Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Uzair Qadeer

Alex­ion has carved out a new po­si­tion for chief di­ver­si­ty of­fi­cer and filled it with an in­side pro­mo­tion.

Uzair Qadeer will now be re­spon­si­ble for their “di­ver­si­ty, in­clu­sion and be­long­ing” strat­e­gy, look­ing to re­shape the biotech’s cor­po­rate cul­ture. A vet­er­an of De­loitte and Bris­tol My­ers Squibb, Qadeer was work­ing on ex­ec­u­tive coach­ing and help­ing cre­ate the di­ver­si­ty pro­gram he now leads.

“At Alex­ion, we be­lieve that di­ver­si­ty is hav­ing a seat at the ta­ble, in­clu­sion is hav­ing a voice, and be­long­ing is hav­ing that voice be heard. Our work isn’t done un­til our em­ploy­ees and pa­tients can feel a true sense of be­long­ing,” Qadeer said. “Mag­ne­tiz­ing and in­cu­bat­ing di­verse tal­ent will al­low us to har­ness di­verse in­sights that fu­el in­no­va­tion and cre­ate val­ue for the pa­tients we serve. I am com­mit­ted to ac­ti­vat­ing this pur­pose­ful vi­sion.”

Yvonne Green­street

→ Af­ter a 17-year stint at Al­ny­lam, pres­i­dent Bar­ry Greene is leav­ing the RNAi biotech and hand­ing the reins over to COO Yvonne Green­street. Green­street, who was SVP of med­i­cines de­vel­op­ment at Pfiz­er and an SVP at Glax­o­SmithK­line be­fore join­ing Al­ny­lam in 2016, takes up the pres­i­dent post at a com­pa­ny fac­ing an im­por­tant and dif­fi­cult tran­si­tion. CEO John Maraganore has set am­bi­tious goals for the com­pa­ny, aim­ing to move them in­to a top 5 biotech in the next cou­ple years, along­side the likes of Am­gen and Re­gen­eron.

“Yvonne has got an in­cred­i­ble strate­gic mind; she’s in­cred­i­bly ef­fec­tive op­er­a­tional­ly,” Maraganore told End­point News’ Ja­son Mast. “With­out a doubt I think our fu­ture is in great hands.”

Mean­while, a search is on­go­ing at Al­ny­lam for a new chief com­mer­cial of­fi­cer.

→ Get­ting in the Covid-19 sweep­stakes with lenzilum­ab be­ing used in a com­bo with remde­sivir for NI­AID’s Big Ef­fect Tri­al, Cameron Dur­rantled Hu­mani­gen has al­so been re­vamp­ing its staff, this time with Tim­o­thy Mor­ris tak­ing over as COO and CFO. Con­cur­rent with the move, Mor­ris will step down from Burlingame, CA-based Hu­mani­gen’s board of di­rec­tors, of which he had been a mem­ber since 2016. Mor­ris leaves his CFO role at Io­vance and has held that role at a string of oth­er com­pa­nies, in­clud­ing Acel­Rx, Vivus and Quest­cor Phar­ma­ceu­ti­cals.

Else­where at Hu­mani­gen, Bob Atwill steps in to a new­ly-cre­at­ed role as head of the Asia-Pa­cif­ic re­gion. Cur­rent­ly a prin­ci­pal at cross-bor­der M&A provider Eaton Square with the same re­gion­al fo­cus, Atwill has been an ex­ec at such Aus­tralian com­pa­nies as Fit­genes and Ben­itec Bio­phar­ma.

Shree­r­am Arad­hye

→ Rid­ing high with its Phase I da­ta re­leased yes­ter­day from their Roche-part­nered RNAi pro­gram for hep B, Dicer­na has found a CMO to take the place of the re­tir­ing Ralf Rosskamp. No­var­tis vet Shree­r­am Arad­hye will be­come EVP and CMO on Sept. 8, while Rosskamp will hold a con­sult­ing role at least through June 2021. Arad­hye makes his way to Dicer­na af­ter be­ing chief de­vel­op­ment of­fi­cer at Ax­cel­la, and for 20 years he held nu­mer­ous ti­tles at No­var­tis and its glob­al af­fil­i­ates, no­tably as glob­al head of med­ical af­fairs and CMO, phar­ma­ceu­ti­cals.

