One year in, Joanne Kotz as­sumes CEO role at Jnana; Pres­i­dent/Ex­ec­u­tive chair duo will now run Black­Thorn

Joanne Kotz

Jnana Ther­a­peu­tics is mark­ing its an­niver­sary with the in­stal­la­tion of a per­ma­nent chief, and it’s go­ing for some­one who’s been there since the be­gin­ning: co-founder and pres­i­dent Joanne Kotz. Amir Nashat, the in­ter­im CEO who will now fo­cus on his oth­er job as man­ag­ing part­ner of Po­laris, cred­its Kotz for build­ing “a tal­ent­ed team and a col­lab­o­ra­tive, em­pow­er­ing cul­ture, while al­so lead­ing im­por­tant work to val­i­date Jnana’s pro­pri­etary drug dis­cov­ery plat­form.” Be­fore launch­ing the SLC trans­porter-fo­cused biotech, Kotz had held lead­er­ship roles at the F-Prime Bio­med­ical Re­search Ini­tia­tive and the Broad In­sti­tute.

Greg Vontz has stepped down as pres­i­dent and CEO of Black­Thorn Ther­a­peu­tics, prompt­ing the pro­mo­tion of CSO Bill Mar­tin to the pres­i­dent and COO role. Mar­tin will now run the com­pa­ny along­side new ex­ec­u­tive chair­man Paul Berns, a vet­er­an biotech ex­ec­u­tive of ARCH, match­ing his fa­mil­iar­i­ty with Black­Thorn’s neu­robe­hav­ioral ther­a­pies with Berns’ prod­uct de­vel­op­ment, strate­gic and com­mer­cial ex­per­tise.

→ Sea­soned di­ag­nos­tics and phar­ma ex­ec Bern­hard Sixt is the new CEO at Ed­in­burgh Mol­e­c­u­lar Imag­ing, tasked with steer­ing its op­ti­cal imag­ing prod­uct on a path to ap­proval and even­tu­al com­mer­cial­iza­tion. EMI-137 has com­pared fa­vor­ably to colonoscopy in a can­cer de­tec­tion tri­al, the com­pa­ny says, and is be­ing test­ed in sev­er­al oth­er can­cer in­di­ca­tions.

Michael Lin­den

Michael Lin­den has cho­sen Touch­light Ge­net­ics as the next stop of his gene ther­a­py jour­ney. As CSO, he is re­spon­si­ble for ap­ply­ing Touch­light’s dog­gy­bone DNA tech on its dis­cov­ery pipeline and trans­la­tion­al re­search ef­forts. A for­mer aca­d­e­m­ic ac­tive­ly ad­vo­cat­ing for gene ther­a­py re­search, Lin­den re­cent­ly served as Pfiz­er’s VP of gene ther­a­py and head of its Ge­net­ics Med­i­cines In­sti­tute.

→ Af­ter months of search­ing for a per­ma­nent CFO, Five Prime Ther­a­peu­tics has de­cid­ed to lock in David Smith, a for­mer Genen­tech staffer and re­cent COO of foren­sics DNA com­pa­ny In­te­genx be­fore Ther­mo Fish­er snapped it up. The South San Fran­cis­co-based im­muno-on­col­o­gy biotech likes his breadth of ex­pe­ri­ence, hav­ing worked at a mix of com­pa­nies span­ning dif­fer­ent scales and stages. Lin­da Ru­bin­stein, who’s been fill­ing in from a CFO ser­vices firm, is sign­ing off.

→ As Steve Frucht­man piv­ots to the pres­i­dent’s job at On­cono­va $ON­TX, he’s tapped Richard Wood­man to suc­ceed him as CMO. Wood­man, a for­mer head of No­var­tis’ hema­tol­ogy fran­chise, in­her­its a late-stage pipeline fo­cused on myelodys­plas­tic syn­dromes. Two oth­er new hires will help him hus­tle the lead drug, rigosert­ib, to­ward an ap­proval: clin­i­cal op­er­a­tions di­rec­tor Matthew Par­ris, who joins from In­ovio; and Cel­gene vet David Evans, who will be as­so­ciate di­rec­tor, reg­u­la­to­ry af­fairs.

