RIP amy­loid be­ta the­o­ry? Nope. Bio­gen part­ner launch­es a new PhI­II be­fore ad­u­canum­ab's corpse turned cold

A day af­ter Bio­gen rat­tled the bio­phar­ma world with the news that its lead late-stage ther­a­py ad­u­canum­ab proved worth­less in treat­ing Alzheimer’s — a dis­as­ter that may dri­ve a stake through the heart of the amy­loid be­ta the­o­ry once and for all — the big biotech’s part­ners at Ei­sai have come up with their next big move.


Right in the wake of a 35% plunge in their stock val­ue, Ei­sai $ESALY is start­ing a Phase III study in­volv­ing 1,566 Alzheimer’s pa­tients with mild cog­ni­tive im­pair­ment for the con­tro­ver­sial Alzheimer’s drug BAN2401. The an­ti-amy­loid an­ti­body was the cen­ter of a firestorm of crit­i­cism over a tardy re­veal that re­searchers had pulled high-risk pa­tients out of their last study, po­ten­tial­ly warp­ing the pos­i­tive re­sults that were claimed, leav­ing that drug un­der a dark cloud.

“We still be­lieve that amy­loid be­ta hy­poth­e­sis is po­ten­tial­ly the right ap­proach for the treat­ment of Alzheimer’s dis­ease,” an Ei­sai spokesman told Reuters.

That’s a po­si­tion that Bio­gen ex­ecs will find tough to jus­ti­fy to­day. A whole slate of ma­jor de­vel­op­ers — Eli Lil­ly and As­traZeneca, Mer­ck and Roche — have re­port­ed out de­ci­sive late-stage fail­ures over the last year that all point to one con­clu­sion: Tar­get­ing amy­loid be­ta alone in symp­to­matic pa­tients may hit your bio­mark­ers on ef­fect, but it doesn’t de­lay the ruth­less march of the dis­ease.

Ei­sai and Bio­gen may not have re­ceived the memo, but a whole host of an­a­lysts have writ­ten off BAN2401 as a los­er. As for this new move, don’t ex­pect any sup­port from Leerink’s Ge­of­frey Porges, who es­sen­tial­ly be­lieves any new work like this is dam­ag­ing to in­vestors and pa­tients. He not­ed this morn­ing:

We as­sume that the com­pa­ny (Bio­gen) takes the re­spon­si­ble de­ci­sion to ter­mi­nate all fur­ther in­vest­ments in be­ta amy­loid-di­rect­ed med­i­cines (which has not oc­curred), and saves their in­vestors the cash and saves pa­tients and in­ves­ti­ga­tors from the bur­den of such stud­ies. If Bio­gen does not make this de­ci­sion, then our ad­just­ed ex­pense fore­cast could be too low, with fur­ther neg­a­tive ef­fects on our val­u­a­tion even com­pared to our new PT.

What will be ahead for Bio­gen? Porges is tak­ing a hard line. It’s worth quot­ing him at length.

In our view, Bio­gen finds it­self in the un­en­vi­able po­si­tion of be­ing a wound­ed cash cow (which we are sur­prised man­age­ment and the board did not con­sid­er as a po­ten­tial out­come and pre­pare for). The next few months are like­ly to con­sist of a mix­ture of re­crim­i­na­tions, ex­pla­na­tions, ne­go­ti­a­tions, and pos­si­bly ter­mi­na­tions and lit­i­ga­tion. We ex­pect the com­pa­ny to be dis­tract­ed and ham­pered by those over­hangs for a cou­ple of quar­ters at least. Con­trary to pop­u­lar be­lief we don’t be­lieve that their board or man­age­ment will have the lat­i­tude to im­me­di­ate­ly piv­ot to ma­jor ac­qui­si­tions that would al­ter the com­pa­ny’s out­look ma­te­ri­al­ly (de­spite our sug­ges­tions in the past that such in­vest­ments were ad­vis­able). To­ward the end of this year, af­ter the dust of this dis­ap­point­ment has like­ly set­tled, we ex­pect Bio­gen to ex­plore both as­set sales and as­set pur­chas­es (af­ter oth­er changes have been made, or im­posed by in­vestors). We be­lieve that the case for re­struc­tur­ing and di­vesti­tures will be as com­pelling as the case for ac­qui­si­tions, par­tic­u­lar­ly in the con­text of such poor re­turns from the com­pa­ny’s re­cent cap­i­tal al­lo­ca­tion de­ci­sions.

Bio­gen shares $BI­IB tum­bled 29% on Thurs­day, wip­ing out $18 bil­lion in mar­ket cap. They won’t get any of that back based on the launch of the BAN2401 tri­al. To the con­trary. At a time they need to re­build con­fi­dence, there’s no sign that the part­ners learned any­thing this week.

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.

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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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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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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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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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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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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