→ No stranger to the C-suite, Paul High­am has tak­en the reins as CEO of Va­lo Ther­a­peu­tics, an im­munother­a­py play­er with of­fices in Ox­ford and Helsin­ki de­vel­op­ing can­cer treat­ments us­ing tu­mor anti­gen-coat­ed on­colyt­ic virus­es. High­am has al­so held the top spot at two Ger­man biotechs, Gly­co­tope and Im­mat­ics Biotech­nolo­gies. He got his start at Bay­er as GM, Swe­den and Den­mark, and then pro­ceed­ed to GSK as their VP, com­mer­cial de­vel­op­ment.

→ Buoyed by its $22 mil­lion Se­ries C round led by Boehringer In­gel­heim Ven­ture Fund, an­ti­body-drug con­ju­gate biotech NBE-Ther­a­peu­tics has a new CEO with Bertrand Damour now at the helm. His pre­de­ces­sor, founder Ulf Grawun­der, will slot him­self in­to the role of chief op­er­at­ing of­fi­cer and chief de­vel­op­ment of­fi­cer. His last CEO gig was at Syn­thena AG, where he was al­so chair­man, and he’s al­so been the top man at Gene­Prot, Mind­NRG and On­coEthix.

Mag­gie Chen

Mag­gie Chen is on board as CFO of Suzhou, Chi­na-based CD­MO CMAB Bio­phar­ma, fo­cused on pre­clin­i­cal and PhI/II clin­i­cal prod­ucts. Be­fore mak­ing the leap to CMAB, Chen had been VP and CFO at Fo­s­un, and pri­or to that, she was al­so CFO at Por­ton Phar­ma So­lu­tions.

→ Deep­en­ing its part­ner­ship with Pfiz­er a month ago with a $15 mil­lion round, Cam­bridge biotech Mis­sion Ther­a­peu­tics has made changes in its lead­er­ship with the pro­mo­tions of Paul Thomp­son to CSO and Nick Ed­munds to chief tech­no­log­i­cal of­fi­cer. An 11-year GSK vet, Thomp­son makes the jump af­ter 2 years as Mis­sion’s VP, clin­i­cal de­vel­op­ment. Ed­munds came from As­traZeneca in 2016, where he had been head of new modal­i­ties, drug safe­ty and me­tab­o­lism, and moves on up from his pre­vi­ous role at Mis­sion as VP, head of DUB (deu­biq­ui­ty­lat­ing en­zymes) dis­cov­ery.

Fang Ni

→ With the dis­tinc­tion of land­ing the first IPO in 2020 — set­ting the ta­ble for the crazi­ness to come in the midst of the pan­dem­ic — on­col­o­gy play­er Black Di­a­mond Ther­a­peu­tics has brought back found­ing CBO Fang Ni to fill the same ca­pac­i­ty.  He had been a prin­ci­pal at Ver­sant Ven­tures and a mem­ber of the in­vest­ment team, serv­ing as in­ter­im CBO at Monte Rosa Ther­a­peu­tics and Bright Peak Ther­a­peu­tics dur­ing that pe­ri­od. He’s al­so a Roche vet who was more re­cent­ly the di­rec­tor, glob­al on­col­o­gy busi­ness de­vel­op­ment & li­cens­ing with­in the Big Phar­ma’s part­ner­ing or­ga­ni­za­tion.

Ken­neth Kobayashi

→ When last we left Aslan Phar­ma­ceu­ti­cals, they were fac­ing the same up­hill bat­tle of tri­al de­lays that have been so per­va­sive dur­ing the pan­dem­ic, paus­ing re­cruit­ment for their study of ASLAN004 in mod­er­ate to se­vere atopic der­mati­tis. Sin­ga­pore-based Aslan has named Ken­neth Kobayashi CMO to con­tin­ue de­vel­op­ment of that lead pro­gram. Kobayashi heads to Aslan from Eli Lil­ly sub­sidiary Der­mi­ra, where he was their se­nior med­ical di­rec­tor. Pri­or to that, he was No­var­tis’ clin­i­cal de­vel­op­ment med­ical di­rec­tor in the im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy glob­al de­vel­op­ment unit.

