Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too of­ten, Alex Ar­faei ar­rived too late. 

An an­a­lyst at BMO Cap­i­tal Mar­kets, he’d meet with biotech or phar­ma­ceu­ti­cal heads for their IPO or sec­ondary fund­ing and his brain, trained on a bi­ol­o­gy de­gree and six years at Mer­ck and En­do, would spring with ques­tions: Why this bio­mark­er? Why this de­sign? Why not this end­point? Not that he could do any­thing about it. These ex­ecs were com­ing for clin­i­cal mon­ey; their de­ci­sions had been made and fi­nal­ized long ago.

“There were so many times where I would be puz­zled at the course of de­vel­op­ment,” Ar­faei told End­points News. “More re­cent­ly what a lot of com­pa­nies would do is seek out my guid­ance and pri­or­i­tize their projects ac­cord­ing­ly. 

“And that’s when I re­al­ized, maybe I should get in­volved at these com­pa­nies at an ear­li­er stage.”

Ar­faei will now join life sci­ences ven­ture firm Pap­pas Cap­i­tal as a part­ner, where he will work on iden­ti­fy­ing com­pa­nies and en­sur­ing those ques­tions have good an­swers from an ear­ly stage. He said his role will be to con­vert the sci­ence to num­bers and un­der­stand the risk-re­ward. 

Pap­pas’s re­cent suc­cess­es in­clude the mi­graine drug Colu­cid and the neu­ro start­up Af­fer­ent Phar­ma­ceu­ti­cals. Ar­faei said he al­ready sees one prospect for a treat­ment of a sys­temic dis­ease with­out good op­tions that has stymied the larg­er com­pa­nies. 

“I don’t want to call it a holy grail, but cer­tain­ly we do see in­vest­ment op­por­tu­ni­ties,” he said. 

Dis­cussing the in­creased rev­enue stress in the in­dus­try and pric­ing pres­sure from law­mak­ers and pres­i­den­tial can­di­dates — briefly on dis­play again at last night’s De­mo­c­ra­t­ic de­bate — Ar­faei in­di­cat­ed his role in the com­pa­ny will dove­tail with in­dus­try trends. He ar­gued those two fac­tors will push the in­dus­try to find drugs that have good “val­ue” for the in­dus­try and pa­tients. Which is the kind of dis­cern­ing stance he will be tak­ing as an in­vestor.

Those fac­tors, he said, would com­pound with the in­dus­try’s grow­ing un­der­stand­ing of the mol­e­c­u­lar caus­es of dis­ease to make treat­ment more ef­fi­cient. 

“With the greater em­pha­sis on the cost — hope­ful­ly with the greater em­pha­sis on cost — there should be greater fo­cus on drugs that meet un­met needs and specif­i­cal­ly low­er the over­all cost bur­den for so­ci­ety,” Ar­faei said. 

Of course, that leaves open ques­tions about drugs that meet un­met needs but don’t nec­es­sar­i­ly low­er the over­all cost bur­den and it may not quite square with rhetoric from the White House and the cam­paign stage fo­cused pri­mar­i­ly on the stick­er price. 

By Ja­son Mast


Klaus Hen­ning Jensen Sanofi

→ Swiss-based Vi­for Phar­ma — the com­pa­ny that paid $1.5 bil­lion back in 2016 for Re­lyp­sa — has wooed Sanofi ex­ec Klaus Hen­ning Jensen as CMO. Jensen was the glob­al ther­a­peu­tic area head at Sanofi be­fore his switch. Pri­or to that, he held sev­er­al roles at No­vo Nordisk. In ad­di­tion, the com­pa­ny an­nounced the de­par­ture of chief com­mer­cial of­fi­cer Dario Ek­lund, who will leave by the end of Sep­tem­ber for oth­er op­por­tu­ni­ties. The com­pa­ny has ini­ti­at­ed a search for a suc­ces­sor. 

