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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.

AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.

Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.

Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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