US paus­es dis­tri­b­u­tion of GSK/Vir's Covid mAb not due to Omi­cron, but greater sup­ply of Eli Lil­ly mAbs

The US gov­ern­ment is shift­ing its dis­tri­b­u­tion of mAb in­fu­sions to fight the coro­n­avirus, de­cid­ing to go from sup­ply­ing tens of thou­sands of dos­es of Glax­o­SmithK­line and Vir’s mAb treat­ment sotro­vimab in re­cent months to ze­ro dos­es for the en­tire month of De­cem­ber.

That halt has led to spec­u­la­tion the gov­ern­ment was pri­or­i­tiz­ing the dis­tri­b­u­tion of Re­gen­eron mAb com­bo of casiriv­imab and imde­vimab and Eli Lil­ly’s com­bo of bam­lanivimab and ete­se­vimab be­cause both com­pa­nies have in­di­cat­ed that their in­fu­sions might not work as well against the Omi­cron vari­ant (when com­pared to Delta).

But an HHS spokesper­son said the rapid rise of the Omi­cron vari­ant was not the cause for this pause in sotro­vimab ship­ments.

“We tem­porar­i­ly paused dis­tri­b­u­tion of sotro­vimab in or­der to uti­lize more of the bam­lanivimab/ete­se­vimab prod­uct, of which we have greater sup­ply and be­cause the prod­uct re­cent­ly re­ceived an ex­pand­ed FDA emer­gency use au­tho­riza­tion to now in­clude pe­di­atric pa­tients,” an HHS spokesper­son said. “We will con­tin­ue to as­sess the COVID-19 en­vi­ron­ment and ad­just prod­uct dis­tri­b­u­tion ac­cord­ing­ly.”

Lil­ly said in a state­ment that it has been ramp­ing up ship­ments over the past three months. In ear­ly No­vem­ber, the com­pa­ny said it signed a $1.29 bil­lion deal to sup­ply more than 600,000 dos­es of the bam­lanivimab with ete­se­vimab com­bo, by no lat­er than Jan. 31, 2022.

In­evitably the Omi­cron vari­ant may end up caus­ing the fed­er­al gov­ern­ment to pri­or­i­tize sotro­vimab again as lab stud­ies in­di­cate GSK and Vir’s mAb may fair bet­ter against the Omi­cron vari­ant than Re­gen­eron or Lil­ly, al­though its ef­fi­ca­cy will like­ly still de­cline. GSK de­clined to com­ment on the gov­ern­ment’s dis­tri­b­u­tion plan.

The FDA is al­so like­ly to of­fer its take on the vari­ant sit­u­a­tion, as the agency in March up­dat­ed its fact sheets on the Eli Lil­ly and Re­gen­eron mAbs, pro­vid­ing new da­ta on how they fared against the pre­vi­ous vari­ants orig­i­nat­ing in the UK, Brazil, South Africa, Cal­i­for­nia and New York.

GSK and Vir, which said last week that their mAb main­tains its ef­fi­ca­cy against Omi­cron, turned over the dis­tri­b­u­tion of their mAb to the US gov­ern­ment in Oc­to­ber af­ter strik­ing a near­ly $280 mil­lion pro­cure­ment deal.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Petro Terblanche, Afrigen Biologics managing director (Kristin Palitza/picture-alliance/dpa/AP Images)

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

NEW YORK — When vaccines from high-income countries did not arrive in Africa, a local WHO-backed company decided to take the matter into its own hands.

The South Africa-based company Afrigen Biologics and Vaccines has developed the continent’s first mRNA Covid-19 vaccine that will enter clinical trials in early 2023. Afrigen developed the shot by copying publicly available sequencing information about Moderna’s shot after the biotech and Pfizer refused assistance.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

Though Moderna’s bivalent vaccine to counter the Omicron variant has cleared the initial hurdles in getting FDA authorization, the vaccine maker is moving on to the next step.

On Twitter, the company announced on Friday that it has filed a EUA for its bivalent vaccine for use in adolescents aged 12 through 17 and for smaller children aged six through 11.