Abeona ap­points new chief as Tim­o­thy Miller moves to CSO; Max­ine Gowen pass­es Treve­na ba­ton to Car­rie Bour­dow; Scott Smith out in Cel­gene re­vamp

Carsten Thiel

→ In a sign of re­newed fo­cus, Abeona Ther­a­peu­tics $ABEO has scooped Alex­ion’s Carsten Thiel to be­come its new chief, free­ing up Tim­o­thy Miller to take on the CSO role while re­main­ing as pres­i­dent. The board likes Thiel’s com­mer­cial­iza­tion work on rare dis­eases at Alex­ion, as well as his op­er­a­tional track record at Am­gen, and hopes he will put it all to use. As for Miller, he will fo­cus on the ever-grow­ing line­up of pre­clin­i­cal and clin­i­cal cell and gene ther­a­py pro­grams for rare ge­net­ic dis­eases.

→ Cap­ping a tenure marked by both rapid growth and tough de­ci­sions, Max­ine Gowen plans to step down, by the end of the year, from the CEO seat at Treve­na $TRVN, the G pro­tein-cou­pled re­cep­tor com­pa­ny she co-found­ed. She is suc­ceed­ed by Car­rie Bour­dow, the old chief com­mer­cial of­fi­cer who got pro­mot­ed to SVP and COO just weeks ago. Pri­or to a stint at Cu­bist Phar­ma, Bour­dow had spent part of her 20 years at Mer­ck mar­ket­ing its pain drugs — an ex­pe­ri­ence that comes in handy at Treve­na, which spe­cial­izes in ther­a­pies for pain. Gowen will re­main in­volved as a board di­rec­tor.   

→ A sud­den man­age­ment re­vamp at Cel­gene $CELG sent pres­i­dent and COO Scott Smith out the door, leav­ing CEO and chair­man Mark Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy. Stag­gered by a se­ries of late-stage set­backs capped by the FDA’s re­fusal to ac­cept its ap­pli­ca­tion on their lead­ing late-stage drug and look­ing vul­ner­a­ble on its num­bers, the big biotech is in des­per­ate need to re­gain in­vestor con­fi­dence. Alles’ re­or­ga­ni­za­tion ap­pears to still be un­der way. Jef­feries’ Michael Yee not­ed Mon­day night: “The com­pa­ny is re­or­ga­niz­ing its ex­ec­u­tive team in the mean­time, and we could hear sev­er­al hires/pro­mo­tions over the com­ing months.”

Macrolide Phar­ma­ceu­ti­cals has some hefty goals about fight­ing dan­ger­ous su­per­bugs by tweak­ing an old class of an­tibi­otics. Long­time No­var­tis ex­ec Ma­hesh Karande is now help­ing them get there as the new CEO of the Wa­ter­town, MA-based biotech, which just raised $20 mil­lion in a Se­ries B round backed by three phar­ma gi­ants. Karande spent sev­er­al years hop­ping around the world, lead­ing No­var­tis’ in­ter­na­tion­al busi­ness units. He was a VP and on­col­o­gy busi­ness head in the US, pres­i­dent and phar­ma head for Africa and Egypt, and head of strat­e­gy and busi­ness de­vel­op­ment for Asia-Pa­cif­ic, Mid­dle East and Africa. But Karande left No­var­tis last year to join Intar­cia as VP and gen­er­al man­ag­er — a role he left to take the helm at Macrolide.

→ While Dan Chicoine tran­si­tions to ex­ec­u­tive chair­man­ship at Cresci­ta Ther­a­peu­tics, Serge Ver­reault has stepped up to the CEO role. Ver­reault joined the Mis­sis­sauga, ON-based der­ma­tol­ogy com­pa­ny as pres­i­dent from a 14-year run at Valeant ex­act­ly a year ago, where he last served as the ex­ec­u­tive di­rec­tor of busi­ness de­vel­op­ment over­see­ing, among oth­er things, a port­fo­lio of skin prod­ucts. He is now ex­pect­ed to lever­age his deal us­ing his ex­pe­ri­ence to grow the com­mer­cial busi­ness on both the non-pre­scrip­tion skin­care and pre­scrip­tion treat­ment sides.  

