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.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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