John Mendlein leaves Mod­er­na for Flag­ship; Paul Sekhri to steer first xeno­trans­plan­ta­tion tri­als as eGe­n­e­sis CEO

John Mendlein is out at Mod­er­na just a year — a mo­men­tous year, no less, that saw Mod­er­na reap a $604 mil­lion IPO — af­ter be­com­ing pres­i­dent of the biotech uni­corn. The new role as ex­ec­u­tive part­ner at Flag­ship Pi­o­neer­ing brings him back to his “roots and pas­sion for cre­at­ing and grow­ing in­no­v­a­tive plat­form com­pa­nies,” he said in a state­ment. He will have stay an­oth­er six months as a con­sul­tant to Mod­er­na, where he led a cross-func­tion­al team prep­ping the com­pa­ny for the pub­lic mar­ket as well as cor­po­rate strat­e­gy, part­ner­ing, le­gal and in­tel­lec­tu­al prop­er­ty.

→ Af­ter hold­ing down the fort at eGe­n­e­sis as in­ter­im CEO for over a year, Julie Sun­der­land is pass­ing the role to Paul Sekhri and fo­cus­ing again on be­ing man­ag­ing di­rec­tor of Bio­mat­ics Cap­i­tal — one of the ma­jor back­ers for eGe­n­e­sis’ rad­i­cal gene edit­ing ap­proach to xeno­trans­plan­ta­tion. A one-time biotech founder, two-time CEO and three-time pres­i­dent, Sekhri has al­so held BD roles at Te­va and No­var­tis be­fore his most re­cent gig at Lyc­era. He is tasked with help­ing the biotech launch its first tests of trans­plant­i­ng mod­i­fied pig or­gans in­to hu­mans.

→ Months af­ter poach­ing As­traZeneca vet Kevin Hor­gan to serve as CMO at mi­cro­bio­me drug de­vel­op­er Seres, the Cam­bridge, MA-based com­pa­ny has el­e­vat­ed CFO Er­ic Shaff to the po­si­tion of CEO, to suc­ceed Roger Pomer­antz, who will re­main board chair­man. Shaff, who will con­tin­ue to serve as Seres’ prin­ci­pal fi­nan­cial of­fi­cer on an in­ter­im ba­sis, joined the com­pa­ny in 2014 as CFO and was giv­en the ad­di­tion­al po­si­tion of COO in ear­ly last year.

On­cono­va Ther­a­peu­tics is hand­ing Steven Frucht­man a sec­ond pro­mo­tion in less than a year as it dou­bles down on Phase III pro­grams for lead drug rigosert­ib and brings an­oth­er can­di­date in­to the clin­ic. Frucht­man, the for­mer CMO who re­cent­ly be­came pres­i­dent, will of­fi­cial­ly take over as CEO af­ter learn­ing close­ly from Ramesh Ku­mar. A hema­tol­o­gist by train­ing — fit­ting with On­cono­va’s pri­ma­ry fo­cus on myelodys­plas­tic syn­dromes — Frucht­man’s pre­vi­ous in­dus­try ex­pe­ri­ence spanned from Or­tho Biotech to No­var­tis.

→ As ArunA Bio looks to move its neur­al ex­o­some plat­form — with ap­pli­ca­tions as both ther­a­peu­tics and de­liv­ery ve­hi­cles — in­to clin­i­cal tri­als and in­dus­try col­lab­o­ra­tions, Steven Stice is switch­ing the CEO of­fice for a CSO role to fo­cus on R&D. His suc­ces­sor, Mark Sir­go, brings fresh ex­pe­ri­ence run­ning spe­cial­ty phar­ma BioDe­liv­ery Sci­ences, which shares a fo­cus on CNS with ArunA.

David Berman — Jeff Ru­mans for End­points News

Click on the im­age to see the full-sized ver­sion

David Berman, who un­til re­cent­ly was head of I/O re­search at As­traZeneca, has been bumped up to the top job in R&D at Im­muno­core, the TCR biotech which re­cent­ly re­cruit­ed Med­Im­mune chief Bahi­ja Jal­lal as CEO. Berman is a well known play­er in on­col­o­gy R&D and comes with cre­den­tials that in­cludes a lengthy stint along­side his new CEO at Im­muno­core, which spe­cial­izes in TCR work. Berman ac­tu­al­ly joined Im­muno­core, which is look­ing to reestab­lish its rep as a leader in its field wor­thy of a hefty uni­corn val­u­a­tion, last Sep­tem­ber ahead of a ma­jor re­vamp. He took over the lead role for the com­pa­ny’s top pro­gram for the late-stage ef­fort on IM­Cgp100.

Omar Khwa­ja has jumped from his post as glob­al head of Roche’s neu­ro­science trans­la­tion­al med­i­cine group as well as rare dis­eases to Voy­ager Ther­a­peu­tics $VY­GR, where he’ll be CMO. His work at Roche in­volved cre­at­ing new gene ther­a­py pro­grams for a list of rare dis­eases, in­clud­ing spinal mus­cu­lar at­ro­phy as well as Hunt­ing­ton’s dis­ease. And he’ll put that ex­per­tise to work now for Voy­ager, which has been strug­gling with a lead pro­gram on Parkin­son’s.

