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.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.