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Regeneron Overcomes Loss of COVID Antibody to Post Positive First Quarter

Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of…



Regeneron Overcomes Loss of COVID Antibody to Post Positive First Quarter


Despite the loss of its COVID-19 antibody, REGEN-COV, earlier this year, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.

In January, the U.S. Food and Drug Administration limited the use of REGEN-COV due to its limited efficacy against the Omicron variant of the SARS-CoV-2 virus that was surging across the nation. With REGEN-COV pulled from usage, Regeneron earned no revenue from the monoclonal antibody during the first three months of the year. Since it was first authorized for use two years ago, the monoclonal antibody has served as a vital revenue source for Tarrytown, N.Y.-based Regeneron.

Although REGEN-COV has seen its use limited, the company had hoped the monoclonal antibody could be used as a prophylaxis in certain individuals or non-hospitalized patients. However, last month the FDA extended the review of a Biologics License Application for REGEN-COV for these indications. The extension was due to additional data Regeneron submitted to the FDA on pre-exposure prophylactic use. The FDA determined that these additional data constituted a major amendment to the BLA and provided a new target action date of July 13. Regeneron will also continue assessing next-generation antibodies in the clinic against multiple COVID-19 variants, including those of the Omicron lineage.

Overall, first-quarter revenues increased to $2.97 billion, with Eylea generating $1.52 billion, an 11% growth, and Dupixent bringing in $1.81 billion, an increase of 43% over the same quarter last year. Dupixent revenues are shared with Sanofi. 

Leonard S. Schleifer, president and chief executive officer of Regeneron, touted the sales growth of the two drugs. He also pointed to the expanded use of Dupixent in Europe. During the quarter, the biologic was approved for use in children with severe asthma ages 6 to 11 and was also granted priority review by the FDA for children ages six months to 5 years who have atopic dermatitis and eosinophilic esophagitis in adolescents 12 and older.

“Regeneron is off to a strong start in 2022. We are well-positioned to reach even more patients with type 2 inflammatory disease through FDA priority review designations for Dupixent in children with atopic dermatitis and in adults and adolescents with eosinophilic esophagitis,” Schleifer said Wednesday morning.

Earlier this year, Regeneron submitted a supplemental BLA for Elyea for an every-16-weeks dosing regimen in patients with non-proliferative diabetic retinopathy. During a conference call this morning, Schleifer said the company believes that Eylea continues to strengthen its leadership position as a treatment for multiple ocular disorders and believes that diabetic eye disease will remain a strong area of growth for the drug. The company also sees other sites where Eylea has the potential to become a preferred medicine.

In February, Regeneron and Sanofi posted data from a study of Dupixent in patients with chronic spontaneous urticarial. The study was in patients that had previously reported positive results from the first trial in biologic-naïve patients not previously treated with omalizumab. Data from the study showed Dupixent significantly reduced itch and hives compared to standard-of-care antihistamines alone. A second study in patients who are refractory to omalizumab was halted due to futility.

lev radin/Shutterstock

Across its pipeline, Regeneron has approximately 35 product candidates in clinical development. Other assets in development include fianlimab, an antibody to LAG-3 that is currently in Phase III development, and odronextamab, a CD20xCD3 bispecific antibody, which was recently granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma.

Other key highlights for Regeneron during the first quarter include its April acquisition of Checkmate Pharmaceuticals for $250 million. The deal is expected to provide Regeneron with a broad portfolio of diverse immune-oncology candidates. 

At the center of the deal was Checkmate’s investigational immune activator, vidutolimod, an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 agonist. Vidutolimod is currently being assessed in melanoma, non-melanoma skin cancers and head and neck cancer. Regeneron anticipates the acquisition to be completed later this year.


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China Suggests It Could Maintain ‘Zero COVID’ Policy For 5 Years

China Suggests It Could Maintain ‘Zero COVID’ Policy For 5 Years

Authored by Paul Joseph Watson via Summit News,

China has suggested it will…



China Suggests It Could Maintain 'Zero COVID' Policy For 5 Years

Authored by Paul Joseph Watson via Summit News,

China has suggested it will maintain its controversial ‘zero COVID’ policy for at least 5 years, eschewing natural immunity and guaranteeing repeated rounds of new lockdowns.