 

A week af­ter Gen­fit CEO Jean-François Mouney hand­ed the reins to his suc­ces­sor Pas­cal Prignet, the com­pa­ny has an­nounced that Car­ol Ad­dy is set to join as CMO. Ad­dy most re­cent­ly served in the same role at Mer­ck sub­sidiary Health Man­age­ment Re­sources and as the as­so­ciate di­rec­tor, di­rec­tor and se­nior prin­ci­pal sci­en­tist at Mer­ck Re­search Lab­o­ra­to­ries

Brain­Storm — a de­vel­op­er of au­tol­o­gous adult stem cell ther­a­peu­tics for neu­rode­gen­er­a­tive dis­eases — has wel­comed Pree­tam Shah as CFO. Shah was the di­rec­tor of health­care in­vest­ment bank­ing at Bar­clays Cap­i­tal, where he was in­volved in clos­ing more than $3.5 bil­lion in M&A and eq­ui­ty trans­ac­tions. Pri­or to that, Shah served as vice pres­i­dent of health­care in­vest­ment and bank­ing at Canac­cord Ge­nu­ity and held a stint at Re­liance Cap­i­tal USA Ven­tures. Shah found­ed and served as the man­ag­ing di­rec­tor of health­care fi­nan­cial con­sult­ing firm Sais­ar­va

Ay­ala Phar­ma­ceu­ti­cals brings on Gary Gor­don as the com­pa­ny’s CMO, just as their lead prod­uct can­di­date, AL101 — a gam­ma sec­re­tase in­hibitor — goes through Phase II for ade­noid cys­tic car­ci­no­ma pa­tients with tu­mor-bear­ing Notch ac­ti­vat­ing mu­ta­tions. Gor­don joins from a stint at Ab­b­Vie as vice pres­i­dent of on­col­o­gy de­vel­op­ment. His oth­er roles in­clude serv­ing at Ab­bott Lab­o­ra­to­ries and as CSO and vice pres­i­dent of clin­i­cal af­fairs at Ova­tion Phar­ma­ceu­ti­cals.

Bio­gen vet Jane Rhodes has joined Verge Ge­nomics — a com­pa­ny fo­cused on the de­vel­op­ment of new drugs for CNS dis­eases — as CBO af­ter a stint as vice pres­i­dent of busi­ness de­vel­op­ment and cor­po­rate strat­e­gy at FOR­MA Ther­a­peu­tics. While at Bio­gen, Rhodes found­ed the Val­ue Based Med­i­cine (VBM) In­no­va­tion Hub. Rhodes al­so co-found­ed soft­ware de­vel­op­ment com­pa­ny Qr8 Health

Xen­cor — best known for its bis­pe­cif­ic an­ti­bod­ies — has ap­point­ed Celia Eck­ert as vice pres­i­dent, gen­er­al coun­sel and cor­po­rate sec­re­tary of the com­pa­ny. Eck­ert joins the com­pa­ny from Syn­thet­ic Ge­nomics, where she served as vice pres­i­dent, cor­po­rate le­gal. Pri­or to that, she held stints at Se­quenom, Prometheus Lab­o­ra­to­ries and Pills­bury Winthrop Shaw Pittman and Jones Day

Ur­vashi Pa­tel Wind­MIL Ther­a­peu­tics

Wind­MIL Ther­a­peu­tics has reeled in Ur­vashi Pa­tel as vice pres­i­dent of reg­u­la­to­ry and qual­i­ty sys­tems, bol­ster­ing their ef­fort to ad­vance mar­row-in­fil­trat­ing lym­pho­cytes for can­cer im­munother­a­py. Most re­cent­ly, Pa­tel served as se­nior di­rec­tor, reg­u­la­to­ry af­fairs at Pre­ci­sion for Med­i­cine and held roles at Janssen and Elan Phar­ma­ceu­ti­cals

David Ep­stein-led can­cer start­up Black Di­a­mond Ther­a­peu­tics has made the ad­di­tion of Thomas (Tom­my) Leggett as CFO. Leggett joins the com­pa­ny af­ter hold­ing the same po­si­tion at Ax­cel­la Health, where he helped in rais­ing $156 mil­lion across three fi­nanc­ings. Pri­or to his time at Ax­cel­la, Leggett was trea­sur­er and head of busi­ness de­vel­op­ment fi­nance at Pur­due Phar­ma. Leggett’s oth­er stints in­clude serv­ing as an in­vest­ment banker for JP Mor­gan Se­cu­ri­ties, Lazard Frères & Com­pa­ny and UBS Se­cu­ri­ties

Thomas Leggett Black Di­a­mond

Onc­ter­nal Ther­a­peu­tics has wel­comed Gun­nar Kauf­mann as CSO and Ig­or Bilin­sky as CBO. Kauff­man comes on board af­ter a stint as SVP, im­munother­a­py, head of re­search and glob­al part­ner­ships at Sor­ren­to Ther­a­peu­tics. He was pre­vi­ous­ly a fac­ul­ty mem­ber at Scripps Re­search and still serves as ad­junct as­sis­tant pro­fes­sor in the de­part­ments of chem­istry and im­munol­o­gy and mi­cro­bial sci­ence. Bilin­sky was COO of Am­pliPhi Bio­sciences Cor­po­ra­tion be­fore tak­ing on this new role. His ca­reer has al­so spanned Igny­ta, Vi­cal, Halozyme Ther­a­peu­tics and An­dro­clus.

