Glax­o­SmithK­line of­fers fill-fin­ish ca­pac­i­ty to No­vavax for UK sup­ply of Covid-19 vac­cine

UK drug­mak­er Glax­o­SmithK­line has tak­en a broad re­sponse to the Covid-19 pan­dem­ic, work­ing on both vac­cines and ther­a­peu­tics. So far, that strat­e­gy hasn’t churned out much suc­cess — but the drug­mak­er is still sign­ing deals, this time with vac­cine play­er No­vavax.

GSK will chip in on pro­duc­ing No­vavax’s re­com­bi­nant Covid-19 vac­cine, pledg­ing fill-fin­ish ca­pac­i­ty for 60 mil­lion dos­es of the shot for use in the UK as part of a deal with the Mary­land biotech and the UK gov­ern­ment an­nounced Mon­day.

The phar­ma will hold ca­pac­i­ty at its Barnard Cas­tle fa­cil­i­ty in north­east Eng­land be­gin­ning as ear­ly as May with tech trans­fer slat­ed to be­gin im­me­di­ate­ly. Fi­nal terms of the deal are pend­ing, GSK said.

No­vavax is on the hook for 60 mil­lion dos­es of its shot to the UK as part of a deal signed back in Au­gust. No­vavax’s con­tract part­ner, Fu­ji­film Diosynth Biotech­nolo­gies, is pro­duc­ing the anti­gen com­po­nent of the shot at its UK site in Billing­ham, Stock­ton-on-Tees.

It’s the lat­est part­ner­ship in GSK’s plan to take as many pos­si­ble shots on goal with Covid-19 as pos­si­ble. The drug­mak­er is cur­rent­ly work­ing on a part­nered vac­cine with French drug­mak­er Sanofi that is cy­cling through a Phase II test, and has chased an­ti­body ther­a­peu­tics as a so­lo project and in part­ner­ship with Vir Biotech­nol­o­gy. The drug­mak­er has al­so pledged to sup­ply up to 100 mil­lion dos­es of a po­ten­tial mR­NA-based Covid-19 vac­cine from Ger­man firm Cure­Vac.

So far, none of those projects have yet crossed the fin­ish line, but GSK’s work with Vir is the like­ly fron­trun­ner.

Late last week, the part­ners filed for an emer­gency use au­tho­riza­tion with the FDA for the an­ti­body, dubbed VIR-7831, to treat mild-to-mod­er­ate Covid-19 who are at risk for pro­gres­sion to hos­pi­tal­iza­tion or death. The sub­mis­sion was based on in­ter­im Phase III da­ta show­ing the drug post­ed an 85% re­duc­tion in hos­pi­tal­iza­tion or death com­pared with place­bo. The tri­al’s In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee rec­om­mend­ed that the tri­al stop en­roll­ment be­cause of the ear­ly sign of ef­fi­ca­cy, and GSK said the an­ti­body could have ben­e­fit against emerg­ing vari­ants.

Notch­ing an ef­fi­ca­cy win even with the es­cape vari­ants in­clud­ed would be a big boost to the part­ners’ re­sume, par­tic­u­lar­ly af­ter Eli Lil­ly’s own Covid-19 an­ti­body was large­ly tak­en off shelves due to a lack of ef­fi­ca­cy there. To­day, the In­dy phar­ma post­ed ear­ly Phase II da­ta show­ing the an­ti­body, bam­lanivimab, and VIR-7831 suc­cess­ful­ly re­duced vi­ral loads over bam­lanivimab alone. The de­gree to which that ben­e­fit was tied to the drug com­bo it­self or just VIR-7831 is un­known, and the com­pa­nies are still en­rolling that study.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.