Tag Archives: molnupiravir

U.S. government to buy $1 billion more worth of Merck’s COVID-19 pill

By Manas Mishra

(Reuters) – The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc and partner Ridgeback Biotherapeutics, the companies said on Tuesday.

The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.

That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract.

The drug has been closely watched since data last month showed that when given early in the illness it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19.

“Molnupiravir, if authorized, will be among the vaccines and medicines available to fight COVID-19 as part of our collective efforts to bring this pandemic to an end,” said Frank Clyburn, president of Merck’s human health business.

President Joe Biden said on Friday that the United States had also secured millions of doses of Pfizer Inc’s rival antiviral drug, which was shown to cut by 89% the chance of hospitalization or death for adults at risk of severe disease.

The Pfizer negotiations were for a deal similar to the one with Merck – 1.7 million courses of the treatment upfront with an additional option for 3.3 million, a senior U.S. health official said on Tuesday, confirming a New York Times report.

Pfizer Chief Executive Officer Alfred Bourla said on Friday that the company plans to sell its treatment for around the same price for high-income countries as Merck, at roughly $700 for a course of therapy.

Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Additional reporting by Jeff Mason in Washington; Editing by Anil D’Silva, Arun Koyyur and Sriraj Kalluvila)

Merck pill seen as ‘a huge advance’, raises hope of preventing COVID-19 deaths

By Deena Beasley and Carl O’Donnell

(Reuters) -An antiviral pill developed by U.S. drugmaker Merck & Co could half the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, with experts hailing it 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’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 around 20% on the news.

Shares of COVID-19 vaccine makers Pfizer Inc and Moderna Inc were off more than 2% and 14%, respectively.

Michael Yee, a biotechnology analyst at Jefferies, said the share move indicated that 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 are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails which have to be given intravenously are approved for non-hospitalized patients.

A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths. It found that 7.3% of those given molnupiravir were hospitalized and none had died by 29 days after treatment, compared with hospitalization of 14.1% of 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.

‘WORK WITH ALACRITY’

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world.

“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.

In the trial, which involved patients from around the world, molnupiravir was taken every 12 hours for five days.

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.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants 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.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more coming next year.

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.

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.”

(Reporting by Deena Beasley; Additional reporting by Josephine Mason, Editing by Lincoln Feast, Kirsten Donovan, Alexander Smith and Bill Berkrot)

Coronavirus can transform pancreas cell function; certain genes may protect an infected person’s spouse

By Nancy Lapid

(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Coronavirus transforms pancreas cell function

When the coronavirus infects cells, it not only impairs their activity but can also change their function, new findings suggest. For example, when insulin-producing beta cells in the pancreas become infected with the virus, they not only produce much less insulin than usual, but also start to produce glucose and digestive enzymes, which is not their job, researchers found. “We call this a change of cell fate,” said study leader Dr. Shuibing Chen, who described the work in a presentation on Tuesday at the annual meeting of the European Association for the Study of Diabetes, held virtually this year. It is not clear whether the changes are long-lasting, or if they might be reversible, the researchers noted earlier in a report published in Cell Metabolism. Chen noted that some COVID-19 survivors have developed diabetes shortly after infection. “It is definitely worth investigating the rate of new-onset diabetes patients in this COVID-19 pandemic,” she said in a statement. Her team has been experimenting with the coronavirus in clusters of cells engineered to create mini-organs, or organoids, that resemble the lungs, liver, intestines, heart and nervous system. Their findings suggest loss of cell fate/function may be happening in lung tissues as well, Chen, from Weill Cornell Medicine in New York, told Reuters.

Certain genes may protect an infected patient’s spouse

A study of couples in which both partners were exposed to the coronavirus but only one person got infected is helping to shed light on why some people may be naturally resistant to the virus. The researchers had believed such cases were rare, but a call for volunteers who fit that profile turned up roughly a thousand couples. Ultimately, they took blood samples from 86 couples for detailed analysis. The results suggest resistant partners more often have genes that contribute to more efficient activation of so-called natural killer (NK) cells, which are part of the immune system’s initial response to germs. When NKs are correctly activated, they are able to recognize and destroy infected cells, preventing the disease from developing, the researchers explained in a report published on Tuesday in Frontiers in Immunology . “Our hypothesis is that the genomic variants most frequently found in the susceptible spouse lead to the production of molecules that inhibit activation of NKs,” study leader Mayana Zatz of the University of São Paulo, Brazil, said in a statement. The current study cannot prove this is happening, she added. Even if the findings are confirmed with more research, the contributions of other immune mechanisms would also need to be investigated, the researchers said.

Experimental pill shows promise against coronavirus variants

Laboratory studies show that Merck & Co’s experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective in patients infected with any of the known variants of the coronavirus, including the dominant, highly transmissible Delta, researchers said on Wednesday in a presentation during IDWeek 2021, the virtual annual meeting of infectious disease organizations. Molnupiravir does not target the spike protein of the virus, which is the target of all current COVID-19 vaccines. Instead, it targets an enzyme the virus uses to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus. Data showed that the drug is most effective when given early in the course of infection, Merck said. The company is conducting two large late-stage trials of the drug – one for treatment of COVID-19 and another as a preventive.

(Reporting by Nancy Lapid and Deena Beasley; Editing by Bill Berkrot)