MERCK MSD (drug EIDD-2801/MK-4482 Ridgeback Biotherapeutics, MK7110, vaccine V590 PHAC, V591 Themis, Bill & Melinda Gates Foundation, CEPI, BARDA)

(May 12, 2020) Federal Whistleblower Says Boss Pushed Him to Purchase Drugs That Hadn’t Been Tested in Humans
In November, Rick Bright, then head of the Biomedical Advanced Research and Development Authority (BARDA), was asked to spend millions of taxpayer dollars purchasing a drug
that was presented as a “miracle cure” for viral diseases. But as Bright detailed in a whistleblower complaint filed last week,
he didn’t think that BARDA should purchase the drug, known as EIDD-2801. Bright had reason to worry that EIDD-2801 might be dangerous.
The antiviral hadn’t undergone basic safety testing in humans,
as is typically required of drugs that BARDA purchases.
And similar drugs in the same class had caused serious reproductive problems in animals,
with animals exposed in the womb born without teeth and with partially formed skulls.
Central to Bright’s whistleblower complaint is Robert Kadlec,
the assistant secretary for disaster preparedness, who proved to be a major obstacle in Bright’s efforts to ramp up the production of N95 masks.
..
The problem partly stemmed from long-simmering tensions between Bright and Kadlec.
According to the complaint, since he was appointed by President Donald Trump in 2017,
Kadlec had repeatedly pushed Bright to award government contracts to politically connected companies,
including one tied to Trump’s son-in-law Jared Kushner.
Prior to that, Kadlec had served on the staff of Sen. Richard Burr, R-N.C.,
who is now best known for dumping his stocks while assuring the public about the coronavirus.

(May 5, 2020) An emerging antiviral takes aim at COVID-19
In late 2019, Painter got a contract from the National Institute of Allergy and Infectious Diseases
to move EIDD-2801 into Phase I clinical trials for influenza.
The plan was to file an investigational new drug application and find a partner to help with the clinical work.
Just as the team was contemplating its next move, word of a virus spreading in Wuhan, China, was starting to make news.
One of Painter’s collaborators, UNC coronavirus expert Ralph Baric,
immediately alerted him that the new pathogen was probably a coronavirus—one
that EIDD-2801 could potentially combat.

(May 26, 2020) Merck inks Themis buyout to join COVID-19 vaccine race
Merck (known as MSD outside the United States and Canada) has struck a deal to buy Themis to accelerate the development
of a COVID-19 vaccine. The takeover will see Merck, a latecomer to the response to SARS-CoV-2,
apply its vaccine capabilities to a candidate based on Themis’ measles vector platform
that is set to enter the clinic this year. Themis is developing a pipeline of vaccines
based on a measles virus vector platform it licensed from Institut Pasteur.
“Together with Institut Pasteur, we have worked on very closely related viruses
like SARS and MERS [and] demonstrated the platform is very useful in eliciting an immune response,”
Themis CEO Erich Tauber said. “We started [SARS-CoV-2] vector design in February.
We have started in vivo models ... and are now preparing for clinical trials.”
Merck is now set to apply its vaccine capabilities to the program.
The Big Pharma has a major human vaccine operation, which generated sales of $8.4 billion last year,
but it stayed on the sidelines in the early days of the pandemic as peers such as AstraZeneca, Pfizer and Sanofi placed bets on COVID-19 vaccine candidates.

(May 26, 2020) IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2
KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI,
a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration
to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology
that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans.
Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA),
part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services (HHS),
to provide initial funding support for this effort.

