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.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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EMA is­sues warn­ing of IVF drug short­age due to man­u­fac­tur­ing is­sues

The European Medicines Agency recently noted the shortage of a drug that is used frequently in IVF procedures where women have ovarian stimulation (i.e. fertility treatment where the ovaries are stimulated to produce more eggs).

The drug, known as cetrotide, is now facing a shortage in Europe due to a potential manufacturing issue.

The EMA’s warning on Wednesday states that a technical issue at the main manufacturing site for cetrotide resulted in the closure of the site between December 2021 and March of this year. This led to reductions and delays in the supply of cetrotide.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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