Bio­gen ex­ec Paul McKen­zie heads to CSL as COO; Pul­ma­trix CEO re­signs

Paul McKen­zie

→ Af­ter Bio­gen’s re­cent cat­a­stro­phe with ad­u­canum­ab, Paul McKen­zie, the com­pa­ny’s EVP for phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy (and mem­ber of its ex­ec­u­tive com­mit­tee), jumped ship. He’s now head­ing to the Aus­tralia-based gi­ant CSL as its COO. His new job en­tails man­ag­ing CSL’s glob­al sup­ply chain. McKen­zie’s last day is May 29.

David Schi­lan­sky

→ French bio­phar­ma­ceu­ti­cal firm DBV Tech­nolo­gies an­nounced on Tues­day the de­par­ture of its deputy CEO and prin­ci­pal fi­nan­cial of­fi­cer, David Schi­lan­sky. Schi­lan­sky will re­main with the com­pa­ny through Au­gust 2019. While a search is un­der­way for a new CFO the role of deputy CEO will not be filled af­ter Schi­lan­sky’s de­par­ture. Shi­lan­sky has been with the al­ler­gy spe­cial­ist since 2011, at one point serv­ing as COO.

Robert Clarke

Pul­ma­trix CEO Robert Clarke stepped down from his po­si­tion on Thurs­day and will be im­me­di­ate­ly suc­ceed­ed by cur­rent CBO Ted Raad. Clarke will stay with the dry pow­der in­haler de­vel­op­er as an ad­vi­sor un­til Au­gust 14, 2019. Clarke was ap­point­ed CEO in 2012.

Ted Raad

Clarke said, “Af­ter fif­teen years at Pul­ma­trix grow­ing with the or­ga­ni­za­tion from Head of R&D to CSO and ul­ti­mate­ly to CEO, I’ve had the op­por­tu­ni­ty to see every as­pect of the com­pa­ny’s busi­ness. With the Pul­ma­zole pro­gram part­nered with Cipla Tech­nolo­gies, and a strong bal­ance sheet for fu­ture de­vel­op­ment, I be­lieve that the busi­ness is now head­ing in­to a promis­ing phase of its evo­lu­tion un­der Ted’s ca­pa­ble lead­er­ship.”

Michael Ca­vanaugh

→  Michael Ca­vanaugh will step up as in­ter­im CEO for Vi­tal­i­ty Bio­phar­ma and cur­rent con­troller and coun­sel of the com­pa­ny, Richard McKil­li­gan, will be pro­mot­ed to CFO and coun­sel. Ca­vanaugh will step in to re­place CEO and di­rec­tor Robert Brooke, who co-found­ed the com­pa­ny to pur­sue cannabi­noid pro­drugs.

Mi­ka Derynck

Amu­nix is fur­ther ex­pand­ing its ex­ec­u­tive team with the ap­point­ment of Mi­ka Derynck as CMO, Dar­cy Mootz as CBO and Yvonne Li as SVP of fi­nance. Ear­li­er this year, Amu­nix ap­point­ed Ang­ie You as CEO and brought on Fra­zier Life Sci­ences as a ma­jor­i­ty share­hold­er to fund and di­rect dis­cov­ery of nov­el pro­tein ther­a­peu­tics on its tech plat­form.

Ang­ie You

The new hires “bring a wealth of skills and ex­pe­ri­ences that will help ac­cel­er­ate the growth of the com­pa­ny,” said You “Their re­cruit­ment speaks to the promise of our Pro-XTEN plat­form in ad­dress­ing the key chal­lenge of on-tar­get, off-tu­mor tox­i­c­i­ty with T-cell en­gagers and cy­tokines.”

