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MRK—Vaxneuvance sBLA for pediatrics gets 3-month extension to 7/1/22:
https://finance.yahoo.com/news/merck-provides-fda-review-supplemental-104500754.html
Vaxneuvance is 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).
p.s. 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).
FDA approves Keytruda monotherapy for recurrent endometrial cancer with MSI-H or dMMR:
https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-203000436.html
The approval is based on ORR from single-arm cohorts of the KEYNOTE-158 trial.
Note: Keytruda plus Lenvima is already FDA-approved in the same setting for patients without either MSI-H or dMMR.
Thanks DewDiligence. The reason I ask, is that after no trial updates since January 2013, on October 27, 2021, ANIP or an undisclosed partner filed a Clinical Trial Certification/Extension request for their 3,656 patient long-term safety/efficacy Libigel trial. A request to delay submitting results for up to 2 years or 30 days after approval. Though it does not specify if it was a Certification or Extension request, a Certification is usually submitted in relation to filing an NDA.
Certification/Extension Submission
In looking at the study design, the trial was completed on December 2012 (pre-commercialization part of the study). However even the if full trial was completed in August 2016, as listed in the clinical trial history (full safety/efficacy study including post approval observations), there is no obligation to submit results, let alone make request for a delay in submitting results, unless they have or were about to file an NDA.
History of Change Comparison
Then Ms. Elizabeth Powell joined the Rare Disease Business Unit at ANI as Chief Compliance Officer and Head of Legal, Rare Disease in February 2022, assuming responsibility for the Legal and Compliance functions. For the past 24 years, Ms. Powell worked at Merck & Co., Inc., where she was responsible for strategic counsel related to commercial, compliance and FDA regulatory issues, and most recently served as Managing Counsel and Executive Director, U.S. Commercial & Compliance Legal.
Ironically, ANIP advanced their Annual Stockholder meeting from June 2, 2021 to April 27, 2022, which is exactly 6 months after they submitted their Certification/Extension request. It makes me wonder if ANIP or more likely a partner filed an NDA and got a 6-month Priority Review for Libigel.
To date ANIP has never publicly released that Libigel reduced Cardiovascular events in post menopausal women at risk of cardiovascular events by at least 70% (discovered in 2011 or earlier) and they never announced the that it reduced Breast Cancer events by an undisclosed amount (discovered in December 2015 or sooner). Both discoveries are only publicly available in patent applications and related prosecutions.
I realize Merck is facing an LOE for Januvia and Janumet in 2022 (China and EU) and January 2023 (US) and wondered if they are looking to Libigel to offset some of the losses. It would be the first FDA approved female testosterone drug with an instant market in replacing existing off label and compounded testosterone, currently being prescribed.
It appears to fit Merck's criteria for acquisition and partnership
- Fills an unmet need.
- Looking at their R&D and Products page, it appears to fit into at least two of their Areas of Focus, Cardio-metabolic disorders and Oncology.
Areas of Focus
If Merck is interested in female testosterone the Global Consensus Position Statement on the Use of Testosterone Therapy for Women will help in marketing it out of the gate.
The following are some indications that the Position Statement identified as needing more information before making recommendations:
- Cognitive performance, or to delay cognitive decline, in postmenopausal women.
- Impact of testosterone treatment on musculoskeletal tissues
- Prevention of breast cancer (Libigel trial appears to answer this)
- Cardiovascular safety in women at risk (Libigel trial appears to answer this and indicates prevention capbilities).
It creates an R&D roadmap, with the potential of female testosterone eventually becoming a franchise drug with multiple indications.
FYI the patient population from the of the Libigel safety/efficacy trial included postmenopausal women suffering from the following.
- Hypertension
- Dyslipidemia
- Diabetes mellitus
It also included smokers.
It may all be coincidences, but evidence supporting an NDA filing, Ms. Powell coming over ANIP after 24 years with Merck, the Areas of Focus for Merck that Libigel addresses and the Pipeline Page's Key Therapeutic Ares having an empty Women's Health box, left me wondering if as you stated was a clerical error. Or, if Merck and ANIP have entered into a yet to be disclosed partnership.
Keep up the good work DewDilligence.
