones, whatever tech they can get their hands on. Glued to it like life support. Zero positive interaction/influence. The easiest way to handle someone's mood that you don't understand is simply, put em on meds. I have seen this countless times now where parents insist their kid has emotion problems. Now your 12 year old is used to taking emotional numbing medication instead of vitamins, fresh air and sunlight. The gates are now opened to stronger meds with a generation being created that cannot handle daily problems without altering their state of mind...if they have kids, will they break the cycle? Unlikely. Now the problem of opioid addiction grows even more and at an accelerated rate. The only obvious answer is to take pharma's to court?... there should be campaigns for the greater good that emphasize Get Outside And Play Sports! That would do more than a $50B lawsuit which won't disperse any of the winnings to fight the problem that they decided to chase down in the first place.
Jmo.
ABBV
Exactly. You'd be surprised how many peeps would have just sold those extra pills to an addict at a random bus stop or a disturbed teenager. That adds to the problem much more than these pharma's selling the product after its been 'FDA' approved.
ABBV
Just to be clear, some doctors share the blame. They tend to overprescribe pain killing opioids. As an example, when I had knee replacement surgery I got a prescription fot 60 tablets of Oxycodone. I was understandably wary of taking too much of it. I ended up taking only two of them, and after that, found the pain manageable with acetominophen only. I can see how some might become addicted if they believed such a high number of pills was necessary. I guess different people have wide variance in pain tolerance.
Never understood how marketing campaigns can be linked to addiction. Only one that gets you addicted is YOU. Everyone trying to pin the blame on others. Let's take McDonald's to court for the rise in obesity then? Pfft
Tentative but the right step.
https://www.fiercepharma.com/pharma/johnson-johnson-abbvie-teva-and-endo-score-industry-s-first-opioid-trial-win
ABBV
And divi's still going strong! ITS A BUY!
ABBV
FDA approves ABBV’s Vuity—(pilocarpine eye drops)—for presbyopia:
https://finance.yahoo.com/news/u-food-drug-administration-approves-213100317.html
The drug works by narrowing the pupil, which improves near focusing. It takes effect in 15 minutes and continues working for approximately 6 hours. The purpose is to avoid having to use reading glasses. I project modest sales.
The drug itself is an old generic, but the formulation is new:
ABBV 3Q21 results:
https://news.abbvie.com/news/press-releases/abbvie-reports-third-quarter-2021-financial-results.htm
Please see #msg-166561607 for info on Botox, specifically.
You beat me to it. Still a great buy plus divi's.
ABBV
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