Wende Chen

Ever­est Med­i­cines wel­comed Wende Chen as chief com­mer­cial of­fi­cer of the com­pa­ny. Chen will al­so serve as an op­er­at­ing part­ner for Ever­est’s found­ing in­vestor, CBC Group, for­mer­ly known as C-Bridge Cap­i­tal. He is tasked with de­vis­ing strate­gies for Ever­est’s port­fo­lio of drugs, in-li­censed from glob­al part­ners and tar­get­ed to Asian mar­kets. Pre­vi­ous­ly, Chen served as vice pres­i­dent of cor­po­rate af­fairs, mar­ket ac­cess and chan­nel man­age­ment at Roche Phar­ma Chi­na.

Wendy Winck­ler

→ Six months af­ter woo­ing Car­o­line Loew from Bris­tol-My­ers Squibb to the helm, Glympse Bio has re­cruit­ed an­oth­er Big Phar­ma vet to its quest for dis­ease-mon­i­tor­ing sen­sors. New CSO Wendy Winck­ler joins from the No­var­tis In­sti­tutes for Bio­med­ical Re­search, where she di­rect­ed next-gen di­ag­nos­tics projects. Spun out of Sangee­ta Bha­tia’s lab at MIT and backed by Arch as well as Po­laris, Glympse Bio is get­ting ready to en­ter the clin­ic with its tech, which both de­tects dis­eases (like NASH and can­cer) and mon­i­tor pa­tients’ re­sponse to drugs.

→ Leav­ing be­hind a 17-year ca­reer at DuPont, William Fee­hery is the new CEO of Cer­tara, a provider of mod­el-in­formed drug de­vel­op­ment, reg­u­la­to­ry sci­ence, re­al-world ev­i­dence and mar­ket ac­cess ser­vices. He re­places Ed­mun­do Mu­niz, who was cred­it­ed for cast­ing a glob­al vi­sion over the past five years that Fee­hery will see to fruition.

Chris­tine Bel­lon

Beam Ther­a­peu­tics made sev­er­al lead­er­ship ap­point­ments to strength­en its man­age­ment team. The gene edit­ing biotech says that Chris­tine Bel­lon has joined as se­nior vice pres­i­dent and chief le­gal of­fi­cer; Su­san O’Con­nor has joined as chief hu­man re­sources of­fi­cer; and Suzanne Flem­ing has joined as se­nior vice pres­i­dent, fi­nance. In ad­di­tion, the com­pa­ny an­nounced that Court­ney Wal­lace has been pro­mot­ed to se­nior vice pres­i­dent and head of busi­ness de­vel­op­ment and strat­e­gy.

Su­san O’Con­nor

Tetra Nat­ur­al Health, a sub­sidiary of Tetra Bio-Phar­ma, said that it had ap­point­ed sev­er­al in­di­vid­u­als to its new board of di­rec­tors. An­dre Ran­court will be­come chair­man, while Greg Dro­han, Guy Cham­ber­land and Richard Giguère al­so joined the board ef­fec­tive Wednes­day. The com­pa­ny al­so an­nounced the ap­point­ment of Chris MacLean as COO, who is al­so COO of Panag Phar­ma and will con­tin­ue to hold the po­si­tion.

→ On Tues­day, Tetra Bio-Phar­ma an­nounced the re­tire­ment of its CFO Bernard Lessard and post­ed the ap­point­ment of Sabi­no Di Pao­la as his re­place­ment, which be­came ef­fec­tive Wednes­day.

Bi­jan Ne­jad­nik is head­ing to San­Bio as CMO of the com­pa­ny, tasked with lead­ing reg­u­la­to­ry af­fairs for its re­gen­er­a­tive med­i­cines by lever­ag­ing his vast ex­pe­ri­ence ac­crued over a long ca­reer span­ning J&J, Jazz Phar­ma, Gale­na Bio­phar­ma and Eu­re­ka Ther­a­peu­tics. Damien Bates, who un­til Wednes­day served as CMO of the com­pa­ny, will con­tin­ue to be with the com­pa­ny and in­stead, hold the po­si­tion of se­nior ad­vi­sor.