(July 2, 2020) Merck and Ridgeback Bio Announce Closing of Collaboration and Licensing Transaction
KENILWORTH, NJ & MIAMI, FL, USA I July 01, 2020 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics LP,
a biotechnology company experienced in anti-viral drug development, today announced that the U.S. Federal Trade Commission (FTC) granted early termination of the waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act. All closing requirements have been completed for the previously announced partnership transaction to advance the development of EIDD-2801,
an investigational orally-available antiviral agent currently in early clinical development for the treatment of patients with COVID-19.
Under the agreement, announced on May 26, 2020, Merck, through a subsidiary, has acquired exclusive worldwide rights to develop EIDD-2801
and related molecules in collaboration with Ridgeback.
Ridgeback will continue to fund and conduct multiple Ridgeback-sponsored Phase 1 and 2 trials and fund manufacturing campaigns for clinical supply.
Going forward, the parties will collaborate on clinical development for COVID-19 and manufacturing, to be led by Merck.

(July 21, 2020) Merck taps contract research firm IRBM for peptides to hit back at pandemic virus
Big Pharma Merck has been pretty quiet on its R&D for COVID-19, but while keen to keep hype to a minimum,
its research work in the background has been growing. Over the past few months, it has penned a series of partnerships,
deals and a buyout with Themis, Ridgeback Bio and the International AIDS Vaccine Initiative (IAVI), with all three focusing on both vaccines and treatments.
Now, it’s striking another new deal but being characteristically quiet about it: In a brief release, and declining an interview with Fierce Biotech,
the pharma has teamed up with Italian biopharma services company IRBM
to “identify and develop novel peptide therapeutics active against different strains of coronavirus, including SARS-CoV-2,” the virus causing COVID-19.
But why peptides in the fight against coronavirus?

(July 31, 2020) Merck to start ‘pivotal’ study of controversial remdesivir alternative in September
The drug is known as MK-4482, and it’s being developed with Ridgeback Biotherapeutics.
The report notes that Merck doesn’t want to “dribble out data” on the drug’s performance
in Phase 2 trials, according to Perlmutter. That’s certainly strange.
MK-4482 was the most advanced COVID-19 therapy from Merck,
per a C&EN report in late May. But MK-4482 wasn’t always known as, well, MK-4482.
BioSpace says the antiviral candidate was known as EIDD-2801 before being renamed under Merck.
CNBC makes no mention of the compound’s controversial history.
Emory University licensed it to Ridgeback, which then partnered with Merck.

(August 4, 2020) Merck betting on ‘swish-and-swallow’ and single administration COVID vaccines
Merck & Co. (known as MSD outside North America) entered the battle against COVID-19 relatively late, inking a triumvirate of deals in May.
Two of the programs focused on vaccine development, one of which –
a collaboration with non-profit research organization IAVI
– is expected to begin clinical studies in the next few months.
The program, known as V590, is based on recombinant vesicular stomatitis virus (rVSV)
technology already proven in Merck’s Ebola Zaire virus vaccine, Ervebo (Ebola Zaire Vaccine, Live) – the first rVSV vaccine approved for use in humans.
If successful, V590 would require a single-dose, Perlmutter (president of Merck Research Laboratories) said,
an advantage also held by a second vaccine candidate born out of Merck’s acquisition of Themis during that deal-heavy May period.
V591 uses technology developed at the Institut Pasteur and licensed to Themis in 2010,
which is based on an attenuated measles vector delivering selected antigen preferentially to macrophages and dendritic cells.
It has been incorporated into vaccine development programs against infectious diseases including SARS, Chikungunya, MERS, and Lassa fever.

(October 22, 2020) IAVI, Merck KGaA, Darmstadt, Germany, and Serum Institute of India
Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
The International AIDS Vaccine Initiative (IAVI), a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges,
and Serum Institute of India Pvt. Ltd., a leading manufacturer of vaccines and biologics, announced an agreement with Merck KGaA, Darmstadt, Germany,
a leading science and technology company, to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs)
co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.
The agreement builds on the advanced antibody discovery
and optimization expertise of IAVI and Scripps Research,
gained from years of experience in HIV broadly neutralizing antibody research and development,
and on Merck KGaA, Darmstadt, Germany’s and Serum Institute’s significant capabilities in design and scale up of accelerated manufacturing processes for mAb production.
The global development plan is being led by the three organizations in partnership.

