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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

Leo Tarkovsky, Fingerpaint Group's new chief commercial officer

Fin­ger­paint Group taps for­mer WPP and Mc­Cann Health ex­ec for new com­mer­cial role

Healthcare agency veteran Leo Tarkovsky has joined Fingerpaint Group as chief commercial officer to oversee its growing portfolio of pharma and healthcare agencies and communications companies.

Tarkovsky came to Fingerpaint from WPP where he was EVP for global healthcare growth over the past year. Before that served at McCann Health for seven years including as president overseeing the New York agencies with pharma clients including AstraZeneca, Bristol Myers Squibb, Eli Lilly and Johnson & Johnson’s Janssen.

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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