UP­DAT­ED: US ships out all re­main­ing sup­plies of the on­ly Covid mAb treat­ment that works against Omi­cron

Right as the new Omi­cron vari­ant is poised to in­crease rapid­ly across the US, the fed­er­al gov­ern­ment has ef­fec­tive­ly run out of the on­ly mon­o­clon­al an­ti­body treat­ment that works against it, and at least one ma­jor hos­pi­tal sys­tem is now halt­ing all mAb in­fu­sions.

Late last month, the fed­er­al gov­ern­ment paused ship­ments of Glax­o­SmithK­line and Vir’s mAb treat­ment sotro­vimab in or­der to con­serve sup­plies of the on­ly treat­ment that might work against the Omi­cron vari­ant. Last week, how­ev­er, HHS told End­points News that the move to hold back sotro­vimab was un­re­lat­ed to Omi­cron, and due to a sur­plus of Eli Lil­ly mAbs, which aren’t ef­fec­tive against Omi­cron.

But late Fri­day, HHS con­firmed to End­points that the gov­ern­ment was with­hold­ing the sup­plies due to the Omi­cron vari­ant (and apol­o­gized for pro­vid­ing in­ac­cu­rate in­for­ma­tion a day ear­li­er).

HHS al­so si­mul­ta­ne­ous­ly an­nounced that it’s ship­ping its re­main­ing 55,000 dos­es of sotro­vimab, which will be­gin ar­riv­ing in the states on Tues­day un­til more sup­plies hope­ful­ly be­come avail­able the week of Jan. 3. The de­part­ment said in a state­ment:

Ear­ly in vit­ro da­ta sug­gests sotro­vimab works against the Omi­cron vari­ant. As such, we are ac­tive­ly prepar­ing ap­prox­i­mate­ly 55,000 dos­es of sotro­vimab for im­me­di­ate al­lo­ca­tion to state and ter­ri­to­r­i­al health de­part­ments. Ju­ris­dic­tions will be­gin re­ceiv­ing the prod­uct as ear­ly as Tues­day, De­cem­ber 21, 2021. Cur­rent sup­ply of sotro­vimab is lim­it­ed; how­ev­er, we ex­pect it to grow to ap­prox­i­mate­ly 300,000 ad­di­tion­al dos­es in Jan­u­ary.

Scott Got­tlieb

“The feds had no choice but to for­ward de­ploy the lim­it­ed stock­piles they have of the on­ly an­ti­body we know is like­ly to be high­ly po­tent against omi­cron,” for­mer FDA com­mis­sion­er Scott Got­tlieb said.

But the about-face from HHS on why it was with­hold­ing sotro­vimab re­veals an agency scrap­ing to turn a mAb short­age in­to a pos­i­tive sto­ry about how it planned ahead.

In re­al­i­ty, very few hos­pi­tals na­tion­wide will have ad­e­quate sup­plies of sotro­vimab lat­er this week and next week, when cas­es will like­ly surge due to hol­i­day trav­el.

New York, Ohio, Penn­syl­va­nia, Michi­gan and Illi­nois were the on­ly states to re­ceive more than 3,000 dos­es of sotro­vimab each in the lat­est ship­ment.

And HHS is ad­vis­ing states to be cau­tious with its lim­it­ed sup­plies, adding, “Un­til lo­cal preva­lence of Omi­cron is greater than 20%, ju­ris­dic­tions are en­cour­aged to di­rect sotro­vimab to sites that can pro­vide IV treat­ment (with­in 48 hours of col­lec­tion of a pa­tient sam­ple) to high­est risk, el­i­gi­ble in­di­vid­u­als di­ag­nosed with a test that may iden­ti­fy a po­ten­tial case of the Omi­cron vari­ant.”

A spokesper­son for Glax­o­SmithK­line said that GSK and Vir have es­tab­lished a strate­gic man­u­fac­tur­ing net­work that will en­able the man­u­fac­ture of ap­prox­i­mate­ly 2 mil­lion dos­es of sotro­vimab to sup­port emer­gency sup­ply in the first year fol­low­ing EUA.

HHS al­so said Fri­day that the two oth­er avail­able mAbs, from Eli Lil­ly and Re­gen­eron, con­tin­ue to work against the Delta vari­ant, which re­mains the dom­i­nant strain in the US. But with Omi­cron now over 70% of Covid-19 cas­es in the US, use of those two mAbs will like­ly be paused.

The Mt. Sinai hos­pi­tal sys­tem in New York said late Sun­day that it’s sus­pend­ing in­fu­sions of the Lil­ly and Re­gen­eron mAbs due to Omi­cron.

“Due to the in­creas­ing preva­lence of the Omi­cron vari­ant of SARS-CoV-2 and the lack of ef­fi­ca­cy of both bam­lanivimab/ete­se­vimab and casiriv­imab/imde­vimab, we have sus­pend­ed of­fer­ing these two treat­ments for treat­ment or for post-ex­po­sure pro­phy­lax­is,” Mt. Sinai said in a state­ment.

Look­ing for­ward, states will have to pro­tect against Omi­cron with­out the mAb treat­ments, which will like­ly com­pound prob­lems for those who re­main un­vac­ci­nat­ed.

Ed­i­tor’s note: This ar­ti­cle was up­dat­ed with com­ment from GSK.

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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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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