CSO Bill Lund­berg tran­si­tions to ad­vi­sor role at CRISPR Ther­a­peu­tics; Prothena los­es CMO Sarah Noon­berg; Sanofi vet Mark Nut­tall jumps to Kymera

Bill Lund­berg

→ Wrap­ping a three-year run marked by the first clin­i­cal tri­al ap­pli­ca­tions for CRISPR-based ther­a­pies, Bill Lund­berg is step­ping down as CSO of CRISPR Ther­a­peu­tics $CR­SP. He will stay with the com­pa­ny as the head of its sci­en­tif­ic ad­vi­so­ry board. This con­tin­ues a pe­ri­od of tran­si­tion af­ter Sam Kulka­rni took over from found­ing CEO Rodger No­vak in Oc­to­ber. Much of the sci­en­tif­ic lead­er­ship now falls up­on Tony Ho, head of R&D.

Su­jay Kan­go, the guy who led the launch of Kypro­lis while at Oynx Phar­ma, will help plan com­mer­cial op­er­a­tions for lus­pa­ter­cept as CCO at Ac­celeron Phar­ma $XL­RN. Cur­rent­ly in PhI­II de­vel­op­ment, lus­pa­ter­cept is a Cel­gene-part­nered ane­mia ther­a­py for dis­eases like myelodys­plas­tic syn­dromes and be­ta-tha­lassemia. Kan­go, who’s amassed some ex­pe­ri­ence at both Ab­b­Vie and In­fin­i­ty, will be “in­stru­men­tal” as Ac­celeron dri­ves the drug to mar­ket.

Abl­ynx $ABLX is switch­ing up its board of di­rec­tors again. Af­ter a mere month in the chair­man‘s seat — a month that saw the Bel­gian biotech get ac­quired by Sanofi no less — Bo Jes­per Hansen has re­signed from the board al­to­geth­er for per­son­al rea­sons. His suc­ces­sor is Rus­sell Greig, a for­mer GSK ex­ec who’s kept him­self busy with a num­ber of board ap­point­ments.

Sarah Noon­berg

→ Af­ter a brief stint at Prothena $PR­TA, Medi­va­tion vet and CMO Sarah Noon­berg has re­signed from the pro­tein im­munother­a­py biotech. Noon­berg’s de­par­ture deals an­oth­er blow to the rare dis­ease play­er, which has al­ready suf­fered a short at­tack from Ker­ris­dale Cap­i­tal’s Sahm Ad­ran­gi as the PhI­II da­ta on its AL amy­loi­do­sis drug looms. The Dublin biotech, which has US of­fices in South San Fran­cis­co, will count on for­mer CMO Mar­tin Koller’s con­sul­ta­tion while it search­es for Noon­berg’s re­place­ment.

→ A top R&D ex­ec on Genen­tech’s Tecen­triq crew has jumped ship to join Hous­ton-based Bel­licum as its chief med­ical of­fi­cer. William Gross­man had led “the glob­al clin­i­cal de­vel­op­ment of Tecen­triq in gas­troin­testi­nal can­cers and of can­cer im­munother­a­py com­bi­na­tions across all sol­id tu­mor types.” He joins Bel­licum on the heels of a clin­i­cal hold for the com­pa­ny’s lead­ing cell ther­a­py.

Selvi­ta, a Pol­ish drug dis­cov­ery com­pa­ny look­ing to build a clin­i­cal port­fo­lio, has re­cruit­ed Mer­ck KGaA vet Stef­fen Heeger to stew­ard that ef­fort. As CMO, Heeger will take charge of all clin­i­cal, med­ical and reg­u­la­to­ry af­fairs, with a spe­cial eye on SEL24, a dual PIM/FLT3 ki­nase in­hibitor cur­rent­ly in Phase I/II stud­ies for acute myeloid leukemia. Selvi­ta has been feed­ing drug can­di­dates emerg­ing from their dis­cov­ery plat­forms in­to its pipeline, bring­ing in part­ners such as Italy’s Menar­i­ni Group and the US’ Leukemia and Lym­phoma So­ci­ety along the way. The hir­ing of Heeger, who spent the past four years head­ing clin­i­cal de­vel­op­ment at Mor­phosys, fits right in­to that de­vel­op­ment strat­e­gy.

