Shire’s Orn­skov dic­tates an­oth­er big re­vamp, with R&D/HQ mov­ing in­to Cam­bridge

Shire CEO Flem­ming Orn­skov is once again re­or­ga­niz­ing the com­pa­ny, con­sol­i­dat­ing a large por­tion of the com­pa­ny’s R&D op­er­a­tions in the heart of the big Cam­bridge, MA hub.

Flem­ming Orn­skov

In a sto­ry bro­ken by the Boston Globe’s long­time biotech scribe Rob Weis­man, Orn­skov says he plans to move hun­dreds of re­searchers in­to the com­pa­ny’s new cam­pus in Kendall Square, which com­bines a new­ly ac­quired build­ing from Sanofi Gen­zyme with the R&D cen­ter picked up in its ac­qui­si­tion of Bax­al­ta.

Shire sent me an out­line of their plan to make Cam­bridge and Lex­ing­ton in­to two cen­tral hubs for the more than 3,000 staffers that work at the com­pa­ny in Mass­a­chu­setts. And it is mov­ing 100 R&D staffers from Aus­tria to Cam­bridge in the near term.

“Giv­en Bax­al­ta’s foot­print in Cam­bridge, along with the aca­d­e­m­ic and biotech ecosys­tem, it made sense to lo­cate much of R&D in an In­no­va­tion Hub there,” says a spokesper­son for the com­pa­ny about its re­de­ploy­ment plan. “In Lex­ing­ton, we de­cid­ed to cre­ate a Tech­nol­o­gy Cen­ter of Ex­cel­lence where we knew we could ac­com­mo­date bi­o­log­ics de­vel­op­ment and man­u­fac­tur­ing, de­vice de­vel­op­ment, launch, etc. in terms of space.”

At one point af­ter the Bax­al­ta buy­out, the big ques­tion was whether Shire planned to keep it. But last fall Shire laid out plans to make it the com­pa­ny’s R&D cen­ter for rare dis­eases. Now Orn­skov says the site will be­come the new US HQ for Shire, which has been trans­formed re­cent­ly with a big­ger pipeline on rare dis­ease drugs. Shire is based in Ire­land, and that isn’t chang­ing in the re­or­ga­ni­za­tion. Orn­skov is al­so tak­ing the reins on R&D, at least dur­ing an in­ter­im pe­ri­od, as Phil Vick­ers ex­its the top re­search job.

The move fol­lows a sim­i­lar path tak­en at Bio­gen, which saw George Scan­gos move the HQ in­to Cam­bridge in 2011, short­ly af­ter he took over, so he could be clos­er to R&D. Like Scan­gos, who has since left to run a start­up on the West Coast, Orn­skov is de­ter­mined to play a big role in what us ar­guably the world’s largest biotech hub, near MIT and Har­vard. And he’ll be tak­ing res­i­dence in a hub that has at­tract­ed a wide va­ri­ety of com­pa­nies, from biotech star­tups to Big Phar­ma ops.

The con­sol­i­da­tion of Shire in­volves bring­ing in staffers from a va­ri­ety of sites scat­tered in the re­gion.

“One of the is­sues we have now is that every­one is spread out in many lo­ca­tions,” Orn­skov told Weis­man. “We want to con­sol­i­date.”

The move, which will take sev­er­al years to com­plete, al­ready has gen­er­at­ed some in­ter­nal com­plaints among staffers who aren’t keen to com­mute to Cam­bridge in a metro area that suf­fers from a mul­ti­tude of headaches brought on by in­tense con­ges­tion.

Orn­skov, though, has made con­cen­trat­ing the com­pa­ny in the area a key fea­ture ever since tak­ing over as CEO. He quick­ly shut­tered out­ly­ing sites in Penn­syl­va­nia and else­where in 2015, ei­ther re­lo­cat­ing or re­plac­ing staffers who wouldn’t make the move.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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An­oth­er one bites the dust: Bris­tol My­ers Squibb pulls 'dan­gling' ac­cel­er­at­ed ap­proval for Op­di­vo in liv­er can­cer

Bristol Myers Squibb has agreed to pull a second-line liver cancer indication for its blockbuster Opdivo as a monotherapy, becoming the second PD-(L)1 indication to bite the dust after the FDA’s oncology adcomm reviewed six “dangling” accelerated approvals in April.

The outside experts voted against two of the six indications discussed at the meeting, including Opdivo as a monotherapy for hepatocellular carcinoma (HCC) patients who have previously been treated with sorafenib, and Merck’s Keytruda as a third-line treatment for stomach cancer. The adcomm voted 5 to 4 not to maintain Opdivo’s indication, after it failed to show clinical benefit in a confirmatory trial.

Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa via AP Images)

Covid-19 roundup: Fau­ci warns that US is head­ed in wrong di­rec­tion, rec­om­mends boost­er; As­traZeneca-Pfiz­er com­bo proves ef­fec­tive in South Ko­rea

A combination of unvaccinated Americans and the Delta variant has led a frustrated NIAID director Anthony Fauci to say the US is headed in the wrong direction, he said on CNN’s show “State of the Union.”

Booster shots may be required for those with suppressed immune systems and public health officials are considering a mask recommendation for those who are already vaccinated, the Associated Press reported. More than 163 million people are vaccinated, but that number is less than half of the US population. And 57% of those who are eligible for the vaccine have been inoculated.

Seth Lederman, Tonix Pharmaceuticals CEO

Small, strug­gling biotech winds up with a 3X los­er as an­oth­er PhI­II of its lead drug col­laps­es

Little Tonix Pharmaceuticals has run into another brick wall as its lead drug — a reformulated muscle relaxant originally approved 44 years ago — has failed another Phase III study, sending shares back into penny stock territory.

Three years after going down in their first Phase III trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for symptoms of PTSD, the biotech — which had been encouraged by a breakthrough designation at the FDA — reported late Friday the drug also failed its second late-stage challenge for pain associated with fibromyalgia. Outside data monitors recommended the Phase III trial be halted for futility after deciding interim data made it unlikely the drug would pass muster.

Hervé Hoppenot, Incyte CEO (Jeff Rumans for Endpoints News)

FDA un­sur­pris­ing­ly brings down the ham­mer on In­cyte's PD-1 — draw­ing a line for fu­ture ac­cel­er­at­ed ap­provals

It appears the PD-(L)1 honeymoon is finally over.

Incyte $INCY revealed late Friday the FDA has slammed its PD-1 retifanlimab — which was under priority review for locally advanced or metastatic squamous cell carcinoma of the anal canal — with a complete response letter, demanding “additional data” to show clinical benefit.

On one hand, the rejection should come as no surprise: Regulators spelled out the problems they saw with Incyte’s data package in no uncertain terms, raising concerns about the low response rates, lack of diversity and dearth of safety data in the single-arm trial. During the ensuing adcomm, the FDA’s cancer czar, Richard Pazdur, suggested the whole episode underscores the need to “reassess” how drugs get approved under the accelerated approval pathway without randomized studies.

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

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If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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