Bio­gen is hus­tling a schiz­o­phre­nia drug in­to PhI­Ib af­ter Pfiz­er lets it go in $590M CNS fire sale

Pfiz­er’s $PFE de­ci­sion to beat a re­treat from its pipeline of neu­ro­sciences drugs has trig­gered its first as­set sale.

Michael Ehlers, Bio­gen

Bio­gen $BI­IB is step­ping up with $75 mil­lion in cash and com­mit­ting up to $515 mil­lion in mile­stones to seal the deal on Pfiz­er’s schiz­o­phre­nia drug PF-04958242. The drug has been through an ear­ly-stage study, and now Bio­gen will add it to a lean pipeline of CNS ther­a­pies.

Bio­gen says this marks their first en­try in­to neu­ropsy­chi­a­try.

The drug is an AM­PA re­cep­tor po­ten­tia­tor, de­signed to un­scram­ble ex­ci­ta­to­ry synap­tic trans­mis­sion in the CNS. In the Phase Ib, re­searchers re­port­ed that they were able to suc­cess­ful­ly treat health vol­un­teers by first trig­ger­ing cog­ni­tive is­sues com­mon­ly as­so­ci­at­ed with schiz­o­phre­nia by dos­ing them with ke­t­a­mine and then fol­low­ing up with the ther­a­py. And that built on the ro­dent da­ta they had gath­ered in an­i­mal stud­ies.

Pfiz­er an­nounced in ear­ly Jan­u­ary that it was aban­don­ing neu­ro­sciences R&D and lay off 300 staffers af­ter a long and un­suc­cess­ful at­tempt to build a port­fo­lio of drugs. The phar­ma gi­ant’s web­site list­ed 8 Phase I and Phase II pro­grams in neu­ro­sciences, its third largest con­cen­tra­tion of pipeline ef­forts. Those drugs in­clude a Phase II GA­BA-A re­cep­tor ag­o­nist PF-06372865 and an­oth­er mid-stage ef­fort on Parkin­son’s dis­ease. There are al­so 4 ear­ly-stage projects on Alzheimer’s.

Bio­gen, mean­while, is boost­ing its neu­rode­gen­er­a­tion work, fo­cus­ing much of its at­ten­tion around the late-stage Alzheimer’s drug ad­u­canum­ab. An­a­lysts have been look­ing for the biotech play­er to make a land­mark deal, but have been dis­ap­point­ed on that score so far. And they were not par­tic­u­lar­ly ex­cit­ed by Bio­gen’s step here to­wards a more holis­tic CNS fu­ture. Baird’s Bri­an Sko­r­ney not­ed:

The crit­i­cal is­sue for Bio­gen right now is how to grow the core busi­ness in­to and through ad­u­canum­ab’s Phase III read­outs. With pres­sures in MS con­tin­u­ing to grow in­to 2019 with Gilenya go­ing gener­ic and po­ten­tial ozan­i­mod ap­proval, and ad­vances by AveX­is in SMA, the Street wants to see de­fin­i­tive moves by Bio­gen to fill po­ten­tial gaps in MS and pro­tect the Spin­raza fran­chise.

Bio­gen, though, isn’t fret­ting pub­licly.

“When cog­ni­tion is im­paired, you lose the abil­i­ty to make sense of the world. Things we of­ten take for grant­ed in our dai­ly lives, in­clud­ing pro­cess­ing in­for­ma­tion, plan­ning and re­mem­ber­ing, all be­come dif­fi­cult or im­pos­si­ble,” said Bio­gen R&D chief Michael Ehlers. “Cog­ni­tion can be im­paired in mul­ti­ple neu­ro­log­i­cal and neu­ropsy­chi­atric dis­eases, in­clud­ing schiz­o­phre­nia. And we know that the ex­tent of cog­ni­tive deficits in pa­tients with schiz­o­phre­nia is a strong pre­dic­tor of dai­ly func­tion­ing. We look for­ward to quick­ly pur­su­ing de­vel­op­ment of this po­ten­tial in­no­v­a­tive ther­a­py to treat such a dev­as­tat­ing dis­ease.”

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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