Covid-19 roundup: Abi­vax pulls the plug on its an­ti-in­flam­ma­to­ry treat­ment; J&J says it could fall short on Q2 vac­cine sup­ply for EU — re­port

An­oth­er Covid-19 treat­ment is bit­ing the dust af­ter an in­de­pen­dent Da­ta Safe­ty and Mon­i­tor­ing Board flagged it for lack of ef­fi­ca­cy.

Paris-based Abi­vax shared last week that it’s slam­ming the brakes on its Phase IIb/III clin­i­cal tri­al for ABX464 in high-risk Covid pa­tients. The study, dubbed miR-AGE, had al­ready re­cruit­ed 500 pa­tients of the planned 1,034.

Re­searchers were test­ing the an­ti-in­flam­ma­to­ry to see if it could pre­vent se­vere dis­ease. But a planned in­ter­im analy­sis of da­ta from 306 pa­tients showed no dif­fer­ence be­tween the drug and a place­bo. ABX464 was well-tol­er­at­ed and safe, Abi­vax not­ed.

The re­sults came as a shock to some re­searchers, in­clud­ing Jorge Kalil, a pro­fes­sor at the Uni­ver­si­ty Hos­pi­tal Cen­ter in São Paulo and na­tion­al co­or­di­na­tor of the miR-AGE study in Brazil.

“As an im­mu­nol­o­gist, I am puz­zled by the out­come of the in­ter­im analy­sis, as ABX464 ad­dress­es both the vi­ral and in­flam­ma­to­ry as­pects of the dis­ease,” Kalil said in a state­ment. “How­ev­er, we rec­og­nize that Covid-19 is a nov­el, hy­per-acute and com­plex dis­ease that in­volves var­i­ous vi­ral and in­flam­ma­to­ry path­ways, plus the co­ag­u­la­tion sys­tem, which are still not ful­ly un­der­stood.”

While Abi­vax CEO Hart­mut Ehrlich called the find­ings “dis­ap­point­ing,” he em­pha­sized that ABX464 has shown pos­i­tive da­ta in ul­cer­a­tive col­i­tis, where it was al­ready be­ing test­ed be­fore en­ter­ing the Covid study.

ABX464 isn’t the on­ly po­ten­tial Covid-19 treat­ment can­di­date to come up short. Just last week, the UK’s RE­COV­ERY tri­al halt­ed en­roll­ment in its colchicine study af­ter a da­ta mon­i­tor­ing com­mit­tee saw “no con­vinc­ing ev­i­dence that fur­ther re­cruit­ment would pro­vide con­clu­sive proof of worth­while mor­tal­i­ty ben­e­fit ei­ther over­all or in any pre-spec­i­fied sub­group.”

J&J says it could fall short on Q2 vac­cine sup­ply for EU re­port

The EU could soon be fac­ing more vac­cine dis­tri­b­u­tion woes, as John­son and John­son wor­ries it won’t be able to meet its Q2 quo­ta.

J&J told the EU that it was “un­der stress” to meet its goal of 55 mil­lion dos­es by the end of June, an un­named EU of­fi­cial told Reuters. The com­pa­ny cit­ed is­sues with the sup­ply of in­gre­di­ents and equip­ment, ac­cord­ing to the of­fi­cial.

The sin­gle-dose vac­cine has al­ready been au­tho­rized by the FDA, and is ex­pect­ed to get the OK for use in the EU on March 11. J&J is on the hook for 200 mil­lion dos­es to the bloc this year, and de­liv­er­ies are ex­pect­ed to start as ear­ly as April, Reuters re­port­ed.

Fail­ing to meet the Q2 goal could spell out a headache for the EU, which has al­ready been deal­ing with dis­tri­b­u­tion lags. Italy threat­ened to take le­gal ac­tion back in Jan­u­ary, al­leg­ing that de­liv­er­ies of the Pfiz­er/BioN­Tech vac­cine were un­ex­pect­ed­ly cut. Ger­many’s Ham­burg al­so re­port­ed re­ceiv­ing a small­er ship­ment. And last week, Italy and the EU blocked a 250,000-dose ship­ment of As­traZeneca’s vac­cine to Aus­tralia to pro­tect its own sup­ply.

Ten­sions rise be­tween EMA and Russ­ian vac­cine de­vel­op­er

Af­ter the head of the EMA’s man­age­ment board ad­vised EU coun­tries to hold off on au­tho­riz­ing Rus­sia’s Sput­nik V vac­cine, the shot’s de­vel­op­ers want an apol­o­gy.

