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.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Man­u­fac­tur­ing roundup: Astel­las to sell Dutch fa­cil­i­ty to Del­pharm; Au­ri­gene in­vest­ing $40M in­to In­dia man­u­fac­tur­ing fa­cil­i­ty

Astellas Pharma is selling its manufacturing plant in Meppel, the Netherlands, to contract manufacturer Delpharm.

Astellas said last week it’s transferring the facility to Delpharm as part of a wider shift for the pharma’s technology and manufacturing business. As part of the deal, for which financial details were not disclosed, Delpharm plans to continue to produce the products that are made in the Meppel plant for Astellas. The employees at the site will also transfer to Delpharm as well. The deal is expected to close by the end of the year.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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