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Merck To Double Production Of 'Breakthrough' COVID Drug As Nations Line Up To Buy

Merck To Double Production Of 'Breakthrough' COVID Drug As Nations Line Up To Buy

Despite safety concerns raised by multiple scientists, Merck is signing deals with countries left and right for its new COVID therapeutic, molnupiravir, as the pharmaceutical giant is already planning to double production of the drug in 2022 as experts expect it to face the same kind of early-days gold rush that greeted approval of the initial COVID jabs.




Merck said it aimed to increase its own production from 10m courses of the drug this year to at least 20m in 2022, which is equivalent to 800m tablets.



But it could provide no guidance on the likely production schedule or pricing for generic manufacturers, which will largely be responsible for supplying developing nations with the treatments.



“We are doing these special purchase agreements as a sort of initial way to get therapy to people as quickly as possible in certain countries and there’s a large number of them that we’re working through,” said Nicholas Kartsonis, Merck’s senior vice-president of clinical research. “But I don’t want to underestimate the second tier of this, which is trying to get to as many people around the world as we can.”




As it submits its data to the FDA for approval (the agency now faces a difficult decision to balance potentially harmful side effects like cancer and birth defects with the drug's ability to cut hospitalization and death rates in half), Merck has signed deals with New Zealand, Singapore, Australia and South Korea in just the past week, and it's already in talks with other countries (the US has already agreed to buy more than a million courses).





While Merck prepares for molnupiravir to be one of the most lucrative drugs of all time, the firm has signed deals with 8 generic manufacturers to accelerate production of the drug.



While Merck will likely be first to market with a COVID anti-viral that can be taken in pill form, the competition is already ramping up.



AstraZeneca, which produced a COVID jab in partnership with Oxford that was later found to have dangerous side effects, announced on Monday that its COVID antibody cocktail also halves the risk of severe disease or death in vulnerable patients. It has also sought emergency authorization for its drug, called AZD7442.



So far, the only COVID therapeutics approved outside hospital settings in the US are monoclonal antibodies developed by Regeneron, Eli Lilly and GlaxoSmithKline, all of which require intravenous infusions. They haven't shown anywhere near the efficacy that molnupiravir has. But while health experts praised molnupiravir as a helpful treatment, they warned that there are drawbacks.




Health experts say the antiviral pill could become an important tool in the battle against the virus, as it can easily be taken at home. But some have expressed concerns over safety, efficacy and access issues.



"Molnupiravir is a welcome advance and could save hundreds of lives in the fight against Covid-19," said David Dowdy, associate professor of epidemiology at Johns Hopkins University school of medicine.



"But it still isn’t a perfect cure...and it depends on people receiving the medicine early enough for it to be helpful," he said.




Unlike mRNA vaccines, which target the spike protein that helps COVID bind to human cells, molnupiravir acts on the virus’s RNA genetic material and effectively throws a wrench in the works of the virus's reproductive code, stopping it in its tracks. However, some scientists have raised concerns that the drug might have serious, even deadly, side effects, even though Merck insists it has done animal trials that show no examples of these types of ill effects.



"Proceed with caution at your own peril, said one scientist who studied the primary ingredient in molnupiravir. Another warned that "biochemistry won't lie": "there is a concern that this will cause long-term mutation effects, even cancer."



 



Tyler Durden
Tue, 10/12/2021 - 10:45