Ab­b­Vie wins a 5-year free pass on mega-block­buster Hu­mi­ra in biosim set­tle­ment with ri­val Am­gen

It was clear from a re­cent sit-down with Leerink’s Ge­of­frey Porges that Ab­b­Vie was feel­ing good about keep­ing its mega-block­buster Hu­mi­ra fran­chise in the US to it­self through 2022. And this morn­ing we got a peek in­to why they were so bull­ish.

Richard Gon­za­lez

Am­gen, which scored the first ap­proval for a biosim­i­lar of Hu­mi­ra in the US, has signed off on a set­tle­ment agree­ment with Ab­b­Vie that will de­lay its roll­out un­til ear­ly 2023. Am­gen can get start­ed in the EU in the fall of next year, with a mar­ket­ing pact that calls on the com­pa­ny to pay roy­al­ties to Ab­b­Vie.

Ab­b­Vie’s shares $AB­BV shot up 6% this morn­ing.

The de­tails on this deal are be­ing kept un­der wraps, but the set­tle­ment re­moves one of the most liti­gious com­pa­nies in the in­dus­try from Ab­b­Vie’s pact. As Ever­cor­eISI’s Umer Raf­fat said in a quick note this morn­ing, the court dates over the patent fight could well have left any fi­nal ap­peals de­ci­sion un­til 2021.

Ab­b­Vie CEO Rick Gon­za­lez is ea­ger to make Hu­mi­ra in­to a $20 bil­lion a year drug be­fore hav­ing to com­pete against biosim­i­lars, and there are at least 10 oth­ers in the late-stage pipeline now with vir­tu­al­ly every­one in the gener­ic bi­o­log­ics busi­ness tack­ling the king of the mar­ket.

The FDA has be­come quite wel­com­ing to new biosim­i­lar ap­pli­ca­tions over the past year. But get­ting an ap­proval and carv­ing up mar­ket share at two com­plete­ly dif­fer­ent things, as Pfiz­er found out when it went af­ter J&J’s Rem­i­cade. Pfiz­er’s knock­off bare­ly made a dent in the mar­ket, and the phar­ma gi­ant re­cent­ly ac­cused J&J of us­ing im­prop­er meth­ods in bar­ring com­pe­ti­tion — a po­si­tion that J&J says was dri­ven by an em­bar­rass­ing in­abil­i­ty to mar­ket the ther­a­py prop­er­ly.

Ab­b­Vie, which has now de­layed the lead threat to its biggest cash cow for an­oth­er five years, was care­ful not to gloat this morn­ing.

Lau­ra Schu­mach­er, ex­ec­u­tive vice pres­i­dent, ex­ter­nal af­fairs, gen­er­al coun­sel and cor­po­rate sec­re­tary, Ab­b­Vie, had this to say:

In reach­ing this agree­ment, we have achieved the bal­ance be­tween pro­tect­ing in­vest­ment in in­no­va­tion and pro­vid­ing ac­cess to biosim­i­lars, which will play an im­por­tant role in our health care sys­tem. We will con­tin­ue to de­fend our in­tel­lec­tu­al prop­er­ty and to rein­vest in fur­ther ad­vance­ments in med­i­cine to bring choic­es to pa­tients in need.

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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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.

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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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.

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 a 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 “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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Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.

Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.