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Vehicles enter the Merck headquarters campus in Whitehouse Station, New Jersey, United States, Thursday, December 13, 2007. Merck & Co.’s Cordaptive cholesterol pill failed to gain approval from US regulators , less than a week after its recommendation. for marketing in the European Union.
Photographer: Emile Wamsteker / Bloomberg
Photographer: Emile Wamsteker / Bloomberg
Merck & Co. is halting development of its two investigational Covid-19 vaccines after initial test data shows that they do not generate immune responses comparable to natural infection or to existing vaccines.
The American drug giant, which has a long history of successful vaccine development, had adopted a different strategy than its competitors Pfizer Inc., Moderna Inc. and Johnson & Johnson, using a more traditional approach of focusing on shots based on weakened viruses. One, called V590, borrowed Ebola inoculation technology from Merck, while the other, V591, is based on a measles vaccine used in Europe.
The V590 and V591 were both late in the vaccine development race. Merck completed recruiting the first participants for preliminary safety studies in late 2020, when pioneers Pfizer and Moderna were preparing to report late-stage data on the effectiveness of their shots. Merck received provisional test results this month.
The results were “disappointing and a little surprising,” said Nick Kartsonis, senior vice president of clinical research in infectious diseases and vaccines at Merck Research Laboratories. Both shots generated fewer neutralizing antibodies to stop the infection than other Covid-19 vaccines and produced lower immune responses than people who had naturally contracted the coronavirus.
“We didn’t have what we needed to be able to move forward,” Kartsonis said in an interview on Sunday. After evaluating the data, Merck’s senior management decided to end the programs and divert resources to the company’s efforts to develop Covid-19 treatments.
Shares fell 0.8% in trading before US markets opened on Monday. They have lost 9.7% in the past 12 months up to Friday’s close.
Vaccine anxiety
While Merck’s vaccines weren’t supposed to be part of the initial U.S. vaccination campaign, the development comes amid heightened anxiety over vaccine supplies and a slow pace of injections. The emergence of new variants of the coronavirus has also raised the question of whether the shots that were erased would lose their effectiveness as the pathogen mutates.
The failure of Merck’s candidates will also leave it shut out of a market that could potentially be dominated by two of its historic US rivals. Pfizer was the first drugmaker to gain approval for a Covid vaccine in the United States, followed closely by Moderna, and in the coming weeks Johnson & Johnson are expected to release data on the effectiveness of their vaccine and request an emergency use authorization.
None of Merck’s candidates ultimately made it into the top six vaccines in the US government’s Operation Warp Speed portfolio, although its executives are watching them closely. The drugmaker and its partner the International AIDS Vaccine Initiative (IAVI) have received government research funding. Both candidates would have been single dose injections.
Merck, based in Kenilworth, New Jersey, will record a pre-tax charge for the fourth quarter of 2020 for costs related to the shutdown of programs. He did not disclose the amount of the charge on Monday. The results of the preliminary trials will be submitted to a peer-reviewed medical journal.
The use of two coronavirus vaccines has been authorized in the United States, but a continued rise in infections has highlighted the need for more treatment options. Merck will direct its resources to two drugs it is at an advanced stage of development to fight the disease, according to Kartsonis.
Read more: Merck-U.S. Covid Drug Agreement Shows Need For Therapies Persists
“In the world of pharmaceutical development, rapid elimination is not a bad thing because it allows you to reposition and reuse your assets,” he said.
Several Merck vaccine manufacturing facilities are being retooled to produce one of its Covid-19 drug candidates, MK-7110, which is complex and difficult to manufacture on a large scale. In an interim study, intravenous therapy significantly improved the likelihood and speed of recovery for patients with severe and critical Covid-19 in need of oxygen, reducing the risk of respiratory failure and death by more than 50%. Full study results are expected in the first quarter.
Merck executives expect U.S. regulators to grant emergency use authorization for the drug following the findings, and Kartsonis said it could reach sick patients by mid-July. the year. The United States has already agreed to pay $ 365 million for 60,000 to 100,000 doses.
Antiviral pill
Merck is also working on a pill for patients with Covid-19 in the early stages of the disease. Known as molnupiravir, antiviral therapy was discovered by scientists at Emory University and is currently being studied in advanced-stage inpatient and outpatient trials. Merck and its partner Ridgeback Biotherapeutics LP expect to have initial data on the drug’s effectiveness in the first quarter and to conclude the studies in May, the company said in a statement.
Marketing director Michael Nally said in December that Merck expects regulatory clearance soon after the company releases data, if successful.
Read more: Single Rolodex Helps Operation Warp Speed Live Until Her name
The antiviral is meant to be taken twice a day for five days, for a total of ten capsules. Merck predicts it will be able to produce more than 20 million treatments, or 200 million capsules, by 2021, Nally said.
The slow roll-out of the vaccine shows that the need for therapeutics will persist, Kartsonis said, and that the drugs could work against future viruses.
(Updates with pre-market trade in the sixth paragraph)
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