Emory and Pfizer partner to develop new COVID-19 treatments

Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution.

Although the threat of COVID has waned over the past year, the virus remains a leading cause of death. CDC data shows 1,862 COVID-related deaths in the U.S.

Pfizer, the developer of Paxlovid and collaborator with BioNTech (Nasdaq:BNTX) on the Comirnaty COVID-19 vaccine, is arguably the most visible COVID drug developer.

For Pfizer, this partnership represents an opportunity to maintain its leadership position in the COVID-19 drug market and potentially increase revenue. The company, however, expects its revenue to slide by as much as one-third this year as a result of ebbi…

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Pfizer to provide up to 6 million Paxlovid courses to developing countries

Pfizer (NYSE:PFE) has reached an agreement to supply as many as six million courses of its oral COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) to the Global Fund, which seeks to help more than 100 low-to-middle income countries fight diseases such as COVID-19, HIV, tuberculosis and malaria.

Pfizer notes that the agreement with the Global Fund is part of a broader strategy to ensure equitable global access to Paxlovid.

The Global Fund’s COVID-19 Response Mechanism offers grant support to developing countries to procure COVID-19 tests, treatments and personal protective gear.

The Global Fund determined which 132 countries were eligible after reviewing data related to income classification and disease burden.

Pfizer will use a tiered pricing scheme for Paxlovid for the 132 countries. According to that plan, low- and lower-middle-income countries will pay a not-for-profit price for the drug, while upper-middle-income countries will pay a rat…

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Zenara Pharma to market generic version of Paxlovid in India

Hyderabad, India–based Zenara Pharma has launched a generic version of Pfizer’s (NYSE:PFE) COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir).

Zenara Pharma is naming the generic version of the pill “Paxzen.”

The antiviral is indicated for mild to moderate symptoms of COVID-19.

India’s Central Drugs Standard Control Organisation (CDSCO) cleared the way for authorization of the drug in the country by approving the generic antiviral last month.

FDA authorized Paxlovid in December 2021. Pfizer signaled its intent to seek full approval of the drug in late June.

Zenara Pharma will manufacture its version of the drug at an FDA- and EU-approved facility in Hyderabad.

The company plans to sell the drug at a maximum retail price of 5,200 rupees per box. One box contains 20 tablets (150 ml) of nirmatrelvir and 10 tablets of ritonavir (100 mg).

“We have launched this product in India with an aim to bri…

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Pfizer CEO tests positive for COVID-19

Pfizer’s (NYSE:PFE) CEO Dr. Albert Bourla acknowledged in a statement that he has COVID-19. 

Bourla, who is 60, has received four doses of the Pfizer-BioNTech Comirnaty vaccine. He also has begun taking a course of the company’s antiviral Paxlovid. 

The Pfizer CEO notes that symptoms to date have been very mild.  

Pfizer’s revenue has soared during the pandemic, largely thanks to the Comirnaty  COVID-19 vaccine. Last year, the vaccine almost doubled Pfizer’s revenue to roughly $81 billion in 2021, making it the largest pharma company. 

Last week, Bourla noted in an earnings call that the company continues to be well-positioned in the pandemic. 

“In the second quarter, we recorded the largest amount of quarterly sales in our history,” Bourla noted in a news release. 

The company continues to develop updated COVID-19 vaccine boosters, which the company expects to be commercially available in the early fall. 

In July, Pfizer and …

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FDA allows pharmacists to prescribe Paxlovid 

FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19.

While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient information to assess patients’ renal and hepatic function and the potential for a drug interaction. In addition, the updated EUA requires a physician to potentially modify the prescription of other medications to avoid an adverse drug interaction. As a result, pharmacists will not be able to prescribe the drug to patients with a potential drug interaction risk who are not able to be monitored.

The FDA rules also require pharmacists to confirm that Paxlovid is an appropriate treatment based on a Fact Sheet for Healthcare Providers.

To verify eligibility, pharmacists must ensure t…

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Pfizer gears up for Paxlovid new drug application submission to FDA

The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year.

Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the EPIC-SR study.

In a press release describing the gathering of new data to support a new drug application submission, Pfizer noted that EPIC-SR data from standard-risk vaccinated and unvaccinated patients were not statistically significant but underscored its efficacy overall.

In the EPIC-SR study, the drug passed the statistically significant threshold of reducing COVID-19-related medical visits per day compared to placebo by 62%. In addition, the study found a non-significant 70% relative risk reduction for the key secondary endpoint of hospitalization or death.…

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Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic 

Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus.

