Three se­nior Chimerix ex­ecs to hold the fort to re­place de­part­ing CEO Berrey

Michelle Berrey — the woman who re­placed Chimerix CEO Ken­neth Moch in 2014 af­ter the com­pa­ny no­to­ri­ous­ly de­nied a dy­ing child com­pas­sion­ate use of its ex­per­i­men­tal treat­ment — has stepped down for undis­closed rea­sons, the Durham, North Car­oli­na-based drug de­vel­op­er said on Wednes­day.

Berrey, who served as the com­pa­ny’s chief med­ical of­fi­cer pri­or to be­com­ing CEO, came to Chimerix from Phar­mas­set where she was al­so CMO un­til the com­pa­ny was swal­lowed by Gilead in 2012, en­abling the lat­ter to gen­er­ate bil­lions in hep C drug sales. She steered the ship at Chimerix as the com­pa­ny sought to spin set­back af­ter set­back in the late-stage de­vel­op­men­tal pro­gram of its oral an­tivi­ral drug, brin­cid­o­fovir, for the pre­ven­tion of cy­tomegalovirus (CMV) dis­ease in kid­ney trans­plant pa­tients.

Gar­rett Nichols

Even­tu­al­ly, the com­pa­ny ter­mi­nat­ed de­vel­op­ing the drug in that in­di­ca­tion and shift­ed fo­cus to test­ing the drug for small­pox, among oth­er pa­tient pop­u­la­tions. Da­ta from two piv­otal small­pox stud­ies in rab­bits and mice are ex­pect­ed this year, and if pos­i­tive will form the ba­sis of a mar­ket­ing ap­pli­ca­tion. Mean­while, an IV ver­sion of brin­cid­o­fovir is al­so in de­vel­op­ment.

Over the last three years, the com­pa­ny has kept a rel­a­tive­ly low-pro­file. On Wednes­day, Chimerix said a new­ly cre­at­ed of­fice of the CEO — en­cap­su­lat­ing three se­nior ex­ec­u­tives Gar­rett Nichols, Tim­o­thy Trost and Michael Al­rutz — will man the fort while a re­place­ment for Berrey is found.

Michael Al­rutz

The three will al­so con­tin­ue to serve in their orig­i­nal posts: Nichols as CMO; Trost as CFO, se­nior VP and cor­po­rate sec­re­tary; and Al­rutz as se­nior VP, gen­er­al coun­sel.

Chimerix de­clined to com­ment on Berrey’s de­par­ture.

The com­pa­ny went pub­lic in 2013 un­der Moch — who quick­ly found a way to tem­per the firestorm of pub­lic crit­i­cism that emerged in re­sponse to the re­jec­tion of the com­pas­sion­ate use re­quest in 2014 — by en­rolling the child Josh Hardy in a small open-la­bel tri­al set up in agree­ment with the FDA.

Moch, who is cur­rent­ly CEO of Cog­ni­tion Ther­a­peu­tics in an emailed state­ment told End­points News: “Ac­tu­al­ly, I no­to­ri­ous­ly got Josh Hardy the drug in 120 hours af­ter our med­ical de­part­ment (led by Michelle Berry) turned down the re­quest from the Hardy fam­i­ly.”

Im­age: Michelle Berrey. CHIMERIX

BREAK­ING: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan

Brent Saun­ders has found his way out of the cur­rent fix he’s in at Al­ler­gan. He’s sell­ing the com­pa­ny to Ab­b­Vie for a re­port­ed $63 bil­lion in the lat­est ex­am­ple of the hot M&A mar­ket in bio­phar­ma.

Ab­b­Vie has agreed to pay $188.24 a share for the trou­bled Al­ler­gan, re­flect­ing a 45% pre­mi­um as in­vestors bid up shares in an­tic­i­pa­tion of a much buzzed about com­pa­ny split. That price re­flects a sharp fall from the $330 peak for Al­ler­gan and Saun­ders 4 years ago — but much bet­ter than any­thing share­hold­ers had in mind for the near fu­ture.

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 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.