Up­dat­ed: Al­ny­lam pro­motes long­time ex­ec Kevin FitzGer­ald to CSO; In­tel­lia Ther­a­peu­tics brings on Lau­ra Sepp-Loren­zi­no

Kevin FitzGer­ald Linkedin

Kevin FitzGer­ald has been with Al­ny­lam since 2005, and with his ex­pe­ri­ence of “lead­ing suc­cess­ful teams on de­liv­ery tech­nolo­gies, tar­get se­lec­tion, and pro­grams in clin­ic,” he’s been pro­mot­ed to CSO of the com­pa­ny.

“Our tech­nol­o­gy is at such an ex­cit­ing stage and there are so many ap­pli­ca­tions for pa­tients in need, pri­or­i­tiz­ing what we do first (and at times, what we do not do) will be a very im­por­tant chal­lenge,” said FitzGer­ald via email.

Al­ny­lam has come a long way from its in­cep­tion in 2002. Last Au­gust the com­pa­ny re­ceived the first and on­ly ever FDA ap­proval for the treat­ment of the polyneu­ropa­thy of hered­i­tary transthyretin-me­di­at­ed (hAT­TR) amy­loi­do­sis in adults with its RNAi ther­a­peu­tic, On­pat­tro (patisir­an) — a lipid com­plex in­jec­tion.  

“Dur­ing my time at Al­ny­lam, we have gone from RNAi is a cool and ex­cit­ing pos­si­bil­i­ty, to clin­i­cal proof of con­cept that the tech­nol­o­gy works ro­bust­ly in man, to a com­mer­cial com­pa­ny with an ap­proved RNAi ther­a­peu­tic prod­uct with sev­er­al oth­ers in Phase III tri­als,” said FitzGer­ald.

FitzGer­ald joined Al­ny­lam af­ter a stint at Bris­tol-My­ers Squibb. When asked why he de­cid­ed to hop on board with the com­pa­ny, FitzGer­ald said “It may sound made up, but from the very be­gin­ning I was look­ing for a tech­nol­o­gy that could change med­i­cine. One of my men­tors told me, ‘If you are go­ing to spend a lot of time, maybe years of your life… ded­i­cat­ed to work­ing on a prob­lem, make sure at the oth­er end of it, some­thing big is the re­sult.’ I saw RNAi as an evo­lu­tion­ary con­served mech­a­nism, that if we could har­ness it, had the po­ten­tial to change how we treat hu­man dis­ease. I be­lieved way back then, but af­ter all these years… and now an ap­proved prod­uct, I am more ex­cit­ed than ever and be­lieve we are at the cusp of re­al­iz­ing what RNAi ther­a­peu­tics could do for hu­man dis­ease.”

Kel­ley Bouch­er Linkedin

In ad­di­tion to FitzGer­ald’s pro­mo­tion, Al­ny­lam has ap­point­ed Kel­ley Bouch­er as the com­pa­ny’s se­nior vice pres­i­dent, chief hu­man re­sources of­fi­cer. Bouch­er has a back­ground of over 15 years of hu­man re­sources and tal­ent ac­qui­si­tion/man­age­ment ex­pe­ri­ence in the biotech sec­tor. Be­fore Al­ny­lam, Bouch­er had a stint at Abio­med. And be­fore that, she spent 10 years at Shire.

“This tran­si­tion, along with the ad­vance­ment of the Com­pa­ny’s ro­bust and di­verse pipeline, will be en­abled by con­tin­ued in­vest­ment in glob­al growth, scal­a­bil­i­ty, and peo­ple de­vel­op­ment,” Bouch­er said. “I hope to help fos­ter this growth by en­sur­ing that we are an em­ploy­er of choice and that we con­tin­ue to cul­ti­vate an in­clu­sive and di­verse cul­ture con­ducive to for­ward think­ing and in­no­va­tion.”

