Merck and Co Inc (MRK) オプション

Merck wins Gardasil litigation over cancer vaccine risks

On Tuesday, Merck & Co (NYSE:MRK) Inc. emerged victorious in a significant legal dispute concerning its Gardasil vaccine, which is designed to prevent cervical and other serious cancers. U.S. District Judge Kenneth Bell, presiding in Charlotte, North Carolina, dismissed more than 200 cases that were part of a consolidated multidistrict litigation.

The plaintiffs in the litigation had accused Merck (NSE:PROR) of failing to warn about potential side effects of Gardasil, specifically an increase in heart rate and ovarian issues. They contended that these warnings should have been included on the vaccine’s labels. However, Judge Bell determined that under federal law, Merck did not have the power to independently add warnings about such risks without more substantial evidence.

In his decision, Bell emphasized the importance of not deterring the use of vaccines that save lives with warnings that are not well-supported by evidence. He stated that federal law demands more than "speculative inferences" before imposing severe warnings on vaccines, which could potentially dissuade people from using them.

Merck responded to the ruling with approval, stating that they were "extremely pleased" with the outcome. The decision effectively resolves a large group of claims that had been brought against the pharmaceutical company regarding its Gardasil vaccine.

This ruling supports the position that vaccine manufacturers are not responsible for independently updating warnings on their products without the explicit direction of the Food and Drug Administration or a solid foundation of scientific proof. The dismissal of the cases underscores the legal protections in place for vaccine makers, especially when the allegations are not substantiated by robust scientific data.

SPECULATION OF ALL CANCER NATIONS BREAKTHROUGH DECLARED

Cancer breakthrough in the clinic broski Rnaz https://www.eurekalert.org/news-releases/1055915

Picked up a few hundred shares today

MRK 2Q24 results:

https://www.businesswire.com/news/home/20240730509685/en

MRK’s RSV prophylactic, Clesrovimab meets_all_endpoints_in_phase-2/3_trial:

https://www.businesswire.com/news/home/20240723229019/en

If approved, Clesrovimab will compete against GSK’s Beyfortus.

Beyfortus and Clesrovimab are effective at preventing RSV for one season, but they do not confer lasting immunity. Patients taking these drugs are likely to contract RSV infection in a subsequent season, and hence the need for RSV treatments, such as those being developed by ENTA, is not diminished.

MRK is doing really well. Wish I invested two years ago. Personalized Immunotherapy is going to be a huge thing very soon. So maybe it's not too late.

ACIP endorses MRK’s Capvaxive pneumococcal vaccine for certain groups—creating parity with PFE’s Prevnar-13 for adult market:

https://www.businesswire.com/news/home/20240627540619/en
• Adults 65 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

• Adults 19-64 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown;

• Adults 19 years of age and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) [PFE’s Prevnar-13] but have not received all recommended PPSV23 [MRK’s Pneumovax]…;

• Additionally, shared clinical decision-making is recommended regarding use of a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 [Prevnar-13] and PPSV23 [Pneumovax]. These ACIP recommendations are essentially the same as the CDC’s existing recommendations for PFE’s Prevnar-20, and hence they should allow MRK’s Capvaxive to gain a meaningful share in the adult portion of the pneumococcal vaccine market. PFE has had an overwhelming (>90%) share of this market in the US because MRK’s other conjugated pneumococcal vaccine, Vaxneuvance, received a less favorable recommendation from the CDC than PFE’s Prevnar-13.

Please see #msg-166441188 and #msg-172452293 for related info.

FDA approves MRK’s Capvaxive—(f/k/a V116)—pneumococcal vaccine for adults:

https://www.businesswire.com/news/home/20240614126575/en

With this approval, MRK should finally get a decent share of the market for adult pneumococcal vaccines, where PFE’s Prevnar franchise has long been dominant.

