Covid-19 roundup: Eu­rope is ‘weeks away’ from remde­sivir de­ci­sion; John Far­ley gets per­ma­nent gig as chief of FDA di­vi­sion steer­ing pan­dem­ic re­sponse

Gilead’s remde­sivir — the first drug shown to ben­e­fit Covid-19 pa­tients in a ran­dom­ized, con­trolled tri­al set­ting — is po­ten­tial­ly a hop, skip and a jump away from se­cur­ing Eu­ro­pean en­dorse­ment for Covid-19.

A rolling ap­pli­ca­tion was kicked off for the ther­a­py in late April, and on Mon­day, the EMA said it ex­pect­ed to pub­lish its opin­ion “with­in weeks.” Pre­vi­ous­ly, the reg­u­la­tor rec­om­mend­ed ex­pand­ing com­pas­sion­ate use of remde­sivir in se­vere Covid-19 pa­tients.

Al­though the failed Ebo­la drug is the on­ly ther­a­py so far to show a sta­tis­ti­cal­ly sig­nif­i­cant im­pact in help­ing hos­pi­tal­ized Covid-19 pa­tients with mod­er­ate-to-se­vere dis­ease re­cov­er faster (by four days) in a ran­dom­ized, place­bo-con­trolled study — the gold-stan­dard for ben­e­fit-risk cal­cu­la­tions — it is by no means a sil­ver bul­let. The drug, which thwarts an en­zyme the virus re­lies on to repli­cate, did not re­duce the rate of mor­tal­i­ty by a sta­tis­ti­cal­ly sig­nif­i­cant ex­tent in the tri­al.

In the Unit­ed States, days af­ter topline da­ta on the drug were an­nounced by the NIH, the FDA is­sued a quick emer­gency use au­tho­riza­tion (a tem­po­rary move to al­low ac­cess to the drug while its mak­er gath­ers more da­ta in or­der to pur­sue stan­dard ap­proval). In the UK, the Gilead has struck a deal with the gov­ern­ment to sup­ply the drug for cer­tain Covid-19 pa­tients.

Gilead has been ret­i­cent about its pric­ing plans, with com­pa­ny chief Dan O’Day em­pha­siz­ing the need for the com­pa­ny to be re­spon­si­ble. “I don’t think there is a prece­dent for this,” he said in re­sponse to the ques­tion posed by SVB Leerink an­a­lyst Ge­of­frey Porges in a post-earn­ings con­fer­ence call last month. “There is no rule­book out there, oth­er than that we need to be very thought­ful about how we can make sure we pro­vide ac­cess to our med­i­cine to pa­tients around the globe and do that in a sus­tain­able way for the com­pa­ny.”

But last week, Porges said he ex­pect­ed the drug to car­ry a list price of $5000 per course in the Unit­ed States, above the cost-ef­fec­tive es­ti­mate of $4,500 gen­er­at­ed by ICER, an in­creas­ing­ly in­flu­en­tial watch­dog that typ­i­cal­ly fa­vors a con­ser­v­a­tive ap­proach to pric­ing based on an in­ter­ven­tion’s ben­e­fit be­yond the stan­dard-of-care.

In Eu­rope, he an­tic­i­pates a price tag of $4,000 per course, and $2,000 for the same reg­i­men in oth­er mar­kets. Over­all, he fore­cast glob­al remde­sivir sales of $1.9 bil­lion by the end of this year, jump­ing to $6.7 bil­lion in 2021 (bol­stered by gov­ern­ment stock­pil­ing).

There’s a new (old) sher­iff in town at the FDA’s Of­fice of In­fec­tious Dis­ease

Last Au­gust, Re­gen­eron lured the long­time head of the FDA’s Of­fice of An­timi­cro­bial Prod­ucts, Ed­ward Cox. Less than six months lat­er, Covid-19 hit US shores.

Cox’s act­ing re­place­ment in the re­vamped Of­fice of In­fec­tious Dis­ease — John Far­ley —  has now been named his per­ma­nent suc­ces­sor.

Far­ley joined the US health reg­u­la­tor more than a decade ago in 2009, and played a role in the im­ple­ment­ing the 21st Cen­tu­ry Cures Act — a $6.3 bil­lion law signed in 2016 by Pres­i­dent Oba­ma to broad­ly ac­cel­er­ate re­search sup­port­ing treat­ments for se­ri­ous ill­ness­es — as well as reg­u­la­to­ry sci­ence re­search on an­timi­cro­bial re­sis­tance and the over­sight of IND pro­grams and NDA re­views. Since tak­ing over the reins from Cox, he has dealt with the kalei­do­scope of chal­lenges that have emerged with the Covid-19 pan­dem­ic.

“Over the past months of this cri­sis, John has shown out­stand­ing lead­er­ship – bring­ing his calm, thought­ful and knowl­edge­able, and col­lab­o­ra­tive ap­proach to su­per­vis­ing the reg­u­la­to­ry re­view of the huge num­ber of pre-IND and IND sub­mis­sions, while at the same time pro­vid­ing FDA lead­er­ship to ex­ter­nal con­sor­tia fo­cused on find­ing COVID-19 ther­a­peu­tics,” said Pe­ter Stein, the di­rec­tor of the of­fice of new drugs.

