Covid-19 roundup: Am­gen toss­es Ote­zla in­to an­ti-in­flam­ma­to­ry mix; Trump thick­ens plot around US probe in­to virus ori­gin

Fol­low­ing in the foot­steps of oth­er large drug­mak­ers who have re­pur­posed their en­trenched ther­a­pies against Covid-19, Am­gen has re­leased an­oth­er weapon in its ar­se­nal that could play a more im­me­di­ate role in the pan­dem­ic.

Ote­zla — the block­buster pso­ri­a­sis drug Am­gen snagged from Cel­gene in a $13.4 bil­lion deal last year — will en­ter the clin­ic “in the com­ing weeks to be in­ves­ti­gat­ed as a po­ten­tial im­munomod­u­la­to­ry treat­ment in adult pa­tients with the dis­ease,” R&D chief David Reese said in an earn­ings call.

The hope is that by block­ing the PDE4 en­zyme, the drug can help pre­vent the res­pi­ra­to­ry dis­tress seen in late-stage Covid-19 pa­tients, CEO Bob Brad­way added.

In the ab­sence of an an­tivi­ral proven to stop the in­fec­tion — al­though Gilead promis­es to change that very soon with buoy­ant da­ta on remde­sivir — mit­i­gat­ing the in­flam­ma­tion that dev­as­tates and kills pa­tients has be­come a pop­u­lar goal. Among the most high-pro­file are a pair of IL-6 drugs, Kevzara from Sanofi/Re­gen­eron and Actem­ra from Roche, al­though da­ta have been mixed. No­var­tis and In­cyte have al­so launched Phase III pro­grams for the JAK in­hibitor Jakafi.

PDE4, though, ap­pears to be a new mech­a­nism in the mix. While Ote­zla is on­ly ap­proved for plaque pso­ri­a­sis and pso­ri­at­ic arthri­tis, a sim­i­lar drug, As­traZeneca’s Dalire­sp, is ap­proved to treat chron­ic ob­struc­tive pul­monary dis­ease.

With the new move Am­gen is now de­ploy­ing three of its core ex­per­tise ar­eas — ge­net­ics, an­ti­body and im­munol­o­gy — against the coro­n­avirus. Its de­CODE sub­sidiary is en­gag­ing in epi­demi­ol­o­gy work while the R&D team has part­nered with Adap­tive to de­vel­op an an­ti­body, backed by a ca­pac­i­ty to man­u­fac­ture at scale.

“Our goal al­so is to re­al­ly iden­ti­fy a very high qual­i­ty ther­a­peu­tic can­di­date, and it’s my be­lief that there may well be more than one gen­er­a­tion of an­ti­body ther­a­peu­tics en­ter­ing the clin­ic,” Reese said. “And as work pro­gress­es, we are up and run­ning in the lab­o­ra­to­ry.” — Am­ber Tong

Chi­na ush­ers an­oth­er in­ac­ti­vat­ed vac­cine can­di­date in­to clin­ic

A sec­ond in­ac­ti­vat­ed vac­cine can­di­date from Chi­na’s Sinopharm Group has been cleared for hu­man tri­als, Chi­na Dai­ly re­port­ed, just as its first pro­gram was hus­tled in­to Phase II.

Bei­jing In­sti­tute of Bi­o­log­i­cal Prod­ucts, a sub­sidiary of its Chi­na Na­tion­al Biotech Group, was be­hind this new vac­cine, which is es­sen­tial­ly a ver­sion of the SARS-CoV-2 virus that has lost dis­ease-pro­duc­ing ca­pac­i­ty. An­oth­er sub­sidiary, Wuhan In­sti­tute of Bi­o­log­i­cal Prod­ucts, co-de­vel­oped the first pro­gram with the Wuhan In­sti­tute of Vi­rol­o­gy (be­fore it was em­broiled in­to heat­ed ac­cu­sa­tions of be­ing ground ze­ro of the pan­dem­ic, the re­search in­sti­tute en­joyed pres­tige as the first biosafe­ty lev­el 4 lab in Chi­na).

Sinopharm chair­man Jingzhen Liu said the com­pa­ny has set aside around $141.33 mil­lion (RMB$1 bil­lion yuan) to sup­port both R&D pro­grams.

Its sprawl­ing op­er­a­tions have ca­pac­i­ty to pro­duce 100 mil­lion vials of vac­cines per year if they prove ef­fec­tive, the com­pa­ny added.

