Up­dat­ed: Trou­bled Emer­gent claims J&J will owe up to $420M if it pulls the plug on its Covid-19 vac­cine

Em­bat­tled con­tract man­u­fac­tur­er Emer­gent BioSo­lu­tions, which trashed tens of mil­lions of J&J’s Covid-19 vac­cine dos­es be­cause of its con­t­a­m­i­nat­ed Bal­ti­more plant, is now telling J&J that it will have to pay some­where in the range of $125 mil­lion to $420 mil­lion if it ter­mi­nates its Covid man­u­fac­tur­ing con­tract with Emer­gent.

In an SEC fil­ing Mon­day, Emer­gent said that it pro­vid­ed Janssen with “a no­tice of ma­te­r­i­al breach” be­cause Janssen is es­sen­tial­ly wind­ing down its Covid-19 vac­cine op­er­a­tions be­fore ful­fill­ing the min­i­mum re­quire­ments in its con­tract with Emer­gent.

But Janssen’s de­ci­sion to pull back from Covid-19 came as the FDA said last month that cas­es of a rare, life-threat­en­ing syn­drome war­rant se­vere­ly re­strict­ing the au­tho­rized use of the vac­cine. The agency said it con­firmed a to­tal of 60 cas­es of what’s known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome, in­clud­ing 9 deaths re­port­ed to the agency’s Vac­cine Ad­verse Event Re­port­ing Sys­tem, out of about 8 mil­lion dos­es of the one-dose shot ad­min­is­tered.

“Cas­es of TTS fol­low­ing ad­min­is­tra­tion of the Janssen COVID-19 Vac­cine have been re­port­ed in males and fe­males, in a wide age range of in­di­vid­u­als 18 years and old­er, with the high­est re­port­ing rate (ap­prox­i­mate­ly 8 cas­es per 1,000,000 dos­es ad­min­is­tered) in fe­males ages 30-49 years; over­all, ap­prox­i­mate­ly 15% of TTS cas­es have been fa­tal,” the agency said in an up­dat­ed fact sheet for health care providers. “Cur­rent­ly avail­able ev­i­dence sup­ports a causal re­la­tion­ship be­tween TTS and the Janssen COVID-19 Vac­cine.”

De­spite the safe­ty is­sues, Emer­gent tries to make the case that its con­tract with Janssen ini­tial­ly was set to pro­duce “drug sub­stance at large scale for up to five years.”

“Ter­mi­na­tion of the Agree­ment will not af­fect the oblig­a­tion of ei­ther par­ty to make any pay­ments for which it is li­able pri­or to or up­on such ter­mi­na­tion, in­clud­ing pay­ment by Janssen for cer­tain raw ma­te­ri­als pur­chased pur­suant to the Agree­ment pri­or to its ter­mi­na­tion, and pay­ment by Janssen for all ser­vices re­lat­ed to the re­quired min­i­mum quan­ti­ty,” Emer­gent said. “At the time of the No­tice, it is the Com­pa­ny’s po­si­tion that the pay­ments owed to the Com­pa­ny by Janssen, if the Agree­ment were to be ter­mi­nat­ed, would be in the es­ti­mat­ed range of ap­prox­i­mate­ly $125 mil­lion to $420 mil­lion.”

A J&J spokesper­son told End­points that it in­formed Emer­gent last week:

“that we in­tend­ed to ter­mi­nate our man­u­fac­tur­ing agree­ment based on Emer­gent’s breach­es, in­clud­ing fail­ure to sup­ply COVID-19 vac­cine drug sub­stance. To­day, John­son & John­son pro­vid­ed for­mal No­tice of Ter­mi­na­tion and Breach. Emer­gent’s SEC fil­ing to­day is false and mis­lead­ing both with re­spect to the con­trived breach al­le­ga­tion against John­son & John­son and in its fail­ure to dis­close our pri­or no­tice that John­son & John­son would ter­mi­nate the sup­ply agree­ment. We have suf­fi­cient ca­pac­i­ty across our glob­al COVID-19 vac­cine man­u­fac­tur­ing net­work, and we con­tin­ue to meet our con­trac­tu­al oblig­a­tions to sup­ply our vac­cine. We re­main fo­cused on en­sur­ing our COVID-19 vac­cine is avail­able where peo­ple are in need.”

News of the no­tice comes as a Con­gres­sion­al re­port from last month found that near­ly 400 mil­lion dos­es of vac­cine (J&J and As­traZeneca) man­u­fac­tured by Emer­gent at its Bal­ti­more plant had to be de­stroyed be­cause of qual­i­ty and con­t­a­m­i­na­tion is­sues. The com­pa­ny al­so re­ceived more than $625 mil­lion from the US gov­ern­ment, and its con­tracts with both J&J and As­traZeneca were worth a com­bined $656 mil­lion, ac­cord­ing to the New York Times.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with J&J com­ment.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Middletown, Delaware’s main claim to fame was the site location for the film the Dead Poets Society, the city will soon play host to a massive manufacturing outfit.

WuXi AppTec’s contract research and manufacturing subsidiary WuXi STA, has broken ground on a 190-acre manufacturing campus in Middletown.

According to the company, this site will be WuXi’s second facility in the US, and it will create around 500 full-time jobs by 2026, but there are plans to kick off operations in 2025.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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