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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.