The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after exposure to a household contact.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) led to risk reductions of 32% at day five of therapy. That figure climbed to 37% at day ten of treatment.

The study was completed during the omicron wave.

The emergency use authorization for the drug calls for the drug to be administered twice daily for five days.

Paxlovid appeared to be well tolerated across the EPIC-PEP study and the related EPIC-HR and EPIC-SR trials. In addition, Pfizer noted that the post-market safety data were also encouraging.

The st…

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The Biden administration vows to increase COVID-19 antiviral supplies

Photo by Tabrez Syed on Unsplash

White House officials have a plan to ramp up the availability of Pfizer’s COVID-19 antiviral Paxlovid, according to a report from Bloomberg.

White House Covid-19 Response Coordinator Dr. Ashish Jha said that the administration would announce more details about the plans to make Paxlovid more widely available in the coming week.

The administration plans to launch a test-to-treat initiative that allows recently diagnosed COVID-19 patients to receive Paxlovid at no cost.

CVS, Walgreens and Walmart plan on participating in the program.

According to White House officials, the use of oral antivirals increased 103% between March 27 and April 10.

Anecdotal evidence from a handful of patients suggests that Paxlovid also may help relieve so-called long COVID-19 symptoms, according to Reuters. However, more data are needed to confirm the drug’s efficacy in re…

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Manufacturers ink deal to make generic version of Pfizer’s oral COVID-19 pill Paxlovid

The Medicines Patent Pool (MPP) announced that it has signed agreements with 35 manufacturers to make an inexpensive version of Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir/ritonavir) to be distributed in 95 low- and middle-income countries.

Vaccination rates in many developing countries lag far behind that of wealthier countries. In Nigeria, for instance, 9.1% of the population has received at least one dose, whereas 77% of those in the U.S. are partially or fully vaccinated.

The U.S. pays roughly $530 for a course of Paxlovid.

Pfizer has previously stressed its goal of providing equitable access to COVID-19 therapies worldwide. In November 2021, the company entered a deal with MPP to ensure the availability of Paxlovid to low- and middle-income countries.

“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,”…

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President Biden vows to make aggressive use of Pfizer’s COVID-19 antiviral 

President Joe Biden [Image courtesy of the White House]President Biden said in his State of the Union address that the U.S. aims to ramp up the use of Pfizer‘s (NYSE:PFE) Plaxovid.

The treatment has been in short supply since it won emergency use authorization late last year.

Last year, when Merck & Co. (NYSE: MRK) and Pfizer were close to winning regulatory authorization for COVID-19 antivirals, many pundits hailed the treatments as a potential gamechanger.

To date, however, the use of antivirals has been limited, although demand has been especially high for Pfizer’s Paxlovid antiviral.

Get the full story from our sister site, Pharmaceutical Processing World. 

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President Biden vows to make aggressive use of Pfizer’s COVID-19 antiviral 

President Joe Biden [Image courtesy of the White House]

President Biden aims to ramp up the use of Pfizer‘s (NYSE:PFE) Plaxovid, even though the treatment has been in short supply.

Last year, when Merck & Co. (NYSE: MRK) and Pfizer were close to winning regulatory authorization for COVID-19 antivirals, many pundits hailed the treatments as a potential gamechanger.

To date, however, the use of antivirals has been limited although demand has been especially high for Pfizer’s Paxlovid antiviral. Demand for Merck’s molnupiravir has been weak, as a recent article from NPR explains.

Now, Biden’s plan calls for providing the antiviral at no cost immediately after individuals receive a positive COVID-19 test result.

Available under emergency use authorization (EUA), Paxlovid is indicated to treat mild-to-moderate COVID-19 in individuals at least 12 years old who weigh …

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Pfizer’s Paxlovid wins positive opinion from CHMP 

The Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer’s (NYSE:PFE) COVID-19 pill be granted conditional marketing authorization.

Specifically, CHMP recommended that the antiviral, comprising PF-07321332 and ritonavir, be used in adults not requiring supplemental oxygen who face an elevated risk of severe COVID-19.

If the European Commission signs off on the drug, it could be the first oral antiviral available in the region.

The organization provided guidance on the potential use of the drug in December.

To reach its recent recommendation, CHMP scrutinized clinical data from a study demonstrating the drug significantly reduced the risk of hospitalization or death in patients at risk of developing severe COVID-19. That study found that 0.8% of Plaxovid recipients required more than 24 hours of hospitalization compared to 6.3% of those who got placebo. There were no deaths in the Plaxovid group, which comprised 1,039 p…

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