Ken­ji Ya­sukawa takes the reins at Astel­las; Voy­ager hunts for new CEO as Steven Paul goes back to re­search

Ken­ji Ya­sukawa

→ As Astel­las pur­sues a new strate­gic plan, Ken­ji Ya­sukawa is tak­ing the reins from Yoshi­hiko Hatana­ka as pres­i­dent and CEO. Ya­sukawa’s re­sume sug­gests that he’s been groomed for the po­si­tion: hav­ing joined the Japan­ese com­pa­ny in its ear­ly ear­ly Ya­manouchi days, he worked his way up the man­age­ment ranks, fi­nal­ly be­com­ing a rep­re­sen­ta­tive di­rec­tor side by side with Hatana­ka. Hatana­ka will re­tain that ti­tle, along­side his new role of board chair­man.

→ Mark­ing al­most 30 years of ser­vice at Boehringer In­gel­heim, Wolf­gang Baik­er has been pro­mot­ed to US pres­i­dent and CEO, suc­ceed­ing Paul Fonteyne, who is re­tir­ing at the end of 2018. Baik­er is cur­rent­ly an SVP and the head of the bio­phar­ma busi­ness unit, hav­ing pre­vi­ous­ly led clin­i­cal de­vel­op­ment and clin­i­cal re­search in Con­necti­cut. Fonteyne, who’s been at the helm for six years and presided over the launch of Spiri­va, will re­main the chair­man of the Boehringer USA board.

Steven Paul

Voy­ager Ther­a­peu­tics $VY­GR is hunt­ing for a new CEO as co-founder and cur­rent chief ex­ec­u­tive Steven Paul has de­cid­ed to fo­cus on pre­clin­i­cal dis­cov­ery re­search and port­fo­lio de­vel­op­ment. Af­ter six years on the front line, he will tran­si­tion to the role of ex­ec­u­tive sci­ence ad­vi­sor and stay on both the board and the sci­ence & tech com­mit­tee. Paul, an Eli Lil­ly vet, was a ven­ture part­ner at Third Rock when he helped form the biotech, known for its gene ther­a­py for Parkin­son’s dis­ease.

→ As No­vo Nordisk $NVO con­tin­ues to hunt for new blood dis­ease as­sets (and in­sists they could not see the val­ue at which Abl­ynx was bought), long­time CFO Jes­per Brandgaard is step­ping down from that po­si­tion but con­tin­u­ing as EVP, re­spon­si­ble for No­vo’s bio­pharm busi­ness and le­gal af­fairs. His suc­ces­sor, Karsten Munk Knud­sen, is al­so a vet­er­an of the Dan­ish gi­ant and has played fi­nan­cial roles in both the head­quar­ters and the US di­vi­sion — most re­cent­ly, SVP of cor­po­rate fi­nance. In oth­er news, board of di­rec­tors chair­man Goran An­do has de­cid­ed not to seek re-elec­tion; Helge Lund was pro­posed to fill his po­si­tion.

Camille Bedrosian

→ While Ul­tragenyx $RARE is mov­ing in­to com­mer­cial op­er­a­tions, it’s shown the world that it’s not for­get­ting its pipeline with the ap­point­ment of Camille Bedrosian as CMO and EVP. Dur­ing her 10-year tenure at fel­low rare dis­ease biotech Alex­ion, Bedrosian over­saw the de­vel­op­ment and even­tu­al ap­proval of Soliris. Her do­main at Ul­tragenyx will span strate­gic lead­er­ship on clin­i­cal de­vel­op­ment and trans­la­tion­al re­search pro­grams, as well as day-to-day over­sight of med­ical af­fairs, clin­i­cal op­er­a­tions and drug safe­ty.

→ Af­ter mak­ing the rounds at big phar­ma of­fices in the re­gion, Ali­na Cul­cea is join­ing Am­gen as its new gen­er­al di­rec­tor in Ro­ma­nia. She has pre­vi­ous­ly man­aged re­gion­al vac­cines sales for Glax­o­SmithK­line, han­dled HR for Pfiz­er and Ac­tavis, and di­rect­ed pub­lic af­fairs for No­var­tis Ro­ma­nia. “Ro­ma­nia is one of the pri­or­i­ty mar­kets for Am­gen and so, the role of gen­er­al man­ag­er of the lo­cal af­fil­i­ate is crit­i­cal for our busi­ness suc­cess,” said ex­ec­u­tive di­rec­tor and re­gion­al gen­er­al man­ag­er Vik­to­ria Anashk­i­na.

In­sys Ther­a­peu­tics $IN­SY has ush­ered in two new ex­ec­u­tives to its se­nior man­age­ment team, as the painkiller mak­er slow­ly shakes off the at­ten­tion around the prob­lem­at­ic mar­ket­ing schemes that led to the ar­rest of its founder. Psy­chi­a­trist Ahmed Elka­shef, a for­mer NIH staffer and aca­d­e­m­ic, has been ap­point­ed VP of clin­i­cal de­vel­op­ment. Al­so join­ing In­sys (and the biotech in­dus­try) as the new VP of hu­man re­sources is Car­ol Sum­mers­gill, whose ca­reer has spanned a num­ber of re­tail and man­u­fac­tur­ing sec­tors.

→ With a PDU­FA date for its Ei­sai castoff com­ing up, Do­va Phar­ma $DO­VA say­ing good­bye to old CFO Doug Blanken­ship and wel­com­ing Mark Hahn as his suc­ces­sor. A Genen­tech vet, Blanken­ship stum­bled up­on the Durham, NC-based biotech when he be­gan a sab­bat­i­cal in the area. Hahn will now take over the charge to tran­si­tion Do­va to a com­mer­cial stage com­pa­ny. Hav­ing spear­head­ed Cem­pra’s fi­nanc­ing ac­tiv­i­ties all the way from its IPO up to the Melin­ta ac­qui­si­tion, Hahn said he is de­light­ed to help the biotech grow around ava­trom­bopag.

