Shire punts late-stage biosim­i­lars of Hu­mi­ra and En­brel back to Mo­men­ta, Co­herus

Mo­men­ta CEO Craig Wheel­er

Just days af­ter Am­gen won an FDA ap­proval for the first biosim­i­lar of Ab­b­Vie’s Hu­mi­ra, Shire $SH­PG has de­cid­ed to throw away its part­ner­ship rights in a ri­val pro­gram now in Phase III. Shire si­mul­ta­ne­ous­ly cut loose of a sep­a­rate deal with Co­herus $CHRS on de­vel­op­ing an En­brel biosim­i­lar, which was al­so in­her­it­ed in its Bax­al­ta ac­qui­si­tion.

Cam­bridge, MA-based Mo­men­ta Phar­ma­ceu­ti­cals says Shire is hand­ing back rights to M923, one of sev­er­al copy­cats of the megablock­buster au­toim­mune drug. But Shire re­mains on the hook for its share of the de­vel­op­ment costs for an­oth­er year, which may well take this drug right up to an FDA ap­pli­ca­tion. Co­herus, mean­while, says that it has suc­cess­ful­ly nav­i­gat­ed a pair of Phase III stud­ies for CHS-0214 and will now rec­og­nize $162.6 mil­lion as col­lab­o­ra­tion and li­cense rev­enues in 2016.

Mo­men­ta has wound down a long road lit­tered with suc­ces­sive part­ners since it orig­i­nal­ly signed a $452 mil­lion deal in 2011 to col­lab­o­rate with Bax­ter on the then nascent field of biosim­i­lars. Shire picked up those rights when it bought out Bax­al­ta, which was spun out of Bax­ter.

Shire’s prime in­ter­est in Bax­al­ta, though, had to do with its drugs for rare dis­eases, which fits well in­to its own strat­e­gy. And Shire’s cast-off is Mo­men­ta’s trea­sure in the lead-up to Phase III re­sults be­fore the end of this year.

“We view Shire’s de­ci­sion as a sig­nif­i­cant op­por­tu­ni­ty for us to cap­ture ad­di­tion­al val­ue from this pro­gram for the Com­pa­ny and its share­hold­ers,” said Mo­men­ta CEO Craig Wheel­er.

Ab­b­Vie has plen­ty to gain and much to lose when it comes to Hu­mi­ra and the biosim­i­lar mar­ket. The com­pa­ny earned about $14 bil­lion off the fran­chise last year, and the num­bers keep head­ed north. In the sec­ond quar­ter, its flag­ship drug brought in $4.15 bil­lion. Hu­mi­ra pro­vides rough­ly two-thirds of its rev­enue and Ab­b­Vie has been fight­ing for time — lots more time, any means nec­es­sary — to de­vel­op new drugs to take its place. The com­pa­ny has said that it can fight off any biosim­i­lar ar­rivals for an­oth­er six years.

Am­gen, mean­while, will be push­ing to get their biosim­i­lar — dubbed Am­je­vi­ta — on the mar­ket some­time next year, hop­ing once the main patent laps­es in De­cem­ber they can fight their way out front. Mean­while, Mer­ck/Sam­sung Bioepis, and No­var­tis al­so have knock­offs in the clin­ic, look­ing to line up for a share of the mar­ket as well.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US,UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as also known as ‘Cozy Bear,’ that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.