#ES­MO18: Car­dio dreams blight­ed, No­var­tis show­cas­es its “block­buster” am­bi­tions for ra­dio­phar­ma­ceu­ti­cals

Vas Narasimhan

No­var­tis down­played the painful news yes­ter­day that the FDA had spurned its ap­pli­ca­tion for canakinum­ab as a car­dio drug, im­per­il­ing its lat­est block­buster am­bi­tions for a heart drug. 

Ex­ecs would much pre­fer to talk about Lu­tathera, their ra­dioiso­tope can­cer drug which is al­ready on the mar­ket and was show­cased in an ear­ly pre­sen­ta­tion at ES­MO in Mu­nich Fri­day.

The drug — lutetium Lu 177 dotatate — is a small mol­e­cule that de­liv­ers a ra­dioac­tive el­e­ment to kill can­cer cells. In a new analy­sis of NET­TER-1 tri­al da­ta for the drug, ap­proved for neu­roen­docrine tu­mors, re­searchers spot­light­ed high­ly sig­nif­i­cant pro­gres­sion-free sur­vival re­sults for pa­tients tak­ing the drug, re­gard­less of liv­er tu­mor bur­den.

That’s an­oth­er pos­i­tive for a drug that No­var­tis bought in their $3.9 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, which No­var­tis CEO Vas Narasimhan boast­ed to in­vestors Thurs­day was en­joy­ing “ex­plo­sive growth.” 

“It’s off to a strong start in the US,” the CEO told an­a­lysts, show­ing off the lat­est set of num­bers to an­a­lysts. “You can see here num­ber of dos­es per quar­ter, and this trend is re­al­ly I think very en­cour­ag­ing. And we’re now start­ing to roll out the med­i­cine in Eu­rope. In the U.S., we have 85 cen­ters that are ac­tive­ly pre­scrib­ing. We have 70% cov­er­age of the rel­e­vant lives. And in the UK now, we have 18 cen­ters ac­tive­ly pre­scrib­ing. And I think, see­ing the strength of the per­for­mance in Lu­tathera, feel­ing now that it’s a po­ten­tial block­buster med­i­cine.

The CEO’s bull­ish­ness ex­plains why No­var­tis just snapped up lit­tle En­do­cyte for $2.1 bil­lion, pay­ing a sig­nif­i­cant pre­mi­um for an­oth­er ra­dioiso­tope ther­a­py that the biotech had in-li­censed for on­ly $12 mil­lion up front.

You can ex­pect to hear a lot more about the plat­form and the com­mer­cial prospects. No­var­tis oc­cu­pies a big place among the phar­ma gi­ants of the world, which are judged by their late-stage de­vel­op­ment pipelines rather than the qual­i­ty of their sci­en­tif­ic bench.

Im­age: ES­MO, John Car­roll End­points News

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

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If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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