→ CRISPR/Cas9 tech­nol­o­gy pi­o­neer In­tel­lia Ther­a­peu­tics wel­comed Lau­ra Sepp-Loren­zi­no as its new ex­ec­u­tive vice pres­i­dent and CSO. Sepp-Loren­zi­no joins the com­pa­ny af­ter a stint at Ver­tex Phar­ma­ceu­ti­cals as vice pres­i­dent, head of nu­cle­ic acid ther­a­pies, re­search lead­er­ship and a mem­ber of the ex­ter­nal in­no­va­tion team. Pri­or to Ver­tex, Sepp-Loren­zi­no de­vel­oped and im­ple­ment­ed the he­pat­ic in­fec­tious dis­ease strat­e­gy at Al­ny­lam and helped the com­pa­ny strength­en its RNA pipeline. Be­fore that, she spent 14 years at Mer­ck ad­vanc­ing RNAi as a nov­el ther­a­peu­tic modal­i­ty.

Ed­ward Con­ner Linkedin

Au­dentes, which is hop­ing to ri­val Sarep­ta Ther­a­peu­tics with its gene ther­a­py for DMD, has un­veiled new mem­bers of its se­nior ex­ec­u­tive team. The San Fran­cis­co-based com­pa­ny has hired for­mer Sang­amo ex­ec­u­tive Ed­ward Con­ner as CMO, and pro­mot­ed Ful­vio Mav­ilio to se­nior VP of trans­la­tion­al sci­ence. Mean­while, Au­dentes’ CMO Suyash Prasad and chief tech­nol­o­gy of­fi­cer John Gray are leav­ing the com­pa­ny.

Brent Hatzis-Schoch Black Di­a­mond

David Ep­stein-led can­cer up­start Black Di­a­mond Ther­a­peu­tics has an­nounced the ap­point­ment of Brent Hatzis-Schoch as COO and gen­er­al coun­sel of the com­pa­ny. Hatzis-Schoch has over 20 years of ex­pe­ri­ence in le­gal af­fairs at com­mer­cial and de­vel­op­ment-stage phar­ma­ceu­ti­cal and biotech­nol­o­gy com­pa­nies. He joins Black Di­a­mond af­ter stints at Ra­dius Health and Merz Phar­ma in Frank­furt, Ger­many. 

In ad­di­tion, Black Di­a­mond has made new ap­point­ments to its se­nior lead­er­ship team in prepar­ing to en­ter its lead pro­gram in­to the clin­ic next year. These ap­point­ments in­clude: Karsten Witt — who was in­volved in the clin­i­cal de­vel­op­ment of NSCLC drug Tarce­va — as se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment, Nigel Wa­ters as vice pres­i­dent of pre­clin­i­cal de­vel­op­ment, As­traZeneca vet Carl Cook, vice pres­i­dent of clin­i­cal op­er­a­tions — cred­it­ed for lead­ing piv­otal stud­ies for Ires­sa — and Mer­sana vet San­na Be­lorusets as vice pres­i­dent of fi­nance.

The com­pa­ny was launched last De­cem­ber and ear­li­er this year, the com­pa­ny had raised $85 mil­lion in a Se­ries B round, bring­ing the funds raised by the first com­pa­ny out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel to $105 mil­lion. 

Jo­han­na Merci­er Linkedin

Gilead chief Daniel O’Day has been mak­ing quite a few changes to his ex­ec­u­tive team and now he’s ax­ing his EVP of world­wide com­mer­cial ops chief Lau­ra Hamill — who ar­rived less than a year ago from Am­gen and will be re­ceiv­ing $1.75 mil­lion in sev­er­ance up­on her for­mal de­par­ture from the com­pa­ny Ju­ly 1 — and bring­ing Jo­han­na Merci­er on board. The 10-year Bris­tol-My­ers vet has been cap­tain on large mar­kets in the US, Eu­rope and Japan. Merci­er will tack­le Gilead’s HIV mar­ket — which has faced heavy crit­i­cism for the price of its drugs — and its cell ther­a­py pipeline.

“She is a tal­ent­ed leader with a deep un­der­stand­ing of the phar­ma­ceu­ti­cal in­dus­try, across ther­a­peu­tic mar­kets and ge­o­gra­phies,” not­ed O’Day, “as well as a proven abil­i­ty to in­put the com­mer­cial per­spec­tive in­to de­vel­op­ment strate­gies.”