Chi­na has now ap­proved three in­ac­ti­vat­ed vac­cines in to­tal for clin­i­cal tri­als, in ad­di­tion to CanSi­no’s re­com­bi­nant ade­n­ovirus vec­tor. Cheng­du-based Clover Phar­ma­ceu­ti­cals has al­so notched ap­proval to be­gin test­ing its sub­unit vac­cine — boost­ed by GSK’s ad­ju­vant — in Aus­tralia. Oth­er pre­clin­i­cal ef­forts are on­go­ing to ad­vance re­com­bi­nant pro­tein vac­cines, nu­cle­ic acid vac­cines as well as vac­cines that use at­ten­u­at­ed flu virus­es as vec­tors.

“The world is rac­ing to de­vel­op COVID-19 vac­cines, yet it is not a com­pe­ti­tion be­tween coun­tries, but rather a race be­tween hu­mans and the virus,” Xi­aom­ing Yang, pres­i­dent of CN­BG, said in an in­ter­view. — Am­ber Tong

While in­tel­li­gence of­fi­cials probe ori­gin of virus, Trump says he’s seen ev­i­dence of links to Wuhan lab

A day af­ter US in­tel­li­gence agen­cies broke with usu­al prac­tice to ac­knowl­edge that it is in­ves­ti­gat­ing the ori­gin of the virus that caus­es Covid-19, Pres­i­dent Don­ald Trump went one step fur­ther and claimed he’s seen ev­i­dence to make his own as­sess­ment.

What­ev­er he said he knows — and he de­clined to elab­o­rate when pressed — has giv­en him a “high de­gree of con­fi­dence” that the Wuhan In­sti­tute of Vi­rol­o­gy is linked to the ori­gin of the virus, he told re­porters in a press brief­ing.

Since the ear­ly days of the out­break in Chi­na there have been ru­mors that SARS-CoV-2 was man-made or ge­net­i­cal­ly mod­i­fied — a the­o­ry that’s been wide­ly re­fut­ed and de­bunked. On Thurs­day, the Of­fice of the Di­rec­tor of Na­tion­al In­tel­li­gence is­sued a state­ment say­ing it con­curs with that sci­en­tif­ic con­sen­sus.

A re­lat­ed yet dis­tinc­tive­ly dif­fer­ent con­cern has emerged that the virus might have been passed on­to hu­mans, by ac­ci­dent, in a Wuhan lab where it was be­ing stud­ied.

Top US of­fi­cials, from the pres­i­dent him­self and Sec­re­tary of State Mike Pom­peo, have fu­eled the idea. Just two days ago Pom­peo said again: “We still haven’t gained ac­cess, the world hasn’t gained ac­cess to the WIV (Wuhan In­sti­tute of Vi­rol­o­gy) there. We don’t know pre­cise­ly where this virus orig­i­nat­ed from.”

The ODNI “will con­tin­ue to rig­or­ous­ly ex­am­ine emerg­ing in­for­ma­tion and in­tel­li­gence to de­ter­mine whether the out­break be­gan through con­tact with in­fect­ed an­i­mals or if it was the re­sult of an ac­ci­dent at a lab­o­ra­to­ry in Wuhan.” — Am­ber Tong

Clin­i­cal tri­al snap­shot in Asia-Pa­cif­ic presents dif­fer­ent pic­ture from glob­al dis­rup­tion

While much of the world grap­ples with a new state of clin­i­cal tri­al re­search, one re­gion ap­pears to have found a way to thrive un­der the pan­dem­ic: Asia-Pa­cif­ic. Ac­cord­ing to da­ta pro­vid­ed by Novotech to End­points News, the num­ber of biotech-spon­sored tri­als ini­ti­at­ed in Asia-Pa­cif­ic dur­ing March and April is about 20% high­er than the num­ber of new tri­als in North Amer­i­ca over the same pe­ri­od.

Places like Aus­tralia, South Ko­rea, Tai­wan, Hong Kong and New Zealand have adapt­ed the best to the sit­u­a­tion, the CRO not­ed, hav­ing kept the in­fec­tion rates low, test­ing rates high and mor­tal­i­ty down. When you look at the top 10 biotech sites in each of these five lo­ca­tions, 70% of the sites are al­low­ing re­cruit­ment and 95% are open for mon­i­tor­ing, both re­mote or on­site. — Am­ber Tong

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

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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 you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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