Merck KGaA's Belén Garijo (AP Images)

Mer­ck KGaA snaps up Ger­man CD­MO in boost to mR­NA port­fo­lio — in­clud­ing for Covid-19

Once thought un­like­ly as a mech­a­nism of ac­tion in vac­cines, mR­NA-based shots have stormed out to a lead in the fight against Covid-19. But mR­NA’s po­ten­tial ef­fect isn’t lim­it­ed to just vac­cines, and now Ger­man drug­mak­er Mer­ck KGaA is look­ing to find out just how far it can take the tech­nol­o­gy.

The Darm­stadt, Ger­many based bio­phar­ma has ac­quired mR­NA CD­MO AmpTec in Ham­burg, say­ing it plans to strength­en its own ca­pac­i­ties to de­vel­op and man­u­fac­ture mR­NA for cus­tomers to use in “vac­cines, treat­ments and di­ag­nos­tics ap­plic­a­ble in Covid-19 and many oth­er dis­eases.”

Fi­nan­cial terms of the agree­ment weren’t dis­closed.

Ste­fan Os­chmann

In a state­ment, Mer­ck KGaA CEO Ste­fan Os­chmann said the promise shown for mR­NA’s use in Pfiz­er and Mod­er­na’s Covid-19 vac­cines piqued the com­pa­ny’s in­ter­est in snap­ping up AmpTec.

“By com­bin­ing AmpTec’s PCR-based mR­NA tech­nol­o­gy with our ex­ten­sive ex­per­tise in lipids man­u­fac­tur­ing, we are able to pro­vide a tru­ly dif­fer­en­ti­at­ed and in­te­grat­ed of­fer­ing across the mR­NA val­ue chain, which will sig­nif­i­cant­ly de­crease sup­ply chain com­plex­i­ty and en­hance speed-to-mar­ket,” Os­chmann said.

AmpTec al­so boasts a di­ag­nos­tics busi­ness that fo­cus­es on pro­duc­ing “cus­tomized long RNAs and DNAs for in vit­ro di­ag­nos­tics,” which will fur­ther com­ple­ment a key com­po­nent of Mer­ck KGaA’s ex­ist­ing ser­vices. All told, the com­pa­ny said it aims to scale up both at AmpTec’s Ham­burg and at the Mer­ck KGaA glob­al head­quar­ters in Darm­stadt.

The ac­qui­si­tion con­tin­ues some re­cent and sub­stan­tive ex­pan­sion plays by Mer­ck KGaA, which an­nounced in De­cem­ber that it agreed to a three-year-deal with Ar­tios worth $30 mil­lion up­front and an­oth­er $865 mil­lion wait­ing in the wings, to dis­cov­er and de­vel­op small mol­e­cule can­cer drugs that tar­get DNA re­pair en­zymes.

Mer­ck KGaA made waves in Sep­tem­ber af­ter it named Belén Gar­i­jo as its new chief ex­ec­u­tive, mak­ing her one of on­ly two women CEOs at Big Phar­ma com­pa­nies. Gar­i­jo will suc­ceed Os­chmann when his tenure ends by the close of April.

In 2019, GSK paid up to $4.2 bil­lion for Mer­ck KGaA’s bi­func­tion­al fu­sion pro­tein-based can­cer im­munother­a­py, bin­tra­fusp al­fa, as the com­pa­ny be­gan a for­ay in­to on­col­o­gy in ad­di­tion to its mR­NA ser­vices.

Al­so of note, in 2017, End­points News re­port­ed, Mer­ck bought four DNA dam­age re­sponse mol­e­cules from Ver­tex for $230 mil­lion. That in­clud­ed two ATR in­hibitors that are now in the clin­ic for their ef­fi­ca­cy in treat­ing sol­id can­cer tu­mors.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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