Stéphane Bancel, Getty

Covid-19 man­u­fac­tur­ing roundup: As the US gov­ern­ment bags an­oth­er 100M dos­es of Mod­er­na shot, the biotech is chip­ping in on UAE roll­out

Pres­i­dent Joe Biden’s ad­min­is­tra­tion has or­dered an­oth­er round of shots.

Mod­er­na and the US gov­ern­ment have reached a deal that will pro­vide the com­pa­ny with an­oth­er 200 mil­lion dos­es of its Covid-19 vac­cine, and in­clude the op­tion to pur­chase oth­er can­di­dates from the com­pa­ny’s pipeline, Mod­er­na an­nounced Wednes­day. The agree­ment brings the to­tal num­ber of Mod­er­na shots to 500 mil­lion. An­oth­er 110 mil­lion will be de­liv­ered in Q4 of 2021 and 90 mil­lion are ex­pect­ed in Q1 of 2021.

As of June 14, the US has re­ceived 217 mil­lion dos­es from Mod­er­na.

“We ap­pre­ci­ate the col­lab­o­ra­tion with the U.S gov­ern­ment for these ad­di­tion­al dos­es of the Mod­er­na COVID-19 vac­cine, which could be used for pri­ma­ry vac­ci­na­tion, in­clud­ing of chil­dren, or pos­si­bly as a boost­er if that be­comes nec­es­sary to con­tin­ue to de­feat the pan­dem­ic,” CEO Stéphane Ban­cel said in a press re­lease.

Mod­er­na tag teams with pri­vate in­vestors to bump up UAE vac­cine roll­out

Tiny UAE is the glob­al leader in per capi­ta terms, and now, it’s get­ting a boost from Mod­er­na and a na­tion­al in­vest­ment com­pa­ny to help dis­trib­ute the vac­cine and fu­ture boost­er shots once au­tho­rized.

Ma­gen­ta In­vest­ments, a phar­ma­ceu­ti­cal and health­care com­pa­ny that is a part of a UAE in­vest­ment and in­dus­tri­al con­glom­er­ate, an­nounced plans to dis­trib­ute the shots in 2021 and 2022. The com­pa­ny is a ma­jor play­er in im­prov­ing health in the Mid­dle East and Africa, it said, and is a part of Mawarid Hold­ing In­vest­ment and the Emi­rates Busi­ness Group.

“We wel­come the op­por­tu­ni­ty to work along­side Ma­gen­ta for the dis­tri­b­u­tion of our vac­cine in the UAE,” Mod­er­na CCO Corinne Le Goff said in a state­ment. “To­geth­er with our part­ners, we hope to ad­vance our goal to ex­pand ac­cess to our vac­cine glob­al­ly, and sup­port gov­ern­ments such as the UAE in pro­tect­ing their cit­i­zens, res­i­dents and vis­i­tors against the pan­dem­ic.”

The an­nounce­ment comes in the mid­dle of a push from Mod­er­na to ex­pand its foot­print across the globe, as it looks to sup­ply ar­eas in need with vac­cines and boost­ers. UAE neigh­bor Sau­di Ara­bia has lagged be­hind in get­ting dos­es in the arms of its peo­ple, and Fri­day, Mod­er­na an­nounced that it will man­u­fac­ture its vac­cine and boost­ers on Sau­di soil.

Since a pledge to pro­duce as many as 3 bil­lion dos­es of its vac­cine per year, Mod­er­na an­nounced part­ner­ships to man­u­fac­ture vac­cines in Spain, South Ko­rea, Aus­tralia and Switzer­land, as well as bol­stered its US op­er­a­tions with ex­pan­sions in Mass­a­chu­setts. CEO Stéphane Ban­cel an­nounced that his com­pa­ny will do­nate 500 mil­lion dos­es to Gavi, the vac­cine al­liance. Last Thurs­day, Mod­er­na filed for emer­gency use au­tho­riza­tion to get its vac­cine in the arms of teens be­tween the ages of 12 and 17. Ear­li­er that week, it filed for au­tho­riza­tion with EU and Cana­di­an reg­u­la­tors as well.

Re­ci­pharm plan in France ap­proved for Mod­er­na’s Covid-19 pro­duc­tion

The EMA has ap­proved a new man­u­fac­tur­ing site for Mod­er­na’s Covid-19 vac­cine.

A Re­ci­pharm plant in Monts, France will pro­duce the fin­ished prod­uct, and al­ter­na­tive sites from Mod­er­na in Nor­wood, MA and Lon­za in Portsmouth, NH have al­so been ap­proved. The up­dates are ex­pect­ed to pro­duce be­tween 1 and 2 mil­lion dos­es of the vac­cine for the Eu­ro­pean mar­ket each month.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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