WuXi Vac­cines — a joint ven­ture formed be­tween WuXi Bi­o­log­ics and Shang­hai-based Hile Bio-Tech­nol­o­gy — has snagged Jian Dong to helm the com­pa­ny as CEO. Dong hopped aboard WuXi Bi­o­log­ics in 2014 and pre­vi­ous­ly served in roles at Eli Lil­ly, Shang­hai Unit­ed Cell Biotech­nol­o­gy and Shen­zhen Kang­tai Bi­o­log­i­cal Prod­ucts.

Frank Zhang

→ Two months af­ter Yuan Xu steered Leg­end Biotech to a $424 mil­lion pub­lic de­but on the Nas­daq, founder and chair­man Frank Zhang is grab­bing the reins as CEO. In con­junc­tion with the move, Zhang is al­so step­ping down from the helm of Gen­Script — a po­si­tion he’s held for 18 years. Ac­cord­ing to a press re­lease, Xu stepped down for “per­son­al rea­sons.”

Cure­Vac, one of the key play­ers in the race to de­vel­op a new mR­NA vac­cine to fight Covid-19 has reshuf­fled the top spots in the ex­ec­u­tive suite. And they’ve brought on Ig­or Splaws­ki, a No­var­tis vet out of Har­vard to spear­head their work on mR­NA as CSO. Splaws­ki played a big role at the No­var­tis In­sti­tutes for Bi­o­log­i­cal Re­search un­der Jay Brad­ner, where he was an ex­ec­u­tive di­rec­tor and site head. Like Brad­ner, Splaws­ki was al­so a pro­fes­sor at Har­vard, where he worked on hu­man ge­net­ic and mol­e­c­u­lar bi­ol­o­gy stud­ies. He wrapped a 3-year stint at Har­vard in 2008.

Alan Smith

→ Ear gene ther­a­py com­pa­ny Ak­ou­os has tapped Alan Smith as chief tech­nol­o­gy of­fi­cer. In ad­di­tion, the com­pa­ny an­nounced that Saira Ra­masas­try — who’s al­so a board mem­ber of Vir and Sang­amo — has been ap­point­ed to its board of di­rec­tors as au­dit com­mit­tee chair, and board mem­ber Arthur Tzian­a­bos, the cur­rent CEO and pres­i­dent of Ho­mol­o­gy Med­i­cines, has been ap­point­ed chair­man of the board. Smith pre­vi­ous­ly served as EVP, tech­ni­cal op­er­a­tions at Bel­licum Phar­ma­ceu­ti­cals and has held ex­ec roles at Cog­nate Bioser­vices and Osiris Ther­a­peu­tics.

→ With a par­tic­u­lar fo­cus on di­a­bet­ic mac­u­lar ede­ma, Bel­gian bio­phar­ma Ox­u­ri­on NV has turned to Grace Chang to be their CMO. Cur­rent­ly an ad­junct clin­i­cal as­so­ciate pro­fes­sor in the oph­thal­mol­o­gy de­part­ment at USC’s Keck School of Med­i­cine, Chang used to be CMO at No­tal Vi­sion. She al­so led glob­al clin­i­cal de­vel­op­ment at for­mer No­var­tis sub­sidiary Al­con Lab­o­ra­to­ries.

Robert Zeldin

→ Part­ner­ing with J&J on their gene ther­a­py for x-linked re­tini­tis pig­men­tosa — and re­leas­ing promis­ing Phase I/II da­ta last month — MeiraGTx has snagged Robert Zeldin as CMO. Zeldin, a Mer­ck and No­var­tis vet, has pre­vi­ous­ly been CMO at sev­er­al biotechs in the last 5 years: Im­muno­vant, Ac­celeron and Abl­ynx.

→ GSK and Dai­ichi Sankyo vet Juan Car­los Jaramil­lo is mov­ing on to French vac­cine com­pa­ny Val­ne­va to take the CMO job, ef­fec­tive Oc­to­ber 1. His pre­de­ces­sor, Wolf­gang Ben­der, is re­tir­ing at the end of Oc­to­ber. Jaramil­lo had been with Dai­ichi Sankyo for 7 years, most re­cent­ly as SVP, head of glob­al mar­ket ac­cess & pric­ing. While at GSK, he was the act­ing head of clin­i­cal de­vel­op­ment and med­ical af­fairs vac­cines, Eu­rope.

