DewDiligence
1 day ago
ABBV reports 2Q24 results:
https://news.abbvie.com/2024-07-25-AbbVie-Reports-Second-Quarter-2024-Financial-Results
2Q24 sales were +6% YoY in constant currency. 2Q24 Humira sales were $2.81B, -30% YoY due to continued uptake of biosimilars in the US market. 2Q24 Skyrizi sales were $2.73B, +46% YoY. 2Q24 Rinvoq sales were $1.43B, +56% YoY. 2Q24 Botox sales (therapeutic + cosmetic) were $1.54B, +8% YoY.
New 2024 non-GAAP EPS guidance is $10.71-10.91, which includes a ($0.60) hit from IPR&D occurring in 1H24, of which the 2Q24 portion ($0.52) was not in the prior full-year 2024 guidance. The midpoint of the new guidance range ($10.81) is -3% from the actual $11.11 in 2023.
DewDiligence
1 month ago
FDA approves ABBV’s Skyrizi for first-line ulcerative colitis:
https://finance.yahoo.com/news/u-fda-approves-skyrizi-risankizumab-221800724.html
• Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND
• Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint
• SKYRIZI is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease ABBV’s Rinvoq, which is oral, is also approved in UC and Crohn’s disease following first-line treatment with a TNF-a agent such as Humira (#msg-171942039). Thus, Skyrizi and Rinvoq together give ABBV a bruising one-two punch in IBD, which accounts for about 40% of the overall market addressed by these agents (and Humira).
ABBV says Skyrizi and Rinvoq will have combined worldwide sales of $27B by 2027, several billion more than the peak annual sales attained by Humira.
DewDiligence
2 years ago
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): new risk minimisation measures, including dose modifications, due to the increased risk for serious cardiac events
This DHPC aims to inform healthcare professionals about an increased risk of fatal and serious cardiac arrhythmias and cardiac failure with the use of ibrutinib.
...Patients with advanced age, Eastern Cooperative Oncology Group (ECOG) performance status >-2, or cardiac co-morbidities may be at greater risk of cardiac events including sudden fatal cardiac events.
The PRAC advises that a clinical evaluation of cardiac history and function should be performed before starting a treatment with ibrutinib. In patients with risk factors for cardiac events, benefits and risks should be assessed before initiating treatment with the medicine and alternative treatment may be considered. Patients should be carefully monitored during treatment for signs of deterioration of cardiac function and be clinically managed.
Ibrutinib should be withheld for any new onset or worsening of grade 2 cardiac failure or grade 3 cardiac arrhythmias. Treatment may be resumed as per new dose modification recommendations.
The DHPC for Imbruvica will be forwarded to EMA’s human medicines committee (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the ‘Direct healthcare professional communications’ page and in national registers in EU Member States.Emphasis added.
TechandBio
2 years ago
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)
$ONCT
$ABBV