Covid-19 roundup: In­vestors call to link CEO salaries to vac­cine ac­cess; Why there aren't more ini­tial sup­plies of the Pfiz­er pill

A group of in­sti­tu­tion­al in­vestors from No­mu­ra, BMO, GAM and more than 60 oth­ers rep­re­sent­ing tril­lions in as­sets are now call­ing on Covid-19 vac­cine de­vel­op­ers to link their ex­ec­u­tives’ pay to en­sure the vac­cines are avail­able glob­al­ly.

“It is clear that cur­rent­ly a large part of the world pop­u­la­tion still does not have suf­fi­cient and eq­ui­table ac­cess to vac­cines,” the in­vestors said in ex­plain­ing their rea­son­ing be­hind Thurs­day’s let­ter to the ex­ecs at Pfiz­er, Mod­er­na, As­traZeneca and J&J.

The push comes as all of the com­pa­nies have pledged to make low­er-cost ver­sions of their vac­cines avail­able, but many coun­tries still lack cru­cial sup­plies. The WHO has sought to reach the mark of 70% vac­ci­nat­ed in every coun­try af­ter al­most half of its par­tic­i­pat­ing mem­ber coun­tries failed to reach 40% vac­ci­nat­ed in 2021, ac­cord­ing to the Fi­nan­cial Times.

House Re­pub­li­can calls for Omi­cron treat­ment hear­ing

Rep. Michael Burgess (R-TX) is call­ing for a hear­ing with fed­er­al pol­i­cy lead­ers to get a bet­ter un­der­stand­ing of how Con­gress can im­prove the US re­sponse, in­clud­ing via the dis­tri­b­u­tion of ef­fec­tive treat­ments, to bat­tle the new vari­ant Omi­cron, ac­cord­ing to a let­ter sent yes­ter­day to House En­er­gy & Com­merce com­mit­tee chair Frank Pal­lone (D-NJ).

“It would be ben­e­fi­cial to in­vite var­i­ous agen­cies such as the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, the Food and Drug Ad­min­is­tra­tion, and the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty to tes­ti­fy on the de­vel­op­ment process for COVID-19 ther­a­peu­tics and an­tivi­rals, such as mol­nupi­ravir and sotro­vimab, and how we can en­sure ad­e­quate dis­tri­b­u­tion of these op­tions,” he wrote.

Burgess al­so not­ed how due to its ex­pect­ed ef­fec­tive­ness against the Omi­cron vari­ant, ship­ments of Glax­o­SmithK­line and Vir’s sotro­vimab were paused to en­sure re­serves would not be de­plet­ed as the vari­ant spread. “Though this de­ci­sion has since been re­versed, I am very con­cerned about the lim­it­ed sup­ply cur­rent­ly avail­able,” he wrote.

The Sen­ate health com­mit­tee is set to meet next Tues­day to hear from CDC, FDA and NIH of­fi­cials, in­clud­ing act­ing FDA com­mis­sion­er Janet Wood­cock and Pres­i­dent Biden’s top med­ical ad­vi­sor Tony Fau­ci.

Man­u­fac­tur­ing dif­fi­cul­ties mean there will be a lot more of Mer­ck’s pill than Pfiz­er’s in the next few months

Un­til at least March, the US is go­ing to have hun­dreds of thou­sands of more cours­es of Mer­ck’s pill to treat Covid-19, known as mol­nupi­ravir, than Pfiz­er’s pill Paxlovid, even as the US has pur­chased 20 mil­lion pills from Pfiz­er.

Part of the rea­son for this ear­ly dis­crep­an­cy is that while Pfiz­er’s pill might be more ef­fec­tive than Mer­ck’s pill (no one ran a head-to-head tri­al), Pfiz­er’s pill is al­so dif­fi­cult to man­u­fac­ture.

Chemist Derek Lowe wrote in Sci­ence re­cent­ly about how and why Pfiz­er’s pill is dif­fi­cult to make, and how there are short­ages of the reagents used to make it.

“So there’s a short­age of the stuff, that’s used to make the stuff, that’s used to make the stuff, that’s used to make two of the start­ing ma­te­ri­als for Paxlovid. And that’s just one of the reagents,” he wrote. “Re­mem­ber, as com­pli­cat­ed as this may seem, there’s a lot more to set­ting up a pro­duc­tion sup­ply chain than this! What it all means is that when some­one says ‘Oh, we can just make Paxlovid in plants all over the world’, they have left out the rest of the sen­tence, which is ‘. . .if we can get the start­ing ma­te­ri­als’.”

White House coro­n­avirus re­sponse co­or­di­na­tor Jeff Zients al­so re­cent­ly said in a press brief­ing that the US is of­fer­ing what­ev­er it can to help Pfiz­er, but the com­plex chem­istry in­volved in cre­at­ing the ac­tive in­gre­di­ent in the pill means pro­duc­tion takes about six to eight months.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.