Please see #msg-173458310 and #msg-172452293 for related info.

https://www.sciencetimes.com/articles/50071/20240508/anavex-life-sciences-alzheimers-treatment-brings-hope-to-millions.htm

https://www.onclive.com/view/pembrolizumab-plus-concurrent-crt-meets-os-end-point-in-high-risk-locally-advanced-cervical-cancer

KEYTRUDA plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind Phase 3 trial

https://www.biospace.com/article/releases/merck-s-keytruda-pembrolizumab-plus-chemoradiotherapy-crt-significantly-improved-overall-survival-os-versus-crt-alone-in-patients-with-newly-diagnosed-high-risk-locally-advanced-cervical-cancer/?keywords=pancreatic+cancer+phase+3

MRK new 52 week high

Bought 11% of EVAX

Why Red fonts?

MRK reports 2Q23 results…

PR:
https://www.businesswire.com/news/home/20230801830764/en

Reuters:
https://finance.yahoo.com/news/1-merck-beats-quarterly-sales-104937970.html Merck & Co raised its full-year revenue forecast on Tuesday as second-quarter sales of its top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil, sailed past Wall Street estimates.

Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion.

…Sales of Gardasil…surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. MRK sharply lowered 2023 non-GAAP EPS guidance due to a $10.2B charge ($4.02/sh) relating to in-process R&D from the acquisition of RXDX (#msg-171696785). The new guidance range is $2.95-3.05.

MRK’s V116 shows non-inferiority to Prevnar-20 in two phase-3 trials (one for pneumococcal-vaccine naïve patients and one for patients who received a prior pneumococcal vaccine):

https://www.businesswire.com/news/home/20230727120762/en

V116 is a 21-valent pneumococcal vaccine intended for the adult market only. PFE’s Prevnar-20 currently owns virtually the entire adult market for pneumococcal vaccines because CDC/ACIP’s recommendations give preferential treatment to Prevnar-20 vs MRK’s 15-valent V114 (a/k/a Vaxneuvance) (#msg-166441188).

The V116 results announced today put MRK back in the ballgame for the adult segment of the market.

See #msg-168548763 for related info.

MRK sues US over IRA drug-price “negotiation”:

https://www.wsj.com/articles/merck-challenges-u-s-governments-new-powers-to-negotiate-drug-prices-127d4b0c Drugmaker Merck & Co. filed a lawsuit on Tuesday challenging the U.S. government’s plan to negotiate drug prices, saying it is unconstitutional.

Drugmakers were expected to file lawsuits challenging the program, especially as Medicare neared the date later this year when it began naming some drugs it would target for price negotiations.

Among the drugs that analysts expected to face price negotiations are Merck’s top-selling product, the cancer immunotherapy Keytruda.

Merck’s complaint takes issue with the negotiation program’s enforcement rules, which include the power to levy an excise tax of up to 95% of a drug’s U.S. sales if a pharmaceutical company refuses to sell the drug to Medicare patients. Merck said the tax would be coercive and violate the constitution’s Fifth Amendment ban on private property being taken for public use without just compensation. [The so-called “takings” clause.]

Merck also said the law would force companies to agree that the government-mandated prices are “fair,” violating its free speech rights under the First Amendment. For biotech investors, there’s a lot riding on the outcome of this lawsuit and related cases.

Want more details? See https://www.cms.gov/files/document/medicare-drug-price-negotiation-program-initial-guidance.pdf (91 pages).

MRK’s ASCO lineup:

https://finance.yahoo.com/news/merck-present-extensive-research-demonstrating-104500565.html

MRK reports 1Q23 results—raises non-GAAP EPS guidance:

https://finance.yahoo.com/news/merck-announces-first-quarter-2023-103000788.html

https://finance.yahoo.com/news/merck-earnings-better-expected-keytruda-103855413.html

2023 non-GAAP EPS guidance was raised to $6.88-7.00 (from $6.80-6.95).

