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.

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.

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 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.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”