Covid-19 roundup: BioN­Tech ex­ec says new pro­duc­tion sites could be added to meet de­mand — re­port; Giv­ing up on the EC, Val­ne­va looks to in­di­vid­ual coun­tries for vac­cine sup­ply deals

BioN­Tech CFO Sierk Po­et­ting says he isn’t rul­ing out the con­struc­tion of new pro­duc­tion sites to meet de­mand for its Pfiz­er-part­nered Covid-19 vac­cine.

Sierk Po­et­ting

Po­et­ting told the Han­dels­blatt news­pa­per, pub­lished in Düs­sel­dorf, Ger­many, that the com­pa­ny is in talks to ramp up ca­pac­i­ty, which could be done in six months if nec­es­sary.

“There is still room for im­prove­ment. But that will ul­ti­mate­ly al­so de­pend on de­mand,” he said, per Reuters. 

Ear­li­er this year, BioN­Tech opened a new site in Mar­burg that it pur­chased from Pfiz­er. CEO Ugur Sahin told Bloomberg TV last month that Pfiz­er and BioN­Tech could in­crease man­u­fac­tur­ing ca­pac­i­ty to pro­duce 3 bil­lion dos­es next year. He added that the part­ners have 1.3 bil­lion dose or­ders in the book, and the abil­i­ty to pump out 2 bil­lion dos­es in 2021. A to­tal of 300 mil­lion dos­es have been promised to the US.

Roll­out of the Pfiz­er/BioN­Tech vac­cine ran be­hind sched­ule at the be­gin­ning of this year, wor­ry­ing some coun­tries and lead­ing Italy to threat­en le­gal ac­tion. Com­pa­nies like Sanofi and No­var­tis even­tu­al­ly stepped up to help with pro­duc­tion.

Ear­li­er this month, EC pres­i­dent Ur­su­la von der Leyen reached an agree­ment with Pfiz­er and BioN­Tech to speed up the de­liv­ery of their vac­cine to the bloc. The EC is al­so strik­ing a third con­tract with the com­pa­nies for 1.8 bil­lion more dos­es be­tween 2021 and 2023.

Giv­ing up on the EC, Val­ne­va looks to in­di­vid­ual coun­tries for vac­cine sup­ply deals

Val­ne­va is giv­ing up on dis­cus­sions with the EC for its in­ac­ti­vat­ed Covid-19 vac­cine can­di­date, and is now pur­su­ing sup­ply agree­ments on a coun­try-by-coun­try ba­sis, it said on Tues­day.

Thomas Lin­gel­bach

The news comes weeks af­ter Val­ne­va said the can­di­date ap­peared to be “high­ly im­muno­genic” in a Phase I/II tri­al, with more than 90% of all study par­tic­i­pants de­vel­op­ing sig­nif­i­cant lev­els of an­ti­bod­ies to the SARS-CoV-2 virus spike pro­tein across all dose groups test­ed. The French biotech says it plans to launch in­to Phase III by the end of this month, which could line it up to ap­proach reg­u­la­tors this fall.

“We’ve com­mit­ted sig­nif­i­cant time and ef­fort to try to meet the needs of the cen­tral EC pro­cure­ment process. De­spite our re­cent clin­i­cal da­ta, we have not made mean­ing­ful progress and have not yet se­cured a sup­ply agree­ment,” CEO Thomas Lin­gel­bach said in a state­ment.

“We are there­fore now fo­cus­ing our ef­forts on those Eu­ro­pean Union mem­ber states, and in­ter­est­ed par­ties out­side the EU, who would like to in­clude our in­ac­ti­vat­ed ap­proach with­in their vac­ci­na­tion strat­e­gy,” he added.

Back in Feb­ru­ary, the UK inked a deal for an ad­di­tion­al 40 mil­lion dos­es of Val­ne­va’s vac­cine in 2022, bring­ing the com­pa­ny’s to­tal com­mit­ment to the coun­try to 100 mil­lion dos­es. British of­fi­cials re­tain op­tions for an­oth­er 90 mil­lion shots be­tween 2023 and 2025. Should all the op­tions be ex­er­cised, the val­ue of the deal would equal €1.4 bil­lion, or about $1.69 bil­lion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Covid-19 roundup: High­er an­ti­body counts seen in spaced-out vac­cine in­ter­vals — study; Roche CEO com­pares IP waiv­er to East Ger­man 'ex­per­i­ments'

Near the outset of the UK’s vaccination campaign, the British government outlined plans to space out shots in larger intervals in order to get more people their first shot. Now, a study has come out saying the approach can drive a higher antibody response — at least in older populations.

In a study with 175 people older than 80, the antibody response was 3.5 times higher in individuals who received their second Pfizer/BioNTech shot 12 weeks after their first, compared to those who followed the typical three-week period. Antibody levels were measured about two to three weeks after the follow-up jabs.

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Brazil­ian Covid vari­ant in Illi­nois leads to a pause in ship­ments of Lil­ly’s mAb com­bo

The US is pausing shipments of Eli Lilly’s Covid-19 treatment combo (bamlanivimab and etesevimab) to Illinois because of the increased frequency of the coronavirus variant that originated in Brazil, known also as the P.1 variant.

The FDA is now recommending that health care providers in Illinois instead use Regeneron’s monoclonal antibody combo therapy of casirivimab with imdevimab, which it said is likely to retain activity against the P.1 variant, until further notice.