Pas­cal Tou­chon Co­gen

Atara Bio­ther­a­peu­tics CEO Isaac Ciechanover made a sur­prise de­ci­sion to leave the com­pa­ny in Jan­u­ary and it’s been an­nounced Tues­day that No­var­tis vet Pas­cal Tou­chon will of­fi­cial­ly join the com­pa­ny June 24. At No­var­tis, Tou­chon worked with­in on­col­o­gy as glob­al head, cell & gene and as a mem­ber of the on­col­o­gy ex­ec­u­tive com­mit­tee, where he was in charge of the glob­al roll­out of Kym­ri­ah. Pre­vi­ous­ly, Tou­chon has worked at Servi­er, Sanofi and Glaxo.

Isaac Ciechanover Atara

Ciechanover has joined the board of SQZ Biotech­nolo­gies, a cell ther­a­py biotech prep­ping a clin­i­cal en­try. “SQZ’s in­no­v­a­tive cell ther­a­py plat­form and the ther­a­peu­tics the com­pa­ny is cre­at­ing have great promise for pa­tients and can im­pact mul­ti­ple dis­eases,” he said. “Cou­pled with their ad­vances in ef­fi­cient cell ther­a­py man­u­fac­tur­ing, this is a tru­ly unique op­por­tu­ni­ty, and I am en­thu­si­as­tic about be­ing a part of the team at this piv­otal stage.”

Di­et­mar Berg­er Atara

Af­ter hop­ping out of Atara Bio­ther­a­peu­tics, Di­et­mar Berg­er has joined Sanofi. Berg­er will be the head of de­vel­op­ment and will over­see the com­pa­ny’s clin­i­cal port­fo­lio across all ther­a­py ar­eas and help the com­pa­ny bring trans­for­ma­tive new med­i­cines to pa­tients. Pri­or to join­ing Atara, Berg­er was the head of de­vel­op­ment for Genen­tech’s hema­tol­ogy and on­col­o­gy unit and is cred­it­ed with play­ing a lead role for top pro­grams like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. And be­fore Genen­tech, he was at Bay­er and Am­gen for over 16 years.

Jef­frey Sprouse Linkedin

Sanofi CSO John Reed is shift­ing away from ma­jor league part­ners like Re­gen­eron and Al­ny­lam to fo­cus on the com­pa­ny’s own on­col­o­gy pipeline.

Howard Federoff Linkedin

Ju­ve­nes­cence’s new ven­ture, Sou­vien Ther­a­peu­tics — which is cre­at­ing in­no­v­a­tive med­i­cines to ad­dress neu­rode­gen­er­a­tive dis­eases by tar­get­ing the epi­ge­net­ic un­der­pin­nings of neu­rode­gen­er­a­tion — an­nounced two new ap­point­ments. Jef­frey Sprouse — who led pre­clin­i­cal pro­grams at both Pfiz­er and Lund­beck — will join the com­pa­ny as its CEO and Howard Federoff — pro­fes­sor of neu­rol­o­gy at the Uni­ver­si­ty of Cal­i­for­nia, Irvine, Col­lege of Med­i­cine and for­mer CEO of UCI Health Sys­tem — as its chair.

Matthew Har­baugh Mallinck­rodt

→ While Mallinck­rodt Phar­ma­ceu­ti­cals re­cent­ly up­dat­ed plans for its spin-off com­pa­ny, it al­so put a full man­age­ment team in place. Matthew Har­baugh, cur­rent pres­i­dent of Mallinck­rodt’s spe­cial­ty gener­ics busi­ness and for­mer CFO of the com­pa­ny is pro­ject­ed to be­come pres­i­dent and CEO of the new com­pa­ny up­on com­ple­tion of the sep­a­ra­tion. Er­ic Slusser — who has for­mer­ly served as CFO for com­pa­nies such as Ex­press Scripts, Gen­ti­va Health Ser­vices and Cen­tene Cor­po­ra­tion —  is pro­ject­ed to serve as CFO. In ad­di­tion, the an­tic­i­pat­ed board of di­rec­tors of the new spe­cial­i­ty gener­ics com­pa­ny will con­sist of nom­i­nat­ed in­de­pen­dent chair­man James Su­lat — who has served as CEO of both Maxy­gen and Mem­o­ry Phar­ma­ceu­ti­cals — and nom­i­nat­ed chair of the au­dit com­mit­tee of the new board of di­rec­tors Michael Atieh — who was the for­mer ex­ec­u­tive vice pres­i­dent and CFO of Oph­thotech Cor­po­ra­tion.