“In the next five years, Beijing will unremittingly grasp the normalization of epidemic prevention and control,” said a story published by Beijing Daily.

The article quoted Cai Qi, the Communist Party of China’s secretary in Beijing and a former mayor of the city, who said that ‘zero COVID’ approach would remain in place for 5 years.

After the story prompted alarm, reference to “five years” was removed from the piece and the hashtag related to it was censored by social media giant Weibo.

“Monday’s announcement and the subsequent amendment sparked anger and confusion among Beijing residents online,” reports the Guardian.

“Most commenters appeared unsurprised at the prospect of the system continuing for another half-decade, but few were supportive of the idea.”

Although western experts severely doubt official numbers coming out of China, Beijing claimed success in limiting COVID deaths by enforcing the policy throughout 2021.

However, this meant that China never achieved anything like herd immunity, and at one stage the Omicron variant caused more more coronavirus cases in Shanghai in four weeks than in the previous two years of the entire pandemic.

Back in May, World Health Organization Director General Tedros Adhanom Ghebreyesus suggested that China would be better off if it abandoned the policy, but Beijing refused to budge.

As we previously highlighted, the only way of enforcing a ‘zero COVID’ policy is via brutal authoritarianism.

In Shanghai, children were separated from their parents in quarantine facilities and others were left without urgent treatment like kidney dialysis.

Panic buying of food also became a common occurrence as the anger threatened to spill over into widespread civil unrest.

Former UK government COVID-19 advisor Neil Ferguson previously admitted that he thought “we couldn’t get away with” imposing Communist Chinese-style lockdowns in Europe because they were too draconian, and yet it happened anyway.

“It’s a communist one party state, we said. We couldn’t get away with it in Europe, we thought,” said Ferguson.

“And then Italy did it. And we realised we could,” he added.

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Tyler Durden Tue, 06/28/2022 - 18:05

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University of Cincinnati enrolling patients for PTSD clinical trials

About 8% of Americans will experience post-traumatic stress disorder at some point in their lives, but there are still few effective options to treat the…



About 8% of Americans will experience post-traumatic stress disorder at some point in their lives, but there are still few effective options to treat the condition.

Credit: Photo/University of Cincinnati

About 8% of Americans will experience post-traumatic stress disorder at some point in their lives, but there are still few effective options to treat the condition.

“There are some medical treatments for PTSD and psychotherapies for PTSD, but patients continue to suffer with symptoms that aren’t responsive to the currently available treatments,” said Lesley Arnold, MD.

June is PTSD Awareness Month, and the University of Cincinnati is currently enrolling patients for clinical trials examining the effectiveness of different medications to better treat PTSD symptoms.

The basics

Arnold said PTSD is a common and often chronic disorder that develops after a traumatic event that is either personally experienced or witnessed by a person.

“People with PTSD often re-experience aspects of the original trauma and can develop symptoms such as avoidance of trauma reminders, negative thoughts and feelings and increased alertness to their surroundings,” said Arnold, director of the Women’s Health Research Program and professor in the Department of Psychiatry and Behavioral Neuroscience in the UC College of Medicine.

Most people who are exposed to a trauma will have an acute stress response in the moment, Arnold said, but about 30% of those who experience a trauma develop PTSD. Symptoms can last for months or years and also include disrupted sleep or nightmares, issues with memory or focus and depression and anxiety. 

In people who are at higher risk for exposure to trauma, such as war veterans, PTSD occurs in even higher proportions, Arnold said. The COVID-19 pandemic has also exacerbated symptoms of PTSD for some individuals.

“It led to some isolation and made it difficult for individuals to seek treatment or to continue to engage in treatment,” Arnold said. 

New trials

Arnold and her team are focused on testing medication-based treatments that could help alleviate the symptoms of PTSD that have not responded to currently available medications, including sleeplessness and nightmares among others.

“The problem that we have is that there are two FDA medications approved for the treatment of PTSD, but these medications aren’t effective for everybody, and they take a long time to work,” Arnold said. 

Each of the clinical trials will test different novel drugs that take new approaches to treat unregulated neurotransmitters in the brain that are involved in PTSD. The randomized trials will measure the effectiveness of the medications compared to a placebo control group.