Se­lec­ta Bio­sciences, which struck a li­cens­ing agree­ment in June to open up its im­mune tol­er­ance plat­form Imm­TOR to Sarep­ta, has re­cruit­ed Pe­ter Tra­ber as CMO. Tra­ber has helmed Galectin Ther­a­peu­tics as pres­i­dent and CEO, and has al­so spent time as their CMO in the crowd­ed but be­lea­guered NASH field. He was for­mer­ly CMO and SVP, clin­i­cal de­vel­op­ment & med­ical af­fairs with GSK and the pres­i­dent and CEO of the Bay­lor Col­lege of Med­i­cine.

Su­san­na High

Su­san­na High has been named chief op­er­at­ing of­fi­cer at Waltham, MA mus­cle dis­ease biotech Dyne Ther­a­peu­tics. She hails from blue­bird bio, where she filled the same role and guid­ed the ap­proval of Zyn­te­glo for trans­fu­sion-de­pen­dent be­ta tha­lassemia. High al­so held a num­ber of po­si­tions at Al­ny­lam, in­clud­ing SVP, strat­e­gy & busi­ness in­te­gra­tion, be­fore she left for blue­bird.

Backed by Mer­ck and Am­gen, Durham, NC-based RNA mod­u­la­tion biotech Ri­bometrix has tapped Bar­clay “Buck” Phillips as COO and CFO. Phillips is stay­ing in the Re­search Tri­an­gle area af­ter a stint at G1 Ther­a­peu­tics as their CFO, SVP of cor­po­rate de­vel­op­ment. He’s al­so led fi­nan­cial op­er­a­tions at No­vavax as SVP, CFO and trea­sur­er from 2013-17.

Enoch Kar­iu­ki

→ Fo­cused on re­cep­tor ty­ro­sine ki­nase-like or­phan re­cep­tor 1 (ROR) and chalk­ing up a $137 mil­lion Se­ries B round in Ju­ly, San Diego-based Velos­Bio has en­list­ed Enoch Kar­iu­ki to be their CFO. Kar­iu­ki skips over from an­oth­er San Diego biotech, Syn­thorx, where he was their SVP, cor­po­rate de­vel­op­ment. Pri­or to Syn­thorx, he was VP at H.I.G. Bio­Health Part­ners, the ded­i­cat­ed health­care in­vest­ment af­fil­i­ate of H.I.G. Cap­i­tal.

→ Stay­ing in San Diego, Kei­th Mar­shall has been ap­point­ed CFO of IBD-fo­cused Prometheus Bio­sciences. Mar­shall hails from Cona­tus Phar­ma­ceu­ti­cals, where he had been EVP, COO and CFO the last 3 years. Be­fore that, he was CFO and head of cor­po­rate de­vel­op­ment at Flag­ship Pi­o­neer­ing com­pa­ny Torque Ther­a­peu­tics (which merged with Co­gen Im­mune Med­i­cine to be­come Reper­toire Im­mune Med­i­cines).

→ More changes at San Diego biotechs abound as De­nis Dry­gin has signed on as CSO of mi­croR­NA play­er Reg­u­lus Ther­a­peu­tics, which forked over its lead drug to Sanofi in No­vem­ber 2018 af­ter sig­nif­i­cant down­siz­ing. Dry­gin co-found­ed and was VP of R&D at Pimera the last 7 years, and be­fore that, he spent 8 years at Cy­lene Phar­ma­ceu­ti­cals in nu­mer­ous posts, leav­ing in 2013 as VP, bi­ol­o­gy.

Nush­mia Khokhar

Nush­mia Khokhar has been pro­mot­ed to SVP, clin­i­cal de­vel­op­ment at Lon­don-based T cell pro­gram­ming bio­phar­ma Au­to­lus. Vi­jay Red­dy has al­so an­nounced he’s leav­ing Au­to­lus as CMO and re­turn­ing to the US. Khokhar was pre­vi­ous­ly the glob­al clin­i­cal leader for the dara­tu­mum­ab (Darza­lex) pro­gram at Janssen be­fore join­ing Au­to­lus as VP of clin­i­cal de­vel­op­ment in 2017. Al­so, Ac­celeron R&D chief Jay Back­strom has been elect­ed to Au­to­lus’ board of di­rec­tors.

