Paxlovid

Enanta Pharmaceuticals is seeking compensation as it develops its own COVID-19 antiviral.

(AbbVie, which holds worldwide marketing and sales rights to the drug, reported $1.7 billion in revenue for Mavyret in 2021.) Not only was it the first COVID-19 antiviral to be made available for patients use at home, it’s also been viewed as a game-changing tool that has helped keep people out of the hospital and from dying. Pfizer’s patent for Paxlovid appears to have been filed three months later, and Enanta’s patent “does appear to cover the chemical space Paxlovid is in,” RBC Capital Markets analyst Brian Abrahams told investors this week. Enanta said it is seeking compensation and does not want to stop the distribution or manufacture of the drug, citing the “importance of Paxlovid’s availability to patients.” The suit, which was filed Tuesday in U.S. District Court in Massachusetts, alleges that Enanta filed an application with the U.S. Patent and Trademark Office “describing coronavirus protease inhibitors invented by Enanta scientists” in July 2020. Enanta Pharmaceuticals ENTA, +3.01%filed a lawsuit against Pfizer PFE,over Paxlovid, alleging that the COVID-19 antiviral expected to bring in $22 billion in sales this yearis based on a patent first filed by Enanta scientists.

According to a Lawsuit filed on Tuesday in U.S. District Court for the District of Massachusetts, Pfizer's blockbuster COVID drug Paxlovid violates ...

Enanta filed a patent infringement lawsuit against Pfizer for the latter's alleged use of its proprietary antiviral component in producing the COVID-19 ...

Enanta is seeking "treble damages" for Pfizer's willful infringement and other financial compensation related to the issue. Enanta filed its U.S. Provisional Patent Application in July 2020 ('048), then a utility patent application in July 2021 claiming priority over the '048 application. However, the company said it needs fair compensation for Pfizer's use of the 3CL protease inhibitor that Enanta's scientists discovered. Pfizer has committed and continues to commit these acts of infringement without license or authorization," the document read. In November 2021, it filed U.S. Patent Application No. 17/522,176 ('176) to further support priority claims made in the previous application. Pfizer's nirmatrelvir, the product's main component, is a SARS-CoV-2 3CL protease inhibitor.

Enanta Pharmaceuticals Inc. alleges that Pfizer Inc.'s Covid-19 antiviral Paxlovid infringes a patent issued last week related to ways to stop a coronavirus ...

US clinical-stage biotech Enanta Pharmaceuticals (Nasdaq: ENTA) yesterday announced that it has filed suit in US District Court for the District of ...

• Unfettered access to industry-leading news, commentary and analysis in pharma and biotech. • All the news that moves the needle in pharma and biotech. If your trial has come to an end, you can subscribe here.

Pfizer is seeing an uptick in litigation related to its mega-blockbuster Covid-19 vaccine and therapeutic, with the latest suit coming from ...

Some infectious disease experts interviewed by ABC News said the new study could influence the way doctors prescribe the drug, potentially declining to ...

When you add all that up, I think that a large swath of people do qualify for Paxlovid potentially as high-risk," Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, told ABC News. So, we should have a lot of evidence to support a very specific recommendation," Brownstein said. Doctors said there are serious considerations to weigh before prescribing Paxlovid. Drug-drug interactions may lead to serious or life-threatening drug toxicities, including medications such as cardiovascular agents and anticonvulsants. "With up to 40-50% of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid," Bourla said in a press release. The Centers for Disease Control and Prevention has provided guidance that the drug is recommended for treatment of mild to moderate COVID-19 among people at high risk for severe disease. But mounting evidence suggests Paxlovid may not benefit everyone equally.

Pfizer's antiviral drug Paxlovid was tied to very few COVID-related visits to the emergency department (ED) or hospital, but people in socially vulnerable ...

From Mar 6 through May 21, the number of antivirals dispensed per 100,000 population increased from 3.3 to 77.4 in low-, from 4.5 to 70.0 in medium-, and from 7.8 to 35.7 in high-vulnerability ZIP codes. In spite of those efforts, by the end of the study period, dispensing rates in high-vulnerability ZIP codes were only about half the rates in medium- and low-vulnerability ZIP codes. About 70% of the oral antivirals were dispensed from Mar 7 to May 21, 2022. The authors conclude, "When administered as an early-stage treatment, Paxlovid might prevent COVID-19–related hospitalization among persons with mild to moderate COVID-19 cases who are at risk for progression to severe disease. They assessed uptake of the drugs by ZIP code areas classified as having low, medium, or high social vulnerability. Among the group, 72.5% had received three or more COVID vaccine doses, and 7.8% were unvaccinated.