 Bay Area Stan­ford spin­out Sur­rozen, which re­cent­ly grabbed a $33M Se­ries A, just ap­point­ed a new CEO and sci­en­tif­ic co-founder. Craig Park­er, the for­mer SVP of cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals, is com­ing on board as the com­pa­ny’s new chief ex­ec­u­tive. He’s tak­ing the reins from Tim Kutzkey, a man­ag­ing part­ner at The Col­umn Group, who’s in­stead tak­ing up the role of chair­man of the board. The com­pa­ny, found­ed in 2016, is re­search­ing the Wnt path­way and the role it plays in re­gen­er­a­tive med­i­cine. In the same news re­lease, Sur­rozen al­so ap­point­ed a new sci­en­tif­ic co-founder in Hans Clevers, a pro­fes­sor of mol­e­c­u­lar ge­net­ics at the Hubrecht In­sti­tute. “The chal­lenge of pro­duc­ing Wnt has been a great source of frus­tra­tion in the field, im­ped­ing the ad­vance­ment of organoid tech­nol­o­gy and a deep­er dis­sec­tion of Wnt sig­nal­ing,” Clevers said in a state­ment. “Sur­rozen’s abil­i­ty to gen­er­ate po­tent and se­lec­tive Wnt path­way ag­o­nists with drug-like prop­er­ties is a re­al break­through.  I’m thrilled to join an es­teemed group of co-founders as Sur­rozen con­tin­ues its rapid pace of dis­cov­ery and fur­ther in­no­vates with its tech­nol­o­gy plat­forms.”

Jack­ie Fouse has as­sem­bled her ex­ec­u­tive team at Der­ma­vant while bag­ging her fifth drug for a beefed up pipeline of skin ther­a­pies. The biotech, part of Vivek Ra­maswamy’s net­work of com­pa­nies at Roivant, re­cruit­ed Glax­o­SmithK­line’s der­ma­tol­ogy R&D chief David Ru­bin­stein as chief sci­en­tif­ic of­fi­cer. Ru­bin­stein ear­li­er had worked at Duke. Richard Pe­ter­son, for­mer­ly at Medicis, has joined as CFO. Ariel Jasie, for­mer CBO at Co­di­ak Bio­Sciences, came on board in the same role, with Chris Van Tuyl join­ing as gen­er­al coun­sel. Fouse joined Ra­maswamy’s group last Ju­ly af­ter step­ping aside as pres­i­dent and COO at Cel­gene.

→ As Au­ro­ra Cannabis fin­ish­es up its buy­out of Can­nimed, it has tapped one of its own ex­ecs to tem­porar­i­ly re­place Brent Zettl, who’s re­signed as the CEO of Can­nimed. An­drċ Jérôme, SVP of busi­ness in­te­gra­tion at Au­ro­ra, was al­ready tasked with fus­ing the new unit in­to the big­ger med­ical cannabis busi­ness — a fit­ting role giv­en that he ar­rived at the role af­ter Au­ro­ra’s ac­qui­si­tion of his own com­pa­ny, H2 Bio­phar­ma.    

Lau­rie My­ers

Lau­rie My­ers is tak­ing a more di­rect role in Cin­gu­late Ther­a­peu­tics, the pre­ci­sion timed-re­lease drug de­liv­ery com­pa­ny she helped found. This fits a pat­tern at the Kansas City biotech: its CEO is al­so a co-founder, and in Jan­u­ary it named an­oth­er co-founder CMO, in charge of ex­e­cut­ing its clin­i­cal pro­gram in AD­HD. All as­pects of My­er’s ex­pe­ri­ence in Big Phar­ma (think No­var­tis and Sanofi) will come in­to play, as she has a broad man­date over clin­i­cal re­search, man­u­fac­tur­ing op­er­a­tions and even­tu­al­ly com­mer­cial func­tions.