→ As Im­pel Neu­roPhar­ma gears up for a cou­ple of mid-stage read­outs of its cen­tral ner­vous sys­tem dis­or­der treat­ments, it has ap­point­ed Ellen Lub­man to scout deals for the drugs and its nasal drug de­liv­ery tech. As chief busi­ness of­fi­cer, Lub­man’s man­date will cov­er “part­ner­ing and ac­qui­si­tion strat­e­gy and ex­e­cu­tion,” not un­like what she did when she was VP of ex­ter­nal sci­ence and in­no­va­tion at Al­ler­gan.

→ With sev­er­al of its pro­grams lined up at the Phase II start­ing line, Alka­h­est has poached vet­er­an sales ex­ec Eliz­a­beth Jef­fords from Roche/Genen­tech to be its chief sales and strat­e­gy of­fi­cer. Jef­fords, who played a big role in mar­ket­ing the big age-re­lat­ed mac­u­lar de­gen­er­a­tion ther­a­py Lu­cen­tis, will now piv­ot to oth­er age-re­lat­ed dis­eases in­clud­ing Alzheimer’s and Parkin­son’s.

→ Cal­gary, Al­ber­ta-based Xortx Ther­a­peu­tics has ap­point­ed James Fair­barin to re­place out­go­ing CFO Dave Matthews. The com­pa­ny is de­vel­op­ing three treat­ments for dif­fer­ent types of pro­gres­sive kid­ney dis­ease.

Farah Ah­mad has jumped from Sy­neos Health to a COO po­si­tion at Strate­gikon Phar­ma, which mar­kets a tool for clin­i­cal tri­al plan­ning and ven­dor man­age­ment.

→ Fol­low­ing a mam­moth $200 mil­lion de­but on the Nas­daq, gene ther­a­py de­vel­op­er Or­chard Ther­a­peu­tics has re­cruit­ed two bio­phar­ma vets to man­age its com­mer­cial op­er­a­tions in the US and the mas­sive bloc re­gion Eu­rope, Mid­dle East and Africa (EMEA), re­spec­tive­ly. Both of them bring sig­nif­i­cant ex­pe­ri­ence with rare dis­eases, Or­chard’s spe­cial­ty. Robin Kense­laar, who spent the past 15 years at Sanofi Gen­zyme, comes on board as SVP of gen­er­al man­ag­er, EMEA com­mer­cial ops. His US coun­ter­part, Brad Math­is, re­cent­ly had a stint at Su­cam­po af­ter 10 years at Alex­ion.   

My­ovant, a mem­ber of Vivek Ra­maswamy’s biotech fam­i­ly fo­cused on women’s health and en­docrine dis­eases, has wooed GSK ex­ec Kim Sablick to be its chief com­mer­cial of­fi­cer. The R&D team is al­so gain­ing a new mem­ber in Jeff Norn­hold, who’s switch­ing a tech­ni­cal op­er­a­tions po­si­tion at Im­pax for a new role as SVP of phar­ma­ceu­ti­cal op­er­a­tions and de­vel­op­ment. Myr­tle Pot­ter and Frank Tor­ti — in­dus­try vets who have re­cent­ly tak­en se­nior roles at Roivant — are join­ing the board along­side Mark Guinan, with Pot­ter ap­point­ed chair­man.   

No­vavax $NVAX has ap­point­ed Rachel King, a sea­soned VC and founder of Gly­coMimet­ics, to its board of di­rec­tors.  

Grail CEO Jen­nifer Cook has tak­en a board seat at De­nali, the high-fly­ing neu­rode­gen­er­a­tion start­up run by some of her for­mer col­leagues from Genen­tech.

→ Hav­ing guid­ed Epizyme through a rough year at the FDA, CEO Robert Baze­more is tak­ing on a side gig as board di­rec­tor at neoanti­gen pi­o­neer Neon 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.

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.