Covid-19 roundup: EU be­gins re­view­ing Mod­er­na vac­cine; Cure­Vac and EU agree to 405M-dose deal

A day af­ter an­nounc­ing their vac­cine is high­ly ef­fec­tive at pre­vent­ing Covid-19, Mod­er­na said Eu­ro­pean reg­u­la­tors have be­gun a rolling re­view of the prod­uct for ap­proval.

The news sets Mod­er­na’s mR­NA-1273 vac­cine to be one of the first Covid-19 vac­cines au­tho­rized on both sides of the At­lantic, with CEO Stéphane Ban­cel an­tic­i­pat­ing in an in­ter­view Sun­day that the FDA will OK both their vac­cine and the vac­cine co-de­vel­oped by Pfiz­er and BioN­Tech in ear­ly or mid-De­cem­ber. Nei­ther com­pa­ny has yet sub­mit­ted to the US agency.

Al­though the sec­ond com­pa­ny to re­lease piv­otal da­ta on a vac­cine, Mod­er­na is the third to be­gin a rolling re­view at the EMA. As­traZeneca and BioN­Tech, both based in Eu­rope, an­nounced in ear­ly Oc­to­ber that reg­u­la­tors have be­gun a rolling re­view of the vac­cine. Mod­er­na said they sub­mit­ted doc­u­ments on Oct 14.

De­signed to speed ap­provals, rolling re­views give the EMA an ear­ly look at cer­tain pre­clin­i­cal, clin­i­cal and man­u­fac­tur­ing da­ta, but the agency doesn’t is­sue de­ci­sions un­til piv­otal re­sults are in. As­traZeneca is hop­ing to re­lease such da­ta be­fore the end of the year, which would like­ly po­si­tion them as the third Covid-19 vac­cine com­pa­ny to do so.

It’s un­clear how long the EMA may take to re­view a vac­cine. The EMA has op­er­at­ed through­out the pan­dem­ic more de­lib­er­ate­ly than their Amer­i­can coun­ter­part. The FDA, for ex­am­ple, au­tho­rized remde­sivir three days af­ter Phase III re­sults came out and near­ly two months be­fore the EMA did.

EMA of­fi­cials, though, in­di­cat­ed last month that they would have been will­ing to au­tho­rize a vac­cine that’s less than 50% ef­fec­tive, the FDA’s bar. Both Pfiz­er and Mod­er­na say their vac­cines are more than 90% ef­fec­tive.

Ban­cel said Sun­day he an­tic­i­pat­ed an FDA ad­vi­so­ry hear­ing on their vac­cine on Dec 7 or Dec 14, with an EUA com­ing a few days lat­er. He pre­dict­ed a sim­i­lar time­line for Pfiz­er-BioN­Tech, with the two vac­cines po­ten­tial­ly shar­ing a sin­gle ad­comm.

Ja­son Mast

Cure­Vac and EU agree to 405 mil­lion-dose deal

Mod­er­na and Pfiz­er/BioN­Tech were the first com­pa­nies to show piv­otal da­ta for their vac­cines, but the third ma­jor mR­NA com­pa­ny, Cure­Vac, is look­ing to be­come the ar­se­nal of Eu­rope.

Al­ready fi­nanced with a €300 mil­lion in­vest­ment from the Ger­man gov­ern­ment and a €75 mil­lion loan from the Eu­ro­pean In­vest­ment Bank, Cure­Vac an­nounced yes­ter­day that they have signed an agree­ment to pro­vide the EU with 405 mil­lion dos­es of their mR­NA vac­cine.

Cure­Vac’s close op­er­a­tions with Eu­ro­pean of­fi­cials stood in con­trast to its com­peti­tors, with Mod­er­na re­ly­ing heav­i­ly on US gov­ern­ment cash and Pfiz­er pro­vid­ing the fund­ing and clin­i­cal and man­u­fac­tur­ing ex­per­tise to ad­vance BioN­Tech’s vac­cine. The bulk of their man­u­fac­tur­ing will oc­cur in Eu­rope as well, with the com­pa­ny an­nounc­ing plans this morn­ing to es­tab­lish a Eu­ro­pean-based net­work of fac­to­ries that can pro­duce 300 mil­lion dos­es in 2021 and 2022.

Cure­Vac did not say on what time­line they will de­liv­er the 405 mil­lion dos­es to Eu­rope.