→ Swedish com­pa­ny Be­ac­ti­ca Ther­a­peu­tics made sev­er­al new ad­di­tions to its team. Vendela Par­row, the new head of pre­clin­i­cal de­vel­op­ment, brings ex­pe­ri­ence from pre­vi­ous po­si­tions at Akin­ion Phar­ma­ceu­ti­cals, Ax­e­lar and Phar­ma­cia Biovit­rum. Join­ing the board of di­rec­tors are Maarten de Chateau, cur­rent CEO of Six­era Phar­ma and Buz­zard Phar­ma­ceu­ti­cals, and Håkan Wick­holm, present­ly a board mem­ber of Gen­o­vis. Fi­nal­ly, Jo­han Har­men­berg, CMO of On­copep­tides, has been brought on as a clin­i­cal ad­vi­sor. 

MaaT Phar­ma — fo­cused on mi­cro­bio­me-based drug prod­ucts — an­nounced two new ap­point­ments: Jean-Marc Re­nard as CBO and Em­manuel Pre­stat as com­pu­ta­tion­al bi­ol­o­gy man­ag­er. Re­nard was pre­vi­ous­ly the vice pres­i­dent of cor­po­rate de­vel­op­ment at Sanofi Pas­teur, where he was re­spon­si­ble for the $750 mil­lion ac­qui­si­tion of Pro­tein Sci­ences. Pre­stat was the as­so­ciate di­rec­tor of re­search and de­vel­op­ment at HalioDx and held a stint with­in the in vit­ro di­ag­nos­tics de­part­ment at QI­A­GEN.

Joel Smith has joined as the gen­er­al coun­sel and EVP of cor­po­rate de­vel­op­ment of Epic Sci­ences — a com­pa­ny part­nered with Ge­nom­ic Health to com­mer­cial­ize the On­co­type DX AR-V7 nu­cle­us de­tect test. Smith comes from Qual­comm Life, where he served as man­ag­ing coun­sel of the com­pa­ny. He has al­so held stints as gen­er­al coun­sel at BioQ, Tri­ad Ther­a­peu­tics and Sien­tra

Pe­ter-Paul Tak-led gut-fo­cused com­pa­ny Kin­tai Ther­a­peu­tics has ush­ered in Mark Nut­tall as CBO. Nut­tall hails from Kymera Ther­a­peu­tics, where he served in the same role. His pre­vi­ous stints in­clude roles at Sanofi Gen­zyme, John­son & John­son, GSK and As­traZeneca

→ Copen­hagen, Den­mark-based Xel­lia Phar­ma­ceu­ti­cals has ap­point­ed Pe­ter Bak­er as CMO, Xel­lia North Amer­i­ca. Bak­er brings ex­pe­ri­ence from his time at Ab­bott Lab­o­ra­to­ries, Hos­pi­ra and Pfiz­er. His ap­point­ment comes at a time when the com­pa­ny is prepar­ing to ex­pand its pro­pri­etary liq­uid fran­chise, which in­cludes the first and on­ly room tem­per­a­ture Van­comycin in­jec­tion pre­mix. 

→ At the end of Au­gust, Soli­genix an­nounced that it had up­dat­ed the late-stage pro­gram for its ex­per­i­men­tal drug, SGX942, by in­creas­ing en­roll­ment by 70 pa­tients to 260 sub­jects. Now, Jonathan Guar­i­no has hopped on board to Soli­genix as their se­nior vice pres­i­dent and CFO — suc­ceed­ing Karen Krume­ich, who will be pur­su­ing new op­por­tu­ni­ties. Guar­i­no most re­cent­ly served as cor­po­rate con­troller for He­p­i­on Phar­ma­ceu­ti­cals and held stints at Co­v­ance, Black­Rock and Barnes & No­ble

