Albert Bourla, AP

Covid-19 roundup: EC strikes deals with Pfiz­er, Mod­er­na for an­oth­er 350 mil­lion vac­cine dos­es; UK ethics body OKs chal­lenge tri­al

The Eu­ro­pean Com­mis­sion has inked deals with Mod­er­na and Pfiz­er for a to­tal of 350 mil­lion more vac­cine dos­es, to be de­liv­ered through­out 2021.

It’s un­clear how much the EC is pay­ing for any of the dos­es. Mod­er­na has promised to de­liv­er 150 mil­lion more dos­es in Q3 and Q4, bring­ing the biotech’s to­tal com­mit­ment up to 310 mil­lion dos­es in 2021. As part of the new agree­ment, the EU al­so holds the op­tion to buy an­oth­er 150 mil­lion dos­es for de­liv­ery in 2022.

“Mod­er­na is com­mit­ted to work­ing re­lent­less­ly to bring to mar­ket vac­cine boosts with the rel­e­vant vari­ants to ad­dress this glob­al pan­dem­ic,” CEO Stéphane Ban­cel said in a state­ment.

The EC al­so struck a deal for 200 mil­lion more dos­es of Pfiz­er and BioN­Tech’s vac­cine, even as com­plaints about dis­tri­b­u­tion lags sur­face across the bloc.

The ad­di­tion­al dos­es will bring the EU’s to­tal sup­ply up to 500 mil­lion dos­es of the vac­cine, which is mar­ket­ed as Comir­naty in Eu­rope — a com­bi­na­tion of the terms Covid-19, mR­NA, com­mu­ni­ty and im­mu­ni­ty. The EU holds the op­tion to re­quest an­oth­er 100 mil­lion more dos­es down the road.

The 200 mil­lion dos­es will be de­liv­ered in 2021, with an es­ti­mat­ed 75 mil­lion com­ing in Q2. It’s un­clear how much the EC paid for the ad­di­tion­al dos­es.

“With this new agree­ment with the Eu­ro­pean Com­mis­sion, we now ex­pect to de­liv­er enough dos­es to vac­ci­nate at least 250 mil­lion Eu­ro­peans be­fore the end of the year,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

The an­nounce­ment comes less than a week af­ter Pres­i­dent Joe Biden said his ad­min­is­tra­tion has pur­chased an­oth­er 100 mil­lion dos­es from Pfiz­er, bring­ing its com­mit­ment up to 300 mil­lion dos­es. The US gov­ern­ment al­so pur­chased an­oth­er 100 mil­lion dos­es of Mod­er­na’s vac­cine, which are sched­uled to ar­rive by the end of Ju­ly.

Mul­ti­ple coun­tries in the EU have is­sued com­plaints about the dis­tri­b­u­tion of Pfiz­er/BioN­Tech vac­cines, in­clud­ing Italy, which threat­ened le­gal ac­tion more than once. Af­ter their vac­cine sup­ply was cut, the Ital­ian gov­ern­ment sent a for­mal let­ter of no­tice to Pfiz­er back in Jan­u­ary, urg­ing them to com­ply with con­trac­tu­al com­mit­ments for vac­cine de­liv­ery, ac­cord­ing to Reuters. Ger­many’s Ham­burg has al­so com­plained of small­er ship­ments — and said they’re hav­ing trou­ble ex­tract­ing a full six dos­es from vials.

Swe­den, on the oth­er hand, said it would refuse to pay Pfiz­er and BioN­Tech un­til they clar­i­fied with the EU how many charge­able dos­es are in a vial. The coun­try said it was charged for six dos­es per vial in­stead of five as they ini­tial­ly agreed, and the sixth dose is im­pos­si­ble to ex­tract with­out a spe­cial sy­ringe. Pfiz­er and BioN­Tech of­fi­cial­ly changed their la­bel in late Jan­u­ary to ac­count for a sixth dose in each vial.

Sev­er­al oth­er biotechs are jump­ing in to as­sist Pfiz­er and BioN­Tech with de­vel­op­ment, in­clud­ing Mer­ck KGaA, which says it can ac­cel­er­ate its sup­ply of cus­tom lipids to BioN­Tech. No­var­tis has al­so agreed to lend a hand with de­vel­op­ment, and Sanofi has of­fered the use of its Frank­furt plant to pro­duce more than 100 mil­lion dos­es. — Nicole De­Feud­is 

UK ethics body ap­proves chal­lenge tri­al

Covid-19 chal­lenge tri­als are one step clos­er to ar­riv­ing.