→ Genome edit­ing vet TJ Cradick has been hand­ed the keys to the CSO car at CRISPR biotech Ex­ci­sion Bio­Ther­a­peu­tics. Cradick was head of genome edit­ing for more than 4 years at CRISPR Ther­a­peu­tics, and ear­ly in his ca­reer, he was a sci­en­tist in the zinc fin­ger nu­cle­ase de­sign & se­lec­tion group at Sang­amo.

Evo­lu­tion Re­search Group, a New Jer­sey-based net­work of clin­i­cal re­search sites, has cho­sen William Mar­tin to be CSO af­ter a near­ly 9-year run at Alk­er­mes in roles of in­creas­ing re­spon­si­bil­i­ty, capped by his year-long tenure as se­nior med­ical di­rec­tor, clin­i­cal de­vel­op­ment & med­ical af­fairs. He al­so spent time at Pfiz­er as as­so­ciate di­rec­tor, clin­i­cal re­search and pre­ci­sion med­i­cine.

James Craven

→ There are a few per­son­nel changes at CN Bio, a bio­engi­neer­ing com­pa­ny out of the UK fo­cused on sin­gle and mul­ti-or­gan mi­cro­phys­i­o­log­i­cal sys­tems (MPS). James Craven, CN Bio’s new chief com­mer­cial of­fi­cer, comes from Brooks Life Sci­ences, where he head­ed their mar­ket strat­e­gy and com­mer­cial de­liv­ery. Pfiz­er and Gen­Script vet Bri­an Man­ning is now the US head of sales af­ter be­ing se­nior di­rec­tor of busi­ness de­vel­op­ment at In­Sphero. Ad­di­tion­al­ly, Sarah Payne has been brought on as prod­uct mar­ket­ing man­ag­er.

→ With teplizum­ab gath­er­ing re­newed mo­men­tum thanks to sol­id June da­ta as a BLA awaits, Ash­leigh Palmer’s Proven­tion Bio has giv­en the new­ly-cre­at­ed role of chief le­gal of­fi­cer to Hei­dy Abreu King-Jones. She leaves Ax­cel­la, where she was SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. From 2013-18, King-Jones al­so filled sev­er­al po­si­tions in the le­gal de­part­ment at Sarep­ta.

Lance Ku­ra­ta

→ Speak­ing of le­gal ap­point­ments, Lance Ku­ra­ta has joined San Diego mR­NA play­er Arc­turus as chief le­gal of­fi­cer. Ku­ra­ta had pre­vi­ous­ly been a part­ner in the cor­po­rate group and mem­ber of the life sci­ences prac­tice group at Mintz.

→ AAV gene ther­a­py com­pa­ny AskBio has named Michael Kran­da as SVP, ther­a­peu­tic prac­tice leader. Pri­or to his new role, Kran­da served as se­nior di­rec­tor of busi­ness de­vel­op­ment at the Allen In­sti­tute. In ad­di­tion, Kran­da has held di­rec­tor roles at Im­munex (now Am­gen) and PTC Ther­a­peu­tics among oth­ers.

Jim Green­wood has be­come a se­nior ad­vi­sor at DLA Piper and will chair their Life Sci­ences, Health, Pol­i­cy and Reg­u­la­to­ry sub­group that was just cre­at­ed. Green­wood re­cent­ly com­plet­ed his 15-year tenure at the helm of BIO.

Cas­san­dra Mat­ney

→ CRO Pre­mier Re­search has wooed Cas­san­dra Mat­ney as se­nior med­ical di­rec­tor. Pri­or to hop­ping aboard the com­pa­ny, Mat­ney held po­si­tions at Astel­las, Janssen, In­cyte and Co­v­ance.

Lund­beck vet Mads Kro­n­berg has joined Dan­ish pep­tide-based med­i­cine biotech Zealand Phar­ma as their head of in­vestor re­la­tions & com­mu­ni­ca­tion. Be­fore mak­ing the jump to Zealand, Kro­n­berg spent more than 12 years at Lund­beck, work­ing his way up to se­nior di­rec­tor, head of cor­po­rate com­mu­ni­ca­tion.