MRK acquires RXDX for $10.8B…

PR:
https://www.merck.com/news/merck-strengthens-immunology-pipeline-with-acquisition-of-prometheus-biosciences-inc/

CC slides:
https://s21.q4cdn.com/488056881/files/doc_presentations/2023/04/Acquisition-of-Prometheus-Biosciences-Investor-Event-Slides-FINAL.pdf

A Delaware judge ruled today that MRK remains liable for talc lawsuits relating to Dr. Scholl’s foot powder, even though MRK sold its OTC- healthcare business to Bayer in 2014:

https://finance.yahoo.com/news/bayer-defeats-merck-lawsuit-over-215120183.html

MRK inherited Dr. Scholl’s in the 2009 takeover of Schering-Plough.

Keytruda shows statsig-superior PFS as addend to chemo in Stage-III/IV (or recurrent) endometrial cancer:

https://www.businesswire.com/news/home/20230327005147/en

The HR for PFS was 0.54 in the pMMR subgroup and 0.30(!) in the dMMR subgroup.

The OS results are not disclosed in the PR, so they are presumably not mature. (OS was a secondary endpoint.)

EMA rejects MRK’s MAA for Molnipiravir:

https://www.businesswire.com/news/home/20230223006077/en Merck and Ridgeback Biotherapeutics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for LAGEVRIO (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion. The appeal would seem to be fruitless. Molnupiravir is simply a bad drug that doesn’t deserve (non-emergency) marketing authorization.

MRK 4Q22 results—2023 guidance:

https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Merck-News-Release-02-02-23-Merck-Announces-4Q-and-FY-2022-Financial-Results.pdf

2023 guidance for non-GAAP EPS is $6.80-6.95; at the midpoint, this is an 8% decline from 2022’s $7.48.

CC slides:
https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Q4-2022-Merck-Earnings-Deck-(Final).pdf

Prepared remarks:
https://s21.q4cdn.com/488056881/files/doc_financials/2022/q4/Q4-2022-Merck-Earnings-Prepared-Remarks-(Final).pdf

FDA approves Keytruda for adjuvant NSCLC following adjuvant treatment with platinum chemo:

https://www.businesswire.com/news/home/20230127005078/en

Keytruda’s HR for DFS (compared to placebo) was 0.73 [95% CI: 0.60-0.89]. This is slightly better than the HR=0.76 that MRK reported when the KEYNOTE-091 trial reported in Mar 2022 (#msg-168241140); I do not know the reason for the discrepancy.

Curiously, in an exploratory analysis of patients (n=167) who did not receive adjuvant chemo, Keytruda’s HR for DFS (relative to placebo) was 1.25 (i.e. the Keytruda arm did worse than placebo), but the 95% confidence interval was wide [0.76-2.05].

That would be the best , most productive purchase they could ever make , but Merck mgt is too stupid. They try to build equivalent to DCVax with every asinine purchase they make. Maybe a new mgt team at Merck with common sense, would get DCVax , the most incredible advancement in GBM and immunology in history.

Keytruda fails again in prostate cancer—one of the few cancer indications where it has not seen a positive outcome:

https://www.businesswire.com/news/home/20230124006084/en/Merck-Announces-KEYNOTE-991-Trial-Evaluating-KEYTRUDA%C2%AE-pembrolizumab-Plus-Enzalutamide-and-Androgen-Deprivation-Therapy-in-Patients-With-Metastatic-Hormone-Sensitive-Prostate-Cancer-to-Stop-for-Futility Merck…today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA…in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

…At the interim analysis, KEYTRUDA in combination with enzalutamide [Xtandi] and ADT did not demonstrate an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT. This is Keytruda’s third recent phase-3 in prostate cancer. In the KEYNOTE-921 trial, which reported results in Aug 2021, Keytruda failed to show a statsig benefit when added to chemo in CRPC (#msg-169574792). In the KEYLINK-010 study, which reported results in Mar 2022, the combination of Keytruda and Lynparza (a PARP inhibitor) failed to show a statisig benefit compared to Xtandi or Zytiga in mCPRC refractory to chemo and either of Xtandi or Zytiga (https://www.clinicaltrials.gov/ct2/show/NCT03834519 ).

Keytruda is a great drug, but it’s not invincible.

