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

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

Post by Abacus on Thu Dec 31, 2020 7:21 pm

(December 4, 1998) Merck And Schering License Adenoviral Product From IntroGene
Merck & Co. and Schering AG have signed licensing agreements with IntroGene,
a European gene therapy company, for IntroGene's PER.C6 adenoviral packaging cell line.
The companies will license the product in exchange for up-front fees,
annual payments and royalties on sales of adenoviral gene therapy products arising from the agreements.
Since its launch last year, IntroGene has already signed licensing agreements for PER.C6 with Genzyme Corp, Cobra Therapeutics (formerly Therexsys) and Rhone-Poulenc Rorer.

(December 27, 2006) Merck and Crucell Sign Cross-Licensing Vaccine Production Agreement
Merck gets exclusive rights to Crucell technology,
while Crucell obtains access to Merck’s manufacturing capabilities.
Crucell received access to Merck & Co.’s large-scale manufacturing technology for its AdVac®-based vaccines.
Also, as part of this cross-licensing agreement, Merck obtained the right to use Crucell technology
on an exclusive basis in additional undisclosed vaccine fields.

(February 23, 2012) Merck & Co. Licenses Protein Sciences’ Insect Cell Vaccine Production Platform
Merck & Co. negotiated nonexclusive rights to Protein Sciences’ expresSF+® serum-free insect cell line (SF+) and related technology for vaccine research,
and an exclusive license to use the overall PS platform for commercial production of a specific vaccine candidate.
Protein Sciences’ severe acute respiratory syndrome (SARS) candidate D3252 is expected to start in Phase I clinical development during 2012.

(November 26, 2014) Merck, NewLink Genetics Partner On Investigational Ebola Vaccine
Merck and NewLink Genetics Corporation have partnered to develop NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.
The companies announced the collaboration in a press release, stating that the vaccine was originally developed by the Public Health Agency of Canada (PHAC).
The rVSV-EBOV vaccine is currently licensed to a wholly-owned subsidiary of NewLink Genetics, while PHAC retains non-commercial rights.
Under the terms of the agreement between Merck and NewLink, Merck acquires the rights to the vaccine candidate and any follow-on products.
PHAC developed the vaccine with funding from the CBRN Research and Technology Initiative, part of Defense Research and Development Canada.
PHAC licensed the vaccine in 2010 to BioProtection Systems (BPS), a NewLink Genetics subsidiary.
BPS has developed the vaccine and moved it into Phase 1 studies at the Walter Reed Army Institute of Research.

The beginning of the discovery work on the rVSV-ZEBOV vaccine traces back to 1999
when the National Microbiology Laboratory (NML) in Winnipeg, Manitoba recruited Heinz Feldmann
from the University of Marburg to become chief of its special pathogens program.
With an exceptional background in hemorrhagic fever virus of the Filoviridae family,
within three years Feldmann and his colleagues developed an Ebola vaccine candidate: rVSV-ZEBOV10.
NML later became part of the Public Health Agency of Canada (PHAC).

(April 13, 2018) Merck and Oxford University announce vaccines partnership
Merck have announced a partnership with Oxford University’s Jenner Institute
to develop more robust and scalable vaccine manufacturing processes.
The aim of the partnership is to make vaccines more affordable and available globally.
Through the collaboration with the Jenner Institute, the partners
will improve the manufacturing process for adenovirus vaccines
(vaccines based on adenovirus, a type of DNA virus, as a carrier) on a real-world feed stream.
Adrian Hill, Director of the Jenner Institute at Oxford University said,
“The newly developed process should match or exceed our existing process in terms of productivity and purity.

(December 7, 2018) Janssen, Merck and GE Healthcare join forces in the UK
The Oxford Science Park (TOSP) is to house the Vaccines Manufacturing Innovation Centre (VMIC), the UK's first facility dedicated to the field.
Located on a new plot close to the Magdalen Centre, home to many SMEs, the £66m VMIC addresses the UK’s gap in late-stage vaccine manufacturing process development.
The VMIC is supported by pharma companies Janssen, part of Johnson & Johnson, and Merck.
Expertise and training in state-of-the-art manufacturing equipment will be provided by GE Healthcare.
The University of Oxford, Imperial College and the London School of Hygiene and Tropical Medicine
have established VMIC-UK to run the centre, which is expected to be up and running by the spring of 2022.
Led by the Jenner Institute, a partnership between the University of Oxford and the Pirbright Institute,
the new centre has been awarded funding by UK Research and Innovation (UKRI)
of £66 million through the UK government’s Industrial Strategy Challenge Fund (ISCF) Medicines Manufacturing challenge.

(August 22, 2019) Merck teams up with Themis to develop vaccines
Merck (known as MSD outside the United States and Canada) has struck a deal to work with Themis Bioscience on vaccine R&D.
The agreement sees Merck invest in Themis and commit up to $200 million (€180 million) in milestones to secure vaccines against an undisclosed target.
Using research funding from Merck, Themis will develop vaccine candidates against the target using its measles virus vector-based platform.
Themis licensed the measles vector from the Pasteur Institute
and has since worked to industrialize the production process,
giving it a platform it thinks can support an upcoming phase 3 trial
of its internal lead asset. The result is a setup Themis CEO Erich Tauber describes as a “true plug-and-play platform.”
The progress of Themis’ internal programs and its work with the Coalition for Epidemic Preparedness Innovations (CEPI)
have provided evidence of the company’s success in building on the licensed vector.

(September 18, 2019) Themis Raises EUR 40 Million in Series D Financing Round Backed by US/EU Consortium to Support Pivotal Study and Expand Clinical Pipeline
Themis announced today the closing of a Series D financing round totaling EUR 40 million (USD 44 million).
The round was co-led by new investors, Farallon Capital and Hadean Ventures.
MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) and Adjuvant Capital,
as well as current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences, also participated.
“The commitment from our new investors Farallon Capital, Adjuvant Capital and Hadean Ventures as well as MSD is a validation of Themis’
achievements and the potential of our platform. This round enables us to continue implementing our strategy to develop novel vaccines
and therapeutic candidates for numerous infectious diseases
and oncology indications,” said Erich Tauber, MD, CEO of Themis.
Farallon manages approximately US$ 28 billion in capital for institutions, including college endowments, charitable foundations, pension plans
and sovereign wealth funds, and for high net worth individuals. Farallon is headquartered in San Francisco and has offices in London, Singapore, Hong Kong, Tokyo and São Paulo.
Hadean Ventures is an Oslo and Stockholm-based life science fund manager that invests in life science companies across Europe
with a particular focus on under-ventured regions. Hadean’s funds are backed by leading European and US-based private and institutional investors.
Adjuvant is a New York-based life sciences fund built to accelerate the development of new technologies for the world’s most pressing public health challenges.
Backed by prominent investors such as the International Finance Corporation, Novartis, and the Bill & Melinda Gates Foundation

(October 8, 2019) 4D Pharma Collaborates With MSD to Develop Live Biotherapeutics for Vaccines
LEEDS, England, Oct. 8, 2019 /PRNewswire/ -- 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics,
today announces that the Company has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA,
to discover and develop Live Biotherapeutics ("LBPs") for vaccines.
Under the terms of the agreement 4D's proprietary MicroRx® platform
will be paired with MSD's expertise in the development and commercialisation of novel vaccines,
to discover and develop LBPs as vaccines in up to three undisclosed indications.


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

Post by Abacus on Thu Dec 31, 2020 7:29 pm

(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.


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

Post by Abacus on Thu Jan 07, 2021 4:59 pm

(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.


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

Post by Abacus on Sat Jan 09, 2021 9:59 pm

(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.


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