US restarts ship­ments of two mAbs that don't work against Omi­cron as Mer­ck pills see wider dis­tri­b­u­tion

For any­one who’s been fol­low­ing how the US gov­ern­ment has been al­lo­cat­ing and ship­ping sup­plies of its Covid-19 treat­ments over the past year, the news has shift­ed so many times that it can be dif­fi­cult to keep track of what’s still be­ing shipped and where.

More change is com­ing this week too, as HHS has now de­cid­ed to re-start ship­ments of both Eli Lil­ly (bam­lanivimab plus ete­se­vimab) and Re­gen­eron (casiriv­imab plus imde­vimab) mon­o­clon­al an­ti­body prod­ucts af­ter a short pause be­cause nei­ther prod­uct works against the new vari­ant Omi­cron. Lil­ly’s com­bo al­so was halt­ed last June due to the pres­ence of oth­er vari­ants.

“If the Delta VOC [vari­ant of con­cern] still rep­re­sents a sig­nif­i­cant pro­por­tion of in­fec­tions in a re­gion and oth­er op­tions are not avail­able or are con­traindi­cat­ed, el­i­gi­ble pa­tients can be of­fered bam­lanivimab plus ete­se­vimab or casiriv­imab plus imde­vimab, with the un­der­stand­ing that these treat­ments would be in­ef­fec­tive if the pa­tients are in­fect­ed with the Omi­cron VOC,” HHS’ AS­PR said in a state­ment.

The an­nounce­ment comes as the US has restart­ed ship­ments of Glax­o­SmithK­line and Vir’s mAb sotro­vimab, which does work against Omi­cron, and as ship­ments be­gan of As­traZeneca’s pro­phy­lac­tic an­ti­body Evusheld, as well as the Mer­ck and Pfiz­er pills to treat Covid, all of which are in short sup­ply as Omi­cron cas­es rise na­tion­wide.

While the restart for the Lil­ly and Re­gen­eron mon­o­clon­al an­ti­bod­ies could po­ten­tial­ly cre­ate is­sues if cer­tain ad­min­is­ter­ing sites can­not iden­ti­fy if some­one who’s test­ed pos­i­tive for Covid-19 has ei­ther the Omi­cron or Delta strain, some doc­tors think the move by HHS still makes sense.

Walid Gel­lad

“I think it’s the right move, since there is still Delta around and some fa­cil­i­ties may have abil­i­ty to de­ter­mine which in­fec­tions are Delta still,” Walid Gel­lad, pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News. “Yes, the risk is some with Omi­cron will get old­er ver­sions, while risk, on the oth­er hand, is pa­tients with Delta not get­ting a mAb be­cause of se­vere short­ages of sotro­vimab. It’s not an ide­al sit­u­a­tion in any way, but bet­ter in my view to have it avail­able for pre­scribers who are knowl­edge­able to have it as an op­tion.”

On­ly re­gions with greater than 80% Omi­cron preva­lence will not re­ceive the Lil­ly and Re­gen­eron mAbs, HHS said. But sites with more than 80% Omi­cron preva­lence may con­tin­ue to re­ceive prod­uct up­on re­quest.

“It re­al­ly is a provider’s de­ci­sion which treat­ment to use. While of course we want the ef­fec­tive treat­ments to be matched with the ap­pro­pri­ate vari­ants, I think our big­ger con­cern is if pa­tients in­fect­ed with Delta who could ben­e­fit from mAbs are not re­ceiv­ing any treat­ment at all due to a false as­sump­tion that they have Omi­cron,” a Re­gen­eron spokesper­son told End­points.

But oth­ers not­ed the time con­straints and dif­fi­cul­ty in guess­ing, now that the CDC says that more than 90% of cas­es na­tion­wide are due to Omi­cron.

“As far as I am aware, the vast ma­jor­i­ty of sites are not equipped to dis­tin­guish the vari­ants in the short time frame nec­es­sary to give mAbs. Ad­min­is­tra­tion in most cas­es is like­ly to be a mat­ter of play­ing the odds about which vari­ant is the most like­ly cause of the in­fec­tion,” Jeff Hen­der­son, as­so­ciate pro­fes­sor in the in­fec­tious dis­ease de­part­ment of Wash­ing­ton Uni­ver­si­ty School of Med­i­cine in St. Louis, told End­points.

He al­so not­ed that con­va­les­cent plas­ma from donors who have re­cov­ered from in­fec­tion and have been im­mu­nized “may be ef­fec­tive with both Omi­cron and non-Omi­cron vari­ants but is in ex­treme­ly lim­it­ed sup­ply un­less col­lec­tions re­sume.” The FDA re­cent­ly changed its EUA for con­va­les­cent plas­ma to al­low for out­pa­tient use in im­muno­sup­pressed pa­tients.

Mean­while, in a call last week with state health of­fi­cials, AS­PR of­fi­cials said the ju­ris­dic­tions are like­ly to see more of the Mer­ck pill than the Pfiz­er pill un­til at least March. So far, the US has shipped out more than 300,000 cours­es of the Mer­ck pill, and about 65,000 of the Pfiz­er pill, which AS­PR said takes longer to man­u­fac­ture.

In to­tal, the US will have ac­cess to 3 mil­lion cours­es of the Mer­ck pill, and 20 mil­lion of the Pfiz­er pill. But Pfiz­er said in a state­ment on Tues­day that 10 mil­lion of those cours­es will be avail­able by June, and the re­main­ing 10 mil­lion to fol­low by the end of Sep­tem­ber.

Cur­rent­ly, the pills are be­ing dis­trib­uted based on pop­u­la­tion da­ta, but AS­PR said the two oral an­tivi­rals will be dis­trib­uted based on dis­ease bur­den in the com­ing weeks. Al­so new: A web­site that says which phar­ma­cies have the Mer­ck and Pfiz­er pills.

“As you can imag­ine we re­ly heav­i­ly on good re­port­ing of use, to see where there’s up­take of prod­uct and match that against sur­veil­lance da­ta on dis­ease bur­den,”  BAR­DA’s Derek Eis­nor said on the call.

Ar­ti­cle up­dat­ed with new in­for­ma­tion on Omi­cron from CDC, and com­ment from Dr. Hen­der­son.

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.