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.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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