Albert Bourla, Pfizer CEO (AP Images)

Covid-19 pill could add an­oth­er $15-25B to Pfiz­er's al­ready tor­rid pan­dem­ic cash flow — an­a­lyst

If you thought Pfiz­er was rak­ing it in with megablock­buster sales of its BioN­Tech-part­nered Covid-19 vac­cine — last pro­ject­ed at $36 bil­lion for 2021 — think again.

As the phar­ma gi­ant sends off its EUA sub­mis­sion for its an­tivi­ral pill to the FDA, the Wash­ing­ton Post, New York Times and oth­ers are re­port­ing that the US gov­ern­ment is plan­ning a $5 bil­lion con­tract to pur­chase 10 mil­lion cours­es of the treat­ment, dubbed Paxlovid.

Bar­clay’s an­a­lysts crunched the num­bers. Their con­clu­sion: That could mean an­oth­er $15 bil­lion to $25 bil­lion in 2022 rev­enue for Pfiz­er if all goes well.

Oral drugs that pa­tients can take at home soon af­ter they start see­ing symp­toms have been hailed as a ma­jor break­through for the pan­dem­ic. Mer­ck was the first to de­liv­er pos­i­tive Phase III re­sults with mol­nupi­ravir, and Pfiz­er quick­ly fol­lowed by show­ing that Paxlovid cut the risk of Covid-re­lat­ed hos­pi­tal­iza­tion or death by 89% com­pared to place­bo.

Mer­ck has fore­cast about $7 bil­lion in mol­nupi­ravir sales through the end of next year.

The re­port­ed terms of Pfiz­er’s sup­ply deal, Bar­clays an­a­lysts wrote, im­ply greater vol­ume but low­er pric­ing than the con­tracts Mer­ck ne­go­ti­at­ed. Where­as mol­nupi­ravir was sold at about $700 per course, Paxlovid’s price is es­ti­mat­ed at $300 to $500 per course.

Be­sides, they added, “the US gov­ern­ment se­cured vol­umes more than 3x what it has al­ready se­cured for Mer­ck’s mol­nupi­ravir (10mn vs. 3.1mn).”

To get the $15-25 bil­lion num­ber, they made the as­sump­tion that 90% of dos­es are dis­trib­uted.

Both com­pa­nies have pledged to share their patents with gener­ic mak­ers and non­prof­its so that de­vel­op­ing coun­tries can ac­cess them at a much low­er cost.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Robert Califf (AP Photo/Manuel Balce Ceneta)

FDA au­tho­rizes boost­er dose of Pfiz­er and BioN­Tech's Covid-19 vac­cine in 5- to 11-year-olds

The latest wave of the pandemic — marked by Omicron and its sub-variants — has seen higher hospitalization rates for young children, health agencies have observed. That’s part of the reason why the FDA is authorizing a booster shot for kids between 5 and 11 years old.

Regulators on Tuesday OK’d a single booster dose of Pfizer and BioNTech’s mRNA vaccine for children who received their primary series with the same vaccine at least five months ago. By Pfizer’s count, that makes more than 8 million 5- to 11-year-olds eligible for another dose.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.