→ When De­pomed $DE­PO re­lo­cates to new of­fices in Lake For­est, IL, its SVP and chief med­ical and sci­en­tif­ic of­fi­cer, San­tosh Vet­ti­ca­den, will not come with them. In­stead, they will be joined by Stan Bukofz­er, who’s been tapped to re­place Vet­ti­ca­den. Most re­cent­ly at Ocera Ther­a­peu­tics (now part of Mallinck­rodt), Bukofz­er man­aged its pipeline of ther­a­pies for acute and chron­ic liv­er dis­ease, but he’s al­so worked in a slate of oth­er ther­a­peu­tic ar­eas while at Ab­bott and Astel­las. The biotech, cur­rent­ly based in Newark, CA, has three drugs on the mar­ket in its neu­rol­o­gy and pain fran­chise. The re­lo­ca­tion will af­fect more than the C-suite: the biotech ex­pects to cut head­quar­ters staff by 40% and save $10 mil­lion in the process.

→ Months af­ter his as­cen­sion to chief op­er­at­ing of­fi­cer, Scott Braun­stein has qui­et­ly left Paci­ra Phar­ma­ceu­ti­cals $PCRX to “pur­sue oth­er op­por­tu­ni­ties.” Braun­stein had spear­head­ed a com­mer­cial col­lab­o­ra­tion with J&J for Ex­par­el — Paci­ra’s ap­proved non-opi­oid treat­ment for post-sur­gi­cal pain — be­fore adding med­ical af­fairs and cor­po­rate de­vel­op­ment to his place. David Stack, chair­man and CEO, will take over Braun­stein’s du­ties.

Lu­ca Rastel­li has land­ed his first CSO job in bio­phar­ma at Kleo Phar­ma­ceu­ti­cals, where he will play a role in se­lect­ing im­munother­a­py clin­i­cal can­di­dates for IND-en­abling work. In ad­di­tion to lead­ing R&D ac­tiv­i­ties, Rastel­li will be the “sci­en­tif­ic ex­ter­nal face” to Kleo’s in­vestors, sci­en­tif­ic peers and pa­tients. For­mer­ly of Mer­ck KGaA, Rastel­li has had plen­ty of ex­pe­ri­ence with im­muno-on­col­o­gy at new­ly pub­lic BioX­cel, where he led R&D for sev­er­al years.

Ma­gen­ta Ther­a­peu­tics has lost COO Bas­tiano San­na. A No­var­tis vet, San­na has been with the shin­ing Cam­bridge up­start since its ear­ly days, lead­ing the op­er­a­tions, fi­nance, com­mer­cial strat­e­gy and pro­gram man­age­ment func­tions en­abling the com­pa­ny’s work on stem cell trans­plan­ta­tions.

→ Cen­tral ner­vous dis­ease play­er Rel­ma­da Ther­a­peu­tics has hired ad­vi­sor Ot­tavio Vi­to­lo full-time with the long ti­tle of SVP, head of R&D and CMO. His pri­ma­ry fo­cus will be dex­tromethadone, or REL-1017, the N-methyl-D-as­par­tate re­cep­tor ag­o­nist that Rel­ma­da re­cent­ly got a bas­ket of glob­al rights for. The drug is be­ing test­ed for de­pres­sion, but he is tasked with ex­pand­ing the port­fo­lio to oth­er neu­ro­log­i­cal in­di­ca­tions. A prac­tic­ing psy­chi­a­trist with pre­vi­ous stints at Pfiz­er and Ho­mol­o­gy Med­i­cines, Vi­to­lo comes to the New York biotech from Mass­a­chu­setts Gen­er­al Hos­pi­tal.

→ In the midst of a re­struc­tur­ing, Ama­ran­tus has ap­point­ed in­vest­ment banker Bar­ney Monte as its in­ter­im COO/CFO and pro­mot­ed Brian Har­vey to chief reg­u­la­to­ry ad­vis­er. Monte will as­sist the cap­i­tal raise that Ama­ran­tus bad­ly needs. But the New York com­pa­ny wants to show it’s still se­ri­ous about the or­phan neu­ro­log­ic, re­gen­er­a­tive med­i­cine and oph­thalmic ther­a­pies that it’s de­vel­op­ing through its sub­sidiaries. Its ad­vi­sor Har­vey, a for­mer FDA staffer who held se­nior roles at both Pfiz­er and Sanofi, seems just the per­son to make the point.