Pe­ter Butera PR

CuraSen Ther­a­peu­tics — a com­pa­ny kick­start­ed by Kath­leen Sere­da Glaub and An­tho­ny Ford out of the lab of Stan­ford’s Mehrdad Sham­loo, fo­cused on the treat­ment of neu­rode­gen­er­a­tive dis­eases, such as Parkin­son’s and Alzheimer’s — has re­cruit­ed Pe­ter Butera to the team as SVP, op­er­a­tions. Be­fore CuraSen, Butera ran the bradan­i­cline pro­gram in chron­ic cough through Phase II at At­ten­ua as their vice pres­i­dent of clin­i­cal op­er­a­tions. Butera al­so held the same role at Af­fer­ent (be­fore its $1.25 bil­lion ac­qui­si­tion by Mer­ck) and Pain Ther­a­peu­tics.  

→ Hav­ing plot­ted com­mer­cial plans at In­ter­cept Phar­ma for the past five years, Kei­th White is bring­ing his mar­ket ac­cess acu­men to Cor­bus. As it en­ters the fi­nal reg­u­la­to­ry stretch with its lead drug, lenaba­sum, Cor­bus is prepar­ing for an in­ti­tal launch in sys­temic scle­ro­sis, close­ly fol­lowed by a pro­gram in der­mato­myosi­tis.

CRO PHAS­TAR has named Jen­nifer Brad­ford as the lead to the com­pa­ny’s da­ta sci­ence group — which is fo­cused on ap­ply­ing AI and ma­chine learn­ing to max­i­mize the val­ue of clin­i­cal tri­al da­ta. Brad­ford’s pre­vi­ous stints in­clude roles at As­traZeneca and Can­cer Re­search UK.

Mar­tin Mack­ay, Stephen Uden and Jef­frey Fry­er have scooped up a for­mer col­league at Alex­ion to beef up the R&D team at Rally­bio, their rare dis­ease start­up. Dou­glas Sheri­dan was a co-in­ven­tor of five clin­i­cal drug can­di­dates, in­clud­ing Alex­ion’s lat­est block­buster hope­ful Ul­tomiris (ap­proved by the FDA in 2018). His lat­est ti­tle at Alex­ion was ex­ec­u­tive di­rec­tor, glob­al pro­gram team leader.

→ For nine months, Tony Coles has been watch­ing close­ly as Adam Kop­pel and Bain’s life sci­ences team built Cerev­el from the ground up, of­fer­ing in­sights in­to its neu­ro­science pur­suit as ex­ec­u­tive chair­man while stay­ing at the helm of his own biotech. But now that he has passed the reins at Yu­man­i­ty to Richard Pe­ters, Coles is com­plet­ing the flip — and the top team puz­zle — by tak­ing the chief ex­ec­u­tive role at Cerev­el.

Tony Coles Yu­man­i­ty

“I’m ex­cit­ed be­cause I get dou­ble the op­por­tu­ni­ty to play a role in two im­por­tant com­pa­nies,” Coles not­ed in an in­ter­view with End­points News.

Coles — a four-time CEO who had a no­table tenure at Onyx Phar­ma, a biotech that was ul­ti­mate­ly sold to Am­gen — has got­ten to know Bain well. 

Most re­cent­ly Or­ly Mis­han, a Bio­gen vet, moved from Bain to be­come chief busi­ness of­fi­cer, join­ing CSO John Renger (who cut his teeth at Mer­ck), CMO Ray Sanchez (Ot­su­ka vet), CFO Kathy Yi (from Sang­amo) and Ken Dipetro, chief hu­man re­sources of­fi­cer.

Coles is still in­volved in Yu­man­i­ty as ex­ec­u­tive chair­man and an in­vestor — an­oth­er part of his grand ef­fort to make a dent in what he calls the next fron­tier in med­i­cine.

Stu­art Levy, co-founder of Paratek Phar­ma­ceu­ti­cals, passed away last week.

“Stu­art was a dis­tin­guished physi­cian who was the fore­front of an­tibi­ot­ic de­vel­op­ment and a ded­i­cat­ed cham­pi­on for the pru­dent use of an­tibi­otics,” said Evan Loh, Paratek CEO. “More im­por­tant­ly, he was a dear friend and men­tor to so many and his pas­sion lives on in each of us as we work to con­tin­ue his mis­sion of com­bat­ing the dai­ly threat of life-threat­en­ing in­fec­tions. We will great­ly miss him.”