Drug resistance or impaired immunity against the coronavirus are likely not the cause of rebound symptoms some patients experience after taking Pfizer's ...

After a course of treatment, researchers found the virus was still responsive to the drug and saw no evidence of mutations that would reduce Paxlovid's effectiveness. Instead, researchers believe insufficient drug exposure is the reason behind the symptom rebound — meaning not enough of the medication was reaching infected cells to bring all viral replication to a halt — and called for additional studies to determine whether certain patients are more vulnerable to recurring symptoms and whether treatment adjustments are necessary. They also sampled the patient's plasma to test their immunity against the virus, according to the study published June 20 in Clinical Infectious Diseases.

Paxlovid is the leading oral medication for preventing severe cases of COVID-19 in high-risk individuals. However, symptoms returned in some patients after ...

In the future, Carlin said he hopes physicians will be able to test whether patients require a longer duration of Paxlovid treatment or if they might be best treated by a combination of drugs. They suggested this may be due to the drug being metabolized more quickly in some individuals or that the drug needs to be delivered over a longer treatment duration. They first isolated the SARS-CoV-2 BA.2 virus from a COVID-19 rebound patient and tested whether it had developed any drug resistance. In a study published June 20, 2022 in Clinical Infectious Diseases, researchers at University of California San Diego School of Medicine evaluated one such patient and found their symptom relapse was not caused by the development of resistance to the drug or impaired immunity against the virus. More research is needed to help us adjust treatment plans as necessary.” Treatment should be initiated within five days of symptom onset and taken twice daily for five consecutive days.

Some infectious disease experts interviewed by ABC News said the new study could affect the way doctors prescribe the drug, potentially refusing to prescribe it ...

“I think there’s a lot to understand, we have a lot of real world data, and so I think it’s fair to understand how well it works, and because it’s so widely available, it will “not be a hard drug. It is also a situation like socioeconomic status and some of the differences that exist. Doctors said there are serious considerations to be weighed before prescribing Paxlovid. Drug interactions can lead to severe or life-threatening drug toxicities, including medications such as cardiovascular drugs and anticonvulsants. So we should have a lot of evidence to support a very specific recommendation,” Brownstein said. But growing evidence suggests that Paxlovid may not benefit everyone equally. “With up to 40-50% of people worldwide assessed to be at high risk, we believe there is still a significant unmet need for treatment options to help combat this disease and we will continue to prioritize efforts to promote the development of Paxlovid, “Bourla said in a press release.

In a recent Morbidity and Mortality Weekly Report (MMWR) published on the United States Center for Disease Control and Prevention (US-CDC) website, ...

Patients with reinfections following Paxlovid treatment were unlikely to get hospitalized or visit ED. Subsequently, less than 1% of patients treated with Paxlovid had to be hospitalized or visited ED due to COVID-19-related complications. These patients had symptoms consistent with COVID-19; however, they represented barely less than 1% of all the Paxlovid recipients during the study period. They searched all the individuals over 12 years of age who received a five-day treatment course of Paxlovid between December 31, 2021, and May 26, 2022. Of these, 4,875 individuals had received at least one COVID-19 vaccine dose, 937 had received two doses at least 14 days before receiving Paxlovid treatment, 3,836 had received three or more vaccine doses, and 412 Paxlovid recipients remained unvaccinated. There are some published reports of recurrence of SARS-CoV-2 infections after completion of the Paxlovid treatment. Nirmatrelvir/ritonavir, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (Mpro) inhibitor, is marketed under the brand name Paxlovid. It received emergency use authorization (EUA) from the Food and Drug Administration (FDA) in December 2021 for mild to moderate COVID-19 cases likely at risk for developing severe disease.

US biotech Enanta Pharma has filed a lawsuit against Pfizer, claiming that its oral antiviral for COVID-19 Paxlovid infringes one of its patents and seeking ...

Either way, the legal wrangling is likely to take years to be resolved. The legal challenge carries a risk as well, as it could cupper the development of Enanta’s drug – and possibly Pardes’ – if Pfizer can prove it was the first to develop a drug candidate targeting the protease. It has since advanced a lead candidate (EDP-235) into phase 1 clinical testing and claimed a fast-track designation for the drug from the FDA, according to court documents.

Since the declaration of COVID-19 as a pandemic in 2020, several therapies have been developed to reduce symptoms of COVID-19 infection and prevent ...

