Kenya wins $500M sweep­stakes for Mod­er­na's first African man­u­fac­tur­ing site

Af­ter a long wait, Mod­er­na now has a home for its first man­u­fac­tur­ing site in Africa.

The biotech en­tered a mem­o­ran­dum of un­der­stand­ing with the Kenyan gov­ern­ment to fi­nal­ize the coun­try as the site for the coun­try’s first man­u­fac­tur­ing op­er­a­tions on the con­ti­nent. Mod­er­na will in­vest $500 mil­lion in the new site that will first fo­cused on drug sub­stance man­u­fac­tur­ing, and can lat­er be ex­pand­ed to in­clude fill-fin­ish and pack­ag­ing on site.

The site will have the ca­pa­bil­i­ties to pro­duce 500 mil­lion dos­es to Africa each year. The site can al­so ben­e­fit mR­NA can­di­dates that are be­ing de­vel­oped to treat HIV and Ni­pah Virus, a vi­ral in­fec­tion that can pass through con­t­a­m­i­nat­ed foods or an­i­mals.

“We are pleased to part­ner with Mod­er­na in the es­tab­lish­ment of this mR­NA man­u­fac­tur­ing fa­cil­i­ty to help pre­pare the coun­try and our sis­ter states on the con­ti­nent through the African Union to re­spond to fu­ture health crises and stave off the next pan­dem­ic,” Kenyan Pres­i­dent Uhu­ru Keny­at­ta said in a state­ment. “This part­ner­ship is a tes­ta­ment to the ca­pa­bil­i­ties of our com­mu­ni­ty and our com­mit­ment to tech­no­log­i­cal in­no­va­tion. Mod­er­na’s in­vest­ment in Kenya will help ad­vance eq­ui­table glob­al vac­cine ac­cess and is em­blem­at­ic of the struc­tur­al de­vel­op­ments that will en­able Africa to be­come an en­gine of sus­tain­able glob­al growth.”

The news comes af­ter months of pub­lic scruti­ny. CEO Stéphane Ban­cel an­nounced at the be­gin­ning of Oc­to­ber that his com­pa­ny would in­vest half a bil­lion dol­lars in­to a plant some­where in Africa, though it didn’t dis­close any fur­ther de­tails, in­clud­ing where ex­act­ly on the con­ti­nent it would be lo­cat­ed.

Mod­er­na is among a num­ber of biotechs that faced crit­i­cism for its vac­cine shar­ing from ad­vo­ca­cy groups, such as Pub­lic Cit­i­zen and mem­bers from Pres­i­dent Joe Biden’s ad­min­is­tra­tion, who ques­tioned why the num­ber of dos­es pledged to low­er- and mid­dle-in­come coun­tries are much low­er than oth­er com­pa­nies. An in­ves­ti­ga­tion from the New York Times found that 1 mil­lion of Mod­er­na’s dos­es have gone to coun­tries clas­si­fied as low-in­come by the World Bank, com­pared with 8.4 mil­lion from Pfiz­er and 25 mil­lion from J&J. That, Ban­cel said in a 2021 in­ter­view with End­points News, can be – in part – chalked up to the dis­par­i­ty in the size of the com­pa­nies.

The two sides will get help from the US gov­ern­ment. In Sep­tem­ber 2021, the US State De­part­ment do­nat­ed 880,320 dos­es of Mod­er­na’s Covid-19 vac­cine to Kenya in col­lab­o­ra­tion with the African Union and Co­v­ax pro­gram. Mod­er­na’s mR­NA pipeline in­cludes 28 vac­cine pro­grams in the pro­phy­lac­tic modal­i­ty for threats to pub­lic health, the com­pa­ny said in a re­lease. The com­pa­ny’s can­di­date mR­NA-1893 is in Phase II tri­als to treat the Zi­ka virus and it is ex­plor­ing treat­ment op­tions for yel­low fever. Once the pan­dem­ic eas­es up, Mod­er­na will be able to switch swift­ly from man­u­fac­tur­ing one drug to an­oth­er, such as from the Zi­ka vac­cine to a flu shot.

BioN­Tech is, so far, the on­ly oth­er biotech to lay out con­crete plans sur­round­ing the long-term use for mR­NA on the African con­ti­nent. The Ger­man com­pa­ny said it would tran­si­tion to mak­ing malar­ia drugs once the pan­dem­ic is un­der con­trol.

The biotech is al­so push­ing to get dos­es of its Covid-19 vac­cine filled in Africa by 2023, so long as the de­mand is there.

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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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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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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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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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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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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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.