Pfiz­er reshuf­fles top ranks with Al­bert Bourla as COO; In­tra-cel­lu­lar nabs No­var­tis vet An­drew Satlin as CMO

Al­bert Bourla

Pfiz­er has pro­mot­ed its In­no­v­a­tive Health chief Al­bert Bourla to the new role of chief op­er­at­ing of­fi­cer, where he’s been giv­en a spe­cial man­date to over­see the day-to-day ac­tiv­i­ty around prod­uct de­vel­op­ment, sales and strat­e­gy. This has been in­ter­pret­ed as CEO Ian Read’s way of anoint­ing his suc­ces­sor, al­though that is far from cer­tain. The move, which be­comes of­fi­cial on Jan­u­ary 1, trig­gered a reshuf­fle in the top ranks at Pfiz­er. John Young, who heads Pfiz­er Es­sen­tial Health, takes Bourla’s old job, while An­gela Hwang suc­ceeds Young.

→ New York-based In­tra-Cel­lu­lar Ther­a­pies has brought on An­drew Satlin as chief med­ical of­fi­cer. The biotech spe­cial­iz­ing in cen­tral ner­vous sys­tem dis­or­ders man­aged to raise $150 mil­lion ear­ly Oc­to­ber part­ly to fund the pre-launch and com­mer­cial ac­tiv­i­ties for lu­mate­per­one, their lead drug in schiz­o­phre­nia, claim­ing that safe­ty con­cerns brought up in March have been cleared. That’s great tim­ing for Satlin to join, they say, as the No­var­tis vet brings in­sight from be­ing the glob­al head of med­i­cine cre­ation strat­e­gy, neu­rol­o­gy busi­ness group at Ei­sai.

→ Dual Flag­ship Pi­o­neer­ing and Alex­ion vet Je­re­my Spring­horn has tak­en on the chief busi­ness of­fi­cer role at Cam­bridge, MA based Sy­ros Ther­a­peu­tics. As one of the in­ven­tors of Soliris, Sp­ing­horn will be re­spon­si­ble for busi­ness de­vel­op­ment and strate­gic plan­ning across the biotech’s $SYRS wide-ranged pipeline.

Macro­Gen­ics $MGNX, the biotech de­vel­op­ing mon­o­clon­al an­ti­body-based ther­a­peu­tics that just out-li­censed a PD-1 check­point drug to In­cyte, has named J&J re­tiree Jay Siegel to its board of di­rec­tors. Siegel spent the first two decades of his ca­reer as a reg­u­la­tor with the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search be­fore join­ing the Big Phar­ma in 2003, even­tu­al­ly tak­ing up R&D and reg­u­la­to­ry af­fairs roles.

→ In a boost to their con­sult­ing prac­tice, con­tract re­search or­ga­ni­za­tion Parex­el has re­cruit­ed three reg­u­la­to­ry/drug de­vel­op­ment staffers as their new vice pres­i­dents: Robert Is­er, VP of reg­u­la­to­ry con­sult­ing ser­vice; Bob (Bhard­waj) De­sai, VP of con­sult­ing, tech­ni­cal (on­col­o­gy); and Chang Lee, VP of con­sult­ing, APAC. To­geth­er, the trio brings ex­pe­ri­ence from the FDA and in­dus­try gi­ants such Pfiz­er and Ab­b­Vie — key sell­ing points as the CRO tries to prove it has much to of­fer out­side the lab.

Bay­er’s $BAYN head of con­sumer health Er­i­ca Mann is de­part­ing next March, and the com­pa­ny has tapped a long­time Nestlé ex­ec­u­tive to fill her shoes. Heiko Schip­per, who led the in­fant nu­tri­tion di­vi­sion while serv­ing as deputy ex­ec­u­tive vice pres­i­dent of Nestlé, will al­so join Bay­er’s board of man­age­ment.

Tony de Fougerolles, for­mer­ly chief sci­en­tif­ic of­fi­cer at Abl­ynx, is the new CEO of Ox­ford, UK-based Evox Ther­a­peu­tics. He takes over from co-founder Per Lundin, who will now fo­cus on be­ing COO. The young biotech aims to cre­ate a plat­form tech­nol­o­gy uti­liz­ing ex­o­somes — “foun­da­tion­al trans­porters in the hu­man body” — to cre­ate bio­ther­a­peu­tics, and fig­ures it could use some help from de Fougerolles, who has al­so helped ad­vance pipelines for Mod­er­na and Al­ny­lam.

Eu­gene Kennedy has been pro­mot­ed from VP of clin­i­cal and med­ical af­fairs to chief med­ical of­fi­cer at NewLink Ge­net­ics $NLNK, the biotech best known for its IDO in­hibitor that has gar­nered (though some­times lost) in­ter­est from big part­ners. His new role is an ex­pan­sion of his pre­vi­ous job, in­volv­ing the start of en­roll­ment in­to NewLink’s piv­otal tri­al of in­dox­i­mod com­bos for ad­vanced melanoma.

→ The small crew at Mus­tang Bio has found a new mem­ber in Bri­an Achen­bach, their new VP of fi­nance and cor­po­rate con­troller who will as­sume re­spon­si­bil­i­ties pre­vi­ous­ly held by in­ter­im CFO David Horin. His fi­nance and ac­count­ing ex­per­tise, last ex­er­cised at Ameri­gen af­ter stints at Con­va­Tec and My­lan, will be need­ed as the tiny biotech tries to tack­le gi­ants in the CAR-T field.

Bris­tol-My­ers Squibb’s Mike Burgess is leav­ing Big Phar­ma be­hind and be­com­ing pres­i­dent of re­search and de­vel­op­ment at Cana­da’s Turn­stone Bi­o­log­ics, where he will lead all R&D ac­tiv­i­ties. The role builds up­on Burgess’ ex­pe­ri­ence at BMS head­ing trans­la­tion­al re­search and can­cer de­vel­op­ment, af­ter stints at Roche and Eli Lil­ly. In a state­ment, Burgess ex­pressed con­fi­dence in the on­colyt­ic con­tender’s two-in-one can­cer vac­cine, which got a boost from Ab­b­Vie just last month: “Turn­stone Bi­o­log­ics is unique­ly po­si­tioned to de­liv­er break­through vi­ral-based im­munother­a­pies for pa­tients with can­cer. … I look for­ward to work­ing close­ly with Turn­stone’s ex­pe­ri­enced team and founders, who are dri­ven by sci­ence and in­no­va­tion, to bring these break­through med­i­cines to pa­tients.”

→ The Med­i­cines Com­pa­ny $MD­CO has brought Pfiz­er vet Geno Ger­mano on­to its board. Ger­mano most re­cent­ly was pres­i­dent of In­trex­on but left af­ter a short stint. Chair­man Fredric Es­hel­man, mean­while, is be­ing bumped up to ex­ec­u­tive chair­man.

CRISPR Ther­a­peu­tics an­nounced that Michael Tom­sicek, for­mer­ly of med­ical im­plant man­u­fac­tur­er Abio­med and Mer­ck-ac­quired phar­ma Cu­bist, will be­come its CFO. The news came on the same day the Swiss gene edit­ing com­pa­ny $CR­SP said it will team up with Cure­Vac to de­vel­op im­proved Cas9 mR­NA con­structs for in vi­vo gene edit­ing, to­geth­er with its joint ven­ture Case­bia.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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