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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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Rob Davis, Merck CEO (The Galien Foundation)

Mer­ck­'s $10.8B Prometheus buy­out can pro­ceed af­ter an­titrust re­view

The government’s waiting period for Merck’s $10.8 billion Prometheus Biosciences buyout expired on Monday, meaning the companies can proceed to close the deal, according to an SEC filing.

Prometheus announced the merger last month after fielding interest from several other pharma companies, including AbbVie and Bristol Myers Squibb, according to a Bloomberg report. It gives Merck PRA023, an experimental anti-TL1A antibody for inflammatory bowel disease that Merck expects will play a big role in its future beyond Keytruda’s patent cliff.

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Bi­par­ti­san law­mak­ers pres­sure FDA on com­mon chemother­a­pies now in short­age

The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages.

Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer.

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