(October 23, 2020) 4D pharma to merge with special purpose acquisition company, Longevity Acquisition Corporation
4D pharma plc, a pharmaceutical company leading the development of live biotherapeutic products (LBPs),
and Longevity Acquisition Corporation, a NASDAQ-listed Special Purpose Acquisition Company (SPAC),
announce the proposed merger of the two companies. The deal is worth up to US$ 37.6 million to 4D pharma.
It is currently planned for the merger to be completed and effective in early 2021,
and 4D pharma ADSs will begin trading on NASDAQ immediately following completion.
4D pharma’s clinical programmes are targeting cancer, including a clinical collaboration with Merck & Co., respiratory diseases including COVID-19 and asthma,
gastrointestinal diseases, and pre-clinical programmes targeting neurological diseases such as Parkinson’s disease, and autoimmune diseases;
in addition, the company has a research collaboration with MSD (Merck & Co.) in the field of vaccines.

(October 31, 2020) Merck collaborates with Mammoth Biosciences for CRISPR-based SARS CoV-2 diagnostic test
Merck, a leading science and technology company, announced collaboration with Mammoth Biosciences,
for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test.
Mammoth’s high-throughput systems will be compatible with both nasal swab and saliva samples
and are targeting approximately 1,500 tests per 8-hour shift with minimal user interaction.
Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year.
The Life Science business of Merck will serve as the contract manufacturer of the DETECTR BOOST SARS-CoV-2 Reagent Kit,
which will use standard, automated liquid handling equipment to allow rapid processing of patient samples.

(December 2, 2020) Drugmaker Merck divests stake in vaccine-maker Moderna
U.S. drugmaker Merck & Co said on Wednesday it has sold its equity investment in Moderna Inc,
after benefiting from a surge in the stock price of the vaccine developer this year.
Merck did not disclose the details of the sale proceeds,
but said it expects to record a small gain from the sale in the fourth quarter of 2020.
Moderna's shares have risen more than seven-fold this year,
valuing the company at US$55.80 billion as of Tuesday's closing price.

(December 23, 2020) Merck to Deliver 100,000 Doses of COVID-19 Therapeutic
Merck announced it has entered into an agreement with the U.S. Government to support the development, manufacture, and initial distribution
of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization from the U.S. FDA.
Additionally, the Biomedical Advanced Research and Development Authority(BARDA) announced it will provide approximately $356 million
to Merck to deliver up to 100,000 doses of MK-7110 by June 30, 2021. BARDA part of the HHS Office of the Assistant Secretary for Preparedness and Response,
collaborated with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command (ACC-APG).
Merck acquired MK-7110 through the acquisition of New Jersey-based OncoImmune.

(This article was removed, now available on webarchive)

(January 6, 2021) Merck to repurpose four U.S. facilities for COVID-19 vaccine manufacturing
Under a new agreement between the U.S. Department of Health and Human Services (HHS) and Merck,
the company will expand domestic manufacturing capacity for COVID-19 vaccines by repurposing four of its existing facilities.
“This collaboration with Merck will help to ensure that the U.S. is prepared to scale up production not just for this pandemic but also for future pandemics and other public health emergencies.”
A $340 million agreement reached with the Biomedical Advanced Research and Development Authority (BARDA), a part of HHS, makes this possible.
In return, Merck will renovate and modify infrastructure to meet large-scale vaccine and therapeutic candidate manufacturing demands.
The new capacity should be operational within the first quarter of this year.

(January 9, 2021) Merck buys Hamburg-based mRNA CDMO, AmpTec
Merck, a leading science and technology company, announced the acquisition of AmpTec,
a leading Hamburg-based mRNA contract development and manufacturing organization (CDMO), Germany.
The agreement strengthens Merck's capabilities to develop and manufacture mRNAs for its customers for use in vaccines,
treatments, and diagnostics applicable to Covid-19 and many other diseases. Financial terms were not disclosed.