Terns Phar­ma­ceu­ti­cals has re­cruit­ed Gilead vet Erin Quirk to re­al­ize its am­bi­tious clin­i­cal plans in NASH. As CMO, Quirk will co­or­di­nate a dis­cov­ery team in San Ma­teo, CA, where she is based, and a small de­vel­op­ment group in Chi­na. The hope is this mod­el could as­sem­ble a pipeline and ef­fi­cient­ly de­vel­op new drugs pri­mar­i­ly for the Chi­nese mar­ket, with op­por­tu­ni­ties to reach US pa­tients si­mul­ta­ne­ous­ly. Most re­cent­ly a VP of clin­i­cal re­search at Gilead, Quirk has al­so run clin­i­cal pro­grams for Mer­ck.

→ Hav­ing steered an an­tibi­ot­ic through to an ap­proval at In­smed, CMO Paul Streck is mov­ing on­to the next project at Alder Bio­Phar­ma­ceu­ti­cals $AL­DR. He will have the same role but work on a much dif­fer­ent drug: eptinezum­ab, a CGRP mi­graine drug look­ing to find a place among big ri­vals, with a sub­mis­sion slat­ed for this quar­ter. Streck, who ran clin­i­cal pro­grams across a range of ther­a­peu­tic ar­eas while at Glax­o­SmithK­line and Shire, suc­ceeds in­ter­im CMO Er­ic Carter.

→ De­spite a de­layed re­view for its peanut al­ler­gy drug — which Aim­mune $AIMT has at­trib­uted to the FDA shut­down, though Com­mis­sion­er Scott Got­tlieb seems to sug­gest oth­er­wise — the com­pa­ny is go­ing ahead with the ap­point­ment of a chief com­mer­cial of­fi­cer. An­drew Ox­to­by jumps from Eli Lil­ly, where he was in charge of the in­sulin busi­ness af­ter stints in the on­col­o­gy unit.

→ As Tri­ci­da $TC­DA hus­tles its late-stage chron­ic kid­ney dis­ease drug to the FDA, it’s brought in Su­san­nah Cantrell as chief com­mer­cial of­fi­cer. A Big Phar­ma vet with stints at Glax­o­SmithK­line and Roche/Genen­tech, Cantrell most re­cent­ly man­aged Gilead’s on­col­o­gy busi­ness.

→ Con­ju­gate vac­cine de­vel­op­er SutroVax has named Elaine Sun its chief strat­e­gy of­fi­cer in ad­di­tion to her cur­rent role as CFO, with re­spon­si­bil­i­ties for fi­nan­cial, cor­po­rate de­vel­op­ment and strat­e­gy func­tions. Sun, who first joined the com­pa­ny in 2017, has a back­ground in fi­nan­cial and busi­ness ad­vi­so­ry with ex­pe­ri­ence lead­ing the health­care groups at Ever­core and Mer­rill Lynch. Mean­while, Jane Wright-Mitchell has been hired as gen­er­al coun­sel.

Richard Christo­pher is the new CFO at In­Vi­vo Ther­a­peu­tics, a biotech found­ed on lab work done by MIT’s Bob Langer and Joseph Va­can­ti to treat spinal cord in­jury.

→ Back in busi­ness to roll out its AD­HD drug af­ter a spell in lim­no, Iron­shore Phar­ma­ceu­ti­cals has tapped Mer­ck vet Lewis War­ring­ton to sup­port the com­mer­cial­iza­tion as VP and head of med­ical af­fairs.

Pe­ter Van Vlas­se­laer is stack­ing up his board ap­point­ments af­ter sell­ing AR­MO Bio­sciences to Eli Lil­ly. He’s tak­ing the chair­man seat at As­ceneu­ron, a Mer­ck spin­off de­vel­op­ing tau mod­u­la­tors for Alzheimer’s and oth­er neu­rode­gen­er­a­tive dis­eases.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

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

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three ma­jor buy­outs an­nounced: Take­da/Shire; Bris­tol-My­ers/Cel­gene and now Ab­b­Vie/Al­ler­gan. And with this lat­est deal it’s in­creas­ing­ly clear that the sharp fall from grace suf­fered by high-pro­file play­ers which have seen their share prices blast­ed has cre­at­ed an open­ing for the growth play­ers in big phar­ma to up their game — in sharp con­trast to the pop­u­lar bolt-on deals that have been dri­ving the growth strat­e­gy at No­var­tis, Mer­ck, Roche and oth­ers.

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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.

SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

→ In a mar­riage of two tech­nolo­gies meant to make cell ther­a­pies more pow­er­ful, SQZ Biotech is team­ing up with France’s Ery­tech Phar­ma for a col­lab­o­ra­tion, with $57 mil­lion re­served for the first project and $50 mil­lion for each sub­se­quent ap­proval (prod­uct or in­di­ca­tion). Hav­ing ac­cess to Ery­tech’s method of fash­ion­ing ther­a­peu­tics from red blood cells, the Cam­bridge, MA-based com­pa­ny said, will am­pli­fy SQZ’s cell en­gi­neer­ing ca­pa­bil­i­ties and al­low them to de­vleop a new class of im­munomod­u­la­to­ry ther­a­pies. Its own tech — so far ap­plied in can­cer but al­so has po­ten­tial in di­a­betes — tem­po­rary dis­rupts the cell mem­brane by squeez­ing the cell, thus cre­at­ing a brief win­dow for tar­get ma­te­ri­als such as anti­gens to en­ter.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.