Stéphane Bancel, Getty

Mod­er­na tur­bocharges its sup­ply chain, up­ping com­mit­ment to 3B dos­es per year for a fu­ture where boost­ers are like­ly

With both As­traZeneca and J&J fac­ing ma­jor hur­dles in their glob­al Covid-19 vac­cine roll­outs, the bur­den has fall­en on Mod­er­na and Pfiz­er/BioN­Tech to step up their games in terms of pro­duc­tion. Now, look­ing at a fu­ture in which boost­ers and vari­ant vac­cines will like­ly be need­ed, Mod­er­na is adding ar­mor to its sup­ply chain.

Mod­er­na is now plan­ning to pro­duce up to 3 bil­lion dos­es in 2022, dou­bling ca­pac­i­ty at con­tract sites in Switzer­land and Spain run by Lon­za and Rovi, re­spec­tive­ly, and in­creas­ing drug sub­stance man­u­fac­tur­ing by 50% at its US fa­cil­i­ties. The ex­pan­sions will al­so al­low Mod­er­na to now pro­duce be­tween 800 mil­lion and 1 bil­lion dos­es in 2021, the com­pa­ny said.

The ac­tu­al num­ber of dos­es will de­pend on the man­u­fac­tur­ing split be­tween 100-mi­cro­gram vac­cine dos­es and po­ten­tial­ly low­er-dose boost­ers and pe­di­atric vac­cines, the com­pa­ny said. The fi­nan­cial terms of the ex­pan­sion weren’t dis­closed, but Mod­er­na said it is fund­ing the move out of pock­et.

“We said ‘what can we do for the world?’ and we ba­si­cal­ly went back to our board and said ‘we need to do mas­sive in­vest­ment,'” Ban­cel told End­points News. “We need to aim to in­crease our ca­pac­i­ty for next year so that we can make sure we can vac­ci­nate and boost every­body.”

While com­peti­tors Pfiz­er, As­traZeneca, Sanofi and J&J have all reached agree­ments with Co­v­ax, the glob­al ini­tia­tive aimed at eq­ui­table ac­cess to COVID-19, Mod­er­na has not. Ban­cel would not dis­cuss the terms of a po­ten­tial deal with the coali­tion Wednes­day, on­ly say­ing that his com­pa­ny is “very ac­tive” in the fi­nal dis­cus­sions.

De­spite the pa­per agree­ments with oth­er com­pa­nies, Co­v­ax has fall­en well short of its goals,  dis­trib­ut­ing just over 40 mil­lion dos­es to date.

On top of fin­ished dos­es, Mod­er­na will al­so stock­pile a “safe­ty stock”  of raw ma­te­ri­als and fin­ished drug sub­stance used in the vac­cine as a means of avoid­ing raw sup­ply short­ages. That’s been a run­ning is­sue for Mod­er­na, re­cent­ly lead­ing it cut the num­ber of dos­es it planned to send to Cana­da by April in half. It’s al­so trou­bled oth­er vac­cine mak­ers, in­clud­ing No­vavax and In­dia’s Serum In­sti­tute.

To­day, the team at Mod­er­na is set to get CEOs of the com­pa­nies that sup­ply raw ma­te­ri­als on the phone, and lay out just what their ex­pec­ta­tions are for the next year, Ban­cel said. The cur­rent short­ages could not have been pre­dict­ed, but if this boost in man­u­fac­tur­ing is to be suc­cess­ful, Ban­cel said it is vi­tal to pre­vent the next one.

“We’re still tight on raw ma­te­ri­als, be­cause a lot of peo­ple around the world are us­ing them,” Ban­cel said.

Aid­ing its am­bi­tious dis­tri­b­u­tion plan is new da­ta un­veiled to­day show­ing the vac­cine can be vi­able with a three-month re­frig­er­at­ed shelf life. That could be a big deal since Mod­er­na’s shot is on­ly ap­proved for re­frig­er­a­tion of up to one month and sev­en months in a stan­dard freez­er. The ex­tend­ed shelf life could be cru­cial for de­liv­er­ing and ad­min­is­ter­ing the vac­cine suc­cess­ful­ly to small­er lo­ca­tions with­in coun­tries in which re­frig­er­a­tion is sparse and freez­ers are a rar­i­ty.

As it looks to ex­pand its part­ner­ship with two of its pri­ma­ry con­tract man­u­fac­tur­ers, Mod­er­na has al­so added some pro­duc­tion heft in re­cent months. French drug­mak­er Sanofi en­tered an agree­ment ear­li­er this week with Mod­er­na to help man­u­fac­ture 200 mil­lion dos­es of the com­pa­ny’s Covid-19 vac­cine at its Ridge­field, NJ site. That will be­gin in Sep­tem­ber.

New Jer­sey CD­MO Catal­ent an­nounced on April 6 that it was up­ping pro­duc­tion ca­pac­i­ty of the vac­cine in its Bloom­ing­ton, IN bi­o­log­ics fa­cil­i­ty through its new high-speed vial fill­ing line. Those dos­es are ex­pect­ed to be ready in May.

“We said look, we have a cer­tain re­spon­si­bil­i­ty as a com­pa­ny and we will in­vest ag­gres­sive­ly … so that next year we can have a big im­pact,” Ban­cel said. “If you think about it, look at the pop­u­la­tion of the plan­et, you see that 70% of peo­ple want the vac­cine, which is what we’re see­ing in polls across the world, and if we can make 3 bil­lion vac­cines, that will be, for a com­pa­ny that just launched its first prod­uct a few months ago, ex­tra­or­di­nary.”

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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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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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.

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.