Covid-19 roundup: EMA be­gins rolling re­view of first Chi­nese vac­cine; Af­ter 100% ef­fi­ca­cy tri­al, teenagers could be el­i­gi­ble for Pfiz­er's vac­cine next week

Sino­vac’s shot — which was just ef­fec­tive enough to meet reg­u­la­to­ry stan­dards — is now the first Chi­nese Covid-19 vac­cine to be con­sid­ered by the Eu­ro­pean Med­i­cines Agency.

The EMA’s hu­man med­i­cines com­mit­tee (CHMP) said on Tues­day that it’s kick­ing off a rolling re­view of the in­ac­ti­vat­ed vac­cine, dubbed Coro­n­aVac in some re­gions, in an at­tempt to speed up the reg­u­la­to­ry process. The agency will look at da­ta as they be­come avail­able to de­ter­mine whether the ben­e­fits of the jab out­weigh the risks.

Hun­gary be­came the first coun­try in the EU to al­low emer­gency use of the shot back in Jan­u­ary, fol­low­ing a gov­ern­ment de­cree that any vac­cine giv­en to at least a mil­lion peo­ple world­wide can now be ap­proved for use with­out pass­ing through the coun­try’s med­i­cines reg­u­la­tor, ac­cord­ing to the AP.

In Feb­ru­ary, Sino­vac an­nounced the can­di­date was just 50.65% ef­fec­tive against all Covid-19 cas­es in Phase III stud­ies con­duct­ed in Brazil and Turkey in health­care work­ers. The biotech said ef­fi­ca­cy was 83.70% for cas­es re­quir­ing med­ical treat­ment, and 100.00% for hos­pi­tal­ized, se­vere, and fa­tal cas­es.

It should be not­ed that in an analy­sis of 29 cas­es among par­tic­i­pants who be­longed to the gen­er­al pub­lic in Turkey, Sino­vac says its can­di­date was 91.25% ef­fec­tive at Covid-19 pre­ven­tion 14 days af­ter the two-dose vac­ci­na­tion.

“EMA will as­sess the com­pli­ance of COVID-19 Vac­cine (Vero Cell) In­ac­ti­vat­ed with the usu­al EU stan­dards for ef­fec­tive­ness, safe­ty and qual­i­ty,” the EMA said in a state­ment.

Coro­n­aVac was one of the vac­cines au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment in Ju­ly, ac­cord­ing to a Reuters re­port cit­ing an un­named of­fi­cial. The can­di­dates were ad­min­is­tered to some med­ical pro­fes­sion­als and bor­der of­fi­cers, a Chi­nese of­fi­cial said in an in­ter­view with state me­dia. — Nicole De­Feud­is

Af­ter 100% ef­fi­ca­cy tri­al, teenagers could be el­i­gi­ble for Pfiz­er’s vac­cine next week

Teenagers be­tween the ages of 12 and 15 could be el­i­gi­ble to re­ceive the Pfiz­er-BioN­Tech Covid-19 vac­cine as ear­ly as next week, The New York Times has re­port­ed. The com­pa­ny re­leased its tri­al re­sults to­ward the end of March, and found that no symp­to­matic in­fec­tions oc­curred in pa­tients with­in this age group.

The an­nounce­ment is a step to­ward an at­tempt at reach­ing herd im­mu­ni­ty. In Feb­ru­ary, NI­AID di­rec­tor An­tho­ny Fau­ci said that chil­dren as young as first graders could be el­i­gi­ble for the vac­cine by the time school starts in Sep­tem­ber. That el­i­gi­bil­i­ty is like­ly to ease the minds of ed­u­ca­tors across the coun­try, who have grap­pled with the del­i­cate bal­ance of pro­vid­ing an ad­e­quate ed­u­ca­tion for stu­dents and pro­vid­ing a safe work en­vi­ron­ment for its staff all year.

Pfiz­er’s tri­al con­sist­ed of 2,260 ado­les­cents, and there were 18 cas­es of Covid-19 that ap­peared in the place­bo group, com­pared to none in the vac­ci­nat­ed group, the com­pa­ny said.