Keytruda monotherapy-vs-placebo DFS HR=0.76 in adjuvant* NSCLC, irrespective of PD-L1 status, in phase-3 KEYNOTE-091 trial:
https://www.businesswire.com/news/home/20220317005084/en
Although the DFS endpoint was statig, the effect size was so-so (HR=0.76). The statsig outcome was reported on 1/10/22 (https://www.merck.com/news/mercks-keytruda-pembrolizumab-showed-statistically-significant-improvement-in-disease-free-survival-versus-placebo-as-adjuvant-treatment-for-patients-with-stage-ib-iiia-non-small-cell/ ), but the details were not disclosed until today.
Curiously, in the pre-specified subgroup with PD-L1>=50%, Keytruda’s DFS compared to placebo had a non-statsig HR=0.82—a worse result than in the overall trial.
The HR for OS, a secondary endpoint that is not yet mature, was 0.87.
All told, this is not a great dataset, IMO, but it may be enough for FDA approval. These data may put Keytruda at a competitive disadvantage to Tecentriq and Opdivo in early-stage NSCLC.
*Stage 1b-IIIa.
That’s a clerical error.
Upon looking at Merck's Pipeline webpage I see that Women's Health is included in their Therapeutic Key Areas, yet when you look at Phase two, Phase 3 and Under Review Sections there are no products in this category.
https://www.merck.com/research-and-products/product-pipeline/
I thought they spun off Women's Health into Organon.
Is this a precursor for an expansion into select women's health products?
COVID SCAM IS OVER... ALL THESE GRIFTER COMPANIES PROFITING OFF BS WILL END PAYING A HEAVY PRICE!!!!!!!
MRK 4Q21 results:
https://finance.yahoo.com/news/merck-announces-fourth-quarter-full-113000870.html
2022 non-GAAP EPS guidance is $7.12-7.27.
BIG PHARMA INCLUDING MERCK IN TROUBLE WITH NEW PATENT FREE ***TRADITIONAL*** COVID VACCINE!!!!!
New Patent-Free COVID-19 Vaccine Developed in Texas
A new patent-free COVID-19 vaccine is being offered to vaccine manufacturers across the world thanks to researchers from the Texas Children’s Hospital and Baylor College of Medicine.
The vaccine, called Corbevax, is based on traditional protein-based technology that has been used safely for decades, according to New Atlas. Similar to the other available COVID-19 vaccines, this one focuses on coronavirus spike protein, but instead of using mRNA to direct our cells to produce those spike proteins, it delivers lab-grown spike proteins to the body.
Researchers took the gene that codes for the spike protein and engineered yeast to produce it. The proteins are collected, purified and combined with an adjuvant to enhance immune responses.
“Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world,” Maria Elena Bottazzi, one of the project’s lead researchers, said.
In late 2020, the team developing the vaccine teamed up with India-based Biological E to begin clinical trials and establish manufacturing capacity. Those trials, in 2021, included thousands of participants and found the vaccine to be safe and effective.
Antibody responses to Corbevax indicate the vaccine should be at least 80 percent effective at preventing symptomatic COVID-19 from the delta variant. Data corresponding to the omicron variant is expected soon.
The vaccine has been developed as a patent-free product that can easily be manufactured around the world. One of the researchers leading the project, Peter Hotez, described it as a “gift to the world.”
“This announcement is an important first step in vaccinating the world and halting the pandemic,” Hotez said. “Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low – and middle-income countries face against the delta variant.”
India Won't Add Merck's COVID-19 Pill To National Treatment Protocol, Citing Safety Concerns
India’s top health research body announced on Wednesday that it won’t be adding Merck’s COVID-19 antiviral pill molnupiravir to its national treatment protocol, citing concerns over its safety.
The state-run Indian Council of Medical Research (ICMR) said it had become aware of “major safety concerns” that prompted the decision, despite India’s drug regulator in December approving the drug for emergency use.
It comes after France in December also canceled its order for the drug, developed by Merck and Ridgeback Biotherapeutics, following disappointing trial data suggesting its drug was markedly less effective than previously thought.
“Molnupiravir has major safety concerns including teratogenicity, mutagenicity, muscle and bone damage. If this drug is given, contraception must be done for three months as the child may have problems,” ICMR Director-General Balram Bhargava told local media on Wednesday.
Bhargava noted that the United States Food and Drug Administration (FDA) issued an emergency use authorization for Merck’s COVID-19 pill based on 1,433 patients with a 3 percent reduction in moderate disease when given in mild cases.
