Therapeutically administered ribonucleoside analogue MK-4482/EIDD-2801 blocks SARS-CoV-2…

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  • Bruno Canard sur le Molnupiravir | Médiapart | 30.10.2021

    https://www.mediapart.fr/journal/france/301021/gelule-contre-le-covid-19-attention-aux-effets-d-annonce-indesirables

    « En tant que médicament mutagène, le Molnupiravir pourrait créer des risques à long terme qui ne sont pas évalués aujourd’hui par manque de recul, comme le fait de modifier l’ADN, ce qui pourrait provoquer un cancer. »
    [...]
    « Le Molnupiravir est une molécule ancienne essayée dans l’espoir de traiter l’hépatite C, par exemple. Mais l’idée a été abandonnée du fait de sa toxicité, d’autant que pour cette maladie, le médicament doit être pris au long court. Néanmoins, c’est différent pour le Covid-19 puisque le traitement dure seulement quelques jours. »
    [...]
    « le Molnupiravir pourrait lui-même créer de nouveaux variants du Sars-CoV-2 »

    Canard connaît la molécule [que MSD a recyclée] depuis bien avant la pandémie, ainsi que ses effets indésirables possibles, soulignés dans une étude scientifique publiée le 2 août 2021.

    Olivier Véran s’est vanté dès le 26 octobre d’avoir précommandé de quoi soigner 50 000 Français avant même de connaître les résultats détaillés de l’essai clinique mené par MSD.

    Vendu 700 dollars par patient pour un coût de fabrication de 18 dollars.

    • [...]

      Olivier Véran s’est vanté dès le 26 octobre d’avoir précommandé de quoi soigner 50 000 Français avant même de connaître les résultats détaillés de l’essai clinique mené par MSD.

      Cette première précommande sera actée à condition que les autorités sanitaires françaises valident son intérêt thérapeutique. Les lots de gélules arriveraient alors « à compter des derniers jours de novembre ou des premiers jours de décembre, c’est-à-dire dès que les traitements sortiront des chaînes de production », a mis en avant Olivier Véran.

      Nationalisme sanitaire

      Le ministère de la santé refuse de communiquer à Mediapart le prix d’achat, mais le tarif américain donne un ordre d’idée de la grille tarifaire. Pourtant, il s’agit d’une molécule facile à fabriquer. Le coût de production est estimé à moins de 18 dollars pour chaque patient.

      Plutôt que de s’allier en priorité aux autres États européens dans la perspective d’une possible commande groupée qui permettrait aux pouvoirs publics de peser davantage dans les négociations face au laboratoire, l’exécutif français choisit d’abord de faire cavalier seul.

      Le nationalisme sanitaire reprend de la vigueur, au point que le ministère ne prévoit pas d’attendre le feu vert de l’Agence européenne des médicaments (AEM) pour distribuer le Molnupiravir en France. L’AEM a pourtant annoncé le 25 octobre le lancement de l’examen accéléré du dossier présenté par MSD.

      « Presser les agences sanitaires et faire comme si leur accord était un détail est un mauvais signal envoyé dans un contexte de défiance. Le gouvernement français cède encore une fois à l’approche marketing de l’industrie pharmaceutique et lui laisse dicter les stratégies de santé », tacle Pauline Londeix, cofondatrice de l’Observatoire de la transparence dans les politiques du médicament.

  • An effective new drug to treat covid-19 emerges from Merck | The Economist
    https://www.economist.com/business/2021/11/04/an-effective-new-drug-to-treat-covid-19-emerges-from-merck

    Thor, the Norse thunder-god, was reputed to carry a hammer known as Mjollnir—a tool for destroying enemies and blessing friends. The hammer has provided suitable inspiration for the name of a powerful new drug to fight covid-19: #molnupiravir. That drug has just been approved by Britain’s national medicines regulatory agency—the first in the world to do so. Molnupiravir, made by Merck, a big pharma firm, and a Florida-based biotech called Ridgeback Biotherapeutics, is the first oral antiviral medicine available to treat covid-19. The approval marks another milestone in the world’s fight against covid-19.

    Other countries are also working quickly to approve the new medicine, which has provoked keen interest. Last month the interim results of a trial found that patients with a risk factor for covid-19 were 50% less likely to be hospitalised or die if the oral antibiotic was taken in the first five days after symptoms. Britain has secured 480,000 courses of molnupiravir, and sales of the drug are already brisk. America, Australia, Britain, the Philippines, Indonesia, Japan, New Zealand, Malaysia, Thailand and Vietnam are some of the countries that have secured deals, or are in the process of doing so.

    #paywall

    • Forum Bourse VALNEVA - 04/11/2021 12:26:41 - molnupiravir - AMM provisoire au UK - Boursorama
      https://www.boursorama.com/bourse/forum/1rPVLA/detail/459289186

      04 nov. 2021•12:26
      La pilule a été homologuée pour les adultes de 18 ans et plus qui ont été testés positifs à la COVID-19 et qui présentent au moins un facteur de risque de développer une maladie grave, comme l’obésité ou une maladie cardiaque.

      Le molnupiravir est également en attente d’examen par les organismes de réglementation aux États-Unis, dans l’Union européenne et ailleurs. La Food and Drug Administration des États-Unis a annoncé le mois dernier qu’elle convoquerait un groupe d’experts indépendants pour examiner l’innocuité et l’efficacité de la pilule à la fin du mois de novembre.

