Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that small­pox vac­ci­na­tion pro­duc­tion is weigh­ing on the mind of the US gov­ern­ment. And man­u­fac­tur­er Bavar­i­an Nordic is the lat­est com­pa­ny to ben­e­fit.

Just a few days af­ter Emer­gent, a com­pa­ny that has made gov­ern­ment con­tracts its lifeblood, ac­quired the ex­clu­sive rights to Tem­bexa from Chimerix, with a $225 mil­lion cash pay­ment and an ex­pect­ed BAR­DA con­tract, the agency has of­fered a con­tract for small­pox vac­cine pro­duc­tion.

BAR­DA has inked a deal with the Dan­ish-based vac­cine and im­munother­a­py man­u­fac­tur­er to sup­ply a freeze-dried ver­sion of the Jyn­neos small­pox vac­cine, al­low­ing for the first dos­es of this ver­sion to be man­u­fac­tured and in­voiced in 2023 and 2024. The op­tions have a $119 mil­lion price tag and rep­re­sent the first op­tions ex­er­cised to con­vert bulk vac­cines in­to freeze-dried dos­es of small­pox vac­cine.

Ad­di­tion­al op­tions on the con­tract are val­ued at $180 mil­lion, and, if ex­er­cised, sup­port con­ver­sion of up to a to­tal of ap­prox­i­mate­ly 13 mil­lion freeze-dried dos­es of the small­pox vac­cine that are ex­pect­ed to be man­u­fac­tured in 2024 and 2025.

The trans­fer of the freeze-dry­ing process to the com­pa­ny’s new fill-and-fin­ish plant in Kvist­gård, Den­mark was ini­ti­at­ed last year and fol­low­ing an FDA in­spec­tion in 2022 will lead to com­mer­cial man­u­fac­tur­ing in 2023. The freeze-dry­ing of a vac­cine, which is be­ing done with some Covid-19 vac­cines, is to pre­serve the vac­cine longer and to trans­port it over longer dis­tances.

Jyn­neos has been part of Bavar­i­an Nordic since 2021. BAR­DA ex­er­cised a $12 mil­lion op­tion to pur­chase more dos­es of the vac­cine as part of a $202 mil­lion or­der made last April for up to 1.4 mil­lion liq­uid-frozen dos­es.

But it seems that small­pox is a high pri­or­i­ty for BAR­DA, as the Emer­gent deal is ex­pect­ed to come with a con­tract in the next three to six months fol­low­ing its clos­ing.

This deal comes about al­so as cas­es of mon­key­pox, which Jyn­neos and oth­er small­pox vac­cines can al­so treat, are ap­pear­ing in Spain, Por­tu­gal and the Unit­ed King­dom ac­cord­ing to Stat.

Mean­while, the deal is an ap­pre­ci­at­ed pick-me-up for Bavar­i­an Nordic, as ear­li­er this month J&J end­ed its col­lab­o­ra­tion and li­cens­ing agree­ments with the Dan­ish com­pa­ny con­cern­ing vac­cines for he­pati­tis B virus and hu­man pa­pil­lo­mavirus­es.

This hasn’t turned back the tide on the stock front, how­ev­er, as its price {$BA­VA.CO} is still down 50% from where it was at the be­gin­ning of the year.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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