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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.