No­var­tis, Am­gen rack up their first PhI­II suc­cess in a crowd­ed CGRP mi­graine drug field

No­var­tis and its part­ners at Am­gen say that their CGRP mi­graine drug erenum­ab (AMG 334) came through in a Phase III study, beat­ing a place­bo re­sponse in cut­ting the av­er­age num­ber of episodes pa­tients ex­pe­ri­enced each month. And an­a­lysts can now start run­ning the num­bers again as they slice and dice the da­ta to see if any of the sev­er­al ri­vals in this field can do bet­ter.

Ge­of­frey Porges, Leerink

The two phar­ma gi­ants en­rolled 577 mi­graine suf­fer­ers for the piv­otal tri­al, track­ing a base­line of 8 mi­graine days per month. The pa­tients in the drug arm get­ting a sub­cu­ta­neous 70 mg dose one month­ly saw that drop an av­er­age of 2.9 days, which was sig­nif­i­cant­ly bet­ter than the 1.8-day drop from a place­bo.

The phar­ma part­ners will now turn to their sec­ond Phase III tri­al, ex­pect­ed to wrap up lat­er this year, which is test­ing a 70 mg and 140 mg dose over 24 weeks. The new da­ta comes on top of pos­i­tive da­ta from a big Phase II study re­leased a few days ago.

Mi­graine is a big mar­ket, but Am­gen and No­var­tis have been scold­ed for fail­ing to dif­fer­en­ti­ate their drug sub­stan­tial­ly from the CGRP pack. The drug blocks the cal­ci­tonin-gene-re­lat­ed-pep­tide re­cep­tor, while com­pet­ing drugs tar­get the lig­and. Am­gen/No­var­tis count that as a ma­jor ad­van­tage, but the ju­ry’s still out on who will come out on top. And if one of these ther­a­pies doesn’t stand out, they’re all go­ing to be bat­tling it out on the mar­ket at rough­ly the same time.

Con­sen­sus sales es­ti­mates for this drug rank it as a block­buster con­tender, with $1.3 bil­lion in 2023 sales. But some an­a­lysts are get­ting ner­vous about how much the com­pe­ti­tion will bite in­to that. Leerink’s Ge­of­frey Porges says that Am­gen should be first on the mar­ket, then things get a lit­tle fuzzy. He writes:

These re­sults in episod­ic mi­graine (from Am­gen) fur­ther sup­port the use of cal­ci­tonin-gene-re­lat­ed-pep­tide (CGRP) in­hibitors for mi­graine pre­ven­tion, but al­so high­light the dif­fi­cul­ty in dif­fer­en­ti­at­ing any one drug from the class giv­en the ef­fi­ca­cy and tol­er­a­bil­i­ty of all re­port­ed thus far. The place­bo-ad­just­ed month­ly mi­graine day re­duc­tion of 1.1 days re­port­ed for AMG 334 in AS­PIRE com­pares fa­vor­ably with the re­duc­tion re­port­ed in the Alder (AL­DR, OP) ALD403 study of 1 days. Te­va’s (TE­VA, OP) TEV-48125 pro­duced a nu­mer­i­cal­ly greater place­bo-ad­just­ed month­ly mi­graine day re­duc­tion of 2.5 days, but pa­tients came in­to the study with a much high­er base­line mi­graine fre­quen­cy of 11.4 days a month com­pared to eight days in the AMGN study and rough­ly nine days in the AL­DR study. On a per­cent­age ba­sis, AMG 334 pro­duced a 36% re­duc­tion (14% place­bo-ad­just­ed), ALD403 a 66% re­duc­tion (14% place­bo-ad­just­ed), and TEV-48125 a 53% re­duc­tion (23% place­bo-ad­just­ed).

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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AbCellera founder and CEO Carl Hansen (L) and Rallybio CEO Martin Mackay

Rally­bio, Ab­Cellera form new part­ner­ship around an­ti­bod­ies for rare dis­ease

Two biotechs that have been working heavily on different stages of antibody candidate development over the past several years are looking to work together to find potential candidates for rare diseases.

Canadian-based AbCellera and Connecticut-based Rallybio have entered a strategic partnership to find, develop and commercialize antibodies primarily for rare diseases. The multi-year, multi-target deal will seek to combine AbCellera’s antibody “discovery engine” with Rallybio’s expertise in rare diseases. However, the dollar amount for the deal was not disclosed.