Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

Covid-19 roundup: Eu­ro­pean Com­mis­sion's le­gal bat­tle against As­traZeneca be­gins; Kaza­khstan gives green light to do­mes­tic vac­cine

The Eu­ro­pean Com­mis­sion’s le­gal case against As­traZeneca for fail­ing to de­liv­er the amount of vac­cine dos­es laid out in a con­tract be­gan in a Brus­sels court on Wednes­day, ac­cord­ing to Reuters. 

The EC re­quest­ed im­me­di­ate de­liv­er­ies from all fac­to­ries list­ed in the con­tract, in­clud­ing ones in Britain, the news agency re­port­ed. It’s been two days since the EC an­nounced it would take le­gal ac­tion.

The dis­pute be­gan back in Jan­u­ary, when As­traZeneca in­formed the EU that it wouldn’t be able to de­liv­er the promised num­ber of dos­es laid out in a sup­ply con­tract due to pro­duc­tion lags. The con­tract al­lowed for the pur­chase of 300 mil­lion dos­es, with an op­tion for 100 mil­lion more. But on­ly 30 mil­lion were de­liv­ered in Q1 2021, and As­traZeneca promised 70 mil­lion in Q2, as op­posed to the 180 mil­lion that had been promised.

The EU pub­lished a heav­i­ly redact­ed ver­sion of the con­tract in an ef­fort to fos­ter trans­paren­cy. But af­ter in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, the EU pub­licly apol­o­gized.

CEO Pas­cal So­ri­ot has as­sert­ed the con­tracts are not legal­ly bind­ing due to a “best ef­fort” clause in the text.

As­traZeneca said in a state­ment Mon­day that al­most 50 mil­lion dos­es are com­ing by the end of April, which it said is “in line with our fore­cast.”

“As­traZeneca deeply re­grets the de­ci­sion of the Eu­ro­pean Com­mis­sion to start this le­gal ac­tion in re­la­tion with the COVID-19 sup­ply agree­ment. We hope to re­solve this dis­pute as soon as pos­si­ble,” com­pa­ny lawyer Hakim Boular­bah said in court, per Reuters.

Two more hear­ings are sched­uled on May 26, and a judge is ex­pect­ed to de­cide on the case in June, Reuters re­port­ed.

Kaza­khstan gives green light to vac­cine be­fore it com­pletes test­ing

Kaza­khstan is rolling out its own Covid-19 shot, dubbed Qaz­Vac, be­fore it has com­plet­ed Phase III test­ing.

“The first batch of Qaz­Vac vac­cine ar­rived in the re­gions of the coun­try,” pres­i­dent Kassym-Jo­mart Tokayev tweet­ed on April 23. “Vac­cine pro­duc­tion will be in­creased to make it avail­able to all cit­i­zens.”

The vac­cine, de­vel­oped by the Re­search In­sti­tute for Bi­o­log­i­cal Safe­ty Prob­lems, en­tered a Phase I/II tri­al in Kaza­khstan back in Sep­tem­ber. Sci­en­tist Lep­ek Ku­tum­be­tov re­port­ed­ly test­ed it on him­self, then told the state-owned me­dia or­ga­ni­za­tion Kaz­in­form it is “harm­less.”

Since then, the re­search in­sti­tute has said that all 222 par­tic­i­pants in the first two stages of test­ing have de­vel­oped im­mu­ni­ty, with no ma­jor side ef­fects, ac­cord­ing to Reuters. A 3,000-per­son Phase III tri­al is ex­pect­ed to wrap up in Ju­ly.

Near­ly a mil­lion cit­i­zens have al­ready been vac­ci­nat­ed with Rus­sia’s Sput­nik V, and the coun­try has or­dered a mil­lion dos­es of Chi­na’s Sinopharm vac­cine, Reuters re­port­ed.

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

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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