The UK gov­ern­ment has giv­en its stamp of ap­proval on what would be the world’s first Covid-19 hu­man chal­lenge tri­al, as the na­tion’s clin­i­cal tri­als ethics body gave the thumbs-up on Wednes­day. Britain will of­fi­cial­ly launch the tri­al with­in a month and has been prepar­ing for the stud­ies since last Oc­to­ber.

“While there has been very pos­i­tive progress in vac­cine de­vel­op­ment, we want to find the best and most ef­fec­tive vac­cines for use over the longer term,” UK busi­ness sec­re­tary Kwasi Kwarteng said in a state­ment. “These hu­man chal­lenge stud­ies will take place here in the UK and will help ac­cel­er­ate sci­en­tists’ knowl­edge of how coro­n­avirus af­fects peo­ple and could even­tu­al­ly fur­ther the rapid de­vel­op­ment of vac­cines.”

Re­searchers plan to re­cruit up to 90 young and healthy vol­un­teers aged 18 to 30 years old, who will be ex­posed to the virus in a con­trolled set­ting in an ef­fort to de­ter­mine the low­est pos­si­ble virus amount need­ed to cause in­fec­tion. Vac­cines could then be giv­en to a small num­ber of vol­un­teers be­fore be­ing ex­posed to the virus.

British of­fi­cials did not say which vac­cine might be used, on­ly those that have proven safe in clin­i­cal tri­als. So far, the UK has OK’ed three vac­cines for use: Pfiz­er/BioN­Tech’s vac­cine, Mod­er­na’s jab and As­traZeneca/Ox­ford’s shot.

In or­der to lim­it the risk to these in­di­vid­u­als, Britain plans to use the orig­i­nal strain of SARS-CoV-2 that first be­gan cir­cu­lat­ing in March, rather than any of the new virus vari­ants.

The study is be­ing run in col­lab­o­ra­tion with the UK gov­ern­ment’s Vac­cines Task­force, Im­pe­r­i­al Col­lege Lon­don, the Roy­al Free Lon­don NHS Foun­da­tion Trust and the com­pa­ny hVI­VO.

De­bate over the chal­lenge tri­als has been on­go­ing since the start of the pan­dem­ic. Pro­po­nents ar­gue that they aren’t any dif­fer­ent than wait­ing for vol­un­teers to get in­fect­ed in a large-scale piv­otal tri­al.

But crit­ics say test­ing the tri­als won’t be rep­re­sen­ta­tive of the most se­vere cas­es be­cause of the age of vol­un­teers, and ex­pos­ing them to the virus can still pose a risk. And un­like chal­lenge tri­als in oth­er dis­eases, there are few, if any, “res­cue ther­a­pies” avail­able should pa­tients fall se­ri­ous­ly ill. — Max Gel­man

Till­man Gern­gross en­ters PhI with new mon­o­clon­al an­ti­body can­di­date

An­oth­er mon­o­clon­al an­ti­body treat­ment — this one from the lab of leg­endary Till­man Gern­gross — has en­tered the clin­ic.

Till­man Gern­gross

Ada­gio Ther­a­peu­tics shared the news on Tues­day that it dosed the first pa­tient in a Phase I tri­al for its lead an­ti­body can­di­date, ADG20. That’s right on track with a plan Gern­gross laid out in Ju­ly, short­ly af­ter he raised $50 mil­lion to launch the biotech.

The CEO said that he was aim­ing for a drug that can be dosed twice a year with 90% ef­fi­ca­cy — enough to cre­ate and main­tain herd im­mu­ni­ty while hold­ing its own against any­thing else that may hit the mar­ket.

The Phase I tri­al will study ADG20’s safe­ty and tol­er­a­bil­i­ty, as well as phar­ma­co­ki­net­ics. Once safe­ty da­ta are eval­u­at­ed, Ada­gio plans on launch­ing glob­al piv­otal tri­als to as­sess its abil­i­ty to treat and pre­vent Covid-19 in­fec­tion.

“We are in the unique po­si­tion of hav­ing a mon­o­clon­al an­ti­body that binds to and pro­tects against com­mon cir­cu­lat­ing SARS-CoV-2 vari­ants as well as SARS-re­lat­ed virus­es with pan­dem­ic po­ten­tial,” Gern­gross said in a state­ment. “This broad­ly neu­tral­iz­ing ac­tiv­i­ty was in­ten­tion­al­ly de­signed in­to ADG20, as we an­tic­i­pat­ed the con­tin­ued emer­gence of re­sis­tance mu­ta­tions, and we took de­lib­er­ate steps to en­gi­neer ADG20 to max­i­mize its po­ten­tial to avoid vi­ral es­cape.” — Nicole De­Feud­is 

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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