Molnupiravir, the only oral anti-viral for Covid, was initially developed by Prof Richard K Plemper (Georgia, Atlanta, USA) now has been licensed to Merck and Emergency Use Approval has been requested from the FDA..
Merck has announced that they will share the formulation enabling 105 developing nations to produce at low cost. Generic drug makers in developing countries are expected to market the drug for as little as $20 per treatment (a 5-day course), compared to the $712 per course that the U.S. government has agreed to pay for its initial purchase. Merck has already negotiated with 8 large drug manufacturers in India. Indian drug makers are restricted in selling it to developed countries & also excludes most middle-income countries, including China and Russia. Also in the exclusion list, countries like Chile, Colombia, Thailand & Mexico. Maybe this will be addressed hopefully.
The WHO welcomed the voluntary licensing agreement by the Medicines Patent Pool (MPP) and MSD to facilitate affordable access to Molnupiravir. They also stated
"We commend MPP for negotiating the licence from a public health perspective – in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles, it is non-exclusive and transparent. We urge the manufacturer to provide data of clinical trials to WHO as soon as possible, so that the agency can evaluate the medicine for global use."
PS: Now to the drug itself. Previously on another thread I noted that this will probably not approved for pregnant mothers. Molnupiravir is a nucleoside analogue N4-hydroxycytidine (NHC). Once it gets incorporated to RNA, the NHC gets recogniszd either as a C or a U by the polymerase. Thus many mutations are introduced into the viral genome, causing lethal mutagenesis and inhibition of infectivity. In simple terms the drug causes the virus to mutate lethally.
Molnupiravir targets the Covid virus RNA-dependent RNA polymerase (RdRp), which mediates replication and transcription of the coronavirus genome. Viral RdRps are proven effective targets for inhibition, with several licensed nucleoside analogs that are used therapeutically. Even Remdesivir targets the RdRp. Additionally Molnupiravir is resistant to the proofreading exoribonuclease encoded by coronaviruses. This makes it more suitable.
But there is a concern, because NHC has the distinct ability of causing mutations in cell DNA. The worry is that such mutations could lead to cancer or birth defects in a developing human foetus. Whether or not Molnupiravir might cause cancer in humans is not known for certain but a lot of tests have been conducted and many more will be done. None of these results are published in the public domain but surely these gets submitted to the FDA.
Merck has announced that they will share the formulation enabling 105 developing nations to produce at low cost. Generic drug makers in developing countries are expected to market the drug for as little as $20 per treatment (a 5-day course), compared to the $712 per course that the U.S. government has agreed to pay for its initial purchase. Merck has already negotiated with 8 large drug manufacturers in India. Indian drug makers are restricted in selling it to developed countries & also excludes most middle-income countries, including China and Russia. Also in the exclusion list, countries like Chile, Colombia, Thailand & Mexico. Maybe this will be addressed hopefully.
The WHO welcomed the voluntary licensing agreement by the Medicines Patent Pool (MPP) and MSD to facilitate affordable access to Molnupiravir. They also stated
"We commend MPP for negotiating the licence from a public health perspective – in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles, it is non-exclusive and transparent. We urge the manufacturer to provide data of clinical trials to WHO as soon as possible, so that the agency can evaluate the medicine for global use."
PS: Now to the drug itself. Previously on another thread I noted that this will probably not approved for pregnant mothers. Molnupiravir is a nucleoside analogue N4-hydroxycytidine (NHC). Once it gets incorporated to RNA, the NHC gets recogniszd either as a C or a U by the polymerase. Thus many mutations are introduced into the viral genome, causing lethal mutagenesis and inhibition of infectivity. In simple terms the drug causes the virus to mutate lethally.
Molnupiravir targets the Covid virus RNA-dependent RNA polymerase (RdRp), which mediates replication and transcription of the coronavirus genome. Viral RdRps are proven effective targets for inhibition, with several licensed nucleoside analogs that are used therapeutically. Even Remdesivir targets the RdRp. Additionally Molnupiravir is resistant to the proofreading exoribonuclease encoded by coronaviruses. This makes it more suitable.
But there is a concern, because NHC has the distinct ability of causing mutations in cell DNA. The worry is that such mutations could lead to cancer or birth defects in a developing human foetus. Whether or not Molnupiravir might cause cancer in humans is not known for certain but a lot of tests have been conducted and many more will be done. None of these results are published in the public domain but surely these gets submitted to the FDA.
