Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

GSK and Vir turn to US for dis­tri­b­u­tion as Covid-19 mAb treat­ment nears block­buster sta­tus

Ever since for­mer Pres­i­dent Trump re­ceived an in­fu­sion of Re­gen­eron’s mon­o­clon­al an­ti­body, all three of the now-au­tho­rized Covid-19 mAb treat­ments have been in the spot­light.

The on­ly one fly­ing some­what un­der the radar is al­so the one to most re­cent­ly re­ceive an emer­gency au­tho­riza­tion, which came last May for Glax­o­SmithK­line and Vir Biotech­nol­o­gy’s mAb sotro­vimab. But that third-to-mar­ket sta­tus hasn’t stopped the com­pa­nies from quick­ly sell­ing about $1 bil­lion worth of dos­es in the first six months and re­cent­ly sign­ing a $280 mil­lion US gov­ern­ment con­tract.

While de­clin­ing to dis­close US stats specif­i­cal­ly, to date, Vir said in an SEC fil­ing that bind­ing agree­ments have been re­ceived for the sale of more than 420,000 dos­es of sotro­vimab world­wide, “in­clud­ing a por­tion of those pro­cured by the U.S. gov­ern­ment.” In ad­di­tion, more than 220,000 dos­es have been re­served through oth­er agree­ments, Vir said.

If sotro­vimab is priced sim­i­lar­ly to Re­gen­eron’s casiriv­imab and imde­vimab com­bo, or Lil­ly’s bam­lanivimab and ete­se­vimab com­bo, as the com­pa­nies said it would be, that list price of about $1,500 would amount to al­most $1 bil­lion for GSK and Vir so far.

And where­as the com­pa­nies pre­vi­ous­ly said that they would hit the open mar­ket and dis­trib­ute the treat­ment them­selves, a GSK spokesper­son con­firmed that af­ter about five months of run­ning their own dis­tro ops, they’ve de­cid­ed to let the US gov­ern­ment take over.

In Au­gust, GSK and Vir saw an al­most 300% spike in or­ders com­pared to Ju­ly.

GSK said in an emailed state­ment to End­points News:

We can con­firm that the U.S. gov­ern­ment has agreed to pur­chase sotro­vimab, an in­ves­ti­ga­tion­al mon­o­clon­al an­ti­body for the ear­ly treat­ment of COVID-19.  As part of the agree­ment, which is worth $279,862,800, GSK will sup­ply sotro­vimab to the U.S. gov­ern­ment, en­abling rapid ac­cess to sotro­vimab at no cost to pa­tients. As the pan­dem­ic con­tin­ues, we rec­og­nize the con­tin­ued ur­gency of pa­tient need across the world and con­tin­ue to en­gage with gov­ern­ments and pro­cure­ment bod­ies to sup­port the pan­dem­ic re­sponse.

With de­mand for Covid treat­ments still tick­ing up across the US, the price for mAbs is al­so in­creas­ing. Re­gen­eron in mid-Sep­tem­ber an­nounced a new, $2.9 bil­lion US gov­ern­ment deal for 1.4 mil­lion more dos­es of its mAb com­bo, bring­ing the to­tal pur­chased dos­es by the U.S. gov­ern­ment to near­ly 3 mil­lion. The 1.4 mil­lion dos­es, which are to be sup­plied by Jan. 31, 2022, come at a cost of $2,100 per dose.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Robert Califf (AP Photo/Manuel Balce Ceneta)

FDA au­tho­rizes boost­er dose of Pfiz­er and BioN­Tech's Covid-19 vac­cine in 5- to 11-year-olds

The latest wave of the pandemic — marked by Omicron and its sub-variants — has seen higher hospitalization rates for young children, health agencies have observed. That’s part of the reason why the FDA is authorizing a booster shot for kids between 5 and 11 years old.

Regulators on Tuesday OK’d a single booster dose of Pfizer and BioNTech’s mRNA vaccine for children who received their primary series with the same vaccine at least five months ago. By Pfizer’s count, that makes more than 8 million 5- to 11-year-olds eligible for another dose.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.