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10/2/21, 2:36 PM All You Need To Know About Merck's Covid Pill Molnupiravir - GreatGameIndia
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All You Need To Know About Merck’s Covid PillMolnupiravir
Molnupiravir was developed for the treatment of Influenza. According towhistleblower complaint Molnupiravir has mutagenic properties and may changeyour DNA. Now, Molnupiravir has been repurposed for COVID-19. Merck has enteredinto agreements with Indian manufacturers and has also announced $5 million ofdonations to enter into Indian market. Here is all you need to know about Merck’sCovid pill Molnupiravir.
Contents [hide]
1 Molnupiravir was developed for Influenza2 Molnupiravir may change your DNA3 Merck’s Covid Pill Molnupiravir4 Merck’s Molnupiravir agreements with India
Molnupiravir was developed for In�uenza
Molnupiravir (development codes MK-4482 and EIDD-2801) is an experimentalantiviral drug which is orally active and was developed for the treatment ofinfluenza.
October 2, 2021
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It is a prodrug of the synthetic nucleoside derivative N4-hydroxycytidine, and exertsits antiviral action through introduction of copying errors during viral RNAreplication.
The drug was developed at Emory University by the university’s drug innovationcompany, Drug Innovation Ventures at Emory (DRIVE).
It was then acquired by Miami-based company Ridgeback Biotherapeutics, who laterpartnered with Merck & Co. to develop the drug further.
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Molnupiravir may change your DNA
In April 2020, Rick Bright, who was removed as head of the Biomedical AdvancedResearch and Development Authority (BARDA) before the approval of the drug,submitted a whistleblower complaint asserting that Ridgeback pressured BARDA toprovide funding to manufacture EIDD-2801 despite Bright’s concerns that similardrugs in its class have mutagenic properties.
A previous company, Pharmasset, that had investigated the Molnupiravir’s activeingredient had abandoned it over similar concerns.
In genetics, a mutagen is a physical or chemical agent that permanently changesgenetic material, usually DNA, in an organism and thus increases the frequency ofmutations above the natural background level.
As many mutations can cause cancer, such mutagens are therefore carcinogens,although not all necessarily are. All mutagens have characteristic mutationalsignatures with some chemicals becoming mutagenic through cellular processes.
These claims were denied by George Painter, CEO of DRIVE, noting that toxicitystudies on Molnupiravir had been carried out and data provided to regulators in theUS and UK, who permitted safety studies in humans to move forward in the spring of2020.
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10/2/21, 2:36 PM All You Need To Know About Merck's Covid Pill Molnupiravir - GreatGameIndia
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At that time, DRIVE and Ridgeback Biotherapeutics stated they planned future safetystudies in animals.
Merck’s Covid Pill Molnupiravir
In late July 2020 Merck, which had been partnering with Ridgeback Biotherapeuticson developing the drug, announced its intention to move Molnupiravir to late stagetrials beginning in September 2020.
On October 19, 2020, Merck began a one year Stage 2/3 trial that focused onhospitalized patients.
In June 2021, the U.S. Department of Health and Human Services committed to buyUS$1.2 billion worth of molnupiravir (approximately 1.7 million courses) from Merckif it received an emergency use authorization (EUA) or approval from the U.S. Foodand Drug Administration (FDA).
On 1 October 2021, Merck stated that an independent advisory board that had beenmonitoring the COVID-19 clinical trial recommended that recruitment into the studybe stopped early because of convincing evidence of the drug’s benefits, reducing therisk of hospitalization or death by 48%.
Merck announced plans to seek an EUA from the FDA, and to submit marketingapplications to other global drug regulators. The company announced plans tolicense the drug to generic manufacturers, to accelerate its availability.
Merck’s Molnupiravir agreements with India
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10/2/21, 2:36 PM All You Need To Know About Merck's Covid Pill Molnupiravir - GreatGameIndia
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Merck has announced that the company has entered into non-exclusive voluntarylicensing agreements for Molnupiravir with five established Indian genericsmanufacturers.
Merck has entered into these agreements to accelerate availability of molnupiravir inIndia and in other low- and middle-income countries (LMICs) following approvals oremergency authorization by local regulatory agencies.
“The scale of human suffering in India at this moment is devastating, and it is clearthat more must be done to help alleviate it. These agreements, toward which wehave been working as we have been studying molnupiravir, will help to accelerateaccess to molnupiravir in India and around the world,” said Kenneth C. Frazier,chairman and CEO, Merck.
“We remain committed to aiding in the global response that will bring relief to thepeople of India and, ultimately, bring an end to the pandemic.”
The agreements have been signed with Cipla Limited, Dr. Reddy’s LaboratoriesLimited, Emcure Pharmaceuticals Limited, Hetero Labs Limited and SunPharmaceutical Industries Limited – five generics manufacturers with World HealthOrganization (WHO) Pre-Qualified Manufacturing facilities and experience as majorsuppliers to global and key LMIC procurers.
Under the agreements, Merck will provide licenses to these manufacturers to supplymolnupiravir to India and more than 100 LMICs. Merck is also in discussions with theMedicines Patent Pool to explore the potential for additional licenses.
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Separately, Merck will also donate more than $5 million worth of oxygen-productionequipment, masks, hand sanitizer and financial aid to support relief efforts in India.
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