Mod­er­na bags an­oth­er US CD­MO to help with fill-fin­ish work for its vac­cine amid boost­er push

Mod­er­na has en­list­ed an­oth­er CD­MO to ramp up Covid-19 vac­cine man­u­fac­tur­ing ca­pa­bil­i­ty in its ef­fort to pro­vide 3 bil­lion dos­es in 2022.

Juan An­dres

Start­ing in Q3, Ther­mo Fish­er Sci­en­tif­ic will car­ry out fill-fin­ish, la­bel­ing and pack­ag­ing ser­vices to sup­port Mod­er­na at the CD­MO’s Greenville, NC site, the com­pa­ny said in a re­lease.

“Ther­mo Fish­er has been a crit­i­cal part­ner in sup­ply­ing raw ma­te­ri­als for our COVID-19 vac­cine and we are now pleased to fur­ther ex­pand our re­la­tion­ship as an im­por­tant man­u­fac­tur­ing part­ner as well,” said Juan An­dres, Mod­er­na’s chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer, in a state­ment. “The ad­di­tion of Ther­mo Fish­er to our net­work will sup­port our ef­forts to scale up our man­u­fac­tur­ing abil­i­ty.”

Mod­er­na has al­so reached an agree­ment with Lon­za to es­tab­lish a new pro­duc­tion line at the com­pa­ny’s Geleen, Nether­lands site, which will add an ad­di­tion­al 300 mil­lion dos­es per year in ca­pac­i­ty.

The pro­duc­tion in Geleen will help Mod­er­na halve the dosage of its vac­cine for pe­di­atric use and as boost­ers against vari­ants. Mod­er­na has stud­ied low­er-dose ver­sions of its jab to help stretch out the sup­ply. So far, dos­es have con­sist­ed of 100 mi­cro­grams, but Mod­er­na has al­so teamed with ROVI in Grana­da, Spain, to sup­ply 600 mil­lion 50 mi­cro­gram dos­es per year. Both of those pacts will be op­er­a­tional be­fore the end of 2021, the com­pa­ny said in the re­lease.

ROVI and France’s Re­ci­pharm have al­ready been per­form­ing fill-fin­ish ser­vices for Mod­er­na’s vac­cine in Eu­rope. These moves are the lat­est an­nounce­ments in a rapid ramp-up in pro­duc­tion.

Last week, Mod­er­na and Sam­sung Bi­o­log­ics inked a deal for fill-fin­ish du­ties at its In­cheon, South Ko­rea plant. Mod­er­na’s al­so pledged to dou­ble its Mass­a­chu­setts lab space for a 50% in­crease in man­u­fac­tur­ing, dou­ble man­u­fac­tur­ing at Lon­za’s Visp, Switzer­land site and Rovi’s Spain fa­cil­i­ty. In April, Sanofi signed on with Mod­er­na to pro­duce its vac­cine. That marked the third com­pa­ny Sanofi part­nered with to pro­duce the Covid-19 shot af­ter its own at­tempts failed. The French drug­mak­er is al­so pro­duc­ing Pfiz­er-BioN­Tech and J&J’s jab at its man­u­fac­tur­ing sites, in­clud­ing the one in Ridge­field, NJ.

Catal­ent — a Mod­er­na part­ner — and Ster­ling are work­ing to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines.

Mean­while, Mod­er­na’s pledged 50o mil­lion dos­es to CO­V­AX ear­ly last month. Those dos­es will be sold at the low­est tiered price, and go to 92 of the low­est in­come coun­tries by the end of next year. Ac­cord­ing to the agree­ment, 34 mil­lion of those dos­es are set to be de­liv­ered in Q4. Gavi, the vac­cine al­liance has al­ready shipped 49 mil­lion Covid-19 vac­cines do­nat­ed from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.