© Reuters
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The American pharmaceutical giant Merck (Co) has announced that it has an experimental antiviral pill capable of reducing the risk of death or hospitalization of those most at risk of developing an acute form of COVID-19. Experts assess the initial data as a potential breakthrough in the way coronavirus is treated.
If authorized by regulators, molnupiravir may be the first oral antiviral drug against COVID-19. The company and its partner Ridgeback Biotherapeutics have announced plans to apply for registration of the drug with the Federal Food and Drug Administration (FDA) as soon as possible.
According to the news, Moderna shares lost 15% of their value on Friday morning or $ 22 billion from the company’s market share. At the end of the day the loss was 10% of the price and these were the weakest shares in the S&P index, which otherwise reported a slight increase of 0.1%. Shares of BioNTech and Novavax (its vaccine has not yet been approved in the United States) depreciated by 13% and 18%, which is another $ 12 billion market estimate. Even Pfizer and Johnson & Johnson, which are far more independent of the vaccine market, lost up to 3% in the morning. At the same time, Merck’s shares rose 9%, adding $ 18 billion to its capital valuation.
Pfizer, Roche and Atea Pharmaceuticals are also testing a similar drug. Comments on Merck’s experimental product are encouraging. According to Amesh Adalja of the Johns Hopkins University Center for Health Security, an oral medication “can change the risk of hospitalization to such an extent that it changes the rules of the game.”
Products such as redmesivir and the generic steroid dexamethasone are only given after the patient has been hospitalized. For patients outside hospitals, an approved treatment is known – an antibody cocktail, which is taken by transfusion. Adalza adds that “existing therapies are complex and logistically difficult to administer, while a simple pill is just the opposite.”
Jefferies analyst Michael Yee explains the reaction in the markets by saying that investors said “people will be less afraid of the coronavirus and less likely to be vaccinated if there is one common pill that treats COVID-19.”
Merck’s data is from the third phase of testing and was reportedly so convincing that outside observers recommended that the entire course not be completed. The analysis of those at risk of severe coronavirus disease among 775 patients in the study showed that only 7.3% of those receiving molnupravir twice daily for 5 days had to be hospitalized and none of the group died 29 days after treatment. In the placebo group, 14.1% had to be hospitalized and three died.
The included patients had a laboratory-confirmed mild to moderate form of COVID-19 disease and symptoms for no more than 5 days. Each of them had at least one risk factor such as obesity or old age. According to the company, the drug is effective against all variants of the coronavirus.
Drugs in the same category as molnupiravir have been linked to birth defects in animal testing, according to Reuters. Merck claims that similar studies of molnupiravir – for longer periods and at higher doses than those used in humans – show that it does not affect mammalian DNA. The degree of side effects is the same in molnupiravir and placebo patients, the company added without giving details.
Molnupiravir cannot cause genetic changes in human cells, Merck said. But during the test, the men had to abstain from sexual intercourse or use contraceptives. Women have also been required to use contraceptives, according to Reuters.
The company has a contract with the US government for a $ 1.7 million (plus another $ 3.5 million) course of treatment at a cost of $ 700 each. The price for contracts with other governments will be determined by the level of income in the country concerned (there is an agreement to license the drug for several manufacturers in India to supply low- and middle-income countries). Merck estimates that it could produce 10 million courses of treatment by the end of the year.
The company is in the third phase of research into molnupiravir and to prevent coronavirus infection.
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