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.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for their Covid-19 vac­cine in a mat­ter of months

CureVac jumped onto Nasdaq Thursday night, landing with an extra $213 million after pricing a batch of shares at $16 a pop. Add in an extra $118 million share purchase by founder Dietmar Hopp — who owns a controlling interest — and another $640 million from deals and the German biotech has raised a cool billion dollars in the space of just 3 weeks.

The company’s stock $CVAC will now start trading this morning, with analysts eager to find out whether the go-go atmosphere on Wall Street will swell the biotech’s share price.

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As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes; Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics

→ The C-suite has shuffled considerably at liver disease-focused Terns Pharmaceuticals out of Foster City, CA. Senthil Sundaram now assumes the CEO post, replacing Weidong Zhong, who was at the helm since Terns was founded and is now moving into two new roles: CSO and chairman of the board. Sundaram makes his way to Terns after 2 years as CFO of Nightstar Therapeutics, which would later be acquired by Biogen. He was also VP and head of business development at NASH player Intercept after 13 years in investment banking.

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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NIH director Francis Collins at a Senate Appropriations subcommittee hearing for Operation Warp Speed (Graeme Jennings/Pool via AP Images)

Covid-19 roundup: 'No­vem­ber or De­cem­ber' Collins' best bet on a vac­cine OK; First plas­ma tri­al sug­gests mor­tal­i­ty re­duc­tion

Count NIH director Francis Collins out for any wager that the FDA would authorize a Covid-19 vaccine in October.

The discussion came up during a call with reporters because some states and local governments have been told by the CDC to have vaccination plans ready to go by Oct. 1. Pharma execs, most notably from Pfizer and BioNTech, have raised hopes about a licensure during that month; President Donald Trump last week sounded an optimistic note about having a vaccine on the market “right around” Election Day on Nov. 3 — or possibly before.

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Charlie Silver (Mission Bio)

'We want to be every­where.' Mis­sion Bio rais­es $70M be­hind re­sis­tance-hunt­ing se­quenc­ing plat­form

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silver’s startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detect early response or resistance to new cancer therapies.