Members of the FDA’s Antimicrobial Drugs Advisory Committee in November voted 13 for and 10 against the emergency use authorization for molnupiravir, agreeing with the idea that the drug’s benefits outweigh its potential risks, including concerns about potential birth defects.
However, “we must remember that this drug has major safety concerns,” Bhargava said, adding that the drug causes teratogenicity, or the ability to cause defects in a developing fetus, mutagenicity, or permanent transmissible changes in the structure of genetic material of cells, cartilage damage, and can also be damaging to muscles.
Moreover, Bhargava said contraception would also have to be given to individuals who take the drug—regardless of whether they are male or female— because “the child born could be problematic with teratogenic influences.”
“The WHO has not included it, the UK has not included it as of now. As of now, the current recommendation stands that it is not part of the national taskforce treatment,” Bhargava said.
However, Bhargava said that experts will continue to discuss the potential use of the treatment in the country, where virus case numbers are currently surging.
Molnupiravir is intended for use at home by adults with mild to moderate COVID-19 who are at high risk of developing severe disease. The drug is taken orally in pill form, twice a day for five days, within five days of symptoms onset.
Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy. Company studies in rats showed that the drug caused birth defects when given at very high doses. FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”
Merck says that there is “no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
Around 13 Indian companies, including Cipla, Sun Pharma, and BDR, are manufacturing molnupiravir.
Indian multinational pharmaceutical company Dr. Reddy’s Laboratories was set to roll out a generic version of the oral antiviral medication starting from next week at an extremely affordable treatment rate of 1,400 rupees ($18.84), 37 times cheaper than in the United States.
The Epoch Times has contacted Dr. Reddy’s Laboratories and Merck for comment.
BIG PHARMA RELYING UPON FRAUDULENT COVID-19 PCR TESTING TO CREALE A FALSE SCAMDEMIC FOR ITS DRUGS IS NOT A SOUND BUSINESS MODEL.
STOP THE TESING FRAUD AND ALL OF A SUDDEN THERE IS NO FAKE MARKET TO SELL TO.
THIS EXPLAINS WHY MERCK AND OTHER BIG PHARMA COMPANIESS ARE GOING DOWN!!!!!
A LOT MORE SELLING AHEAD!!!!!
MERCK IS LATE TO THE PARTY, WITHOUT 94% FALSE POSITIVE PCR TESTING THERE IS NO PANDEMIC, SO NOW THERE IS NO REASON FOR COVID-19 VACCINES OR PILLS. THE WHOLE SCAMDEMIC IS UNRAVELLING!!!!
MRK UNDER PRESSURE!!!
ISN'T IT INTERESTING HOW BIG PHARMA IS TAKING A HIT NOW THAT PCR TESTING IS NO LONGER APPROVED FOR COVID-19 TESTING.
MRK GOING LOWER!!!!!
FDA grants EUA for MRK’s Molnupiravir—with_a_major_limitation:
https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-for-treatment-of-covid-19-in-certain-adults-301450419.html
Merck’s New Covid Pill Is a Disaster
STORY AT-A-GLANCE
- An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — by a narrow 13-to-10 margin
- Among those who received the drug, the rate of all-cause hospitalization or death was 6.8%, compared to 9.7% in the placebo group — a relative risk reduction of just 30%
- The full data showed more hospital admissions among patients taking molnupiravir (6.2%) than among those taking a placebo (4.7%)
- Molnupiravir works by triggering mutations that ultimately kill the virus; a risk of cancer and birth defects is possible, and the drug shouldn’t be taken by pregnant or breastfeeding women or children
- By driving mutations but not killing off all of the virus — such as if people don’t take the full course of the drug — new and deadlier variants could be unleashed across the globe
- The U.S. government is already on the hook for about 3.1 million courses of molnupiravir, which it bought for approximately $2.2 billion
https://freedomfirstnetwork.com/2021/12/mercks-new-covid-pill-is-a-disaster
Any time I see the term "PCR-confirmed Covid cases" I stop reading!
A study published this week by researchers at the University of Hong Kong’s Faculty of Medicine said that the omicron variant replicates 70 times faster in human airways than delta, but infection in the lungs appears to be less severe compared with the original virus strain.
