Sunao Man­abe takes top job at Dai­ichi Sankyo in wake of As­traZeneca deal; CAR-T play­er Celyad pro­motes Fil­ip­po Pet­ti to CEO

Sunao Man­abe

→ Bare­ly a day af­ter Dai­ichi Sankyo wrapped a mam­moth col­lab­o­ra­tion deal with As­traZeneca, the Japan­ese phar­ma an­nounced a suc­ces­sion plan for its CEO. George Nakaya­ma, who’s keep­ing his chair­man seat, is pass­ing the reins to Sunao Man­abe, cur­rent­ly pres­i­dent and COO. This marks one of the fi­nal tran­si­tions as Nakaya­ma winds down his decades-long ca­reer run with the com­pa­ny, start­ing at Dai­ichi sub­sidiary Sun­to­ry in 1979. He del­e­gat­ed the pres­i­dent role two years ago.

Celyad, the Bel­gian biotech now mak­ing a low-pro­file run for off-the-shelf CAR-T suc­cess along­side more promi­nent peers like Cel­lec­tis, Servi­er and Al­lo­gene, has pro­mot­ed CFO Fil­ip­po Pet­ti to CEO. He re­places Chris­t­ian Hom­sy, who’s step­ping aside to a non-ex­ec­u­tive, sup­port­ing role af­ter lead­ing the com­pa­ny through a tran­si­tion from stem cell ther­a­py for the heart to im­muno-on­col­o­gy dur­ing his 12-year tenure.

→ Palm Beach Gar­dens, Flori­da-based Xcov­ery has tapped two Big Phar­ma vets for top posts at its on­col­o­gy op­er­a­tion. Li Mao, a long time aca­d­e­m­ic, is tak­ing the helm af­ter a stint as head of the John­son & John­son Chi­na Lung Can­cer Cen­ter. Gio­van­ni Sel­vag­gi, who’s served roles at Glax­o­SmithK­line, No­var­tis and Bris­tol-My­ers Squibb in the past nine years, joins as CMO. To­geth­er, they will steer de­vel­op­ment of en­sar­tinib and vorolanib, Phase III and Phase I/II drugs for ALK-pos­i­tive non-small cell lung can­cer and tho­racic can­cer, re­spec­tive­ly — both in­di­ca­tions that Sel­vag­gi be­came fa­mil­iar with over the course of both his med­ical and in­dus­try ca­reers.

Willem Scheele

→ As Imara gets up to full speed with its mid-stage pro­gram for sick­le cell dis­ease, the biotech has wooed Pfiz­er’s rare dis­ease head to be its per­ma­nent CMO. Hav­ing scored a $63 mil­lion round co-led by Ar­ix and Or­biMed just days ago, the Cam­bridge, MA-based biotech is an­tic­i­pat­ing some da­ta on its ex­per­i­men­tal med IMR-687, a phos­pho­di­esterase-9 in­hibitor, by June. Scheele re­places Shi Yin Foo, an ex­ec of the or­phan drug ac­cel­er­a­tor Cy­dan who was help­ing out on an in­ter­im ba­sis.

Rekha Hem­ra­jani is join­ing Ar­cus Bio­sciences $RCUS as chief op­er­at­ing and fi­nan­cial of­fi­cer, a role that com­bines her ex­pe­ri­ence at FLX Bio and 3-V Bio­sciences. The biotech, led by Ter­ry Rosen’s crew at Flexus, is busy eval­u­at­ing sev­er­al Phase I read­outs for its slate of can­cer drugs: AB928, a dual A2a/A2b re­cep­tor an­tag­o­nist; AB154, an an­ti-TIG­IT an­ti­body, and AB680, a small-mol­e­cule CD73 in­hibitor.

Shree­r­am Arad­hye has fol­lowed his old col­league Bill Hin­shaw out No­var­tis’ doors and in­to Ax­cel­la’s C-suite. As EVP and chief de­vel­op­ment of­fi­cer, Arad­hye will steer the Flag­ship-found­ed biotech’s non-IND clin­i­cal stud­ies fo­cused on re­pro­gram­ming me­tab­o­lism with en­doge­nous meta­bol­ic mod­u­la­tors. Karen Lewis, Bio­gen’s for­mer head of hu­man re­sources, has al­so come on board in a sim­i­lar role.

