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Merck pill seen as 'huge advance,' raises hope of preventing COVID-19 deaths

Stock MarketsOct 01, 2021 07:30PM ET
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2/2 © Reuters. FILE PHOTO: An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. Merck & Co I 2/2

By Deena Beasley and Carl O'Donnell

(Reuters) -An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.

If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.

"An oral antiviral that can impact hospitalization risk to such a degree would be game-changing," said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

Current treatment options include Gilead Sciences Inc (NASDAQ:GILD)'s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.

"This is going to change the dialogue around how to manage COVID-19," Merck Chief Executive Robert Davis told Reuters.

Existing treatments are "cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that," Adalja added.

The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.

Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up more than 21% on the news.

Shares of COVID-19 vaccine makers https://www.reuters.com/business/healthcare-pharmaceuticals/merck-covid-19-pill-success-slams-moderna-shares-shakes-up-healthcare-sector-2021-10-01 Moderna (NASDAQ:MRNA) Inc were off more than 10%, while Pfizer (NYSE:PFE) was down less than 1%.

Jefferies (NYSE:JEF) analyst Michael Yee said investors believe "people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID."

Pfizer and Swiss drugmaker Roche Holding AG (OTC:RHHVF) are also racing to develop an easy-to-administer antiviral pill https://www.reuters.com/business/healthcare-pharmaceuticals/covid-19-pill-developers-aim-top-merck-pfizer-efforts-2021-09-28 for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.

White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is "a potential additional tool... to protect people from the worst outcomes of COVID," but added that vaccination "remains far and away, our best tool against COVID-19."

A planned interim analysis of 775 patients in Merck's study looked at hospitalizations or deaths among people at risk for severe disease. It found that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after treatment. That compared with a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.

"Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback's CEO, said in a statement.

'A HUGE ADVANCE'

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world, 700,000 of them in the United States.

“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID," said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-research-shows-its-covid-19-pill-works-against-variants-2021-09-29 of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.

It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.

The U.S. drugmaker said it expects to produce 10 million courses of the treatment by the end of 2021.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.

The U.S. government has the option to purchase up to an additional 3.5 million treatment courses if needed, a U.S. health official told Reuters. The official asked to remain anonymous because they were not authorized to comment publicly on the contract.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.

Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck's research labs, said, "they are going to try to work with alacrity on this."

Merck pill seen as 'huge advance,' raises hope of preventing COVID-19 deaths
 

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Comments (10)
Ricardo Diogo
Rcd72 Oct 02, 2021 2:44AM ET
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Prof Peter Horby of the University of Oxford, said: “It’s really encouraging to see some positive clinical data in a trial. If the results hold out this would be a very positive result.”Horby said caution was needed, however, as with relatively small numbers involved the efficacy figure can wobble up and down based on the outcomes of just a handful of patients.
Ricardo Diogo
Rcd72 Oct 02, 2021 2:44AM ET
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very strange announcement timestrange how Merck started to rise 2 weeks ago...smells fake
John Laurens
John Laurens Oct 01, 2021 4:25PM ET
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Does this mean the fascist dems will start minding their own business? Will Aussies get their freedom,  liberty and dignity back?
Jurgen Daub
Jurgen Daub Oct 01, 2021 4:25PM ET
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portugal has 85 pct fully vaccinated. the will get OFFICIALLY there freedom back i believe in the next few weeks.the pill changes DNA of the virus. why not for the person who takes it?50 % efficiency. cost 10 times for full treatment compared to vaccine.wake up or stay out of the way of the really free
Josh Davis
Josh Davis Oct 01, 2021 4:25PM ET
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Jurgen Daub once your freedoms sre gone they dont come back. This is a fallacy in citizens thoughts
Libby Arndt
Libby Arndt Oct 01, 2021 3:24PM ET
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I have been reading article on Barrons about these pills from all three companies as Biden rolled out his mandate. I believe Merck is seeking approval before the end of the year.
Alex Chillak
Alex Chillak Oct 01, 2021 1:32PM ET
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The powers that be will ****the development of this drug because it doesn't fit the world narrative. World ******through obedience towards the government. Vaccine mandates ensure this control. Why would they want a fix like taking a pill to rid of covid?
Chris Poulos
Chris Poulos Oct 01, 2021 1:32PM ET
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you sound very smart
Marco cuevas
Marco cuevas Oct 01, 2021 12:04PM ET
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BIG PHARMA drooling over that givt, money.
Chan Choung Ming
Chan Choung Ming Oct 01, 2021 11:00AM ET
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Monulpilaviar USD700/course is too expensive.
Hans Meier
Hans Meier Oct 01, 2021 10:33AM ET
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" which has killed almost 5 million people around the world." Correctly it must say 5 m people died WITH Covid, some studys indicate that only 15% die directly on Covid.
Josh Davis
Josh Davis Oct 01, 2021 10:33AM ET
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Way less than that bro.
Josh Davis
Josh Davis Oct 01, 2021 10:33AM ET
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Kaveh Sun
Kaveh Sun Oct 01, 2021 9:18AM ET
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people live in developed countries believe ‘cures’ from third world countries is simply s t u p id
David Bruyere
David Bruyere Oct 01, 2021 7:08AM ET
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Ivermectin already works better and is $5 per treatment.
Anony Mous
Anony Mous Oct 01, 2021 7:08AM ET
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NO NO NO !!!
William Rasmussen
William Rasmussen Oct 01, 2021 7:08AM ET
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Just inject bleach like your oompa loompa savior preached too. Sadly I dont think youre joking, but outside of harming innocent people, helping out natural selection for your irrational, anti-science tribe will benefit humanity.
Josh Davis
Josh Davis Oct 01, 2021 7:08AM ET
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William Rasmussen that is science ivermectin, hcq, dexamethasone, pulmicort etc. Nice try dem so outnof touch with reality. Get your booster
HD HD
HD HD Oct 01, 2021 7:08AM ET
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Are you a horse?
Josh Davis
Josh Davis Oct 01, 2021 7:08AM ET
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HD HD fyi zofran is used in dogs so i guess thw antiemetic is only useful in dogs by your logic? So when youre vomiting dont get zofran cause your not a dog
David Bruyere
David Bruyere Oct 01, 2021 7:07AM ET
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Ivermectin already works better and is $5 per treatment
 
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