REGEN-COV lowers risk of symptomatic COVID-19 infections by 81% in study

Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus.

When delivered subcutaneously, REGEN-COV was 81.4% effective at reducing the risk of symptomatic infections and led to a 92.6% reduction of symptomatic infections after the first week.

Consisting of the monoclonal antibodies casirivimab and imdevimab, REGEN-COV also appeared to accelerate the recovery of COVID-19-infected individuals. In recipients who received the drug, symptoms resolved two weeks faster than in placebo recipients.

Study investigators also found that the drug was generally well-tolerated.

“This peer-reviewed NEJM publication demonstrates that RE…

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Regeneron uncovers genetic mutations that guard against obesity

Regeneron Pharmaceuticals (NSDQ:REGN) has announced that its Regeneron Genetics Center (RGC) has discovered rare genetic mutations associated with protection against obesity.

RGC researchers learned that people with at least one inactive copy of the GPR75 gene tend to weigh about 12 pounds less than those without that mutation. In addition, those individuals faced a 54% reduced risk of obesity.

The center made the finding after sequencing 640,00 exomes, which are part of the genome composed of exons.

A study published in Science that summarized the findings concluded that inhibiting “GPR75 may be a therapeutic strategy for obesity.”

Regeneron is working with partners such as Alnylam Pharmaceuticals to develop drug candidates that mimic the genetically afforded protection.

The mutations were only present in roughly one out of every 3,000 people. Some 645,000 volunteers from the U.K., U.S. and Mexico, participated in the study.

Regener…

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The pandemic and cumulative disease burden are ‘existential’ threats, experts argue 

Image courtesy of Pixabay

While the pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and addressing the burden of all diseases, Yancopoulos added.

Society needs new strategies for addressing the disease burden. “By the year 2050, there will be 10 to 20 million Americans with Alzheimer’s disease with no treatment,” Yancopoulos said. While Biogen’s (NSDQ:BIIB) recently-approved aducanumab could be the first disease-modifying therapy, it remains unclear if the drug is effective.

Added to the disease burden are growing rates of obesity, diabetes, cancer and heart disease — “not to mention the potential of seeing th…

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Regeneron exec pay draws backlash

Regeneron’s (NSDQ:REGN) top two execs, CEO Dr. Leonard Schleifer and CSO Dr. George Yancopoulos, are two of the best-paid in biotech. 

Two proxy advisory service firms, Glass Lewis (San Francisco, Calif.) and Institutional Shareholder Services (Rockville, Md.), are balking at Regeneron’s executive pay program and practices. 

The two firms are urging shareholders to oust George Sing from the company’s board at the company’s annual general meeting on June 11. Sing is a member of Regeneron’s compensation committee. 

Last year, Schleifer earned $135.4 million, including some $130.0 million in stock awards, according to an SEC proxy filing. For comparison, he earned $21.5 million in 2019. 

Chief science officer Yancopoulos earned $134.4 million in 2020, including $130.0 million in stock awards. He earned $20.7 million in 2019. 

The two execs’ earnings last year resulted from a decision from Regeneron’s board to provide Schleifer and Yancopoulos …

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FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …

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HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. 

The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above. 

HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…

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Regeneron exec shares how Ebola inspired COVID-19 treatment

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award.

“But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.

NIAID director Dr. Anthony Fauci and fellow Regeneron co-founder Dr. Leonard Schleifer also were honored at the event. 

Scientists had been working on mRNA on vaccines for more than a decade before the emergency use authorizations of COVID-19 vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). “Similarly, the technologies we use to develop our REGN-COV2 antibody cocktail were not available 10 or 20 years ago,” shared Yancopoulos, who is currently president and chief scientific officer of Regeneron. “We had to invent them and perfect them.” 

The antibody treat…

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Roche retools COVID-19 strategy 

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have complicated recruitment. 

“There’s just simply not enough patients to enroll with the speed we were hoping for,” said Bill Anderson, head of Roche’s pharmaceutical division, in a conference call. 

Roche and Atea hoped AT-527 would offer a more convenient alternative to intravenous treatments such as antibody cocktails or Gilead Science’s (NSDQ:GILD) remdesivir.

One of the two canceled Phase 2 studies was for the monoclonal antibody astegolimab (RG6149), which the company had licensed from Amgen (NSDQ:AMGN). 

The other Phase 2 trial Roche halted related to RG7880 (efmarodocokin alfa), which the company hoped…

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Regeneron touts 70% death risk reduction in COVID-19 antibody drug

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials.

The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared by placebo, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

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Regeneron touts 70% death risk reduction in COVID-19 antibody drug

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials.

The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared by placebo, according to a news release.

REGEN-COV also met all secondary endpoints, which included a reduction in symptom duration. Additionally, a companion trial showed that the lowest dose (300 mg IV/600 mg subcutaneous) had significant viral load reductions over the first seven days, even reaching a level comparable to the highest performing doses (2,400 mg and 1,200 mg IV doses).

“This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results d…

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Medtech stocks help boost S&P rally

Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic.

Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more than 50% since the index’s previous record high before the pandemic in February.

Get the full story at our sister site, MassDevice.

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Medtech stocks help boost S&P rally

Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic.

Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more than 50% since the index’s previous record high before the pandemic in February.

The report attributed the S&P’s rise in part to the economic stimulus in response to the pandemic, as the index has risen more than 50% from its low on March 23 and is up nearly 5% for the year so far.

Currently, the S&P 500 is up 0.2% for the day at 3,389.78 points.

Medtech’s part in the S&P 500’s rise falls in line with the performance of MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device co…

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