So far, there have been about 65 mil­lion dos­es of Covid-19 vac­cines that have been de­liv­ered but not ad­min­is­tered, the Times said. A lit­tle less than half — 31 mil­lion — of those are Pfiz­er-BioN­Tech’s vac­cine, which re­quires 2 dos­es per in­di­vid­ual to be ful­ly ef­fec­tive. — Josh Sul­li­van

Lil­ly do­nates 400,000 baric­i­tinib tablets to In­dia

Eli Lil­ly said Tues­day that it’s ini­tial­ly do­nat­ing 400,000 baric­i­tinib tablets to the In­di­an gov­ern­ment for el­i­gi­ble hos­pi­tal­ized Covid-19 pa­tients and the com­pa­ny said it will work ur­gent­ly to in­crease the quan­ti­ty of do­nat­ed prod­uct mul­ti­fold over the com­ing weeks.

The RA drug baric­i­tinib when com­bined with Gilead’s remde­sivir has an emer­gency use au­tho­riza­tion in the US to treat those hos­pi­tal­ized with Covid-19. Lil­ly said that on Mon­day it re­ceived per­mis­sion for re­strict­ed emer­gency use for baric­i­tinib (2 mg and 4 mg) in com­bi­na­tion with remde­sivir, for treat­ment of sus­pect­ed or lab­o­ra­to­ry con­firmed Covid-19 in hos­pi­tal­ized adults re­quir­ing sup­ple­men­tal oxy­gen, in­va­sive me­chan­i­cal ven­ti­la­tion, or ex­tra­cor­po­re­al mem­brane oxy­gena­tion. — Zachary Bren­nan

A law­suit in Rus­sia chal­lenges gov­ern­ment who tasked do­mes­tic com­pa­ny to make Gilead’s remde­sivir

Gilead has sued the Russ­ian gov­ern­ment for al­low­ing an­oth­er com­pa­ny to make its remde­sivir treat­ment for pa­tients with Covid-19, ac­cord­ing to fil­ings.

The fil­ing ac­cus­es The Phar­masyn­tez Com­pa­ny of us­ing Gilead’s process for man­u­fac­tur­ing remde­sivir with­out the con­sent of the patent hold­er.

Late in 2020, the gov­ern­ment is­sued a com­pul­so­ry li­cense to Phar­masyn­tez, who then ap­proached Gilead about po­ten­tial­ly man­u­fac­tur­ing a ver­sion of the med­i­cine, STAT re­port­ed. The com­pa­ny had plans to sell the drug at half the cost for na­tion­al se­cu­ri­ty’s sake.

Court ses­sion for the suit is sched­uled to be­gin on May 27.

The de­ci­sion comes with a de­bate over glob­al ac­cess to Covid-19 treat­ments and vac­cines for coun­tries in need. As the US has se­cured 1 bil­lion dos­es of the vac­cine, some ethi­cists have said that dos­es should be shared with oth­er coun­tries soon­er rather than lat­er. Bill Gates re­cent­ly re­ceived back­lash for say­ing in an in­ter­view that the US should keep vac­cine patents ex­clu­sive, cit­ing se­cu­ri­ty and cost is­sues. — Josh Sul­li­van

No­vavax will ex­pand Phase III tri­al to teenagers

Just hours be­fore it was re­port­ed that Pfiz­er/BioN­Tech’s Covid-19 vac­cine will be avail­able for ado­les­cents at the be­gin­ning of next week, No­vavax has an­nounced that it has ini­ti­at­ed the pe­di­atric ex­pan­sion of its Phase III clin­i­cal tri­al for its own vac­cine.

The tri­al will eval­u­ate 3,000 ado­les­cents be­tween the ages of 12 and 17 at 75 sites through­out the US, the com­pa­ny said in a state­ment. Par­tic­i­pants will ei­ther re­ceive the vac­cine or the place­bo in 2 dos­es 21 days apart from each oth­er, and they will be mon­i­tored for safe­ty up to 2 years af­ter the fi­nal dose.

The com­pa­ny’s jab has still not yet been ap­proved any­where in the world.

No­vavax an­nounced Mon­day that it will ship 200 mil­lion dos­es to the EU as a part of a draft sup­ply deal that was signed in De­cem­ber, de­spite the fact that the mak­er has been plagued with pro­duc­tion prob­lems. In a con­ver­sa­tion with End­points’ Ja­son Mast, No­vavax said it has worked to over­come sup­ply-chain chal­lenges, in­clud­ing for ma­te­ri­als as di­verse as Chilean tree bark and biore­ac­tor bags. — Josh Sul­li­van

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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.