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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.