Ac­cept­ing the po­si­tion of CMO, Ne­jad­nik com­ment­ed, “I have been in­volved in the de­vel­op­ment of many new phar­ma­ceu­ti­cal drugs with a view to meet­ing un­met med­ical needs that lack ef­fec­tive treat­ment. San­Bio is a pi­o­neer in drug de­vel­op­ment for pa­tients suf­fer­ing cen­tral ner­vous sys­tem dis­or­ders. I un­der­stand that the de­vel­op­ment of SB623 has al­ready come close to the stage of prod­uct launch in Japan; tak­ing ad­van­tage of my past ex­pe­ri­ences, I will do my best to bring SB623 to pa­tients world­wide as soon as pos­si­ble.”

Christo­pher Heery

Christo­pher Heery stepped up as the new CMO of Pre­ci­sion Bio­sciences. Pre­vi­ous­ly, Heery served as CMO at Bavar­i­an Nordic. Chief de­vel­op­ment of­fi­cer, David Thom­son, com­ment­ed, “Chris brings a high­ly unique and sought-af­ter skill set to Pre­ci­sion Bio­Sciences. He has been a trans­la­tion­al clin­i­cal tri­al­ist at one of the world’s pre­em­i­nent re­search in­sti­tu­tions, NCI, where his first-in-hu­man im­munother­a­py clin­i­cal tri­als in­clud­ed a Phase I study of an an­ti-PD-L1 treat­ment (avelum­ab) that is now ap­proved for use in the Unit­ed States. Chris’s most re­cent ex­pe­ri­ence as Chief Med­ical Of­fi­cer at Bavar­i­an Nordic has giv­en him a strong un­der­stand­ing of reg­u­la­to­ry re­quire­ments, clin­i­cal tri­al over­sight, and lead­er­ship that will al­low him to play a key role in help­ing Pre­ci­sion Bio­Sciences build a suc­cess­ful clin­i­cal or­ga­ni­za­tion.”

→ Hav­ing re­cent­ly wrapped up a Phase I study for its neu­ro­pro­tec­tion drug, Barcelona’s Bionure is step­ping up its clin­i­cal game with a new leader. As CMO, Lu­cia Sep­tien will help fi­nal­ize and ex­e­cute Phase II plans for BN201, a po­ten­tial treat­ment for acute op­tic neu­ri­tis and mul­ti­ple scle­ro­sis. Sep­tien jumps from DBV Tech­nolo­gies, where she held the same role fol­low­ing pre­vi­ous stints at Pfiz­er, GSK and Ipsen.

An­tho­ny Pe­traglia

Geron is con­tin­u­ing to build its de­vel­op­ment team by adding two new se­nior lead­er­ship ap­point­ments. Ying Wan was an­nounced as vice pres­i­dent, bio­met­rics, while Patrick Mur­phy was an­nounced as vice pres­i­dent, man­u­fac­tur­ing. Both po­si­tions will sup­port the com­pa­ny’s late-stage clin­i­cal de­vel­op­ment, which in­cludes the “planned open­ing of the Phase III clin­i­cal tri­al of ime­tel­stat in low­er risk myelodys­plas­tic syn­dromes for screen­ing and en­roll­ment by mid-year 2019.”

Geo­cann an­nounced the ap­point­ment of An­tho­ny Pe­traglia as CMO of the com­pa­ny as well as chair­man of the sci­en­tif­ic and med­ical ad­vi­so­ry board. Pe­traglia is a neu­ro­sur­geon at Rochester Re­gion­al Health and serves as the ex­ec­u­tive di­rec­tor of the hos­pi­tal’s con­cus­sion pro­gram. In his new role, Pe­traglia will work close­ly with the com­pa­ny’s glob­al part­ner tech­nol­o­gy ex­change, in­clud­ing Zurich, Switzer­land-based Vesi­fact AG, as well as the or­ga­ni­za­tion’s sci­en­tif­ic and med­ical ad­vi­so­ry board com­prised of physi­cians, nurs­es and prod­uct for­mu­la­tors.

Am­ber Tong con­tributed re­port­ing

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.