Astel­las shed­ding 600-plus jobs as CEO shakes up R&D and sales ops in re­struc­tur­ing

Ken­ji Ya­sukawa

As Astel­las pres­i­dent and CEO Ken­ji Ya­sukawa maps out a strate­gic plan for the com­pa­ny he’s just re­cent­ly tak­en over, he’s al­so pre­scribed a round of re­struc­tur­ing with a goal to cut at least 600 em­ploy­ees through an ear­ly re­tire­ment scheme.

The Japan­ese com­pa­ny is look­ing at an over­haul in R&D and sales and mar­ket­ing as well as re­struc­tur­ing its group com­pa­nies in Japan. That means shut­ting down Astel­las Re­search Tech­nolo­gies, Astel­las Mar­ket­ing and Sales Sup­port, and Astel­las Learn­ing In­sti­tute. It’s al­so plan­ning to di­vest Astel­las An­a­lyt­i­cal Sci­ence Lab­o­ra­to­ries to Eu­rofins Phar­ma Ser­vices by the end of this fis­cal year.

Astel­las is of­fer­ing an ear­ly re­tire­ment in­cen­tive pro­gram to the hun­dreds of em­ploy­ees af­fect­ed by the change. When asked whether any more lay­offs are in store, an Astel­las spokesper­son told me “there is no plans to add ear­ly re­tire­ment at this time. We will con­tin­ue to main­tain ap­pro­pri­ate num­ber of em­ploy­ees for pur­su­ing op­er­a­tional ex­cel­lence.

An­tic­i­pat­ing a dip in prof­it in 2019, Ya­sukawa’s plan calls for in­vest­ing in three strate­gic goals: max­i­miz­ing val­ue for mar­ket­ed and late-stage prod­ucts through new and ex­pand­ed ap­provals; tak­ing a fo­cus area ap­proach to ear­ly-stage R&D; and cre­at­ing a new di­ag­nos­tic and dig­i­tal de­vice busi­ness in a move termed Rx+.

Xtan­di, the prostate can­cer ther­a­py Astel­las shares rights on with Pfiz­er, will be a key rev­enue dri­ver once it’s ap­proved for ear­li­er lines of treat­ment, says the CEO, ex­pect­ed to yield peak sales of ¥400-¥500 bil­lion ($3.6-$4.5 bil­lion) in 10 years’ time.

Astel­las is al­so gear­ing up reg­u­la­to­ry fil­ings for a num­ber of as­sets, in­clud­ing fe­zo­line­tant for menopause-re­lat­ed va­so­mo­tor symp­toms as well as can­cer drugs en­for­tum­ab ve­dotin and gilter­i­tinib.

On a con­fer­ence call Ya­sukawa spot­light­ed eight fo­cus ar­eas for ear­ly-stage re­search, ac­cord­ing to Bio­Cen­tu­ry. Their slide pre­sen­ta­tion shows that ranges from cell ther­a­pies in oph­thalmic dis­eases, anti­gen-spe­cif­ic im­munother­a­pies aimed at cur­ing al­ler­gic dis­eases and im­muno-on­col­o­gy ther­a­pies tar­get­ing tu­mors with in­ad­e­quate re­sponse to PD-1/PD-L1 in­hibitors to mi­to­chon­dria bi­ol­o­gy-in­spired treat­ments for neu­ro­mus­cu­lar dis­eases.

The plans al­so fea­ture a new em­pha­sis in med­ical so­lu­tions tan­gen­tial to ther­a­peu­tics, such as new can­cer di­ag­nos­tics us­ing Astel­las’ an­ti­body tech­nol­o­gy or dig­i­tal soft­ware.

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.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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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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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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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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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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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.