Mean­while, the des­per­a­tion for a quick fix to com­bat the Covid-19 cri­sis has steered the at­ten­tion of oth­er se­nior of­fi­cials at the agency.

In late May, the chief­tain of the FDA’s drug eval­u­a­tion di­vi­sion, Janet Wood­cock was de­tached from the agency to fo­cus her full ef­forts on the White House-led Op­er­a­tion Warp Speed to fast-for­ward the de­vel­op­ment of a vac­cine for cit­i­zens of the Unit­ed States, about a week af­ter crit­ics crit­i­cized her and CBER chief Pe­ter Marks’ in­volve­ment in the pub­lic-pri­vate ini­tia­tive as a clear con­flict of in­ter­est in how the agency ex­er­cis­es over­sight on new ap­provals.

CDER deputy di­rec­tor Pa­trizia Cavaz­zoni is hold­ing the fort tem­porar­i­ly for Wood­cock.

Not just a vac­cine de­vel­op­er: As­traZeneca brings an­ti­bod­ies to the Covid-19 fight

The British drug­mak­er As­traZeneca — al­ready a re­cip­i­ent of US fund­ing for its vac­cine ef­fort — is set to move two an­ti­body ther­a­pies li­censed from US re­searchers in­to the clin­ic in the com­ing months.

The Unit­ed States’ De­fense Ad­vanced Re­search Pro­jects Agency (DARPA) and Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA) is back­ing the project — but the fi­nan­cial terms of the agree­ments were not dis­closed on Tues­day.

The com­pa­ny will join a myr­i­ad of an­ti­body ef­forts on the dock­et. Re­gen­eron and Vir an­nounced pro­grams in late Jan­u­ary and ear­ly Feb­ru­ary. But the first ef­fort to make it in­to the clin­ic was the one cham­pi­oned by part­ners Eli Lil­ly and Ab­Cellera. On­ly days ago Ab­b­Vie un­veiled a col­lab­o­ra­tion with the Nether­lands’ Utrecht Uni­ver­si­ty and Eras­mus Med­ical Cen­ter and the Chi­nese-Dutch biotech Har­bour Bio­Med to de­vel­op a neu­tral­iz­ing an­ti­body.

As­traZeneca’s can­di­dates have come out of its April-an­nounced col­lab­o­ra­tion with Van­der­bilt Uni­ver­si­ty.

On the vac­cine front, As­traZeneca is one of the lead­ing groups with a po­ten­tial shot. The vac­cine, dis­cov­ered by Ox­ford Uni­ver­si­ty, is al­ready in heavy de­mand as coun­tries scram­ble to se­cure an an­ti­dote for their cit­i­zens, trig­ger­ing fears that peo­ple in de­vel­op­ing coun­tries will be last in line.

In May, BAR­DA dis­patched more than a bil­lion dol­lars back­ing the vac­cine, lin­ing up 300 mil­lion dos­es for the Unit­ed States that could start ar­riv­ing as soon as Oc­to­ber. The in­jec­tion dwarfs the ad­di­tion­al £84 mil­lion ($102 mil­lion) in fund­ing for 30 mil­lion dos­es (up to 100 mil­lion dos­es) from the Unit­ed King­dom, which en­vi­sions in­oc­u­lat­ing at least half its pop­u­la­tion by Sep­tem­ber.

Fac­ing vial short­ages as vac­cine pro­duc­tion ramps up, glass mak­er gets BAR­DA in­jec­tion

Glass mak­er Corn­ing, which late last month tied up with Covid-19 vac­cine hope­ful Pfiz­er in a deal to pro­duce vials for ex­ist­ing and new ther­a­peu­tics, has now scored $204 mil­lion from BAR­DA.

The fund­ing will be used for vials for vac­cines that are shep­herd­ed by Op­er­a­tion Warp Speed. Five groups — Mod­er­na, J&J, the joint As­traZeneca-Ox­ford, the Pfiz­er, BioN­Tech part­ner­ship and Mer­ck — have made it to the whit­tled-down short­list for the ini­tia­tive, as re­port­ed by the NYT and Bloomberg.

Pub­lic health ex­perts have stressed that com­pa­nies should ramp up vac­cine pro­duc­tion to meet glob­al de­mand for bil­lions of dos­es even be­fore they have sub­stan­tial ev­i­dence of safe­ty and ef­fi­ca­cy. But with that mam­moth ef­fort comes chal­lenges such as vial short­ages; As­traZeneca, for in­stance, has flagged po­ten­tial short­falls.

Vials will need to car­ry five to 10 dos­es of the vac­cines to cope with de­mand for huge vac­cine vol­umes and the rel­a­tive short­age of vials, J&J chief sci­en­tif­ic of­fi­cer Paul Stof­fels said last month.

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

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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