→ Beltsville, MD-based NextCure has poached Kevin Heller from In­cyte to be its CMO, while wel­com­ing Steve Cobourn as the new CFO. Steeped in clin­i­cal on­col­o­gy for the past 20 years, Heller brings knowl­edge not on­ly from his re­cent stint at In­cyte (where he man­aged mon­o­clon­al an­ti­body de­vel­op­ment) but al­so a lengthy run at Bris­tol-My­ers Squibb. Mean­while Cobourn, jump­ing from Vac­cinex, will be re­spon­si­ble for grow­ing the op­er­a­tion built up­on an im­munother­a­py dis­cov­ery tech.  

→ Flush with cash from a $100 mil­lion mega-round, Tmu­ni­ty has brought on a man­u­fac­tur­ing ex­pert to hone its pa­tient-spe­cif­ic T cell im­munother­a­pies. Ja­son Krentz joins the Penn-al­lied start­up as chief tech­nol­o­gy of­fi­cer and head of tech­ni­cal op­er­a­tions, hav­ing tak­en sim­i­lar roles at En­do Phar­ma, Aux­il­i­um Phar­ma and Ten­gion. On top of man­ag­ing process de­vel­op­ment and the fa­cil­i­ties, he will work with part­ners — at Penn and be­yond — to im­prove the man­u­fac­tur­ing process with au­toma­tion and an­a­lyt­i­cal tech­nolo­gies. His hir­ing aligns with an in­sight CEO Us­man “Oz” Azam told End­points News ear­li­er: suc­cess in this field re­quires “em­brac­ing man­u­fac­tur­ing and tech­ni­cal com­pe­ten­cies ear­ly on. That’s been the biggest chal­lenge for the field. Not just aca­d­e­m­ic set­ting suc­cess, but mak­ing prod­ucts.”

Bruce Wen­del is the new chief busi­ness de­vel­op­ment of­fi­cer at Promet­ic, where he will be busy scout­ing part­ner­ships and li­cens­ing deals for both its small mol­e­cule and plas­ma-de­rived drug can­di­dates. Hav­ing sat on the board for 10 years, the Bris­tol-My­ers Squibb vet is quite fa­mil­iar with the Laval, Que­bec-based biotech, and its key fi­nanc­ing strate­gies. He now brings a mix of BD and ex­ec­u­tive skills to the team from his days as He­palink’s chief strat­e­gy of­fi­cer and Abrax­is’ last CEO (be­fore its ul­ti­mate ac­qui­si­tion by Cel­gene).

Jack­ie Pap­koff

→ Sig­ni­fy­ing its con­tin­ued in­ter­est in mi­cro­bio­me R&D, As­sem­bly Bio­sciences $ASMB has signed on Jack­ie Pap­koff to dri­ve the pipeline strat­e­gy and plat­form. With the for­mal ti­tle of SVP and CSO mi­cro­bio­me, Pap­koff in­her­its sev­er­al re­search pro­grams in in­flam­ma­to­ry bow­el dis­eases with Al­ler­gan and will have au­thor­i­ty to open up new ther­a­peu­tic ar­eas. While her back­ground was large­ly in on­col­o­gy, her time at J&J Cal­i­for­nia In­no­va­tion Cen­ter and then Evelo Bio­sciences led her down the path of can­cer mi­cro­bio­me.

→ Two bio­phar­ma vets have joined the lead­er­ship team at San Fran­cis­co-based Con­cen­tric Anal­gesics. Mike Roy­al has been hired as CMO af­ter train­ing in clin­i­cal roles at places like Sor­ren­to, while Genen­tech vet Su­san Kramer is lead­ing the dri­ve to mar­ket as ex­ec­u­tive VP, pro­gram man­age­ment and strat­e­gy. Jump­ing from neu­rode­gen­er­a­tive com­pa­ny An­nex­on, Kramer said she is drawn to Con­cen­tric’s work with cap­saicin in its port­fo­lio of pain treat­ments.