“We de­mand a pub­lic apol­o­gy from EMA’s Christa Wirthumer-Hoche for her neg­a­tive com­ments on EU states di­rect­ly ap­prov­ing Sput­nik V,” a post from the of­fi­cial Sput­nik V Twit­ter ac­count reads. “Her com­ments raise se­ri­ous ques­tions about pos­si­ble po­lit­i­cal in­ter­fer­ence in the on­go­ing EMA re­view.”

Wirthumer-Hoche said dur­ing a talk show on Sun­day that the EU should wait to au­tho­rize the vac­cine while the EMA re­views its safe­ty and ef­fi­ca­cy, ac­cord­ing to a Reuters re­port.

While the vac­cine has been met with much skep­ti­cism, a Lancet study pub­lished last month sug­gests Sput­nik V has an ef­fi­ca­cy rate of 91.6%. The re­sults came from a 20,000-per­son Phase III tri­al, and ef­fi­ca­cy rate was based on the num­ber of Covid-19 cas­es tracked 21 days af­ter the first dose was ad­min­is­tered. Sput­nik V’s pro­tec­tion ap­plied to all age groups, in­clud­ing those old­er than 60, the Lancet re­sults said. No se­ri­ous ad­verse events re­lat­ed to the vac­cine were not­ed, though 45 pa­tients in the vac­cine group ex­pe­ri­enced se­ri­ous side ef­fects un­re­lat­ed to the vac­cine, ac­cord­ing to the Gama­leya Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy.

Rus­sia reg­is­tered the vac­cine back in Au­gust — and Pres­i­dent Vladimir Putin says his daugh­ter took it — well be­fore Phase III stud­ies were com­plet­ed. The move spurred much back­lash, in­clud­ing from the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions, which wrote a let­ter urg­ing Russ­ian health min­is­ter Mikhail Murashko not to give out an un­proven vac­cine.

“EMA did not al­low such state­ments about any oth­er vac­cine. Such com­ments are in­ap­pro­pri­ate and un­der­mine cred­i­bil­i­ty of EMA and its re­view process,” the Sput­nik V ac­count tweet­ed. “Vac­cines and EMA should be above and be­yond pol­i­tics.”

Pfiz­er/BioN­Tech vac­cine neu­tral­izes vari­ant spread­ing in Brazil — study

In a test to see how Pfiz­er and BioN­Tech’s vac­cine fares against new vari­ants emerg­ing around the world, the jab was able to neu­tral­ize the P.1 vari­ant, which was first de­tect­ed in Brazil, ac­cord­ing to a let­ter to the ed­i­tor of the New Eng­land Jour­nal of Med­i­cine. 

The jab al­so neu­tral­ized vari­ants first de­tect­ed in the UK (B.1.1.7-spike) and South Africa (B.1.351-spike), and two sub­sets of mu­ta­tions de­rived from B.1.351 lin­eage. But com­pared to an ear­ly iso­late of the virus, neu­tral­iza­tion of the South Africa vari­ant was weak­er by about two-thirds.

From the let­ter:

Our da­ta are al­so con­sis­tent with poor­er neu­tral­iza­tion of the virus with the full set of B.1.351- spike mu­ta­tions than virus with ei­ther sub­set of mu­ta­tions and sug­gest­ed that virus with mu­tant residues in the re­cep­tor-bind­ing site (K417N, E484K, and N501Y) is more poor­ly neu­tral­ized than virus with Δ242-244, which is lo­cat­ed in the N-ter­mi­nal do­main of the spike pro­tein.

Geo­met­ric mean neu­tral­iz­ing titers against the UK and Brazil vari­ants were “rough­ly equiv­a­lent” to those pro­duced against the ear­ly iso­late, while titers against the South African vari­ant were “ro­bust but low­er,” the au­thors from the Uni­ver­si­ty of Texas Med­ical Branch wrote.

Pri­or stud­ies have sug­gest­ed that Pfiz­er and BioN­Tech’s vac­cine can pro­tect against vari­ants spread­ing in the UK and South Africa, though may be less po­tent against the South Africa vari­ant. The com­pa­nies are test­ing boost­er op­tions, in­clud­ing a third dose of the cur­rent vac­cine and a new for­mu­la­tion that specif­i­cal­ly tar­gets the vari­ant.

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

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Albert Bourla (Photo by JOHN THYS/POOL/AFP via Getty Images)

As boost­er sea­son awaits, US re-ups sup­ply of Pfiz­er Covid-19 vac­cine with new $3.2B deal

The US government said late Wednesday that it will pay Pfizer and its partner BioNTech $3.2 billion upon receipt of the first 105 million Covid-19 vaccine doses, potentially the new Omicron-adapted boosters pending EUA.

Under this agreement, the US government also has the option to purchase up to 195 million additional doses, bringing the total number of potential new doses to 300 million. The US has now spent almost $15 billion on Pfizer’s Covid-19 vaccine.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.