Mer­ck trig­gers a new round of lay­offs in R&D re­or­ga­ni­za­tion, push­ing more jobs in­to Cam­bridge, San Fran­cis­co

Mer­ck is con­firm­ing that it’s trig­gered a new round of lay­offs in its R&D group as it con­cen­trates and ex­pands its drug re­search work in two ma­jor biotech hubs, Cam­bridge, MA and San Fran­cis­co. The re­struc­tur­ing in­cludes adding a new lab in Cam­bridge, which will fo­cus on the fast-grow­ing mi­cro­bio­me field.

A spokesper­son for Mer­ck tells me:

“With­in Mer­ck Re­search Lab­o­ra­to­ries, we are mak­ing some or­ga­ni­za­tion­al changes with­in our dis­cov­ery, pre-clin­i­cal and ear­ly de­vel­op­ment area to en­able ear­li­er ac­cess to emerg­ing ex­ter­nal sci­ence and tech­nol­o­gy to aug­ment our lead­ing dis­cov­ery and de­vel­op­ment ca­pa­bil­i­ties. These changes in­clude in­creas­ing our in­vest­ment in ex­plorato­ry bi­ol­o­gy in ar­eas where bio­med­ical re­search is con­verg­ing, specif­i­cal­ly in Cam­bridge, Mass. and the San Fran­cis­co Bay area, Calif.  Un­for­tu­nate­ly, these changes will re­sult in work­force re­duc­tions at our Ke­nil­worth and Rah­way, N.J. sites and our North Wales, Pa. screen­ing fa­cil­i­ty as we shift re­sources and per­son­nel.

“Ad­di­tion­al­ly, here’s some back­ground on Cam­bridge and the San Fran­cis­co Bay area sites:

“We are ex­pand­ing MRL’s ear­ly dis­cov­ery re­search ca­pa­bil­i­ties by in­vest­ing in new lab­o­ra­to­ries at our Cam­bridge, Mass. site. Re­search will fo­cus on emerg­ing sci­ence, ag­nos­tic of ther­a­peu­tic area. Ini­tial ex­plorato­ry re­search will in­clude host-pathogen in­ter­ac­tions and the role of the mi­cro­bio­me in dis­ease process­es. The site is sched­uled to open in late 2016.”

The spokesper­son de­clined to spec­i­fy ex­act­ly how many jobs are be­ing cut. “We’re not pro­vid­ing a break­down of the changes or spe­cif­ic num­bers at this time, as it will in­clude sep­a­ra­tions and moves,” she not­ed.

Mer­ck’s move fol­lows a ma­jor trend in bio­phar­ma R&D, as the biggest com­pa­nies con­cen­trate more and more of their work in the big hubs. And vir­tu­al­ly all of the ma­jor play­ers have down­sized at one time or an­oth­er.

Close to three years ago, Mer­ck trig­gered a ma­jor re­or­ga­ni­za­tion in its R&D ranks, as the then new R&D chief Roger Perl­mut­ter set in mo­tion a plan that in­volved 8,500 lay­offs, all of which were piled on a re­struc­tur­ing ef­fort that was an­nounced ear­li­er.

Those lay­offs fol­lowed a years-long gap in sig­nif­i­cant new drug ap­provals and a string of clin­i­cal set­backs. Since then, though, Mer­ck land­ed a land­mark ap­proval of Keytru­da, now the num­ber two check­point in­hibitor on the block­buster can­cer mar­ket, along with an OK ear­ly this year for its hep C com­bo, Zepati­er, which is be­ing sold in a ri­val-in­fest­ed field.

Derek Lowe at In the Pipeline, a close­ly fol­lowed blog that has fre­quent­ly been a leader in flag­ging scut­tle­butt about R&D re­or­ga­ni­za­tions, was the first to spot­light ru­mors of a move. He re­port­ed:

The North Wales, PA site is be­ing closed (the screen­ing op­er­a­tions there are mov­ing to Ke­nil­worth). New Jer­sey dis­cov­ery chem­istry (Ke­nil­worth and Rah­way) is be­ing cut by 20%, and Rah­way’s med-chem is en­tire­ly mov­ing to Ke­nil­worth over the next few months. Dis­ease area bi­ol­o­gy in Ke­nil­worth is shut­ting down (not sure what the ram­i­fi­ca­tions of that one might be). I’m told that some peo­ple will be of­fered a chance to move to the Boston or Bay area sites, and all of these de­ci­sions will be made by the end of Sep­tem­ber. And ap­par­ent­ly they’ve al­so told every­one that more changes will be com­ing in the next few weeks, so I’m sure that’s calmed every­thing down as well.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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