→ A cou­ple months re­moved from the ap­point­ment of Ja­son O’Neill as CEO, im­munother­a­py-fo­cused Den­dreon has brought in Dar­lene Romine to be SVP of sales and mar­ket ac­cess as well as a mem­ber of the ex­ec­u­tive com­mit­tee. Romine has pre­vi­ous­ly held sim­i­lar posts at J&J, Bio­gen and Mallinck­rodt.

Jonathan Yu

→ Tar­get­ing hema­to­log­ic dis­eases, Disc Med­i­cine is giv­ing its staff a boost with Jonathan Yu com­ing in as SVP of cor­po­rate strat­e­gy and William Sav­age as VP of clin­i­cal de­vel­op­ment to help ad­vance their hep­cidin path­way mod­u­la­tor pipeline to­ward the clin­ic. Yu co-found­ed and was VP of cor­po­rate strat­e­gy, fi­nance and op­er­a­tions for Qpex Bio­phar­ma, while Sav­age, a Shire/Take­da vet, was se­nior med­ical di­rec­tor at Ma­gen­ta Ther­a­peu­tics.

Ellen For­est has got­ten the call to be chief hu­man re­sources of­fi­cer at Yu­man­i­ty Ther­a­peu­tics, which tar­gets neu­rode­gen­er­a­tive dis­eases. Pri­or to Cam­bridge, MA-based Yu­man­i­ty, For­est was SVP and head of hu­man cap­i­tal for Co­gen Im­mune Med­i­cine and VP, head of hu­man re­sources for Mer­ri­mack Phar­ma­ceu­ti­cals.

→ On­col­o­gy and in­flam­ma­to­ry dis­ease-fo­cused bio­phar­ma RAPT Ther­a­peu­tics has called up­on Phyl­lis Loud Gray to be VP of hu­man re­sources. Gray moves on from Sune­sis Phar­ma­ceu­ti­cals, where she was their se­nior di­rec­tor and head of hu­man re­sources.

→ Co-found­ed by Bob Langer and rais­ing $56 mil­lion in their May IPO, ENT-fo­cused Lyra Ther­a­peu­tics is bring­ing in Pamela Nel­son as SVP of reg­u­la­to­ry af­fairs. Nel­son, held the VP of reg­u­la­to­ry af­fairs post at Ave­dro pri­or to Lyra, start­ed her reg­u­la­to­ry ca­reer at Gen­zyme and Alk­er­mes.

Rich Hey­man

→ Less than a year af­ter pulling in an im­pres­sive $62 mil­lion Se­ries C round, PMV Phar­ma has named Rich Hey­man as chair­man of its board. Hey­man joins right as the Cran­bury, NJ-based com­pa­ny brought in $70 mil­lion from a Se­ries D fi­nanc­ing round. Hey­man comes to PMV af­ter found­ing the biotechs Aragon (ac­quired by J&J) and Ser­agon (ac­quired by Roche and Genen­tech), each of which sold for more than $1 bil­lion in the span of 12 months back in 2013 and 2014.

→ Ex-Pur­due CEO Mark Tim­ney has been named chair­man of the board at fi­bro­sis-fo­cused Blade Ther­a­peu­tics, suc­ceed­ing Luke Evnin, who was chair­man since its 2015 found­ing. Tim­ney al­so helmed and was a board mem­ber at The Med­i­cines Com­pa­ny.

Ted Love

Pablo Legor­re­ta’s Roy­al­ty Phar­ma, which made waves with its prodi­gious $2.2 bil­lion IPO in June, has added to its board of di­rec­tors with Glob­al Blood Ther­a­peu­tics pres­i­dent CEO Ted Love. MSCI chair­man and CEO Hen­ry Fer­nan­dez is al­so join­ing the board.

→ Buf­fa­lo-based Athenex has elect­ed Robert Spiegel to its board of di­rec­tors. Spiegel has held the CMO job at PTC Ther­a­peu­tics and Sch­ler­ing-Plough.

→ J&J vet Chris Ha­lyk is now on the board of di­rec­tors MediPharm Labs out of Toron­to. Ha­lyk spent 33 years at the phar­ma gi­ant un­til 2019, when he was pres­i­dent of Janssen (Cana­da).

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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