“We are in urgent need of treatments for PTSD,” Arnold said. “That’s why these trials are so important because they offer a novel approach that we hope to be effective in helping patients overcome the problems associated with PTSD and return to full function.”

Adults, both women and men, over the age of 18 with PTSD are eligible to participate in the trials, with patients with a variety of different trauma experiences being recruited. The trials will involve about three months of participation from patients.

“We’re asking for volunteers to help us with our trials, those individuals who continue to have symptoms of PTSD,” Arnold said. “We are conducting these trials actively, and I would encourage individuals to come forward to help.”

Arnold said there has been an increased interest in finding drug treatments for PTSD in about the last five years.

“This is an exciting time and a hopeful time for people with PTSD because we are actively seeking out better treatments,” she said. “There’s been a growing interest and a recognition of the unmet need in this population, so I’m really gratified to be able to have these trials going on now and to be able to offer some hope to individuals with PTSD.”

For more information on the PTSD trials at UC, call 513-558-6612.

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Efficacy Of Pfizer’s Paxlovid COVID Drug Crashes, According To NIH-Funded Study

A new National Institutes of Health (NIH) funded study sheds new light on the waning effectiveness of Pfizer’s Paxlovid to prevent patient hospitalizations…



A new National Institutes of Health (NIH) funded study sheds new light on the waning effectiveness of Pfizer’s Paxlovid to prevent patient hospitalizations due to COVID. The drug—the most prescribed FDA-approved oral COVID medication in the United States—has seen its efficacy rate drop in half, according to the report. The findings may validate the concerns of some researchers that predict Paxlovid’s efficacy could decrease over time, given its reliance on antiviral mode-of-action.

The study was lead by Dr. Scott Dryden-Peterson, an infectious disease specialist with Brigham and Women’s Hospital in Boston. The population-based cohort study measured patients from a large healthcare system providing care for 1.5 million patients in Massachusetts and New Hampshire during the Omicron wave, from January 1 to May 15, 2022. Doctors maintained staged access and capacity to prescribe nirmatrelvir plus ritonavir (Paxlovid), and 30,322 non-hospitalized adults with a 87.2% vaccination rate, over age 49 with COVID-19 and without medication contraindications participated. A full 6036 patients—or 19.9% of the study—were prescribed Paxlovid while 24,286 (80.1%) patients were not.

Adjusting for limitations arising from differential access and uptake of COVID-19 vaccines, diagnostics, and treatment, the study found the overall risk of hospitalization was 45% lower among patients prescribed Pfizer’s Paxlovid. While still significant, the efficacy rate provided in the NIH-funded study is appreciably lower than the 89% reduction in hospitalizations indicated in Paxlovid’s high-risk clinical trial, which took place during the Delta wave.

Final data available from all patients enrolled in the 2021 Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial confirmed prior results of interim analysis showing Paxlovid reduced risk of hospitalization or death by 89% within three days of symptom onset and 88% within five days of symptom onset. Furthermore, this data measured hospitalization within a 28-day window of those receiving a COVID-19 diagnosis, as opposed to 14 days in the NIH-funded study.

Although not an apples-to-apples comparison, the results put Pfizer’s Paxlovid drug at a similar relative effectiveness as Tamiflu to prevent influenza hospitalizations, according to Dr. Scott Dryden-Peterson. Influenza and SARS-CoV-2 viruses both consist of RNA viruses, although they differ in regards to the protein layer that encapsulates the RNA.

We obviously would have loved to see that it was as protective as was seen in the trial, the 90% reduction rather than the 45% reduction. But we see a very similar reduction to that which has been observed with influenza and Tamiflu in the past.

Source: U.S. News

While the NIH-funded study appears to show Pfizer’s Paxlovid losing efficacy, such outcomes have long been predicted for the drug which relies on antiviral mode-of-action to administer effect.

As an inherent survival mechanism, viruses will naturally attempt to utilize their proteins to antagonize the host innate immune system by either targeting viral sensors or blocking downstream antiviral signaling molecules. This produces diminishing returns for antiviral medications as the virus evolves, which is why effective medications that eradicate coranavirus and influenza-type viruses have been difficult to develop.

The post Efficacy Of Pfizer’s Paxlovid COVID Drug Crashes, According To NIH-Funded Study appeared first on The Dales Report.

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