June Al­menoff Linkedin

Red­Hill Bio­Phar­ma — a bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on gas­troin­testi­nal dis­eases — has ap­point­ed June Al­menoff as its first CSO. Al­menoff has served in var­i­ous roles, in­clud­ing stints at Fu­riex and GSK. At Fu­riex — ac­quired by Ac­tavis, now Al­ler­gan — Al­menoff worked as pres­i­dent and CMO of the com­pa­ny where the lead prod­uct, Viberzi, was ap­proved by the FDA in 2015 for the treat­ment of ir­ri­ta­ble bow­el syn­drome with di­ar­rhea (IBS-D).

John Renger Cerev­el

Cerev­el ther­a­peu­tics ex­pands their ex­ec­u­tive team with three new ap­point­ments, which in­clude John Renger as CSO, Kathy Yi as CFO and Ken DiP­i­etro as chief hu­man re­sources of­fi­cer.

Kathy Yi Cerev­el

“Cerev­el Ther­a­peu­tics was pur­pose-built to fo­cus on the unique needs of peo­ple im­pact­ed by dev­as­tat­ing ner­vous sys­tem dis­eases—a mod­el that is at­tract­ing busi­ness lead­ers with di­verse back­grounds from across the in­dus­try,” said Tony Coles, ex­ec­u­tive chair­man of Cerev­el Ther­a­peu­tics. “John, Kathy, and Ken each have a proven track record in their re­spec­tive ar­eas of ex­per­tise and will be in­stru­men­tal in ac­cel­er­at­ing our pur­suit of lead­ing-edge so­lu­tions that can mean­ing­ful­ly im­pact pa­tients’ lives.”

Ken DiP­i­etro Cerev­el

MiMedx — a com­pa­ny spe­cial­ized in wound care — has adopt­ed a com­pre­hen­sive plan — de­vel­oped by the com­pa­ny’s largest share­hold­ers, Pre­science Point Cap­i­tal Man­age­ment — to re­fresh the com­po­si­tion of its board of di­rec­tors. This comes af­ter the com­ple­tion of the com­pa­ny’s au­dit com­mit­tee’s in­de­pen­dent in­ves­ti­ga­tion in­to al­leged wrong­do­ing by the pri­or se­nior man­age­ment team and en­gage­ment of BDO USA as the com­pa­ny’s new in­de­pen­dent reg­is­tered pub­lic ac­count­ing firm.

“It is time to be­gin the Board tran­si­tion and re­fresh­ment process. […] With the Au­dit Com­mit­tee’s in­ves­ti­ga­tion com­plete and a plan to re­fresh the Board in place, the Com­pa­ny is now in a po­si­tion to fo­cus on its fu­ture and en­hance its busi­ness, for the ben­e­fit of all stake­hold­ers,” said Charles Evans, chair­man of the board.

M. Kath­leen Behrens Wilsey Linkedin

The com­pa­ny says that un­der the plan, “six new di­rec­tors, in­clud­ing MiMedx’s new CEO, Tim­o­thy Wright, would be added to the board. The re­fresh­ment plan in­cludes the ap­point­ment of three of Pre­science Point’s nom­i­nees, in­clud­ing M. Kath­leen Behrens Wilsey, as the new chair­woman of the board, as well as K. Todd New­ton, who is ex­pect­ed to be­come the chair­man of the au­dit com­mit­tee af­ter the com­pa­ny’s 2019 an­nu­al meet­ing of share­hold­ers. Oth­er ap­point­ments/nom­i­na­tions for elec­tion to the board in­clude Richard Bar­ry and James Bier­man.

 


An ear­li­er ver­sion of the sto­ry did not in­clude ap­point­ments at Black Di­a­mond Ther­a­peu­tics

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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 weeks 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.