Re­gen­eron to seek EUA for low­er dose of Covid-19 mAb cock­tail as new tri­al shows ma­jor drop in risk of hos­pi­tal­iza­tion or death

The suc­cess of mon­o­clon­al an­ti­body (mAb) cock­tails in keep­ing peo­ple with Covid-19 out of the hos­pi­tal con­tin­ued Tues­day, with Re­gen­eron an­nounc­ing that even a low­er-than-au­tho­rized dose of its com­bi­na­tion of mAbs re­duced hos­pi­tal­iza­tion or death by 70% in non-hos­pi­tal­ized Covid-19 pa­tients.

George Yan­copou­los

“We will rapid­ly dis­cuss the new da­ta with reg­u­la­to­ry au­thor­i­ties and re­quest that the 1,200 mg dose be added to the U.S. Emer­gency Use Au­tho­riza­tion, in or­der for the an­tic­i­pat­ed RE­GEN-COV sup­ply to be avail­able to treat even more pa­tients,” George Yan­copou­los, pres­i­dent and CSO of Re­gen­eron, said in a state­ment.

The place­bo-con­trolled tri­al of more than 4,500 peo­ple showed how casiriv­imab and imde­vimab re­duced the risk of hos­pi­tal­iza­tion or death by 70% for the 1,200 mg IV dose, and 71% for the au­tho­rized 2,400 mg IV ver­sion, when com­pared to place­bo, the com­pa­ny said.

In ad­di­tion, Re­gen­eron said a dose-rang­ing Phase II tri­al of 815 non-hos­pi­tal­ized Covid-19 pa­tients showed “sig­nif­i­cant and com­pa­ra­ble vi­ral re­duc­tions” for all dos­es test­ed of the mAb com­bo, in­clud­ing as low as 300 mg. A com­pa­ny spokesper­son said fur­ther dis­cus­sions with the FDA will be nec­es­sary to dis­cuss sub­cu­ta­neous ad­min­is­tra­tion, and “even low­er dose pos­si­bil­i­ties in the fu­ture.”

Walid Gel­lad

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, who’s un­af­fil­i­at­ed with the re­sults, said that they show yet an­oth­er ex­am­ple of how ef­fec­tive these mAbs are for out­pa­tient use to re­duce hos­pi­tal­iza­tion.

“Com­pa­nies in a pan­dem­ic should be ap­plaud­ed for test­ing low­er dos­es, which will ex­tend sup­ply,” he added.

De­spite the pos­i­tive new da­ta, dos­es of the Re­gen­eron and Eli Lil­ly mAb cock­tails have been dif­fi­cult to come by and states have had to grap­ple with fig­ur­ing out new ways to ad­min­is­ter the in­fu­sions.

A Re­gen­eron spokesper­son said the com­pa­ny so far has de­liv­ered near­ly 300,000 dos­es to the US (al­though the gov­ern­ment’s web­site still says it’s dis­trib­uted about 150,000 as of ear­ly Feb­ru­ary). Be­gin­ning in April, Re­gen­eron will de­liv­er sup­plies of the mAb cock­tail un­der its sec­ond con­tract with the US gov­ern­ment, which will pro­vide 750,000 or more dos­es by mid-year.

“Most re­cent­ly we have said we ex­pect to pro­vide ap­prox­i­mate­ly 750,000 dos­es at the 2,400 mg dose lev­el by June 30, but now we an­tic­i­pate be­ing able to pro­vide more if the 1,200 mg dose is added to the EUA,” the spokesper­son added.

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.

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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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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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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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

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.