In­ves­tiga­tive re­port calls for re­newed scruti­ny on Aca­dia drug; Im­bru­vi­ca fails in front­line DL­B­CL PhI­II

→ The spot­light on Aca­dia Phar­ma­ceu­ti­cals’ $ACAD Parkin­son’s drug has turned more in­tense as in­ves­tiga­tive jour­nal­ist Rod­dy Boyd (you might re­mem­ber his re­port­ing on Valeant) drops an ex­posé on the com­pa­ny. Fol­low­ing a se­ries of re­ports from CNN and ProP­ub­li­ca high­light­ing Nu­plazid’s dan­gers, Boyd’s ac­count pound­ed on both the con­tro­ver­sial his­to­ry of its ap­proval and its spot­ty safe­ty record since then.

Boyd, writ­ing on the South­ern In­ves­tiga­tive Re­port­ing Foun­da­tion, al­so ques­tioned the mar­ket­ing tac­tics of Aca­dia’s sales team, many of whom had been scooped from an­oth­er scan­dal-prone com­pa­ny, Avanir: “For 2017, Aca­dia paid more than $8.6 mil­lion to 7,051 physi­cians, with 62 doc­tors re­ceiv­ing more than $50,000 apiece, and 26 re­ceiv­ing at least $100,000 each.” And there ap­pears to be an over­lap be­tween fre­quent pre­scribers of the drug and those who re­ceived con­sult­ing fees.

The at­ten­tion on safe­ty is­sues has pushed a steep drop in Aca­dia shares, which have lost more than half their val­ue over the past months. Nu­plazid — des­ig­nat­ed a “break­through” drug — is now un­der re­view again at the FDA.

→ Re­searchers at Ab­b­Vie say that Im­bru­vi­ca failed as a front­line ther­a­py for dif­fuse large B-cell lym­phoma. Their drug in com­bi­na­tion with oth­er agents was un­able to beat the stan­dard of care — R CHOP — for treat­ing the dis­ease. They did, though, add that their drug ap­par­ent­ly worked in a sub­set of pa­tients and plan to fol­low up with more re­search.

Em­ma Walm­s­ley’s re­make of the ex­ec­u­tive round­table at GSK is near­ing com­ple­tion. To­day the phar­ma gi­ant not­ed that gen­er­al coun­sel Dan Troy is leav­ing the com­pa­ny af­ter 10 years. He’s be­ing re­placed by James Ford, cur­rent­ly SVP and gen­er­al coun­sel for Glob­al Phar­ma.

→ France’s Antabio has added €5.2 mil­lion to their Se­ries A, bring­ing the to­tal to €12.5 mil­lion. The biotech is work­ing on a in­hibitor of bac­te­r­i­al met­al­lo ß-lac­ta­mases for drug re­sis­tant cas­es. Omnes, BNP Paribas Développe­ment, and Sham In­no­va­tion San­té (Turenne Cap­i­tal) stepped in, with ex­ist­ing share­hold­er Galia Ges­tion.

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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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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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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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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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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