The Scan­gos lega­cy: A block­buster MS record with lin­ger­ing doubts about the pipeline

Six years ago, George Scan­gos was re­cruit­ed to head a turn­around team at what was billed as a trou­bled Bio­gen. And it wasn’t long be­fore a big ap­proval for a new mul­ti­ple scle­ro­sis block­buster trig­gered a round of ap­plause—and a bull­ish surge in the com­pa­ny’s stock price—that last­ed for years.

To­day, Scan­gos says his time is up at Bio­gen, well af­ter the ap­plause pe­tered out last year and the mar­ket be­gan to grow rest­less over the CEO’s less suc­cess­ful sec­ond act in a bear­ish mar­ket. In the next few months, he’ll step aside, once his suc­ces­sor can be found to helm the in­flu­en­tial Big Biotech, an in­sti­tu­tion­al land­mark in­side the Boston/Cam­bridge hub.

In some ways, he’s leav­ing Bio­gen $BI­IB in the same shape he found it, ei­ther the tar­get of a po­ten­tial buy­out or in need of a sub­stan­tial ac­qui­si­tion or some oth­er pipeline move that can re­gen­er­ate ex­cite­ment in the com­pa­ny’s fu­ture. As Scan­gos isn’t stick­ing around to ex­e­cute an an­tic­i­pat­ed deal, you can ex­pect to hear plen­ty of spec­u­la­tion that it’s more like­ly that Bio­gen could be bought. This next CEO will step in dur­ing a tur­bu­lent, un­cer­tain phase in the com­pa­ny’s long his­to­ry.

CEO George Scan­gos

Dur­ing his tenure, Scan­gos made Tec­fidera the new top earn­ing drug at Bio­gen, build­ing up the com­pa­ny’s MS port­fo­lio and wield­ing huge in­flu­ence over that sec­tor of the mar­ket. Bio­gen was fre­quent­ly cit­ed along­side Cel­gene and Gilead as an ex­am­ple of the new breed of Big Biotech, ca­pa­ble of de­vel­op­ing im­por­tant new drugs while rack­ing up ma­jor sales growth. But the com­pa­ny’s re­lent­less in­sis­tence on suc­cess ran in­to some grum­bling last year, when erod­ing growth in the big MS fran­chise forced the man­age­ment team to lay off more than 800 staffers in a big re­or­ga­ni­za­tion.

Scan­gos leaves be­hind a pipeline that has huge po­ten­tial, but plen­ty of lin­ger­ing doubts. In a swing-for-the-fences strat­e­gy, Bio­gen tack­led Alzheimer’s, per­haps the sin­gle biggest frus­tra­tion in R&D, with a new drug called ad­u­canum­ab. That drug is now in a late-stage study af­ter scor­ing some mixed ear­ly re­sults. (In Alzheimer’s R&D, which has known lit­tle but de­feat over the past decade, mixed ear­ly re­sults for a drug that tar­gets amy­loid be­ta is con­sid­ered quite an achieve­ment.)

Bio­gen’s hopes for stir­ring some ex­cite­ment for the pipeline, though, hit a bit­ter set­back just a few weeks ago. A Phase II study of its MS drug opicinum­ab (an­ti-LIN­GO-1) failed a Phase II study and left an­a­lysts unim­pressed at Bio­gen’s seem­ing­ly far-off set of pipeline cat­a­lysts. Once again, its shares were bad­ly dam­aged.

Scan­gos is leav­ing short­ly af­ter key mem­bers of his turn­around team moved on to new projects in biotech. R&D chief Doug Williams left to start Co­di­ak last year. Steve Holtz­man, head of cor­po­rate de­vel­op­ment, jumped ship at about the same time and is now run­ning Third Rock’s start­up Deci­bel.

Scan­gos him­self re­mains an out­sized fig­ure in biotech. He has a long re­sume in drug de­vel­op­ment and will like­ly re­main an in­flu­en­tial—though low­er pro­file—play­er long af­ter his suc­ces­sor has been named. In biotech, re­tire­ment is usu­al­ly the step you take be­fore start­ing your third act.

He hint­ed at that third act in a state­ment:

“This is the right time for a new leader to take the reins and lead Bio­gen through its next stage of de­vel­op­ment, and I look for­ward to re­turn­ing to the West Coast to take on one more set of ac­tiv­i­ties and spend more time with my fam­i­ly.”

Michel Younatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application.

The big biotech also notes that the “FDA has stated that, if possible, it plans to act early on this application under an expedited review.”

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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