      Les approvisionnements initiaux seront limités. Merck a déclaré qu’elle pouvait produire 10 millions de traitements jusqu’à la fin de l’année, mais une grande partie de cet approvisionnement a déjà été achetée par les gouvernements du monde entier.

    • An effective new drug to treat covid-19 emerges from Merck

      The Economist | 2021-11-04

      ~
      It hopes to make the drug available in poor countries as well as rich ones
      ~

      Thor, the Norse thunder-god, was reputed to carry a hammer known as Mjollnir—a tool for destroying enemies and blessing friends. The hammer has provided suitable inspiration for the name of a powerful new drug to fight covid-19: molnupiravir. That drug has just been approved by Britain’s national medicines regulatory agency—the first in the world to do so. Molnupiravir, made by Merck, a big pharma firm, and a Florida-based biotech called Ridgeback Biotherapeutics, is the first oral antiviral medicine available to treat covid-19. The approval marks another milestone in the world’s fight against covid-19.

      Other countries are also working quickly to approve the new medicine, which has provoked keen interest. Last month the interim results of a trial found that patients with a risk factor for covid-19 were 50% less likely to be hospitalised or die if the oral antibiotic was taken in the first five days after symptoms. Britain has secured 480,000 courses of molnupiravir, and sales of the drug are already brisk. America, Australia, Britain, the Philippines, Indonesia, Japan, New Zealand, Malaysia, Thailand and Vietnam are some of the countries that have secured deals, or are in the process of doing so.

      Demand is likely to be very high. The drug will be used to treat patients who have not been vaccinated, or who remain at high risk despite having had a jab. Doctors now have a medicine to offer those most at risk from covid, which patients can take at home. The drug is also expected to be affordable globally. It is expected that rich countries will pay $700 a course for the drug, but low-income ones will pay something closer to $20—and maybe less as time goes on.

      Given the difficulties that low- and middle-income countries have faced in obtaining vaccines this year, it is reasonable to wonder whether rich countries are going to hoard the supply of this new drug, or even prevent it from being exported from the countries in which it is made. That seems unlikely. Since the summer of last year when it bought the rights to the new molecule from Ridgeback, Merck has been looking for ways to make the drug widely available, such was its promise.

      Known then as EIDD-2801 the molecule had been shown to inhibit the replication of RNA viruses including SARS-CoV-2 but had not yet been through trials in humans to test its efficacy. As part of its covid-19 response, Merck chose to work on two vaccines and two drugs. With the exception of molnupiravir all its other products failed during development.

      Merck increased its own production and has licensed the drug to be made by others. It expects to produce 10m courses of treatment by the end of 2021 and hopes to be able to double manufacturing capacity next year. At the same time, five Indian manufacturers of low-cost generic drugs, including Cipla, Dr Reddy’s and Sun Pharmaceuticals have already signed deals to make generic versions of molnupiravir. Merck says it is also setting aside 3m courses of its own supply for low- and middle-income countries, to make sure not all early supplies are snaffled up by rich countries.

      Another notable move came on October 27th. Merck signed a voluntary licensing agreement with the Medicine Patent Pool—a United Nations-backed organisation that negotiates drug licences on behalf of less wealthy countries. The agreement will allow many more firms around the world to manufacture generic versions of molnupiravir. (One lesson of the pandemic has been the need to have a global manufacturing footprint.)

      Trevor Mundel, president of global health at the Gates Foundation, says that because many generic drug firms are waiting to gauge demand for molnupiravir in less wealthy countries, the foundation has made $120m available to get manufacturing going. This money will support guarantees to manufacturers that a certain volume of the new drug will be bought. The foundation says it is hoping to speed up production by generic manufacturers, some of which can make as many as 10m courses a month.

      In the past year firms such as Pfizer and Moderna have been criticised for the lack of global access to their vaccines and their unwillingness to share the know-how to make them. Will Merck get much thanks for all its generosity? Mr Mundel thinks the speed and global breadth of the launch of molnupiravir will be without precedent in history. If so, that will mark a high-water mark in global health. Not everyone is happy. Médecins Sans Frontières, a humanitarian charity, says the Merck licence from the MPP does not go far enough. James Love, director of Knowledge Ecology International, a “social justice” non-profit, disagrees, saying that the agreement goes further than any other company has done during the pandemic.

      Asked how much Merck had invested in its covid-19 research programme so far, the firm would only say “billions”. It is not likely to recoup this soon from low- and middle-income countries. There are also concerns about whether the drug will be safe for everyone to take. Its ability to cause mutations in viruses could also pose a risk to fetal development. Regulatory agencies may thus choose to limit the use of the drug to certain groups for these reasons. Nonetheless, countries struggling to beat down high numbers of covid hospitalisations and deaths, will find molnupiravir a powerful new hammer. ■

      Dig deeper

      All our stories relating to the pandemic can be found on our coronavirus hub [1]. You can also find trackers showing the global roll-out of vaccines [2], excess deaths by country [3] and the virus’s spread across Europe [4].

      [1] https://www.economist.com/news/2020/03/11/the-economists-coverage-of-the-coronavirus
      [2] https://www.economist.com/graphic-detail/tracking-coronavirus-across-the-world
      [3] https://www.economist.com/graphic-detail/coronavirus-excess-deaths-tracker
      [4] https://www.economist.com/graphic-detail/tracking-coronavirus-across-europe