→ Since spin­ning out of Irv Weiss­man’s lab at Stan­ford, Forty Sev­en has not had to wor­ry much about mon­ey, and it has brought on a new CFO, Ann Rhoads, to make sure it stays that way as the com­pa­ny hus­tles its CD47-tar­get­ing an­ti­bod­ies through clin­i­cal de­vel­op­ment. With a back­ground in in­vest­ment bank­ing and con­sult­ing, Rhoads has han­dled pri­vate and pub­lic fi­nanc­ings as well as li­cens­ing pacts as the CFO of Zo­genix.

→ As MyoKar­dia $MYOK care­ful­ly preps a ground­break­ing tri­al for its ge­net­i­cal­ly tar­get­ed heart drug, it has tapped Tay­lor Har­ris to over­see the num­bers, in­fra­struc­ture and in­vestor re­la­tions as CFO. Join­ing Har­ris in the C-suite will be Jake Bauer, who’s been el­e­vat­ed to the role of chief busi­ness of­fi­cer from SVP, fi­nance and cor­po­rate de­vel­op­ment. A for­mer banker, Har­ris cut his teeth in biotech at Tho­r­atec — which makes med­ical de­vices for heart fail­ure pa­tients — and lat­er Zel­tiq Aes­thet­ics.

→ Sea­soned CFO Bri­an Pos­ner is jump­ing from re­gen­er­a­tive med mak­er Alli­qua Bio­Med­ical to can­cer fight­er Cel­lec­tar Bio­sciences $CLRB. The Madi­son, WI-based biotech has a pipeline of drugs de­vel­oped from its phos­pho­lipid ether drug con­ju­gate plat­form, with a cou­ple of pro­grams in Phase II.

Gá­bor Il­lés is up­ping his in­volve­ment with Tre­os Bio, where he’s been an in­vestor di­rec­tor since the com­pa­ny’s in­cep­tion, by join­ing the ex­ec­u­tive team. Lon­don-based Tre­os is at the cusp of its first hu­man tri­als, a crit­i­cal point that will see it turn its at­ten­tion to rais­ing more cap­i­tal and ne­go­ti­at­ing part­ner­ships for its pre­ci­sion can­cer vac­cine port­fo­lio. Il­lés was the found­ing part­ner of BXR Part­ners, an in­vest­ment ad­vi­so­ry group he co-found­ed with­in BXR Group, which pro­vid­ed some of the first fund­ing for Tre­os.

As­cendis Phar­ma, a Sanofi-part­nered rare dis­ease play­er with a spe­cial fo­cus on en­docrinol­o­gy, has wooed Thomas Lar­son from Mit­subishi Tan­abe Phar­ma Amer­i­ca to be­come its own chief com­mer­cial of­fi­cer. The read­out of As­cendis’ $AS­ND Phase III tri­al of TransCon growth hor­mone for pe­di­atric growth hor­mone de­fi­cien­cy isn’t due un­til ear­ly next year, but the Copen­hagen-based com­pa­ny is al­ready look­ing to pre­pare for com­mer­cial­iza­tion. Lar­son had hopped around launch projects at gi­ants like Boehringer In­gel­heim and J&J be­fore help­ing build the com­mer­cial struc­ture of Marathon Phar­ma.

Velox­is Phar­ma­ceu­ti­cals has ap­point­ed Morten Marott as its new CFO, task­ing the for­mer in­vest­ment banker with grow­ing the op­er­a­tion.

Di­aMed­ica Ther­a­peu­tics is wel­com­ing new CFO Scott Kellen as it waves good­bye to David Gur­ney, who has re­signed from the VP of fi­nance post. Com­ing from the same role at Sun Bio­Phar­ma, he will steer the fi­nan­cial strat­e­gy for the com­pa­ny as it ad­vances its neu­ro­log­i­cal and kid­ney dis­ease drugs.