Merck's acquisition of AmpTec and its PCR technology leverages its extensive experience in lipid manufacturing,
enabling Merck to have a truly unique and comprehensive offering throughout the entire mRNA value chain,
reducing significantly increase the complexity of the supply chain and improve speed to market.
Lipids, which are part of the SAFC portfolio in Merck's life sciences business,
are one of the critical components for formulating mRNA therapies, including Covid-19 vaccines.

PCR technology is another important component of mRNA manufacturing. AmpTec uses a differentiated technology based on PCR for the manufacture of mRNA,
which has proven to have advantages over other manufacturing technologies such as advantages in homogeneity, purity, activity and flexibility,
higher quality and better performance and flexible cap addition options to meet specific performance requirements.
In addition to specializing in mRNA technology, AmpTec has a diagnostic business that focuses on producing custom long RNA and DNA for in vitro diagnostics.

(January 25, 2021) Merck's COVID-19 Vaccine Candidates Discountinued
New Jersey-based Merck (MSD) announced that the company is discontinuing
the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591.
This decision follows Merck’s review of findings from Phase 1
clinical studies for the vaccines, stated a Merck press statement.
Merck and its collaborators plan to submit the results of the Phase 1 studies for V590 and V591 for publication in a peer-reviewed journal.
precisionvaccinations.com/vaccine-breaking-news

(February 10, 2021) SARS-CoV-2 Infection Prevented and Treated in Human Lung Tissue Model
Now, scientists at UNC have found that the orally administered experimental drug EIDD-2801 (now known as molnupiravir or MK-4482)
halts SARS-CoV-2 replication and prevents infection of human cells in a new in vivo lab model containing human lung tissue.
Separate Phase II and III clinical trials are ongoing to evaluate molnupiravir safety in humans
and its effect on viral shedding in COVID-19 patients, and the first results could be released as early as March.
This work is published in Nature in the paper titled, “SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801.”
Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Therapeutics.

Mouse models can be useful in studying highly pathogenic human coronaviruses including SARS-CoV-2 and compounds that might control infection.
But human coronaviruses do not replicate in mice unless researchers alter the virus,
genetically modify the mice, or introduce the individual human receptor genes into mice so the virus can infect cells.
Such mouse models have added to the scientific community’s understanding of coronavirus infection and disease progression,
but none of these models possess the diverse human cells found in human lungs where viral infection can cause severe disease.

UNC scientists created a solution to this problem—a line of mice with human lung tissue
that includes all the primary human cells infected when individuals fall ill with COVID-19.
In this study, they used a single experimental platform based on human lung-only mice (LoM)
to demonstrate efficient in vivo replication of all recently emerged human coronaviruses
(SARS-CoV, MERS-CoV, and SARS-CoV-2) and two highly relevant endogenous pre-pandemic SARS-like bat coronaviruses.
genengnews.com/news/sars-cov-2-infection-prevented-and-treated-in-human-lung-tissue-model/

(February 8, 2021) Merck(KGaA) and BioNTech to boost lipid supply for Covid-19 vaccine production
Merck and BioNTech have announced a further expansion of their strategic partnership
to accelerate the supply of urgently needed lipids
and boost the amount of their delivery by the year-end.
The lipids will be used for producing the Pfizer and BioNTech Covid-19 vaccine (BNT162b2).
Lipids are vital to the drug delivery system of mRNA therapies to the body for a vaccine to be effective.
The Life Science business sector is currently backing more than 50 vaccine projects worldwide with products and technologies.
Furthermore, with its recently announced acquisition of AmpTec, Merck strengthened its capabilities and capacities for mRNA development and production.
pharmaceutical-technology.com/news/merck-biontech-lipid-supply/

