Mod­er­na bags an­oth­er US CD­MO to help with fill-fin­ish work for its vac­cine amid boost­er push

Mod­er­na has en­list­ed an­oth­er CD­MO to ramp up Covid-19 vac­cine man­u­fac­tur­ing ca­pa­bil­i­ty in its ef­fort to pro­vide 3 bil­lion dos­es in 2022.

Juan An­dres

Start­ing in Q3, Ther­mo Fish­er Sci­en­tif­ic will car­ry out fill-fin­ish, la­bel­ing and pack­ag­ing ser­vices to sup­port Mod­er­na at the CD­MO’s Greenville, NC site, the com­pa­ny said in a re­lease.

“Ther­mo Fish­er has been a crit­i­cal part­ner in sup­ply­ing raw ma­te­ri­als for our COVID-19 vac­cine and we are now pleased to fur­ther ex­pand our re­la­tion­ship as an im­por­tant man­u­fac­tur­ing part­ner as well,” said Juan An­dres, Mod­er­na’s chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer, in a state­ment. “The ad­di­tion of Ther­mo Fish­er to our net­work will sup­port our ef­forts to scale up our man­u­fac­tur­ing abil­i­ty.”

Mod­er­na has al­so reached an agree­ment with Lon­za to es­tab­lish a new pro­duc­tion line at the com­pa­ny’s Geleen, Nether­lands site, which will add an ad­di­tion­al 300 mil­lion dos­es per year in ca­pac­i­ty.

The pro­duc­tion in Geleen will help Mod­er­na halve the dosage of its vac­cine for pe­di­atric use and as boost­ers against vari­ants. Mod­er­na has stud­ied low­er-dose ver­sions of its jab to help stretch out the sup­ply. So far, dos­es have con­sist­ed of 100 mi­cro­grams, but Mod­er­na has al­so teamed with ROVI in Grana­da, Spain, to sup­ply 600 mil­lion 50 mi­cro­gram dos­es per year. Both of those pacts will be op­er­a­tional be­fore the end of 2021, the com­pa­ny said in the re­lease.

ROVI and France’s Re­ci­pharm have al­ready been per­form­ing fill-fin­ish ser­vices for Mod­er­na’s vac­cine in Eu­rope. These moves are the lat­est an­nounce­ments in a rapid ramp-up in pro­duc­tion.

Last week, Mod­er­na and Sam­sung Bi­o­log­ics inked a deal for fill-fin­ish du­ties at its In­cheon, South Ko­rea plant. Mod­er­na’s al­so pledged to dou­ble its Mass­a­chu­setts lab space for a 50% in­crease in man­u­fac­tur­ing, dou­ble man­u­fac­tur­ing at Lon­za’s Visp, Switzer­land site and Rovi’s Spain fa­cil­i­ty. In April, Sanofi signed on with Mod­er­na to pro­duce its vac­cine. That marked the third com­pa­ny Sanofi part­nered with to pro­duce the Covid-19 shot af­ter its own at­tempts failed. The French drug­mak­er is al­so pro­duc­ing Pfiz­er-BioN­Tech and J&J’s jab at its man­u­fac­tur­ing sites, in­clud­ing the one in Ridge­field, NJ.

Catal­ent — a Mod­er­na part­ner — and Ster­ling are work­ing to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines.

Mean­while, Mod­er­na’s pledged 50o mil­lion dos­es to CO­V­AX ear­ly last month. Those dos­es will be sold at the low­est tiered price, and go to 92 of the low­est in­come coun­tries by the end of next year. Ac­cord­ing to the agree­ment, 34 mil­lion of those dos­es are set to be de­liv­ered in Q4. Gavi, the vac­cine al­liance has al­ready shipped 49 mil­lion Covid-19 vac­cines do­nat­ed from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Tim Miller, Forge Biologics CEO

CNS-fo­cused gene ther­a­py biotech forges man­u­fac­tur­ing deal for hear­ing loss drug

A growing gene therapy company is teaming up with one of the largest gene therapy manufacturers to get its drug into patients in clinical trials.

Myrtelle announced on Monday that it inked a deal with Forge Biologics to make Myr-201, a gene therapy indicated for monogenic hearing loss. The target patient population, Myrtelle said, is people with a type of hearing loss called DFNB8, or autosomal recessive deafness 8.

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Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Two CRLs lat­er, Illi­nois-based CD­MO hit with FDA warn­ing let­ter over 's­pore-form­ing' bac­te­ria and fun­gi

Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.

Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Carolyn Bertozzi, predicted by some to become a Nobel laureate, clinched one of the world’s top awards in the wee hours of Wednesday, winning the Nobel Prize in Chemistry alongside a repeat winner and a Copenhagen researcher.

The Stanford professor, Morten Meldal of University of Copenhagen and 2001-awardee K. Barry Sharpless of Scripps shared the prize equally. The Nobel is sometimes split in quarters and/or halves.