Mark Nut­tall

→ Af­ter two decades in Big Phar­ma, Mark Nut­tall is switch­ing gears to do busi­ness for a lit­tle biotech hunt­ing for ground­break­ing pro­tein degra­da­tion drugs. At­las-backed Kymera emerged from stealth mode just last Oc­to­ber, and Nut­tall — com­ing from the near­by of­fice of Sanofi Gen­zyme — is one of a dozen new staff that CEO Lau­rent Au­doly plans to hire this year. As chief busi­ness of­fi­cer, Nut­tall is tasked with ex­plor­ing new part­ner­ships and col­lab­o­ra­tions — some­thing he’s had plen­ty of ex­pe­ri­ence with while at Sanofi and J&J. In the spir­it of wel­com­ing, the Cam­bridge, MA-based com­pa­ny has al­so ap­point­ed Nim­bus CEO Don Nichol­son to its board of di­rec­tors.

→ As Liq­uidia Tech­nolo­gies ad­vances the first prod­uct can­di­date en­gi­neered from its own tech plat­form, it has tapped Kevin Gor­don to lead fi­nance op­er­a­tions and cor­po­rate de­vel­op­ment as pres­i­dent and CFO. Most re­cent­ly the COO and EVP of con­tract re­search gi­ant Quin­tiles, Gor­don helped ex­e­cute the Quin­tiles-IMS merg­er that gave life to IQVIA.

→ In an­oth­er ex­pres­sion of its dogged faith in Afrez­za, MannKind has en­list­ed di­a­betes ex­pert David Kendall’s help in achiev­ing the growth po­ten­tial that they be­lieve the in­haled in­sulin still has. Even though Sanofi pulled out of a mar­ket­ing part­ner­ship af­ter de­cid­ing the mar­ket isn’t there, Kendall — who joins from Eli Lil­ly — can still see the meal­time in­sulin be­com­ing the stan­dard of care for di­a­bet­ics.

Marc Beer has re­signed from the board chair­man role at Min­er­va Neu­ro­sciences $NERV, trig­ger­ing the el­e­va­tion of CEO Rémy Luthringer to ex­ec­u­tive chair­man­ship. Join­ing him at the board will be William Doyle, ex­ec­u­tive chair­man of Novo­cure, who’s been ap­point­ed as lead in­de­pen­dent di­rec­tor. The change­up hap­pens at a time the cen­tral ner­vous sys­tem spe­cial­ist is look to piv­ot to com­mer­cial stage with its lead drug, MIN-101, cur­rent­ly in PhI­II test­ing for schiz­o­phre­nia.

Ac­er Ther­a­peu­tics $AC­ER, the biotech look­ing to mar­ket a rare dis­ease drug that some fear would be the next Em­flaza, has an­nounced four ad­di­tions to the ex­ec­u­tive ranks. John Klopp is the VP of man­u­fac­tur­ing; Ter­rie Kellmey­er, VP of clin­i­cal sci­ence; Ja­son Knee­land, VP of fi­nance and con­troller; and Kim Thar­ald­sen, se­nior di­rec­tor of mar­ket­ing. Klopp is the star hire here, hav­ing worked on or­phan drug de­vel­op­ment at Bio­Marin and Ul­tragenyx for a decade. The ex­pan­sion of the man­age­ment team is part of a big­ger dri­ve to build a com­mer­cial op­er­a­tion in an­tic­i­pa­tion of the NDA fil­ing for Ed­si­vo (celipro­lol), a drug for vas­cu­lar Ehlers-Dan­los syn­drome bought cheap­ly out­side the US.

Pan­na Shar­ma has stepped down as CEO and pres­i­dent of Can­cer Ge­net­ics, the Ruther­ford, NJ-based out­sourc­ing group that spe­cial­izes in di­ag­nos­tic and test­ing ser­vices for per­son­al­ized on­col­o­gy treat­ment. COO Jay Roberts will take the helm in the in­ter­im.

Po­sei­da Ther­a­peu­tics, an up­start look­ing to catch up in the CAR-T field with a suite of gene en­gi­neer­ing tech­nolo­gies, has tapped Mar­tin Giedlin to lead tech­ni­cal op­er­a­tions as a vice pres­i­dent. A Sang­amo vet, Giedlin’s claim to fame is di­rect­ing the man­u­fac­tur­ing process in sup­port of Kym­ri­ah while he’s at No­var­tis. Po­sei­da’s most ad­vanced cell ther­a­py, for mul­ti­ple myelo­ma, is still in Phase I, but the San Diego biotech is hop­ing Giedlin’s ex­per­tise in process de­vel­op­ment will give them an edge in as­sem­bling its wide-rang­ing pipeline.

