Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

Covid-19 roundup: As­traZeneca launch­es new virus R&D di­vi­sion; US buys more of Mer­ck­'s an­tivi­ral pill

As­traZeneca is launch­ing a new di­vi­sion to en­com­pass its vac­cine and an­ti­bod­ies busi­ness­es.

The sub­unit will fo­cus on its Covid-19 vac­cine and long-act­ing an­ti­body com­bi­na­tion, a com­pa­ny spokesper­son told End­points News in an email, as As­traZeneca looks to move past its ear­ly pan­dem­ic stum­bles. Iskra Reić, who cur­rent­ly serves as ex­ec­u­tive VP for Eu­rope and Cana­da, will lead the di­vi­sion.

“In or­der to op­ti­mise the man­age­ment of our ex­ist­ing port­fo­lio of vac­cines and an­ti­bod­ies for vi­ral res­pi­ra­to­ry in­fec­tions, we are cre­at­ing a ded­i­cat­ed Vac­cines and Im­mune Ther­a­pies Unit that brings to­geth­er R&D, man­u­fac­tur­ing, com­mer­cial and med­ical teams,” the spokesper­son wrote. “The team will be ded­i­cat­ed to our COVID-19 vac­cine, our long-act­ing an­ti­body com­bi­na­tion and our de­vel­op­men­tal vac­cine ad­dress­ing mul­ti­ple vari­ants of con­cern, as well as to our ex­ist­ing port­fo­lio for res­pi­ra­to­ry vi­ral dis­ease.”

The Fi­nan­cial Times first re­port­ed the news Tues­day morn­ing. There like­ly won’t be any sig­nif­i­cant in­vest­ment to go along with the re­or­ga­ni­za­tion, FT re­port­ed, with an­oth­er As­traZeneca of­fi­cial claim­ing CEO Pas­cal So­ri­ot will be able to hone in more on oth­er busi­ness­es like on­col­o­gy.

As­traZeneca start­ed off the Covid-19 vac­cine race as one of the in­dus­try’s lead­ers, part­ner­ing with Ox­ford Uni­ver­si­ty on a shot based on ade­n­ovirus tech­nol­o­gy. The com­pa­ny start­ed its large-scale Phase III around the same time as Pfiz­er/BioN­Tech and Mod­er­na, en­rolling thou­sands of par­tic­i­pants in sum­mer 2020.

But around La­bor Day of that year, As­traZeneca halt­ed that Phase III study glob­al­ly af­ter a par­tic­i­pant de­vel­oped symp­toms thought to re­sem­ble a neu­ro­log­i­cal con­di­tion. The tri­al soon re­sumed out­side the US, but didn’t get the FDA go-ahead for about an­oth­er month af­ter the ini­tial pause.

Then, in March 2021, As­traZeneca drew fire from sci­en­tists af­ter re­veal­ing in­ter­im re­sults from the Phase III, with NI­AID di­rec­tor An­tho­ny Fau­ci crit­i­ciz­ing the com­pa­ny for post­ing “out­dat­ed in­for­ma­tion.” At the time, the lat­est da­ta re­port­ed by As­traZeneca in­clud­ed re­sults on­ly through Feb. 17, 2021, more than a month be­fore send­ing out its press re­lease.

When the com­pa­ny scram­bled to an­nounce the newest da­ta, though, hours lat­er, the ef­fi­ca­cy was vir­tu­al­ly the same.

Around the same time, sev­er­al Eu­ro­pean coun­tries — where the shot had al­ready been au­tho­rized — were halt­ing use of the vac­cine over fears of blood clots. Some coun­tries al­so threat­ened to sue As­traZeneca over vac­cine ship­ment de­lays.

The vac­cine has nev­er­the­less served as the pri­ma­ry Covid-19 shot for large swaths of the globe, in­clud­ing for many places un­able to ac­quire mR­NA shots. As­traZeneca and its part­ner the Serum Serum have shipped over 1.3 bil­lion dos­es.

It’s been a long, bumpy road for As­traZeneca’s Covid-19 R&D, but Tues­day’s re­port is os­ten­si­bly an at­tempt to move past the mis­steps. As­traZeneca’s vac­cine is still not au­tho­rized in the US, how­ev­er, and it’s un­clear if the new di­vi­sion will al­so take on the com­pa­ny’s at­tempts to per­suade the FDA. — Max Gel­man

US opts in­to buy­ing more Mer­ck an­tivi­ral pills

As the race for Covid-19 an­tivi­ral pill treat­ments heats up be­tween Mer­ck and Pfiz­er, the for­mer is try­ing to en­sure it can cap­ture as much of the mar­ket as pos­si­ble be­fore a po­ten­tial au­tho­riza­tion.

