News brief­ing: No­var­tis hands off NASH drug to biotech col­lab­o­ra­tor, al­so plans to build new Basel pro­duc­tion unit

Robert Arm­strong

Af­ter build­ing up its work on NASH, No­var­tis is hand­ing over one of its can­di­dates to Boston Phar­ma­ceu­ti­cals.

The pri­vate biotech, which didn’t dis­cuss terms, gets the new­ly dubbed BOS-580, an FGF21 drug. And they get to launch a clin­i­cal for­ay in­to a field marked by mul­ti­ple set­backs over the last 2 years.

“No­var­tis has de­signed the BOS-580 prod­uct can­di­date with a dif­fer­en­ti­at­ed pro­file,” says Boston Phar­ma­ceu­ti­cals CEO Robert Arm­strong, who grabbed 3 can­di­dates from No­var­tis back in 2018. Boston Phar­ma­ceu­ti­cals will now jump in­to a NASH niche that in­cludes Akero $AKRO and 89bio $ETNB. — John Car­roll

No­var­tis to build new pro­duc­tion unit near head­quar­ters

No­var­tis is ex­pand­ing its foothold in its home coun­try.

The Swiss phar­ma an­nounced Tues­day that it is spend­ing about $77.5 mil­lion to con­struct a new pro­duc­tion unit on the out­skirts of Basel, Switzer­land, where it is head­quar­tered. No­var­tis’ in­vest­ment will go to­ward two new pro­duc­tion lines for the man­u­fac­tur­ing of “com­plex ac­tive in­gre­di­ents” in ex­per­i­men­tal med­i­cines, the com­pa­ny said.

Cur­rent plans call for the re­fur­bish­ment of ex­ist­ing build­ings in the area’s in­dus­tri­al sec­tor. The pro­duc­tion lines will be com­mis­sioned some­time around the end of 2021.

Tues­day’s news comes af­ter No­var­tis an­nounced the clos­ing of an API plant in Ire­land last Oc­to­ber, which had been open since 1994. That move cut about 320 jobs, and prod­ucts man­u­fac­tured at the site are be­ing trans­ferred to ex­ter­nal sup­ply part­ners with the goal of be­ing fin­ished by mid-2022.

No­var­tis is not the on­ly ma­jor phar­ma to re­struc­ture its API plans, as Sanofi has been work­ing on spin­ning out its busi­ness in the sec­tor. The French phar­ma has been met with heavy re­sis­tance in the face of the Covid-19 pan­dem­ic threat­en­ing sup­ply chains, how­ev­er, as French pres­i­dent Em­manuel Macron per­son­al­ly pledged to keep drug pro­duc­tion in France. — Max Gel­man

As­traZeneca’s Imfinzi wins ap­proval for ES-SCLC in­di­ca­tion 

Dave Fred­er­ick­son

As­traZeneca’s Imfinzi won ap­proval in the EU as a first-line treat­ment for ex­ten­sive-stage small cell lung can­cer in com­bi­na­tion with chemother­a­py.

The PD-L1 in­hibitor is al­ready ap­proved for Stage III non-small cell lung can­cer af­ter chemo in the US, Japan and Chi­na, and across the EU, and for pre­vi­ous­ly treat­ed pa­tients with ad­vanced blad­der can­cer in some coun­tries, in­clud­ing the US.

Imfinzi’s ES-SCLC ap­proval was based on the com­pa­ny’s Phase III CASPI­AN tri­al, in which the drug re­duced pa­tients’ risk of death by 27% com­pared to chemother­a­py alone. Ac­cord­ing to an up­dat­ed analy­sis, pa­tients’ mean over­all sur­vival af­ter a two-year fol­low-up was 12.9 months, ver­sus 10.5 months for those on chemo on­ly. Imfinzi can be used with a va­ri­ety of chemother­a­pies: etopo­side, plus ei­ther car­bo­platin or cis­platin.

“This is the first im­munother­a­py reg­i­men to of­fer both a sus­tained sur­vival ben­e­fit and an im­proved re­sponse rate, as well as a choice of chemother­a­pies and con­ve­nient dos­ing every four weeks dur­ing main­te­nance,” Dave Fredrick­son, EVP of As­traZeneca’s on­col­o­gy busi­ness unit, said in a state­ment. — Nicole De­Feud­is 

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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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

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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