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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.