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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations.