John Butler, Akebia CEO

In a one-two gut punch af­ter kid­ney drug CRL, Ake­bia slapped with par­tial hold and will lay off 42% of staff

Snakebit af­ter a sur­pris­ing CRL for its lead pipeline pro­gram last week, Ake­bia Ther­a­peu­tics is fac­ing an­oth­er road­block at the FDA — and lay­offs are now on the way.

In a fil­ing with the SEC on Thurs­day morn­ing, Ake­bia said that on April 1, three days af­ter re­ceiv­ing its CRL for vadadu­s­tat to treat ane­mia due to chron­ic kid­ney dis­ease in adults, the FDA is­sued a par­tial clin­i­cal hold on the drug’s pe­di­atric stud­ies. As a re­sult, Ake­bia will sus­pend all vadadu­s­tat stud­ies in chil­dren.

Then, on Mon­day, Ake­bia ap­proved a 42% re­duc­tion in its staff, it told the SEC. Ake­bia ex­pects to com­plete the lay­offs rather quick­ly, not­ing the process should be com­plet­ed by the end of the sec­ond quar­ter.

The lay­offs rep­re­sent Ake­bia’s ef­fort to “re­fo­cus its strate­gic pri­or­i­ties around its com­mer­cial prod­uct, Au­ryx­ia, and its de­vel­op­ment port­fo­lio.” Ake­bia did not spec­i­fy the de­vel­op­ment pro­grams on which it in­tends to fo­cus.

Ake­bia shares, al­ready well be­low $1 apiece, showed no change ahead of the open­ing bell on Thurs­day.

Once a high­fli­er in the biotech world, Ake­bia has fall­en on hard times in re­cent years, and not just as a re­sult of its CRL. Back in Sep­tem­ber 2020, the biotech re­port­ed a Phase III study for its in­jectable kid­ney drug, ESA dar­be­po­et­in al­fa, missed non-in­fe­ri­or­i­ty on the all-im­por­tant MACE safe­ty mea­sure.

The study came in pa­tients who were not on dial­y­sis, and while an­oth­er Phase III for those un­der­go­ing dial­y­sis did pass the safe­ty test, Ake­bia’s stock tanked more than 70% in the wake of the miss.

At the time, the whiff was ex­pect­ed to hand Ake­bia’s ri­val Fi­bro­Gen a huge ad­van­tage in the CKD are­na, but that com­pa­ny al­so ran in­to FDA head­winds when the agency is­sued rox­adu­s­tat a CRL in the sum­mer of 2021. A neg­a­tive ad­comm vote in­di­cat­ed reg­u­la­tors were con­cerned with safe­ty here as well.

For Ake­bia, the lay­offs and par­tial hold al­so came af­ter the biotech put to­geth­er $85 mil­lion to com­mer­cial­ize vadadu­s­tat, thanks to a re­or­ga­ni­za­tion of its deal with Vi­for. The mon­ey came from $20 mil­lion in stock pur­chas­es, an ac­cel­er­at­ed $25 mil­lion mile­stone and $40 mil­lion in re­fund­able work­ing cap­i­tal.

Ake­bia is just one of many biotechs fac­ing tough work­force-re­lat­ed de­ci­sions in re­cent months as the biotech bear mar­ket con­tin­ues. Among the oth­er com­pa­nies to re­duce their staff are blue­bird bio, Taysha, Zosano, Ovid, Paci­ra, Pas­sage, Adap­tive and Athenex.

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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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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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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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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