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.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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