Japan can­cels 140M dose or­der for No­vavax Covid vac­cine amid 'low­er than ex­pect­ed' de­mand

Japan has can­celed an or­der for more than 140 mil­lion dos­es of No­vavax’s Covid-19 vac­cine, Take­da re­vealed in an SEC fil­ing.

The coun­try ini­tial­ly agreed in 2021 to pur­chase 150 mil­lion dos­es of the vac­cine from Take­da, which has been pro­duc­ing No­vavax’s vac­cine at its Hikari-based fa­cil­i­ty. But af­ter on­ly pur­chas­ing 8.24 mil­lion dos­es, the Min­istry of Health, Labour and Wel­fare has can­celed the re­main­ing 141.76 mil­lion dos­es.

“We are see­ing low mar­ket de­mand for Nu­vax­ovid, low­er than ex­pect­ed giv­en the cur­rent sit­u­a­tion of vac­ci­na­tion in Japan and preva­lence of Omi­cron,” Cos­ta Saroukos, CFO at Take­da, said dur­ing the com­pa­ny’s Q3 call last week.

Be­cause the dos­es were be­ing man­u­fac­tured as or­ders from the gov­ern­ment came in, there will be no “dis­pos­al” of dos­es as a re­sult of the can­ce­la­tion, Take­da said in the fil­ing on Fri­day.

“Avail­able dos­es of Nu­vax­ovid al­ready sup­plied to the mar­ket can still be used as an op­tion for in­di­vid­u­als who can­not re­ceive a bi­va­lent omi­cron mR­NA vac­cine, or who wish to re­ceive a re­com­bi­nant pro­tein vac­cine,” the SEC fil­ing reads.

How­ev­er, this may not be the end of Take­da’s part­ner­ship with Mary­land-based No­vavax in Japan. Take­da said it’s work­ing with No­vavax to de­vel­op vac­cines against fu­ture vari­ants of Covid-19, and it will “con­tin­ue to work close­ly with the MHLW on the de­liv­ery of COVID-19 vac­cines in FY 2023, in­clud­ing the po­ten­tial de­liv­ery of vac­cines for the Omi­cron vari­ant.”

Two weeks ago, No­vavax CMO Fil­ip Dubovsky said dur­ing the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee that the com­pa­ny is pre­pared to de­liv­er “ei­ther a mono­va­lent or a bi­va­lent vac­cine for the 2023-2024 vac­ci­na­tion sea­son” based on FDA guid­ance. The com­mit­tee vot­ed unan­i­mous­ly in fa­vor of “har­mo­niz­ing” Covid vac­cine com­po­si­tions, mean­ing all fu­ture vac­cine re­cip­i­ents would re­ceive a bi­va­lent vac­cine, re­gard­less of whether they’ve got­ten their pri­ma­ry se­ries.

Take­da said the can­ce­la­tion is “im­ma­te­r­i­al” and doesn’t change the full-year con­sol­i­dat­ed fore­casts for the fis­cal year end­ing in March.

Ac­cord­ing to the SEC fil­ing, “there is no change in the ap­prox­i­mate­ly 50.0 bil­lion JPY rev­enue con­tri­bu­tion from COVID-19 vac­cines, in­clud­ing Spike­vax In­tra­mus­cu­lar In­jec­tion, in FY2022.”

The No­vavax shot was orig­i­nal­ly ap­proved in Japan in April of last year for pri­ma­ry and boost­er im­mu­niza­tion in in­di­vid­u­als aged 18 and old­er. Dis­tri­b­u­tion in Japan be­gan in May 2022.

Take­da and No­vavax de­clined to share ad­di­tion­al in­for­ma­tion oth­er than what was in the SEC fil­ing.

Ed­i­tor’s Note: The sto­ry has been cor­rect­ed to ref­er­ence Take­da’s Q3 re­cent re­port, not Q4.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

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Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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