Levy co-found­ed Paratek more than 20 years ago along with Wal­ter Gilbert. He was in­stru­men­tal in the de­vel­op­ment of the com­pa­ny’s lead an­tibi­otics, Nuzyra and Seysara. Levy dis­cov­ered the ef­flux mech­a­nism for drug (tetra­cy­cline) re­sis­tance and was among the first sci­en­tists to doc­u­ment the trans­fer of re­sis­tant bac­te­ria from an­i­mals to farm­work­ers. His 1992 book, The An­tibi­ot­ic Para­dox: How Mir­a­cle Drugs Are De­stroy­ing the Mir­a­cle, has been cit­ed wide­ly and trans­lat­ed in­to four lan­guages.

The news comes a few weeks af­ter the com­pa­ny pub­lished pos­i­tive Phase III da­ta for Nuzyra for pa­tients with AB­SS­SI.

John Furey

Im­vax has wooed John Furey, for­mer COO of Spark Ther­a­peu­tics, to the helm as CEO and to its board of di­rec­tors. Furey suc­ceeds in­ter­im CEO David An­drews, the com­pa­ny’s co-founder and CMO. Dur­ing his time at Spark, Furey led the US launch of pi­o­neer­ing gene ther­a­py Lux­tur­na. Pri­or to Spark, Furey served as SCP and head of glob­al op­er­a­tions at Bax­al­ta. He al­so held a stint at Pfiz­er, where he ini­ti­at­ed the re­struc­tur­ing and di­vesti­ture of Bax­ter In­ter­na­tion­al’s vac­cines fran­chise to Pfiz­er.

In his new role, Furey will steer Philadel­phia-based Im­vax through a Phase II for its au­tol­o­gous tu­mor cell vac­cine for glioblas­toma mul­ti­forme, a no­to­ri­ous­ly hard-to-treat can­cer.

Lisa M. DeAn­ge­lis MSKCC

It’s of­fi­cial. Memo­r­i­al Sloan Ket­ter­ing has picked a brain can­cer ex­pert as its new physi­cian-in-chief and CMO, re­plac­ing José Basel­ga, who left un­der a cloud af­ter be­ing sin­gled out by The New York Times and ProP­ub­li­ca for fail­ing to prop­er­ly air his lu­cra­tive in­dus­try ties. His re­place­ment, who now will be in charge of MSK’s cut­ting-edge re­search work as well as the can­cer care de­liv­ered by hun­dreds of prac­ti­tion­ers, is Lisa M. DeAn­ge­lis. DeAn­ge­lis had been chair of the neu­rol­o­gy de­part­ment and co-founder of MSK’s brain tu­mor cen­ter and was moved in­to the act­ing CMO role in the wake of Basel­ga’s de­par­ture.

→ Af­ter wel­com­ing J&J deal­mak­er Mar­i­anne De Backer to their team as BD chief a lit­tle more than a week ago, Bay­er an­nounced that it will be re­duc­ing the size of the com­pa­ny’s board of man­age­ment. Hart­mut Klusik and Ke­mal Ma­lik will be hit­ting the ex­it and the com­pa­ny doesn’t plan on re­tain­ing those po­si­tions — tak­ing the board from sev­en to five mem­bers.

Ac­cord­ing to the com­pa­ny, as of Jan­u­ary 1, 2020, the board of man­age­ment will con­sist of chair­man Wern­er Bau­mann, CFO Wolf­gang Nickl and di­vi­sion pres­i­dents Liam Con­don (Crop Sci­ence), Ste­fan Oel­rich (Phar­ma­ceu­ti­cals) and Heiko Schip­per (Con­sumer Health).

→ Months af­ter UK-based Mo­gri­fy re­lo­cat­ed to the Bio-In­no­va­tion Cen­tre at the Cam­bridge Sci­ence Park and added 15 new staff mem­bers to its sci­en­tif­ic and man­age­ment teams, the com­pa­ny has wooed a high-pro­file leader to chair their board. Jane Os­bourn, a bio­phar­ma vet, was vice pres­i­dent for re­search and de­vel­op­ment and site leader at Med­Im­mune (for­mer­ly Cam­bridge An­ti­body Tech­nol­o­gy). She is a rec­og­nized ex­pert in an­ti­body en­gi­neer­ing cred­it­ed for the dis­cov­ery and de­vel­op­ment of eight mar­ket­ed drugs, such as Hu­mi­ra and Benlysta.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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UP­DAT­ED: Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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