The new deal will add to the up to 300 mil­lion dos­es Pfiz­er and BioN­Tech agreed to sell to the EU and the 300 mil­lion-dose deal Sanofi and GSK signed back in Sep­tem­ber. Mod­er­na is still in dis­cus­sions with the Eu­ro­pean Com­mis­sion, with of­fi­cials re­port­ed­ly look­ing to ne­go­ti­ate the price down to be­low $25 per dose.

Ur­su­la von der Leyen

“This is the fifth con­tract with a phar­ma­ceu­ti­cal com­pa­ny for our COVID-19 vac­cine port­fo­lio. And we are work­ing on a sixth one, with Mod­er­na,” Eu­ro­pean Com­mis­sion pres­i­dent Ur­su­la von der Leyen said in a state­ment. “We hope to fi­nalise the con­tract soon.”

Cure­Vac is still in Phase I of clin­i­cal test­ing. They have talked about re­ceiv­ing ap­proval by the third quar­ter of 2021 and tout­ed a vac­cine that’s sta­ble at re­frig­er­a­tor tem­per­a­tures as a key ad­van­tage over oth­er mR­NA ap­proach­es.

Af­ter Mod­er­na, Pfiz­er news, World Health Or­ga­ni­za­tion cau­tions long road ahead

The world now has da­ta to sug­gest two vac­cines are high­ly ef­fec­tive against Covid-19, but WHO of­fi­cials cau­tioned Mon­day that proof a vac­cine works is just one small step in a long path to­ward end­ing the pan­dem­ic.

Ed­ward Kel­ly

“It’s not vac­cines that save peo­ple,” Ed­ward Kel­ly, di­rec­tor of the WHO’s work on ser­vice de­liv­ery and safe­ty, told re­porters, ac­cord­ing to The Wash­ing­ton Post. “It’s vac­ci­na­tions that will ac­tu­al­ly save peo­ple.”

And it will take a long time to vac­ci­nate the globe. As com­pa­nies and of­fi­cials have warned, dos­es will be in short sup­ply for the fore­see­able fu­ture; Mod­er­na and Pfiz­er ex­pect to make enough to vac­ci­nate be­tween 800 mil­lion and a bil­lion peo­ple next year, but the world pop­u­la­tion num­bers more than 7 bil­lion.

More­over, the cold chain re­quire­ments for each vac­cine will lim­it how wide­ly they can be dis­trib­uted in less de­vel­oped ar­eas of the world. Mean­while, wealthy coun­tries and par­tic­u­lar­ly the US have bought much of the ear­ly sup­ply of vac­cine, leav­ing low and mid­dle in­come parts of the world wait­ing.

These fac­tors, along with lin­ger­ing un­knowns about how long the vac­cines last and the still-surg­ing lev­els of virus, un­der­score the need to con­tin­ue mea­sures such as so­cial dis­tanc­ing and test­ing, of­fi­cials said.

“A vac­cine on its own will not end the pan­dem­ic,” WHO Di­rec­tor-Gen­er­al Tedros Ad­hanom Ghe­breye­sus said.

Pfiz­er be­gins pi­lot pro­gram to dis­trib­ute its vac­cine

A week af­ter read­ing out long-await­ed in­ter­im Phase III re­sults from their Covid-19 vac­cine tri­al, Pfiz­er and BioN­Tech are talk­ing dis­tri­b­u­tion.

The vac­cine, which Pfiz­er and BioN­Tech said is more than 90% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19, must be shipped in -70 de­grees Cel­sius (-94 de­grees Fahren­heit) tem­per­a­tures to re­main sta­ble, then used with­in 5 days of be­ing thawed. De­liv­ery pos­es a ma­jor chal­lenge, with some coun­tries say­ing they can’t af­ford to build the dis­tri­b­u­tion sys­tem re­quired to han­dle the vac­cine.

To test the wa­ters, Pfiz­er has launched a pi­lot de­liv­ery pro­gram in Rhode Is­land, Texas, New Mex­i­co and Ten­nessee, ac­cord­ing to Reuters. The four states were cho­sen for their dif­fer­ences in size, di­ver­si­ty of pop­u­la­tions, in­fra­struc­ture, and ur­ban and rur­al set­tings, the news agency re­port­ed.

“We are hope­ful that re­sults from this vac­cine de­liv­ery pi­lot will serve as the mod­el for oth­er U.S. states and in­ter­na­tion­al gov­ern­ments, as they pre­pare to im­ple­ment ef­fec­tive COVID-19 vac­cine pro­grams,” Pfiz­er said, per Reuters.