Why

The MRK-SGEN deal reputed to be nearly done last summer (#msg-169332904) can probably be dismissed after MRK’s ADC collaboration with China’s Kelun-Biotech today:

https://finance.yahoo.com/news/merck-kelun-biotech-announce-exclusive-114500834.html

MRK/MRNA cancer vaccine shines in adjuvant melanoma (RFS HR=0.56):

https://www.accesswire.com/731571/Moderna-and-Merck-Announce-mRNA-4157V940-an-Investigational-Personalized-mRNA-Cancer-Vaccine-in-Combination-with-KEYTRUDAR-pembrolizumab-Met-Primary-Efficacy-Endpoint-in-Phase-2b-KEYNOTE-942-Trial …the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA…demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection.

Adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p-value=0.0266) compared with KEYTRUDA alone. Note: If this had been a phase-3 trial, it would’ve been considered a failure since the standard cutoff for a one-sided p-value is 0.025. For a phase-2b, however, these results are just fine.

MRK acquires IMGO for $36.00/sh cash—a 107% premium to Friday’s close:

https://finance.yahoo.com/news/merck-acquire-imago-biosciences-inc-114500059.html

The nominal deal value is $1.35B. The buyout price is a 125% premium to IMGO’s IPO price 16 months ago (#msg-164945919).

I would take the other side of that bet!

Ehhhhh seems a lot more likely today

Unlikely, haha.

NWBO next purchase of Merck?

MRK 3Q22 CC slides:

https://s21.q4cdn.com/488056881/files/doc_financials/2022/q3/Q3-2022-Merck-Earnings-Deck-(Final).pdf

MRK 3Q22 results:

https://finance.yahoo.com/news/merck-announces-third-quarter-2022-103000305.html

MRK exercises option_to_commercialize MRNA cancer vaccine:

https://www.accesswire.com/720004/Merck-and-Moderna-Announce-Exercise-of-Option-by-Merck-for-Joint-Development-and-Commercialization-of-Investigational-Personalized-Cancer-Vaccine

https://finance.yahoo.com/news/1-merck-opts-jointly-develop-113551661.html

MRNA receives $250M in immediate cash from MRK’s opt-in.

Sotatercept phase-3 in PAH hits primary endpoint:

https://finance.yahoo.com/news/merck-announces-positive-top-line-104500840.html

Sotatercept is the drug MRK picked up in the $11.5B XLRN acquisitions last year (#msg-166156870).

Lagevrio misses_primary_endpoint_in_large_Oxford_U_trial:

https://ca.finance.yahoo.com/news/merck-ridgeback-biotherapeutics-clinical-non-235000071.html The PANORAMIC study, a UK-based clinical trial sponsored by the University of Oxford, included 25,783 participants who were randomized to open label treatment with LAGEVRIO plus usual care (n=12,821) or usual care alone (n=12,962); mean age of participants was 56.6 years. Primary outcome data were available in 25,000 (97%) participants. Nearly all (>98%) participants were vaccinated, with approximately 95% receiving three or more doses of a SARS-CoV-2 vaccine.

In the preliminary analysis, the primary endpoint of reduction of hospitalizations and deaths within 28 days of randomization, compared to usual care, was not met; 0.8% of patients in both the LAGEVRIO group (n=103/12,516) and the usual care group (n=96/12,484) were hospitalized or died in the first 28 days. Separately, in a retrospective study based on electronic medical records of high-risk patients in Israel, Lagevrio showed a benefit in reducing hospitalizations and death in the patients age 65+ but not in patients age 40-64.

Bottom line: Legevrio (molnupiravir) remains a poor choice for treating COVID. It is being prescribed only when Paxlovid is either unavailable or contra-indicated due to drug-drug interactions (from ritonavir).

