Covid-19 man­u­fac­tur­ing roundup: Catal­ent adds freez­er part­ner for vac­cine pro­duc­tion push; In need of vol­un­teers, Lon­za turns to food work­ers

As Catal­ent ramps up its pro­duc­tion of Covid-19 vac­cines in a re­cent push to dou­ble its pro­duc­tion, it has se­cured more of the  tech­nol­o­gy to store them.

Catal­ent and Ster­ling will work to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines. The part­ner­ship has al­ready re­sult­ed in the in­stal­la­tion of over 200 freez­ers at Catal­ent fa­cil­i­ties with plans for an­oth­er 60 to be in­stalled at cell and gene ther­a­py sites across the US, Eu­rope and Asia.

The freez­ers can op­er­ate at tem­per­a­tures as low as -86 de­grees Cel­sius and as high as -20 de­grees Cel­sius.

The freez­ers use 100% nat­ur­al re­frig­er­ants and will pro­duce 30% of the car­bon diox­ide over a 10-year span than a typ­i­cal freez­er would pro­duce, the com­pa­ny said. The Athens, OH-based com­pa­ny al­so claims the in­dus­try’s on­ly portable so­lu­tion for re­mote clin­i­cal tri­als and drug de­liv­ery.

On Thurs­day, Mod­er­na an­nounced that it would ex­pand pro­duc­tion of its mR­NA-based Covid-19 vac­cines at sev­er­al of its fa­cil­i­ties, in­clud­ing Catal­ent’s, in an ef­fort to keep up with virus vari­ants and pro­vide dos­es to coun­tries in need. One of the is­sues it faces is keep­ing the vac­cine cold enough — at least -20 de­grees Cel­sius — while de­liv­er­ing the vac­cines to coun­tries that do not have easy ac­cess to mod­ern re­frig­er­a­tion de­vices.

In need of vol­un­teers, Lon­za turns to food work­ers to help make vac­cine

As a num­ber of com­pa­nies have pledged to ramp up Covid-19 vac­cines fol­low­ing re­cent sec­ond waves around the world, drug­mak­ers are in need of em­ploy­ees to help speed up pro­duc­tion.

In Switzer­land, Lon­za has re­cruit­ed staff from food gi­ant Nes­tle to make in­gre­di­ents, ac­cord­ing to Reuters.

Mod­er­na re­cent­ly an­nounced that it would dou­ble the vac­cine pro­duc­tion at sev­er­al of its plants, and Lon­za’s site in Visp is one of them. Last week, the com­pa­ny blamed de­lays in ship­ments on pro­duc­tion bot­tle­necks. Em­ploy­ees at a west­ern Switzer­land Nes­tle re­search cen­ter were asked a week ago to vol­un­teer to step in­to the vac­cine man­u­fac­tur­ing world for a three-month mis­sion, Reuters said.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.