→ With the res­ig­na­tion of CFO Robert Dick­ey IV, co-founder and long­time board mem­ber Jonathan Gold is step­ping in as his tem­po­rary re­place­ment at Mo­tif Bio $MTFB. The UK an­tibi­ot­ic de­vel­op­er has gar­nered some at­ten­tion with its plans to re­sub­mit iclaprim, a drug that has been re­ject­ed by the FDA and changed hands a cou­ple times since.

→ Hav­ing qui­et­ly re­signed from Te­va, An­drew Boy­er is pop­ping up on the oth­er end at Am­neal Phar­ma, an­oth­er gener­ic mak­er about to merge with Im­pax Lab­o­ra­to­ries. Boy­er, who start­ed a decades-long ca­reer in gener­ics at Al­ler­gan, was the trou­bled Is­raeli gi­ant’s pres­i­dent and CEO of North Amer­i­ca. Now, he will lead com­mer­cial op­er­a­tions for the com­bined com­pa­ny as EVP.

→ Switzer­land’s Ad­dex Ther­a­peu­tics is wel­com­ing back Jean-Philippe Rocher to work on the com­pa­ny’s small mol­e­cule al­losteric mod­u­la­tor plat­form — which he helped build with Robert Lüt­jens — as the co-head of dis­cov­ery. “The team will ini­tial­ly fo­cus on de­liv­er­ing on our fund­ed re­search pro­grams which are be­ing con­duct­ed in col­lab­o­ra­tion with In­di­v­ior PLC and The Michael J. Fox Foun­da­tion for Parkin­son’s Re­search,” said Ad­dex CEO Tim Dy­er. The part­ner­ship with In­di­v­ior tar­gets ad­dic­tion treat­ments and car­ries up to $330 mil­lion in po­ten­tial mile­stones. Rocher, who was most re­cent­ly at Pierre Fab­re, will al­so over­see the pre­clin­i­cal port­fo­lio.

→ Af­ter a months-long hunt, Al­ler­gan $AGN has locked in Matthew Walsh as the suc­ces­sor of out­go­ing CFO Maria Tere­sa Hi­la­do, who an­nounced the de­sire to re­tire in Sep­tem­ber. Most re­cent­ly CFO at out­sourc­ing com­pa­ny Catal­ent, Walsh — al­so named EVP — is tasked with un­lock­ing growth po­ten­tial even as Al­ler­gan con­tends with the im­mi­nent gener­ic com­pe­ti­tion fac­ing its Resta­sis fran­chise. “Matt brings to Al­ler­gan a unique com­bi­na­tion of skills, in­clud­ing a tech­ni­cal back­ground, a deep un­der­stand­ing of the health­care in­dus­try, a rich ex­pe­ri­ence across fi­nan­cial dis­ci­plines, and the abil­i­ty to lead com­plex health care or­ga­ni­za­tions,” said CEO Brent Saun­ders in a state­ment. “I’m pleased to wel­come Matt to our team and look for­ward to part­ner­ing with him as we con­tin­ue to dri­ve strong fi­nan­cial per­for­mance and de­ploy our cap­i­tal to in­crease share­hold­er re­turn over the short- and long-term.”

→ Now that In­tel­lia Ther­a­peu­tics $INTL is sail­ing steadi­ly to­ward its first hu­man stud­ies with Ab­b­Vie vet John Leonard at the helm, Nes­san Berming­ham will of­fi­cial­ly re-join At­las Ven­ture as a ven­ture part­ner. Berming­ham had been CEO of the At­las-backed CRISPR/Cas-9 up­start (which he co-found­ed) for four years, lead­ing the com­pa­ny from seed in­vest­ment through an IPO to clin­i­cal de­vel­op­ment. Back in his ven­ture cap­i­tal­ist shoes, he will be scout­ing for new biotechs for the At­las plat­form.

→ Pre­clin­i­cal ser­vice provider Sin­clair Re­search has brought in Alex Wake­field, a dual Eli Lil­ly and Co­v­ance vet, as its first VP of re­search and op­er­a­tions.

Kai­ji Hu is the lat­est re­search sci­en­tist to join cannabi­noid-de­rived med­ica­tion de­vel­op­er Medipure Phar­ma­ceu­ti­cals, with a spe­cif­ic man­date to spear­head pso­ri­a­sis and fat­ty liv­er dis­ease/NASH project.

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.