Covid-19 man­u­fac­tur­ing roundup: Af­ter Emer­gent dis­as­ter, As­traZeneca in talks to move to Catal­ent plant — re­port; Sinopharm says it has ca­pac­i­ty to pro­duce 5B vac­cines

Af­ter months of pro­duc­tion of its vac­cine plagued by a mix­up at a Bal­ti­more Emer­gent plant that has been tak­en over by the FDA, As­traZeneca is in talks with the US gov­ern­ment to move pro­duc­tion to a fac­to­ry owned by Catal­ent, the New York Times re­ports.

The news comes just days af­ter news broke that J&J is ex­pect­ing to an­nounce that the con­t­a­m­i­na­tion prob­lems at the plant have been re­solved and pro­duc­tion is set to re­sume. Emer­gent an­nounced that af­ter a month of the FDA tak­ing over the Bayview site, a laun­dry list of is­sues has been solved, it said in a state­ment. With an agree­ment with the FDA, mil­lions of the dos­es of the J&J vac­cine that were quar­an­tined could be freed up for de­liv­ery and ad­min­is­tra­tion.

Catal­ent, a New Jer­sey-based CD­MO, will use its Mary­land fac­to­ry in which it al­ready pro­duces the drug sub­stances used in As­traZeneca’s jab to man­u­fac­ture the vac­cine, the Times re­ports.

Ear­ly in the man­u­fac­tur­ing process, Emer­gent was forced to trash mil­lions of ma­te­ri­als tied to As­traZeneca’s vac­cine, some­thing CEO Bob Kramer blamed on a flawed man­u­fac­tur­ing process sent over by the drug­mak­er.

The vac­cine has been ap­proved in sev­er­al coun­tries around the world, but not the US be­cause of a rare but se­ri­ous blood clot in the brain that has been re­port­ed in some who’ve re­ceived that vac­cine.

Mean­while, Emer­gent is now try­ing to over­come the ef­fects that come with shut­ting down op­er­a­tions for two months. Ma­te­ri­als from As­traZeneca’s vac­cine came in close con­tact with me­dia pre­pared for a J&J run, caus­ing cross con­t­a­m­i­na­tion. Lat­er, a Form 483 from the FDA re­vealed that the plant had un­san­i­tary con­di­tions, in­clud­ing black and brown sub­stances — and mold — present in the build­ing and a fail­ure to de­con­t­a­m­i­nate waste be­fore dis­pos­ing of them.

Kramer was called in front of the US House of Rep­re­sen­ta­tives Sub­com­mit­tee on the Coro­n­avirus Pan­dem­ic on May 19 and said that his plant would be good to re­sume op­er­a­tions with­in a few days if it was giv­en the OK by the FDA.

Sinopharm says it has ca­pac­i­ty to sup­ply 1B dos­es out­side Chi­na

Sinopharm has the ca­pac­i­ty to sup­ply the world with more than 1 bil­lion Covid-19 vac­cine dos­es out­side Chi­na, and has the ca­pac­i­ty to pro­duce 5 bil­lion dos­es an­nu­al­ly in to­tal, its chair­man Liu Jingzhen said Wednes­day.

Right now, two vac­cines from Sinopharm are be­ing used in Chi­na, and one of them has been grant­ed emer­gency use au­tho­riza­tion by the WHO. Sinopharm has al­so planned a man­u­fac­tur­ing fa­cil­i­ty for its third vac­cine, which is in ear­ly-stage clin­i­cal tri­als.

Liu would not say how many dos­es have been pledged to CO­V­AX, how­ev­er. In Feb­ru­ary, the Chi­nese gov­ern­ment pledged 10 mil­lion dos­es to the or­ga­ni­za­tion.

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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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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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.

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.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Ver­tex and CRISPR Ther­a­peu­tics un­veil more pos­i­tive gene ther­a­py da­ta, but busul­fan again casts a shad­ow over the field

Less than 12 hours after revealing a flop on its second shot for alpha-1 antitrypsin deficiency, Vertex plowed ahead with another data drop from its partnership with CRISPR Therapeutics. And though the topline proved positive, concerns over conditioning agents continue to linger over the collaboration, as well as the entire gene therapy space.

Presenting data from two trials at the European Hematology Association annual meeting, the pair announced that follow-up data of at least three months for 22 patients with genetic blood disorders indicated a “consistent and sustained” response to the experimental drug CTX001. All 15 patients with transfusion-dependent beta thalassemia did not need further blood transfusions and all seven with severe sickle cell disease were pain free, the biotechs announced.