→ Is­rael’s In­tec Phar­ma has brought in Michael Gen­dreau as CMO to lead the Phase III tri­al of its com­bo for Parkin­son’s dis­ease as well as oth­er clin­i­cal de­vel­op­ment of the Ac­cor­dian Pill tech­nol­o­gy plat­form. Gen­dreau was a found­ing mem­ber at San Diego-based Cy­press Bio­sciences (now owned by Roy­al­ty Phar­ma), where he worked for 15 years be­fore found­ing his own con­sult­ing firm.

Ole Larsen is de­part­ing the CFO po­si­tion at Bavar­i­an Nordic, where he’s spent the past 10 years. The Dan­ish biotech has at­tract­ed some big name part­ners with its vac­cine plat­form, but has stayed rel­a­tive­ly qui­et since a PhI­II can­cer vac­cine tri­al flopped last year.

Bob Hug­in

→ Af­ter or­ches­trat­ing the emer­gence of one of the biggest biotechs to come along in the art 20 years, Bob Hug­in has an­nounced his re­tire­ment as ex­ec­u­tive chair­man of Cel­gene. Hug­in start­ed at Cel­gene $CELG as CFO and went on to daz­zle Wall Street by build­ing the fran­chise around Revlim­id. More re­cent­ly Cel­gene CEO Mark Alles, who Hug­in had groomed for the top spot, man­aged to rat­tle the mar­ket with some shaky fore­casts. But the com­pa­ny quick­ly bounced back with deals to ac­quire Im­pact and most no­tably Juno, po­si­tion­ing the com­pa­ny as one of the lead­ers in the CAR-T field. His de­par­ture comes right on the heels of word that Hug­in, a com­mit­ted Re­pub­li­can and ma­jor league con­trib­u­tor to the con­ser­v­a­tive par­ty in New Jer­sey, has been con­sid­er­ing a run for the Sen­ate in a show­down with De­mo­c­ra­t­ic Sen­a­tor Bob Menen­dez.

Mer­ck vet Di­ane Plotkin is the new VP of clin­i­cal de­vel­op­ment at Los An­ge­les-based Rit­ter Phar­ma $RT­TR, a tiny com­pa­ny tak­ing on lac­tose in­tol­er­ance. As Rit­ter pre­pares to launch a piv­otal Phase III tri­al for its sole pro­gram, mi­cro­bio­me mod­u­la­tor RP-G28 (with al­tered end­points), Plotkin’s clin­i­cal knowl­edge and ex­pe­ri­ence will like­ly be im­por­tant for cash-strapped team. Like com­pa­ny founder An­drew Rit­ter, Plotkin said she’s drawn to the work giv­en her per­son­al ex­pe­ri­ence with the con­di­tion. En­roll­ment for the trail — ex­pect­ing 500 pa­tients — will be­gin this sum­mer.

→ Af­ter build­ing McK­in­sey’s bio di­vi­sion as a part­ner for the past few years, Ralf Ot­to is re­turn­ing to the bio­phar­ma world as the COO at Rentschler Bio­phar­ma. He suc­ceeds Thomas Sik­losi, who will move to the par­ent cor­po­ra­tion of the Ger­man con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion.

→ In­dus­try vet­er­an Jack Shan­non has moved up again in the CRO world, hav­ing land­ed the ti­tle of chief com­mer­cial of­fi­cer at Syn­ter­act. Here, he over­sees the glob­al sales and mar­ket­ing func­tions — some­thing he’s done be­fore as VP of glob­al busi­ness de­vel­op­ment bio­phar­ma at Chiltern.

→ Bue­na, NJ-based gener­ic mak­er Teligent has re­cruit­ed As­traZeneca vet Dami­an Finio to re­place out­go­ing CFO Jen­nifer Collins. Finio, who’s join­ing from Vir­tus Phar­ma, has built a ca­reer on fi­nan­cial po­si­tions in phar­ma, in­clud­ing a brief stint as au­dit com­mit­tee chair at Teligent back when it was known as IGI Lab­o­ra­to­ries.

→ Cam­bridge, UK-based RNA epi­ge­net­ics drug dis­cov­ery spe­cial­ist Storm Ther­a­peu­tics has ap­point­ed No­bel Prize win­ner Thomas Cech as a sci­en­tif­ic ad­vis­er. Cech, a Mer­ck board mem­ber and ex­pert in the field, pre­vi­ous­ly helped found an RNAi biotech that lat­er be­came an Al­ny­lam sub­sidiary.

→ Cana­da’s Xortx Ther­a­peu­tics has ap­point­ed two new di­rec­tors, Al­lan Williams and Paul Van Damme, as co-founder and long­time di­rec­tor Alan Moore re­signs from his po­si­tion. He re­mains with the kid­ney dis­ease com­pa­ny as a se­nior ex­ec­u­tive con­sul­tant for clin­i­cal and reg­u­la­to­ry af­fairs.

Frank Per­abo has stepped down from the CMO seat at Es­sa Phar­ma $EPIX, but will re­main in­volved with the Cana­di­an can­cer com­pa­ny as part of the med­ical ad­vi­so­ry com­mit­tee.

→ Oslo, Nor­way-based can­cer biotech Nordic Nanovec­tor has ap­point­ed Ma­lene Brond­berg as VP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions.

Cure Phar­ma­ceu­ti­cal has hired Vered Gi­gi to dri­ve growth for CURE­film, its drug re­lease for­mu­la­tion plat­form, as VP of strat­e­gy and busi­ness de­vel­op­ment.

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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