No more hands-off Roche su­per­vi­sion? Genen­tech brings out the axe, slash­ing 223 HQ staffers 'across de­part­ments'

Genen­tech is whack­ing 223 staffers at its head­quar­ters base in South San Fran­cis­co.

The news was filed with the state of Cal­i­for­nia in a WARN no­tice about up­com­ing cuts, re­ceived on Au­gust 9.

In a re­ply to my query, a spokesper­son for the com­pa­ny not­ed: “The po­si­tions are in South San Fran­cis­co and var­ied across de­part­ments.” There were no de­tails on who will be cut, though the lay­offs will run in­to No­vem­ber.

The com­pa­ny did not re­spond to my query about whether this was the first such cut at HQ.

Genen­tech is one of the most suc­cess­ful big biotechs in the in­dus­try, com­ing up with a string of new drugs. And while par­ent com­pa­ny Roche — one of the biggest R&D spenders in bio­phar­ma with a re­search bud­get of about $8 bil­lion — has been adding a set of new block­busters to its port­fo­lio, it al­so faces biosim­i­lar com­pe­ti­tion for sev­er­al of its biggest fran­chise ther­a­pies.

It’s not un­usu­al to see hun­dreds of jobs gained or lost at the big play­ers’ man­u­fac­tur­ing op­er­a­tions. Last fall Genen­tech cut 130 staffers at its Va­cav­ille, CA man­u­fac­tur­ing fa­cil­i­ty. But Roche has been par­tic­u­lar­ly sen­si­tive about leav­ing its main Genen­tech op­er­a­tions free of the kind of but­toned-down scruti­ny that ap­plies to the Roche side of the busi­ness.

This new re­or­ga­ni­za­tion seems to sig­nal an end to that hands-off at­ti­tude.

Tim An­der­son, who re­cent­ly left Bern­stein, had a chance not long ago to sit down with Roche CEO Sev­erin Schwan, who may have sig­naled what was com­ing. Was Schwan in­ter­est­ed in in­te­grat­ing the two big R&D groups at Roche’s pRED and gRED? 

“Over my dead body,” replied the CEO. But that didn’t mean Schwan had stopped look­ing for ways to carve costs out of the re­search and de­vel­op­ment groups.

There are ar­eas where he con­cedes ROG is not very pro­duc­tive, for ex­am­ple, da­ta man­age­ment. ROG is build­ing da­ta sets that share com­mon sys­tems across busi­ness units, where there’s not on­ly an ef­fi­cien­cy el­e­ment, but al­so a pro­duc­tiv­i­ty el­e­ment when you can bet­ter share da­ta. ROG has talked a lot about lever­ag­ing re­al-world da­ta, but it starts with shar­ing your own da­ta from your own clin­i­cal tri­als too. So, they’re do­ing both in par­al­lel.

Fier­cePhar­ma was the first to re­port the cuts.

Here’s the full state­ment Genen­tech has:

At Genen­tech, we pur­sue ground­break­ing sci­ence to de­vel­op break­through med­i­cines for peo­ple with se­ri­ous dis­eases. The suc­cess of our busi­ness de­pends on our abil­i­ty to re­spond to change, ap­pro­pri­ate­ly al­lo­cate re­sources, and man­age our op­er­a­tions ef­fi­cient­ly.

We have been eval­u­at­ing some of our op­er­a­tions to en­sure we re­main well-po­si­tioned to meet the needs of pa­tients to­day and de­liv­er on our pipeline of new med­i­cines in the fu­ture. As a re­sult of this process, we have made the dif­fi­cult de­ci­sion to elim­i­nate some po­si­tions.

We great­ly ap­pre­ci­ate the sig­nif­i­cant con­tri­bu­tions of those im­pact­ed by these changes and will sup­port them through this tran­si­tion with fi­nan­cial ben­e­fits, ex­tend­ed health­care cov­er­age, and ca­reer coach­ing.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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