→ Af­ter sev­en years at com­mu­ni­ca­tions firm Edel­man, Kim­ber­ly White is go­ing back in­side biotech as SVP and chief com­mu­ni­ca­tions of­fi­cer of Ver­tex $VRTX — the same role she had dur­ing her time at Bax­ter.

Mod­er­na has tapped Megan Pace to man­age ex­ter­nal re­la­tions of its ever-grow­ing busi­ness or­ga­ni­za­tion. In her new job as chief cor­po­rate af­fairs of­fi­cer, Pace will seek to trans­late the mes­sen­ger RNA work done at the biotech uni­corn to dif­fer­ent stake­hold­ers. It is a role that will like­ly blend all her skills from Agios, Ver­tex, Genen­tech and Eli Lil­ly, rang­ing from gov­ern­ment af­fairs, pa­tient ad­vo­ca­cy, in­vestor re­la­tions, pro­gram lead­er­ship to cor­po­rate plan­ning.

→ Cam­bridge up­start Re­lay Ther­a­peu­tics has just added sev­er­al mem­bers to its lead­er­ship team. Ex-Mer­sana CMO Don Bergstrom is join­ing as EVP, head of R&D, spear­head­ing Re­lay’s first ther­a­peu­tic pro­grams in on­col­o­gy. Pri­or to that, Bergstrom was part of the trans­la­tion­al ef­forts in the on­col­o­gy units at Mer­ck and Sanofi. Bri­an Adams of Keryx Bio­phar­ma and Tom Cati­naz­zo of Foun­da­tion Med­i­cine will be the new gen­er­al coun­sel and VP of fi­nance, re­spec­tive­ly.

→ With hu­man tri­als loom­ing in the gene edit­ing field, CRISPR Ther­a­peu­tics $CR­SP has brought on Steve Caf­fé to lead reg­u­la­to­ry af­fairs. Caf­fé brings to the Zug, Switzer­land biotech a packed re­sume fea­tur­ing sim­i­lar po­si­tions at Ra Phar­ma, Su­cam­po, Med­Im­mune and Bax­ter among oth­ers.

→ Fol­low­ing al­most a decade of glo­be­trot­ting for Pfiz­er, Fredrik Wet­ter­lundh is now head of hu­man re­sources at So­bi. In ad­di­tion to his in­ter­na­tion­al out­look, the Stock­holm-based rare dis­ease phar­ma es­pe­cial­ly liked Wet­ter­lundh’s ex­pe­ri­ence with com­pa­ny in­te­gra­tion fol­low­ing M&A.

Melvin Booth has de­cid­ed to re­tire from the board of Mallinck­rodt af­ter a five-year term as chair­man, pass­ing the ti­tle on­to Ex-Shire CEO An­gus Rus­sell. Booth, who is leav­ing along­side Di­ane Gulyas, joined the UK com­pa­ny when it first went pub­lic and has since over­seen a num­ber of ac­qui­si­tions — the most re­cent be­ing rare dis­ease drug de­vel­op­er Su­cam­po.

Re­zo­lute has a new vice chair­man on the board of di­rec­tors in Hoy­oung Huh, a se­r­i­al ad­vis­er and con­sul­tant to bio­phar­ma com­pa­nies.

→ Sev­er­al months af­ter leav­ing the helm of Hu­man Longevi­ty, Cyn­thia Collins is go­ing back in­to the world of cell ther­a­pies — tak­ing a board seat at Tri­umvi­ra Im­muno­log­ics, an Austin-based biotech tack­ling can­cer with a T Cell-anti­gen cou­pler tech.

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.

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 requires the divestiture of the blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay. That’s delaying the completion of the buyout, which the pharma giant says now may not be done before early 2020, rather than Q3 as promised. And the news quickly blew a hole in its stock price as investors reacted to the surprise switch up in plans.

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. But Bristol’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. And Bristol-Myers is sticking with its experimental drug, discounting Otezla’s future.

That’s not what the analysts were expecting.

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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.

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.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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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.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.