Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Gov­ern­ment gears for un­prece­dent­ed chal­lenge of Eli Lil­ly an­ti­body roll­out as ef­fi­ca­cy ques­tions linger

Af­ter months of an­tic­i­pa­tion, the FDA has au­tho­rized the first an­ti­body treat­ment for Covid-19. Now what?

The US gov­ern­ment faces a chal­lenge un­like vir­tu­al­ly any it has faced dur­ing or be­fore the pan­dem­ic. They will have to dis­trib­ute scarce quan­ti­ties of a much-sought drug through­out the coun­try at a time when cas­es are reach­ing record lev­els, over­bur­den­ing hos­pi­tals to the point where, in North Dako­ta, Covid-19 pos­i­tive nurs­es have been au­tho­rized to con­tin­ue work­ing.

The gov­ern­ment did not ini­tial­ly fare well last time it had to roll out a Covid-19 drug; in the spring, baf­fled doc­tors re­port­ed that hos­pi­tals with few Covid-19 pa­tients re­ceived pre­cious vials of remde­sivir, while those with many were over­looked. Dis­trib­ut­ing an an­ti­body pos­es an even greater chal­lenge, as it’s in­di­cat­ed for pa­tients with mild or mod­er­ate dis­ease — a much larg­er group of peo­ple, none of whom are al­ready in a hos­pi­tal, where an IV in­fu­sion can be eas­i­ly ad­min­is­tered.

On Tues­day, CDER chief Janet Wood­cock, who stepped away from the FDA to run the treat­ment arm of Op­er­a­tion Warp Speed, out­lined the gov­ern­ment’s plan to dis­trib­ute the 300,000 dos­es they’ve agreed to pur­chase from Eli Lil­ly. They will re­ly large­ly on a sys­tem that of­fi­cials even­tu­al­ly de­vel­oped for dis­trib­ut­ing remde­sivir: Rather than give the drug di­rect­ly to med­ical cen­ters, they will al­lo­cate it to states and ter­ri­to­ries ac­cord­ing to how many Covid-19 cas­es and hos­pi­tal­iza­tions they have. Lo­cal gov­ern­ments would then al­lo­cate it with­in their ju­ris­dic­tions.

For ex­am­ple, in the first al­lo­ca­tion this week, the large and hard-hit state of Texas will re­ceive 5,780 dos­es. Ver­mont, which is small and has kept the virus un­der rel­a­tive con­trol, will re­ceive 20.

Still, out­side ex­perts said that left key ques­tions unan­swered. Much of the coun­try still does not have enough test­ing ca­pac­i­ty to catch cas­es with­in the nar­row win­dow where ear­ly stud­ies in­di­cate the an­ti­body may be ben­e­fi­cial. And al­though au­thor­i­ties want to re­serve the drug for pa­tients who are at high risk, such as those with di­a­betes or obe­si­ty, that still leaves far more de­mand than sup­ply.

“In some pop­u­la­tions, you have half the peo­ple who will meet that high-risk cri­te­ria, so who you give it to and how you make that de­ci­sion isn’t clear,” said He­len Bouch­er, chief of in­fec­tious dis­eases at Tufts Med­ical Cen­ter in Boston, told The Wash­ing­ton Post. “The wor­ry is whether black and brown peo­ple get ac­cess who we know are be­ing dis­pro­por­tion­ate­ly af­fect­ed by this dis­ease.”

The dis­tri­b­u­tion will hap­pen while ques­tions linger about how ef­fec­tive the drug re­al­ly is. Al­though on­ly the medi­um, 2800 mg dose of the an­ti­body met the pri­ma­ry end­point of re­duc­ing vi­ral load in Lil­ly’s piv­otal tri­al, the FDA au­tho­rized a 700 mg dose and HHS is send­ing vials con­tain­ing that dose to the states.

The 700 mg dose will al­low them to give the drug to far more peo­ple, and Lil­ly says that all dos­es showed “sim­i­lar clin­i­cal ef­fects,” such as de­creas­ing the risk of hos­pi­tal­iza­tion and re­duc­ing symp­toms. Wood­cock de­fend­ed the gov­ern­ment’s de­ci­sion on a call with re­porters, point­ing to the da­ta Eli Lil­ly col­lect­ed on hos­pi­tal­iza­tion and symp­tom al­le­vi­a­tion.

She ar­gued that most peo­ple clear the virus on their own and that, among those who didn’t, all three dos­es of the drug re­duced vi­ral load. The p-val­ue for the 700 mg dose was 0.38.

“I think you are sort of ac­cept­ing a di­choto­mous view of p-val­ues,” she said, ac­cord­ing to Bio­Cen­tu­ry. “If you look at the vi­rol­o­gy da­ta, there was al­most no dif­fer­ence in virus clear­ance amongst the dif­fer­ent dos­es.”

For Wood­cock, the big­ger ques­tion is the roll­out. The gov­ern­ment is plan­ning to dis­trib­ute the an­ti­body in two phas­es, and even­tu­al­ly hopes to dis­trib­ute it, via states, to park­ing lot tents or trail­ers, which may be more ac­ces­si­ble. First, though, they’ll have to see if old-fash­ioned hos­pi­tals, ur­gent care cen­ters and ERs can do the trick.

“For the next two weeks, what we’re go­ing to be look­ing at very close­ly is the abil­i­ty of the health­care sys­tem to ac­tu­al­ly get this in­to peo­ple’s veins,” Wood­cock said.

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.