FDA allows some Islatravir trials to_resume_at_a lower dose:

https://finance.yahoo.com/news/merck-initiate-phase-3-clinical-104500524.html

Keytruda narrowly_misses_statsig OS/PFS as_addend_to Lenvina in_ first-line HCC:

https://finance.yahoo.com/news/merck-eisai-present-results-phase-063000955.html

In the final analysis of the trial, there was a trend toward improvement for one of the study’s dual primary endpoints, overall survival (OS), for patients treated with KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (HR=0.84 [95% CI: 0.71-1.00]; p=0.0227). The median OS was 21.2 months (95% CI: 19.0-23.6) for KEYTRUDA plus LENVIMA and 19.0 months (95% CI: 17.2-21.7) for LENVIMA monotherapy.

Additionally, treatment with KEYTRUDA plus LENVIMA resulted in a trend toward improvement in the trial’s other dual primary endpoint of progression-free survival (PFS) versus LENVIMA monotherapy; however, the results did not meet the pre-specified threshold at the first interim analysis for statistical significance (HR=0.87 [95% CI: 0.73-1.02]; p=0.0466). These results were presented at ESMO.

Merck snatched up ROR1 veslobio for 2.75 Billion I think they may try and Buy ONCT better acting drug partnered with ABBV ibrutinib the combo works 50% better than the drug alone. Pcyc ibrutinib now ABBV is going to do 9.5-10 Billion in sales next year. I think Merck might buy ONCT more data further along in trials very robust pipeline. ROR1 expression on many tumor types
• Potential safety and efficacy advantages
• MK-2140 ADC data at ASH 2021: no apparent off-
tumor, on-target ROR1 toxicities.
ROR1 Expressed on Multiple
Solid and Liquid Tumor's
MCL 95%
CLL 95%
Uterus 96%
Lymphoma 90%
Prostate 90%
Skin 89%
Insiders have been buying it up just broke the 50 day moving average. I think Merck might come in to add to there Ror1 portfolio.
https://www.fiercebiotech.com/biotech/boehringer-inks-1-5b-nbe-buyout-joining-merck-ror1-adc-race

$MRK

Keytruda fails phase-3 in CRPC:

https://www.businesswire.com/news/home/20220803005334/en Merck…today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. Keytruda will soon overtake Humira as the biggest-selling non-COVID drug from any company; however, it is not invincible.

FDA approves MRK’s pneumococcal vaccine, Vaxneuvance for infants/children:

https://finance.yahoo.com/news/u-fda-approves-merck-vaxneuvance-104500312.html

Vaxneuvance was already FDA-approved for adults (#msg-164961310), but I don’t think Vaxneuvance will compete effectively with PFE’s Prevnar-20, which has broader coverage of pneumococcal serotypes and a simpler (one-shot) treatment course (#msg-166441188).

PFE's Prevnar-20 is FDA approved for adults, but is not yet approved for infants/children, so MRK does have a head start in the pediatric market.

MRK pays PFE a royalty of 7.25% on worldwide Vaxneuvance sales during 2022-2026 and a 2.5% royalty during 2027-2035 (#msg-166075692).

WHAT ARE YOU TALKING ABOUT??? COVID-19 IS JUST RENAMED INFLUENZA.... ITS A TOTAL SCAM!!!!!

BIG PHARMA ARE CRIMINALS DUPING THE PUBLIC!!!!!!!!

ENOUGH WITH THE MINDLESS HYSTERIA ALREADY!!!!!!!

Pay attention, looks like we have a change in the last immune escape variants. They may have also become more heat tolerant, or more stupid monkeys are hanging out with eachother. Uptick in Delta.


Don't forget to order your Ivermectin while everyone is distracted by idiot Joe.

MRK slides from ASCO webcast:

https://s21.q4cdn.com/488056881/files/doc_events/2022/06/ASCO-2022-Slide-Presentation-Final.pdf

Synopsis of (anti-LAG-3) favezelimab data from ASCO abstract:

https://www.biopharmadive.com/news/asco-merck-favezelimab-lag3-hodgkin-trial/624457/

Favezelimab might eventually compete with BMY’s Opdualag (#msg-168259768), but it has a long way to go.

Please see #msg-168259803 and https://twitter.com/DewDiligence/status/1395141087413538822 for related info.