CEO Martin VanTrieste (Civica Rx)

Flush with cash to change the gener­ics sup­ply chain, Civi­ca Rx looks to break ground on first in-house man­u­fac­tur­ing site

Look­ing to over­haul the gener­ics sup­ply chain for fu­ture pan­demics, the Trump ad­min­is­tra­tion in May doled out a hefty four-year, $354 mil­lion con­tract to the fledg­ling Phlow Cor­po­ra­tion, based in Rich­mond, Vir­ginia. That con­tract, which could in­crease to as much as 10 years and $812 mil­lion, in­clud­ed build­ing a new man­u­fac­tur­ing fa­cil­i­ty to re­duce US de­pen­dence on for­eign drug pro­duc­tion.

A day af­ter Trump left Wash­ing­ton, DC, the first steps of that plan fi­nal­ly be­gan to take shape.

Civi­ca Rx, a non-prof­it gener­ic drug man­u­fac­tur­er found­ed in 2018, an­nounced on Thurs­day that it would in­vest $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, Vir­ginia — close to Phlow and the oth­er part­ners in the gov­ern­ment con­tract, Med­i­cines for All In­sti­tute and AM­PAC Fine Chem­i­cals.

The con­tract raised some eye­brows in the bio­phar­ma in­dus­try when it was first an­nounced, as Phlow’s CEO Er­ic Ed­wards is per­haps best known for drug pric­ing con­tro­ver­sies stem­ming from Kaléo, a com­pa­ny he co­found­ed, which up­charged an EpiPen vari­a­tion some 700% sev­er­al years ago.

Civi­ca’s 120,000-square-foot site will take sev­er­al years to be­come ful­ly op­er­a­tional, the com­pa­ny has said pre­vi­ous­ly, but will man­u­fac­ture vials and sy­ringes of in­jectable med­i­cines used for Covid-19 pa­tient care, as well as drugs used in emer­gency rooms, surg­eries, and the treat­ment of se­ri­ous in­fec­tions and hy­per­ten­sion.

“Our part­ner­ship and co-man­u­fac­tur­ing lo­ca­tion with Phlow and AM­PAC will be in­stru­men­tal in our ef­forts to sim­pli­fy what is typ­i­cal­ly a very com­plex sup­ply chan­nel,” Civi­ca CEO Mar­tin VanTri­este said in a state­ment. “This is a dream come true for Civi­ca and our hos­pi­tal part­ners as we work to­geth­er to sta­bi­lize the sup­ply of qual­i­ty med­i­cines for pa­tients across the coun­try.”

De­spite be­ing less than three years old, Civi­ca has built a big foot­print in the gener­ic drug man­u­fac­tur­ing in­dus­try. The com­pa­ny is as­so­ci­at­ed with over 50 health sys­tems across the coun­try, which amounts to some 1,350 hos­pi­tals and over a third of the na­tion’s to­tal li­censed hos­pi­tal bed ca­pac­i­ty.

Vir­ginia Gov­er­nor Ralph Northam heaped praise on Civi­ca’s in­vest­ment in the state, as well as the fed­er­al part­ner­ship. The Civi­ca fa­cil­i­ty when com­plet­ed will bring close to 200 new jobs to the Old Do­min­ion state and will serve a key pur­pose as the pan­dem­ic con­tin­ues to un­fold, Northam said in a state­ment.

“This project is a tremen­dous win that will ce­ment Vir­ginia’s sta­tus as a leader in phar­ma­ceu­ti­cal man­u­fac­tur­ing, an in­dus­try that re­mains at the fore­front of re­spond­ing to the glob­al pan­dem­ic,” Northam said. “Civi­ca’s part­ner­ship with Phlow Cor­po­ra­tion, Med­i­cines for All In­sti­tute, and AM­PAC Fine Chem­i­cals will en­sure the gen­er­al pub­lic has ac­cess to high-qual­i­ty, life­sav­ing med­i­cines and pro­vide a crit­i­cal av­enue for do­mes­tic drug man­u­fac­tur­ing ca­pa­bil­i­ties.”

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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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.

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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Ugur Sahin, AP Images

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

BioNTech, Pfizer’s partner on its Covid-19 vaccine, will look to establish mRNA vaccine production facilities in Africa, the Financial Times reported Wednesday.

The move is a part of a larger push to tackle diseases beyond Covid-19, and as the EU looks to up its manufacturing capacity on the continent. Right now, Africa imports over 99% of the vaccines it uses, the FT reports. The plan was outlined in a call between CEO Ugur Sahin and European Commission President Ursula von der Leyen before the G7 summit.