The pi­lot states won’t get dos­es ear­li­er than oth­er states or have spe­cial con­sid­er­a­tion, ac­cord­ing to Pfiz­er. The phar­ma said it plans on fil­ing for an EUA around the third week of No­vem­ber, once it has the nec­es­sary safe­ty da­ta to ap­proach reg­u­la­tors.

Ding Sheng, di­rec­tor of the Bei­jing-based Glob­al Health Drug Dis­cov­ery In­sti­tute, told Bloomberg that pro­duc­tion of Pfiz­er and BioN­Tech’s can­di­date is “cost­ly” and re­quires cold-chain trans­porta­tion. Philip­pines’ health sec­re­tary Fran­cis­co Duque told Reuters that the cold chain re­quire­ment is “hefty,” and that the coun­try does “not have such fa­cil­i­ty.”

Pfiz­er has de­signed “ther­mal ship­pers” that can be stored at room tem­per­a­ture and keep the vac­cine cold for 10 days if re­plen­ished with dry ice, which they say will lessen the bur­den on coun­tries.

The US struck a $1.95 bil­lion deal for 100 mil­lion dos­es of Pfiz­er and BioN­Tech’s vac­cine, with the op­tion to ac­quire an­oth­er 500 mil­lion down the road. Last week, the drug­mak­ers fi­nal­ized a deal with the EU for 200 mil­lion dos­es, with the op­tion for 100 mil­lion more lat­er on, though the par­ties didn’t dis­close the cost.

Mod­er­na said its can­di­date — which in­ter­im re­sults have shown to be 94.5% ef­fec­tive — can be kept for months at -20 de­grees Cel­sius (-4 Fahren­heit) and at re­frig­er­a­tor tem­per­a­tures for up to 30 days. — Nicole De­Feud­is 

Eli Lil­ly teams with Sam­sung Bi­o­log­ics to mass pro­duce its Covid-19 an­ti­body

Be­lea­guered by ques­tions about how safe­ly it can make its Covid-19 neu­tral­iz­ing an­ti­body, Eli Lil­ly has pulled out a card they placed at the be­gin­ning of the pan­dem­ic.

Sam­sung Bi­o­log­ics dis­closed yes­ter­day that they signed an agree­ment back in May to mass-pro­duce its an­ti­body and, af­ter de­lays in se­cur­ing raw ma­te­ri­als, had re­cent­ly be­gun pro­duc­tion, Reuters re­port­ed.

The FDA re­cent­ly au­tho­rized the an­ti­body, known as bam­lanivimab, for mod­er­ate and mild cas­es of Covid-19 — a huge pop­u­la­tion at a time when the US is record­ing 100,000 cas­es.

Ex­perts such as ex-FDA chief Scott Got­tlieb have warned for months that the US was un­der-in­vest­ing in the in­fra­struc­ture to mass pro­duce the mon­o­clon­al an­ti­bod­ies in de­vel­op­ment at Lil­ly, Re­gen­eron and else­where.

Lil­ly has said they can make 1 mil­lion dos­es by the end of this year, with 300,000 of those ear­marked for the US. But they’ve been dogged by qual­i­ty con­trol ques­tions at one of the plants churn­ing out the drug. Al­though they au­tho­rized the an­ti­body ear­li­er this month, the FDA stip­u­lat­ed that Lil­ly would have to hire out­side con­sul­tants to test batch­es and con­firm the qual­i­ty con­trol da­ta.

It was not im­me­di­ate­ly clear whether the Sam­sung pro­duc­tion was baked in­to pre­vi­ous dose es­ti­mates from Lil­ly or would add new ca­pac­i­ty. The Big Phar­ma has talked about ramp­ing up pro­duc­tion next year as new plants came on­line. In Sep­tem­ber, they an­nounced a man­u­fac­tur­ing col­lab­o­ra­tion with Am­gen.

Lil­ly’s Covid-19 an­ti­body will not be the first Sam­sung has agreed to help mass pro­duce. The South Ko­re­an com­pa­ny has al­so signed agree­ments with Vir Biotech­nol­o­gy to pro­duce the neu­tral­iz­ing an­ti­body they are co-de­vel­op­ing with Glax­o­SmithK­line. — Ja­son Mast

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

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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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.