Hal Barron (GSK via YouTube)

Year-end earn­ings show tur­bu­lent times for Hal Bar­ron's Glax­o­SmithK­line turn­around

Em­ma Walm­s­ley GSK

Hal Bar­ron and Em­ma Walm­s­ley’s big Glax­o­SmithK­line piv­ot may ul­ti­mate­ly prove suc­cess­ful, de­liv­er­ing block­busters in can­cer, au­to-im­mune con­di­tions and in­fec­tious dis­ease. But the path to get there is al­ready look­ing rocky.

GSK an­nounced their year-end earn­ings Wednes­day morn­ing, re­veal­ing that they had cut two more pipeline can­di­dates af­ter they failed in ear­ly stage tri­als and dis­ap­point­ing in­vestors with news that prof­its had fall­en and earn­ings per share would de­cline by mid to high sin­gle dig­its.

GSK’s stock $GSK fell 4% Wednes­day, from $37.57 to $35.94.

The low­er prof­it mar­gins re­flect the British phar­ma’s in­creased R&D spend­ing — some­thing an­a­lysts and in­vestors some­times re­ward when it pays off. But Bar­ron has seen a slate of R&D set­backs in just the past few weeks. In Jan­u­ary, they an­nounced that the cen­ter­piece of a $4 bil­lion im­muno-on­col­o­gy part­ner­ship with Mer­ck KGaA failed in a Phase III lung can­cer tri­al. Two days lat­er, they scrapped an ul­cer­a­tive col­i­tis study for LAG-3 drug af­ter it failed an in­ter­im re­view.

Mean­while, their high-pro­file Covid-19 part­ner­ship with Sanofi faced a ma­jor set­back that knocked the pair out of the cast of vac­cine fron­trun­ners, while an­oth­er vac­cine biotech, Clover, sloughed off their work with GSK en­tire­ly, opt­ing to use a dif­fer­ent ad­ju­vant.

The Q4 re­vealed the com­pa­ny al­so shelved an OX40 ag­o­nist they had been de­vel­op­ing with Mer­ck for sol­id tu­mors and an OSM-tar­get­ing ul­cer­a­tive col­i­tis drug, with­draw­ing it from a Phase II study be­fore any pa­tients were en­rolled. An ef­fort to com­bine the au­toim­mune drug Benlysta with Rit­ux­an for the rare dis­ease Sjö­gren’s syn­drome al­so fell short.

With the ex­cep­tion of the Sanofi and Mer­ck KGaA deals, the set­backs did not come in GSK’s ma­jor pro­grams, and the com­pa­ny saw a smat­ter­ing of suc­cess­es, in­clud­ing the first-ever FDA ap­proval for lu­pus nephri­tis and sim­i­lar nods for a BC­MA-tar­get­ing mul­ti­ple myelo­ma drug and, through its HIV sub­sidiary Vi­iV, the first long-act­ing an­ti­retro­vi­ral ther­a­py. Still, col­lec­tive­ly they amount to a thou­sand cuts for a com­pa­ny that has spent, by one es­ti­mate, $29 bil­lion over just 3 years to for­ti­fy its pipeline with clear po­ten­tial block­busters.

Bar­ron and Walm­s­ley will have a hand­ful of op­por­tu­ni­ties to right the ship in the near fu­ture, be­gin­ning with the an­ti­body they de­vel­oped with Vir, which is due to read out on its first tri­al this quar­ter. The com­pa­ny al­so ex­pects new da­ta on Nu­cala and the launch of a piv­otal study for their RSV vac­cine, a long-sought and po­ten­tial­ly high­ly lu­cra­tive prod­uct.

The com­pa­ny has al­so just made a bet on a new ma­jor Covid-19 vac­cine ef­fort, re­dou­bling on their past sup­port for Cure­Vac with a new in­fu­sion of $180 mil­lion to ramp up man­u­fac­tur­ing and help de­vel­op a new vac­cine against emerg­ing vari­ants.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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