Covid-19 roundup: US buys 50M Pfiz­er pe­di­atric dos­es; Vir and GSK pub­lish mAb da­ta in NE­JM

More vac­cine dos­es are on the way as pe­di­atric vac­cines could be­gin to roll out as ear­ly as next week.

The US on Thurs­day pur­chased 50 mil­lion more dos­es of the Pfiz­er/BioN­Tech Covid-19 vac­cine, as part of ef­forts to sup­port pre­pared­ness for all pe­di­atric vac­ci­na­tions, in­clud­ing for chil­dren un­der 5 years of age, pend­ing au­tho­riza­tion. The com­pa­nies said they ex­pect to de­liv­er the dos­es by April 30, 2022. Ini­tial da­ta on the vac­cine for the youngest kids, down to 6 months, are ex­pect­ed as soon as the fourth quar­ter of this year or ear­ly first quar­ter 2022.

The cost of these 50 mil­lion dos­es was not ini­tial­ly made avail­able, al­though the cost of the Pfiz­er vac­cines has steadi­ly risen for the US. The gov­ern­ment ini­tial­ly paid $1.95 bil­lion for the first 100 mil­lion dos­es (about $19.50 per dose) in Ju­ly 2020, but in Ju­ly 2021 paid $24 a dose for 200 mil­lion more dos­es.

This most re­cent pur­chase of 50 mil­lion dos­es is the fi­nal pur­chase op­tion un­der the ex­ist­ing U.S. sup­ply agree­ment with the com­pa­nies, they said, bring­ing the to­tal num­ber of Pfiz­er vac­cine dos­es se­cured un­der the agree­ment since the start of the pan­dem­ic to 600 mil­lion. Sep­a­rate­ly, the com­pa­nies al­so pro­vid­ed 1 bil­lion dos­es to the US gov­ern­ment at a not-for-prof­it price for do­na­tion to low- and low­er-mid­dle-in­come coun­tries.

In to­tal, Pfiz­er and BioN­Tech ex­pect to man­u­fac­ture 3 bil­lion dos­es world­wide in 2021, and 4 bil­lion dos­es next year.

Vir and GSK un­veil PhI­II mAb find­ings in NE­JM

Vir Biotech­nol­o­gy and Glax­o­SmithK­line on Wednes­day evening pub­lished in the New Eng­land Jour­nal of Med­i­cine their Phase III tri­al re­sults for their re­cent­ly au­tho­rized mon­o­clon­al an­ti­body treat­ment for Covid-19, which has been shown to re­duce the risk of dis­ease pro­gres­sion in high-risk pa­tients with mild-to-mod­er­ate dis­ease.

The place­bo-con­trolled tri­al of 583 pa­tients showed that 3 pa­tients (1%) in the sotro­vimab group, ver­sus 21 pa­tients (7%) in the place­bo group, had dis­ease pro­gres­sion lead­ing to hos­pi­tal­iza­tion or death (rel­a­tive risk re­duc­tion, 85%; 97.24% con­fi­dence in­ter­val, 44 to 96; P=0.002).

Au­tho­rized by the FDA in May, the com­pa­nies re­cent­ly tran­si­tioned from dis­trib­ut­ing the treat­ment them­selves, to let the US gov­ern­ment take over. About 100,000 dos­es of sotro­vimab have been dis­trib­uted in the US so far, and Vir said in an SEC fil­ing that bind­ing agree­ments have been re­ceived for the sale of more than 420,000 dos­es of sotro­vimab world­wide.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.