Dawn O’Connell, HHS' assistant secretary for preparedness and response (Michael Brochstein/Sipa USA)(Sipa via AP Images)

US ex­pects to soon run out of gov­ern­ment Covid-19 funds for vac­cines, treat­ments

The US gov­ern­ment is sound­ing the alarm that com­ing up lat­er this year and in 2023, it won’t be able to pay for Covid-19 vac­cines, treat­ments and pro­phy­lac­tics mov­ing for­ward, and these prod­ucts will tran­si­tion to the com­mer­cial mar­ket.

While the US will dole out about 170 mil­lion of the up­com­ing bi­va­lent boost­ers for free this fall and win­ter, start­ing as ear­ly as Jan­u­ary 2023, the Biden ad­min­is­tra­tion an­tic­i­pates “no longer hav­ing fed­er­al funds to pur­chase or dis­trib­ute vac­cines and will need to tran­si­tion these ac­tiv­i­ties to the com­mer­cial mar­ket,” Dawn O’Con­nell, HHS’ as­sis­tant sec­re­tary for pre­pared­ness and re­sponse, wrote in a blog post yes­ter­day.

The drop-off in pay­ments comes as Con­gress couldn’t get its act to­geth­er to pass ad­di­tion­al fund­ing re­lat­ed to Covid-19, as Re­pub­li­cans pre­vi­ous­ly called on HHS to re­pur­pose mon­ey that it al­ready re­ceived in pri­or spend­ing pack­ages. But Sen­ate Dems late last month pro­posed $22 bil­lion in 2023 emer­gency sup­ple­men­tal fund­ing for the next phase of the pan­dem­ic, in­clud­ing $16 bil­lion to sup­port the R&D, man­u­fac­tur­ing, pur­chase and dis­tri­b­u­tion of vac­cines, ther­a­peu­tics, di­ag­nos­tics and oth­er med­ical coun­ter­mea­sures.

As far as when these tran­si­tions to the com­mer­cial mar­ket may oc­cur, on the ther­a­peu­tic side, where Eli Lil­ly’s bebtelovimab al­ready tran­si­tioned ear­li­er this month, the re­main­ing fed­er­al sup­ply of As­traZeneca’s pre­ven­ta­tive treat­ment Evusheld (about 750,000 cours­es of the 1.5 mil­lion or­dered re­main) as soon as ear­ly 2023, fol­lowed by Mer­ck’s oral an­tivi­ral Lagevrio (about 2.5 mil­lion cours­es re­main) some­time in Q1 or Q2 of next year, and Pfiz­er’s Paxlovid (7.3 mil­lion cours­es or­dered by states of the to­tal US or­der for 20 mil­lion cours­es) in mid-2023.

HHS yes­ter­day con­vened a meet­ing of more than 100 rep­re­sen­ta­tives from state and lo­cal gov­ern­ments, health care providers, in­sur­ers, phar­ma com­pa­nies, pa­tient ad­vo­cates, and more, to dis­cuss the path­way to com­mer­cial­iza­tion for both vac­cines and ther­a­peu­tics.

“Dur­ing the meet­ing, we dis­cussed our shared goals of tran­si­tion­ing these prod­ucts in a way that en­sures con­tin­ued eq­ui­table ac­cess for all Amer­i­cans and pre­pares us for what­ev­er may come next with this virus that has been any­thing but pre­dictable,” O’Con­nell said.

But all hope isn’t lost that Con­gress may find some agree­ment on ad­di­tion­al funds for Covid vac­cines and ther­a­peu­tics. Two top Re­pub­li­can sen­a­tors this week urged the Biden ad­min­is­tra­tion to put to­geth­er a plan for the next wave of vac­cine R&D.

Sens. Richard Burr of North Car­oli­na, who’s re­tir­ing this year, and James In­hofe of Ok­la­homa asked Biden to sub­mit to Con­gress a “con­crete pro­pos­al” to es­tab­lish an Op­er­a­tion Warp Speed 2.0 by the end of the year

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.