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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.