I call BS! 70X is mass cell destruction! Should be worse a whole lot quicker! Well at least in the countries that don't use Ivermectin.
https://www.cnbc.com/2021/12/17/no-evidence-that-covid-omicron-variant-less-severe-than-delta-uk-study.html
Bah... what's a little cancer or a bunch of birth defects!
This is about MONEY!
Clearly the FDA needs to be purged... follow the money!
NY Times Casually Admits New FDA-Approved Merck COVID Drug Might Actually Mutate Healthy Human DNA by Accident and Impact Male Fertility.
In normal times, in a normal world, this news might make headlines.
But in 2020 during the Big Pharma bonanza pandemic, it’s stuffed at the bottom of the New York Times article.
The new Merck drug molnupiravir was approved two weeks ago by the Food and Drug Administration. The “expert” committee narrowly voted to recommend authorizing the drug.
But hidden towards the bottom of the article you learn molnupiravir might actually mutate healthy DNC by accident.
How serious a problem is that?
A team of researchers at the University of North Carolina studied the use of molnupiravir in isolated hamster cells over 32 days and found that the drug did induce mutations in DNA.
Those mutations could “contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells,” the authors of that study wrote.
The drug targets only dividing cells, which are relatively sparse in an adult. That poses a narrower risk than other mutagens, like radiation, which can damage DNA in all types of cells.
Still, Ronald Swanstrom, an HIV researcher at the University of North Carolina at Chapel Hill who helped lead the hamster cell study, said that adults had enough dividing cells — in bones, for example, and in the lining of the gut — to cause concern. He also noted that men were constantly making dividing sperm cells that could carry potential mutations.
Oh, and it could affect men wanting to become fathers.
The FDA advisers also noted that the risks could extend to other patients, including men wanting to become fathers, though those risks remain poorly understood and Merck said its own studies had turned up no evidence that the drug causes DNA mutations.
Re: MRK’s Islatravir safety
From 11/23/21 post (#msg-166887916):
FDA places clinical hold on all Islatravir studies:
https://finance.yahoo.com/news/merck-announces-clinical-holds-studies-220000979.html
Just ship the Ivermectin and we can all get back to our normal lives!
FDA approves Keytruda monotherapy in adjuvant melanoma:
https://www.businesswire.com/news/home/20211203005607/en
The adjuvant setting is slowly but surely becoming an important revenue source for checkpoint inhibitors.
Vaxneuvance pediatric sBLA has 4/1/22 PDUFA (with FDA priority review):
https://finance.yahoo.com/news/u-fda-accepts-priority-review-114500858.html
I sure wouldn't... and will discourage everyone I know to stick with safe and proven drugs!
It was a close vote. I doubt many people will actually use the drug.
FDA advisers vote to recommend emergency use authorization of Merck's pill to treat Covid-19
Re: Observed fall-off in Molnupiravir efficacy
From #msg-166912284 (posted last week):
Merck's COVID-19 pill significantly less effective in new analysis
Nov 26 (Reuters) - Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck's drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc's trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.
Merck's shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency's staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.
EASIER TREATMENT
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck's is designed to introduce errors into the genetic code of the virus. Pfizer's drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.
Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.
The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also had to use birth control.
Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
FDA approves Keytruda monotherapy in adjuvant RCC:
https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-114500052.html
Guilt by association!
FDA to meet with MRK for its COVID antiviral pill, on 11-30-21 --
The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-30-2021-antimicrobial-drugs-advisory-committee-meeting-announcement-11302021-11302021
AS I SAID BEFORE "Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't."
SHAME ON MERCK FOR PUSHING THIS DANGEROUS DRUG ON THE UNSUSPECTING PUBLIC!!!!
MRK IS GOING LOWER.... A LOT LOWER!!!!
SELL BEFORE ITS TOO LATE!!!!
Was there news that caused that drop?
I had a TON of puts that would have expired worthless today!
Largest % gain of the year for me!
Awaiting the SEC's letter asking me to explain my trade...
I bailed @ 89 but hope to grab again some day. :)
TIMMMMMBBBBBBEEEEEERRRRRRR!!!!!!!!
<THUD>
Thanks for the tip.
Sure... who cares about cancers... THERE IS MONEY TO BE MADE!
Huge uptrend this week going into earnings….. they have a lot working for them and with another variant, the pill will get fast tracked
It's going to be tough for MRK to garner much market share in this market (#msg-166441220).
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