→ Af­ter work­ing with Abing­worth on a num­ber of co-in­vest­ments (in­clud­ing Wil­son Ther­a­peu­tics and Val­ne­va) as a se­nior part­ner at MVM Part­ners, Bali Mu­ralid­har is join­ing Tim Haines’ promi­nent biotech fund. He will be­come part of a glob­al team spread be­tween Lon­don, Boston and Men­lo Park that iden­ti­fies new in­vest­ment op­por­tu­ni­ties and sup­ports star­tups in the ex­ist­ing port­fo­lio.

Turn­ing Point Ther­a­peu­tics has hired ex­pe­ri­enced health­care com­mu­ni­ca­tor Jim Maz­zo­la to lead cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions as it preps its lead ki­nase in­hibitor for a Phase II tri­al in the sec­ond half of the year.

→ In Abzena’s lat­est ef­fort to beef up its man­age­ment team, the bi­o­log­ics con­tract re­search or­ga­ni­za­tion is ap­point­ing Camp­bell Bunce and Bo Adair to the new po­si­tions of CSO and SVP process and op­er­a­tions. Bunce will keep his oth­er role as the head of Abzena’s Cam­bridge, UK, which he’s filled since 2015. Adair, on the oth­er hand, comes from a reg­u­lar con­sult­ing gig fol­low­ing a re­cent job at Ap­tu­it.

Wind­MIL Ther­a­peu­tics has tapped San­jin Zvonić, a sea­soned ex­ec who most re­cent­ly led Prog­en­i­tor Cell Ther­a­py’s in­te­gra­tion in­to Hi­tachi, to lead its process­es and man­u­fac­tur­ing.   

“At Wind­MIL, we’re al­ways look­ing to the fu­ture of can­cer im­munother­a­py, so San­jin’s abil­i­ty to bridge re­search and man­u­fac­tur­ing makes him an ide­al fit for us as we de­liv­er both the cur­rent gen­er­a­tion of MILs and look to­ward de­vel­op­ing the next gen­er­a­tion,” in­ter­im CEO Don Hay­den said, re­fer­ring to the Bal­ti­more biotech’s mar­row-in­fil­trat­ing lym­pho­cytes tech­nol­o­gy.

→ On the heels of a sec­ond glau­co­ma drug ap­proval, Aerie Phar­ma­ceu­ti­cals $AERI has  re­cruit­ed An­gela Jus­tice (for­mer­ly of Sun Phar­ma) as west­ern re­gion­al di­rec­tor, med­ical sci­ence li­ai­son, and Bri­an Saku­ra­da (for­mer­ly of Intar­cia Ther­a­peu­tics) as di­rec­tor of sci­en­tif­ic mar­ket ac­cess. Con­cur­rent­ly, No­var­tis alum David El­lis is join­ing as di­rec­tor of chem­istry while  Karis­ma Shar­ma has been named VP, hu­man re­sources.

→ Af­ter try­ing out re­search and ear­ly de­vel­op­ment at Roche and No­var­tis, Shao­lian Zhou has re­turned to the CRO world. He is now the SVP and lab di­rec­tor for bio­an­a­lyt­i­cal ser­vices at World­wide Clin­i­cal Tri­als, re­spon­si­ble for the over­all op­er­a­tions of the lab fa­cil­i­ty in Austin.

→ As In­tra-Cel­lu­lar Ther­a­pies plots a turn­around and quick launch for its schiz­o­phre­nia drug lu­mate­per­one, it has ap­point­ed Bris­tol-My­ers Squibb vet John Bar­di to spear­head mar­ket ac­cess, pol­i­cy and gov­ern­ment af­fairs. Bar­di jumps to the New York-based biotech $IT­CI from Ot­su­ka, where he played a sim­i­lar role in bring­ing the an­tipsy­chot­ic Abil­i­fy to mar­ket.

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.