(February 18, 2021) Gates, Merck and Novartis-backed Adjuvant Capital raises $300M for neglected diseases
A major group of pharma and charitable groups have joined forces to raise a $300 million venture round for Adjuvant Capital
as it goes after forgotten diseases across the globe. Those big names include Merck, Novartis, IFC, the Bill & Melinda Gates Foundation,
the Children's Investment Fund Foundation, Dalio Philanthropies, the Doris Duke Charitable Foundation, ELMA Investments Ltd., the Ford Foundation,
the MacArthur Foundation, Global Health Investment Corporation, CDC Group, Anthos Fund & Asset Management and others.
First launched back 2019, Adjuvant has already backed 14 companies developing technologies for high-impact
indications ranging from rare conditions such as melioidosis, a tropical flu-like illness, to widespread global emergencies such as COVID-19.
fiercebiotech.com/biotech/gates-merck-and-novartis-backed-adjuvant-capital-raises-300m-for-neglected-diseases

(March 3, 2021) Merck to support manufacturing of Johnson & Johnson’s Covid-19 vaccine
Merck (MSD) has signed an agreement with Janssen Pharmaceuticals (JPI),
one of the Janssen Pharmaceutical Companies of Johnson & Johnson,
to support the manufacturing and supply of its Covid-19 vaccine.
Merck’s US facilities will be utilised for the production of the drug substance,
as well as the formulation and filling of vaccine vials for the Johnson & Johnson vaccine.
Merck became the ninth manufacturer to be part of Johnson & Johnson’s global network,
with the latest manufacturing arrangement encouraging increase in the vaccine production capacity.
The company also entered an agreement with the US Biomedical Advanced Research and Development Authority (BARDA).
pharmaceutical-technology.com/news/merck-manufacturing-covid-19-vaccine/?utm_source=Army%20Technology&utm_medium=website&utm_campaign=Must%20Read&utm_content=Image

(April 27, 2021) MSD ties up with 5 Indian pharma majors for supply of oral COVID-19 drug Molnupiravir
MSD Pharmaceuticals Pvt. Ltd., a wholly-owned subsidiary of Merck Sharp & Dohme and known as Merck & Co., Inc.,
has entered into non-exclusive voluntary licensing agreements with five top Indian generic manufacturers for supply of molnupiravir,
an investigational oral antiviral agent currently being studied in a Phase-3 trial for the treatment of non-hospitalised patients with confirmed COVID-19, in India.
The agreements have been signed with Cipla Ltd., Dr. Reddy’s Laboratories, Emcure Pharmaceuticals Ltd., Hetero Labs Ltd. and Sun Pharmaceutical Industries Ltd.
Under the agreements, Merck & Co., Inc., U.S. will provide licenses to these manufacturers to supply molnupiravir to India.
thehindu.com/business/Industry/msd-ties-up-with-5-indian-pharma-majors-for-supply-of-oral-covid-19-drug-molnupiravir/article34422728.ece

Posted wrong date in article above, should be (January 15, 2015)

(June 11, 2021) U.S. federal government to acquire 1.7 million doses of Merck’s molnupiravir COVID-19 antiviral following FDA authorization
A new agreement struck between the Biden administration and Merck & Co. will provide the U.S. government with 1.7 million courses
of the company’s investigational COVID-19 antiviral treatment, molnupiravir (MK-4482 - EIDD-2801).
The Biomedical Advanced Research and Development Authority (BARDA),
Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND),
and Army Contracting Command will pay out $1.2 billion for the five-day treatment courses once FDA decides on them.
homelandprepnews.com/stories/69943-u-s-federal-government-to-acquire-1-7-million-doses-of-mercks-molnupiravir-covid-19-antiviral-following-fda-authorization/

Robert W Malone, MD
@RWMaloneMD (November 4, 2021)

The clinical trial has not been completed, but "Britain Is First Country To Approve Molnupiravir"
https://www.upi.com/Top_News/World-News/2021/11/04/uk-merck-covid-molnupiravir-approved/7421636026452/

twitter.com/RWMaloneMD/status/1456307032508751874