More studies are required to assess the clinical characteristics and severity in those patients and to determine the cause. Those adverse events were mild and resolved spontaneously [6]. Our patients reported no side effects following treatment with Paxlovid. Given the nature of the available data, it is unclear if the symptoms are due to progression of COVID-19 infection, relapse following treatment, or re-infection. More studies are required to further assess clinical characteristics, severity, and treatment, and to determine the cause of the emergence of the phenomenon. Ritonavir is a potent cytochrome P450 (CYP) 3A4 that is co-packaged with nirmatrelvir to inhibit its metabolism and boost its activity [5]. A double-blind randomized controlled trial (EPIC-HR) compared the risk of progression in symptomatic unvaccinated COVID-19 patients who received nirmatrelvir with ritonavir to placebo. In a case series of eight patients published in May of 2022, relapse symptoms in patients who have received ritonavir-boosted nirmatrelvir were reported 9-12 days following initial diagnosis [9]. The time from diagnosis to recurrence of symptoms was slightly longer in our patients: 11 and 14 days. A health advisory was issued in May of 2022 by CDC about the recurrence of symptoms in patients who are treated with Paxlovid. Symptoms are usually mild and resolve without additional treatment [4]. Our patients developed recurrence and worsening of their initial symptoms at diagnosis, and both patients improved with symptomatic management and without further antiviral treatment. On day 14 of her COVID-19 diagnosis, she had episodes of hypoxia at home with oxygen saturation down to 80%; she called her primary care physician who ordered lab work and imaging. He continued to have fatigue and started to develop worsening shortness of breath on day 11 of his diagnosis. Current therapies include neutralizing antibodies targeting M spike protein and antivirals targeting vital steps in viral replication [2]. On December 22, 2021, an emergency use authorization (EUA) was issued by the United States Food and Drug Administration (FDA) for the oral main protease (M pro) inhibitor nirmatrelvir and ritonavir to be used in the treatment of patients with mild-to-moderate COVID-19 who are at a risk of progression to severe disease [3]. After some cases of recurrence of COVID-19 symptoms (COVID-19 rebound) two to eight days following treatment with Paxlovid, a healthcare advisory was issued by the Centers for Disease Control and Prevention (CDC) on May 24, 2022 [4]. We present two cases of COVID-19 rebound following treatment with ritonavir-boosted nirmatrelvir. Her symptoms improved, and she was discharged home on day 20 of COVID-19 diagnosis. He was requiring 2 L of oxygen at his nursing home and was sent to the emergency department. On day 0 of COVID-19 diagnosis, he received Paxlovid 300-100 mg twice daily for five days with improvement of his symptoms following the completion of the treatment course.

Biotechnology company Enanta Pharmaceuticals slapped Pfizer with a patent infringement lawsuit and is seeking compensation for the vaccine-maker's antiviral ...

Enanta filed the patent in July 2020, two years before the U.S. Patent and Trademark Office approved it, according to a press release. The targeted ingredient is Paxlovid's nirmatrelvir tablets, according to the suit. The complaint, filed June 22, alleges Pfizer breached Enanta's patent that "discloses and claims compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection."

New data shows that Paxlovid, an antiviral Covid drug, provides little benefit to people that are healthy and fully vaccinated.

Prasad points to a claim that the Moderna vaccine is 38 percent effective against the virus. Data revealed last week by Pfizer shows that many of these people did not need the drugs at all. Paxlovid is to be used by a Covid positive person to limit symptoms and prevent them from becoming serious enough to require intense medical care. 'The studies were too small to achieve statistical significance when evaluating efficacy against mild or severe Covid-19 infection. The New York City-based pharma giant published its Phase 2/3 trial data analyzing the drug's ability to prevent hospitalization or death depending on a person's vaccination status and individual risk profile. President Biden (pictured) has been a proponent of Paxlovid, heralding it at his State of the Union address this year and making it the center of his 'Test to Treat' Covid response

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 has ...

They speculated this may be because the uninfected children had more "fear of the unknown disease and more restricted everyday life due to protecting themselves from catching the virus." And among 12- to 14-year-olds, 46% of those with COVID-19 and 41% of those without it had long-lasting symptoms. Researchers said they have previously found active virus in the gastrointestinal tract of children weeks after the initial coronavirus infection, and other researchers have found genetic evidence of the virus "in multiple anatomic sites up to seven months after symptom onset." Among kids ages 4 to 11, persistent symptoms were seen in 38% with COVID-19 and 34% without it. They also found their patient's antibodies could still block the virus from entering and infecting new cells. Register now for FREE unlimited access to Reuters.com