This Could Be Pfizer's Next COVID Blockbuster -- and It Isn't a Vaccine
Category: News & Politics
Via: just-jim-nc-ttth • 3 years ago • 23 commentsBy: Keith Speights (MSN)
Interesting. This could be big.
S E E D E D C O N T E N T
In 2019 and 2020, Pfizer's (NYSE:PFE) top-selling product was pneumococcal vaccine Prevnar 13. It generated over $5.8 billion in sales in both years. That's a lot of money for a very successful product.
© Provided by The Motley Fool This Could Be Pfizer's Next COVID Blockbuster -- and It Isn't a Vaccine
But Prevnar 13 is no longer Pfizer's top-selling product. The COVID-19 vaccine BNT162b2, developed by Pfizer and BioNTech (NASDAQ:BNTX), generated sales of $7.8 billion in the first half of 2021 alone. Pfizer expects the vaccine will rake in $33.5 billion over the entire year. Even with the company splitting profits with BioNTech, Pfizer should conservatively make in the ballpark of $17 billion from BNT162b2 this year.
Even more money could be on the way. Pfizer is busy working on its next potential COVID-19 blockbuster -- and it isn't a vaccine.
© Getty Images A capsule with COVID-19 printed on it on top of a face mask.
Stopping the coronavirus in its tracks
Pfizer has stated for a while that it wouldn't restrict its efforts to fight COVID-19 to only vaccines. It has also focused on developing potential treatments for the infectious disease. The company provided an update on one especially promising therapy in its second-quarter conference call last week.
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Protease inhibitors are a class of antiviral drugs that have been effective in treating HIV and hepatitis C. These therapies bind to protease enzymes in viruses and prevent the virus from replicating.
Pfizer initiated an early stage clinical study evaluating oral protease inhibitor PF-07321332 in March of this year. The company had good news to report from that study in its Q2 update.
Chief scientific officer Mikael Dolsten said that in the phase 1 study, PF-07321332 exceeded the level predicted to inhibit coronavirus viral replication by more than fivefold. Dolsten also stated that the experimental protease inhibitor showed powerful antiviral activity in preclinical testing that could be effective against "all currently known COVID-19 variants."
So far, the experimental antiviral drug appears to have a good safety profile. Dolsten said that there haven't been any safety issues in giving doses of up to 500 milligrams twice per day over a 10-day period.
Based on these encouraging results, Pfizer advanced the oral protease inhibitor into phase 2/3 testing in July. The company will evaluate PF-07321332 in five-day and 10-day treatments for individuals who have been in close contact with someone with COVID-19.
A big market opportunity
Pfizer estimates that the addressable market for its protease inhibitor could be in the hundreds of millions of patients. That doesn't seem farfetched considering the rapid spread of COVID-19 exposure due to the delta variant.
The U.S. Food and Drug Administration (FDA) has already granted Emergency Use Authorization (EUA) to Regeneron's (NASDAQ:REGN) antibody cocktail REGEN-COV as a treatment for hospitalized COVID-19 patients and for post-exposure prophylaxis. However, there are a few drawbacks to Regeneron's therapy.
First, REGEN-COV is expensive -- more than $2,000 per dose. Second, it must be administered via infusion or subcutaneous injection. Third, the current U.S. EUA for post-exposure prophylaxis only applies to individuals who have been exposed to COVID-19 who have a high risk of developing COVID-19 and who haven't been fully vaccinated.
Pfizer's PF-07321332 would be much more convenient than REGEN-COV since it's taken orally. Although the big drugmaker hasn't given any hints about what the pricing for the antiviral therapy might be should it win EUA or approval, a lower price tag could open up a wide market that might include lower-risk individuals who are exposed to COVID-19.
Coming soon?
There shouldn't be a long wait for Pfizer's next potential COVID-19 blockbuster. Assuming the phase 2/3 testing goes well, the company thinks that it will be able to file for U.S. EUA in the fourth quarter of this year.
Pfizer CEO Albert Bourla said in the company's Q2 call that he's given the green light to manufacture "significant quantities" of the oral protease inhibitor so that large volumes of doses will be available if EUA is granted. He added that Pfizer is absorbing the risk of making this investment because "it is the right thing to do."
PF-07321332 probably won't be as big a catalyst for the big pharma stock as the Pfizer-BioNTech COVID-19 vaccine. However, Pfizer won't have to split the profits on the oral therapy as it does with BNT162b2. If the company's late-stage testing of the COVID-19 drug is successful, Pfizer seems very likely to have another blockbuster on its hands in 2022.
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And the beat goes on................necessity being the mother of invention.
Hmmm ... from the 'Trump' vaccine to the 'Biden' pill in 2 short years.
Technology, ain't it great?
Don't really think that Mr. Biden knows this is going on but if you need a small victory for the man, have at it.
You should know my 'sarcasm' by now Jim.
I do LOL. Just thought I'd throw that out there for our readers lest they thought it a serious talking point to be carried forward. Saves some grief that way.
How is the Biden administration involved with development of this product?
There's a really small US government agency called the FDA that is part of the Biden Administration.
I don't think the FDA is involved yet. Sounds to me like Pfizer is doing their own internal testing. I may be wrong but.....................
The same way the Trump administration was involved in the Pfizer COVID vaccine. It's not.
I would agree. Government approval comes later.
So to bring you up to date on my writing style, I use single quotation marks at either end of a word or a phrase to indicate sarcasm. It's not common usage but it is less cumbersome than a /S.
It is in the sense that the FDA does monitor the clinical trials. I found 2 on a simple google search.
Who streamlined the FDA process again?
Certainly not the Turd Reich.
Has nothing to do with the actual development.
So many folks don't dully understand the nature of Capitalism (when its operating properly...).
The true drivers of the economy, the thing that creates wealth &has the potential to increase prosperity...is American innovation by creative entrepreneurs...not by the government!
That's been tried under Communism...and has been a miserable failure, remember?
P.S. "Full Disclosure": I own shares of Pfizer
People in Administrations prior to Mr. Trump
However it was a Trump pet project.
In 2018 the FDA did announce they had "streamlined" "many processes" without naming them or President Trump,
as announced by his choice for leading the FDA Dr. Scott Gottlieb. This was well before CoViD
Oh Trump wanted the COVID vaccines fast tracked and claimed he did, pressuring the next FDA commissioner Stephen Hahn to allow the FDA to make a medical decision on a political directive. An absolute charade.
But the truth is that the current vaccines are not yet FDA approved.
They are approved on an emergency basis only, hence the waivers you sign before each vaccine shot.
Gottlieb was an outstanding FDA director and had he not resigned the response to Covid could have been completely different.
He returned to private practice, made it on to several drug company boards and chronicled the
Trump Administrations failure to treat Covid seriously in a new book Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic
He probably won't be invited to any future Trump events.
This is good news. Thanks for seeding it, Jim
Great news! Hope they get it up and running as soon as safely possible.