Mer­ck an­nounced Tues­day that the US gov­ern­ment had pur­chased an­oth­er 1.4 mil­lion cours­es of mol­nupi­ravir, the in­ves­ti­ga­tion­al pill the com­pa­ny said can cut hos­pi­tal­iza­tion and death from Covid-19 by 50%. In ex­change for the pills, Mer­ck will net rough­ly $1 bil­lion should the EUA come through in the next few weeks.

Mol­nupi­ravir is slat­ed for an ad­comm on Nov. 30 af­ter Mer­ck and its part­ner Ridge­back Bio­ther­a­peu­tics sub­mit­ted their pitch last month.

Frank Clyburn

“In light of the con­tin­ued im­pact of the pan­dem­ic on hun­dreds of thou­sands of peo­ple every day, all of us at Mer­ck are mov­ing with ur­gency and rig­or to bring mol­nupi­ravir, with its com­pelling da­ta show­ing a sig­nif­i­cant re­duc­tion in death and hos­pi­tal­iza­tions, to pa­tients as quick­ly as we can,” Mer­ck pres­i­dent of hu­man health Frank Clyburn said in a state­ment.

With Tues­day’s new op­tions ex­er­cised, the US has now pur­chased more than 3 mil­lion cours­es of the Covid-19 an­tivi­ral, to be ac­quired from au­tho­riza­tion through ear­ly 2022, Mer­ck said. The con­tracts have earned Mer­ck a cool $2.2 bil­lion so far, and there are two mil­lion cours­es avail­able through fur­ther op­tions.

Mer­ck and Ridge­back first an­nounced their pill could re­duce the chance that a new­ly di­ag­nosed Covid-19 pa­tient would be hos­pi­tal­ized or die at the be­gin­ning of Oc­to­ber, claim­ing a po­ten­tial pan­dem­ic break­through. Should it be au­tho­rized, the pill would give doc­tors and hos­pi­tals a new tool — on top of mon­o­clon­al an­ti­bod­ies — to keep at-risk in­di­vid­u­als out of in­ten­sive care.

Though the an­ti­body treat­ments have proved po­tent, they re­quire IV in­fu­sions or in­jec­tions and can prove rel­a­tive­ly in­ac­ces­si­ble in ar­eas with lim­it­ed re­sources.

But soon af­ter Mer­ck’s rev­e­la­tion, Pfiz­er saun­tered in with a pill it claims can re­duce hos­pi­tal­iza­tions and deaths in new Covid-19 pa­tients by 89%. Pfiz­er, which an­nounced the news last Fri­day, added that it hasn’t agreed to any US deal just yet, though it has signed ad­vance agree­ments with sev­er­al oth­er coun­tries.

All eyes will like­ly be on the up­com­ing arms race for a po­ten­tial­ly multi­bil­lion dol­lar mar­ket, and it’s one where Mer­ck may face some added pres­sure. Pfiz­er’s Covid-19 vac­cine was the first ap­proved and has made the com­pa­ny bil­lions, while Mer­ck — the world’s lead­ing vac­cine mak­er pri­or to the pan­dem­ic — struck out in its ear­ly vac­cine at­tempts. — Max Gel­man

In­ovio gets FDA per­mis­sion to start PhI­II vax tri­al

Small biotech In­ovio has been fac­ing sev­er­al road­blocks in the US with its Covid-19 vac­cine can­di­date.

The com­pa­ny’s planned Phase II/III tri­al got put on hold last Sep­tem­ber. Af­ter the FDA signed off on the Phase II seg­ment of the tri­al more than a month lat­er, it left the Phase III por­tion in lim­bo. Then, the DoD scut­tled its fund­ing for the PhI­II por­tion ear­li­er this year.

Now, the biotech fi­nal­ly gets to start the next phase of the tri­al in the US.

In­ovio said via a press re­lease this morn­ing that the FDA grant­ed au­tho­riza­tion to the biotech to start the Phase III seg­ment of a clin­i­cal tri­al for the in­ves­ti­ga­tion­al INO-4800 in the US, by lift­ing the par­tial clin­i­cal hold put on the study near­ly 14 months ago.

This comes three months af­ter Brazil OK’d the Phase III seg­ment of the tri­al.

“To­day’s U.S. an­nounce­ment builds on our in­ten­sive glob­al ef­forts in In­dia, Brazil, Philip­pines, Mex­i­co, Colom­bia, and Thai­land where we have re­ceived au­tho­riza­tions to date,” said CEO Joseph Kim in a state­ment.

In­ovio is part­ner­ing with Ad­vac­cine Bio­phar­ma­ceu­ti­cals, based in Suzhou, Chi­na, to con­duct the Phase III seg­ment of the tri­al in mul­ti­ple coun­tries in the Amer­i­c­as, Asia, and Africa, which will eval­u­ate the ef­fi­ca­cy of the vac­cine in two dos­es, giv­en one month apart. — Paul Schloess­er

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

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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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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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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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.

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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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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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