John Kaiser finds next CEO role at Duke spin­out Evecx­ia; Im­muno­core vet Namir Has­san moves to I/O biotech Zel­lu­na

Duke spin­out Evecx­ia has re­cruit­ed bio­phar­ma vet John Kaiser to steer clin­i­cal and busi­ness plans for its 5-hy­drox­ytryp­to­phan slow-re­lease de­pres­sion treat­ment. This will be his third time in a CEO role. Af­ter leav­ing a 28-year sales and mar­ket­ing ca­reer at Eli Lil­ly, Kaiser found­ed and ran a now-de­funct biotech, then had a stint as in­ter­im CEO at Cere­cor, where he had or­ches­trat­ed sev­er­al li­cens­ing deals as chief busi­ness of­fi­cer (Cere­cor is al­so de­vel­op­ing, among oth­er things, a de­pres­sion drug). Evecx­ia is now in the clin­ic with EVX-101, a first-line ad­junc­tive treat­ment for de­pressed pa­tients re­spond­ing in­ad­e­quate­ly to con­ven­tion­al an­ti­de­pres­sants, though it’s un­clear ex­act­ly what stage they are in.

Steven Paul has de­cid­ed to ex­tend a 35-year track record with one last shot at a big de­vel­op­ment pro­gram. He is the new chief ex­ec­u­tive of Karuna, a start­up which wants to show that one of the drugs he once cham­pi­oned at Eli Lil­ly can now be read­ied for prime time as a sig­nif­i­cant new an­ti-psy­chot­ic for schiz­o­phre­nia — and then some. Paul, who’s been serv­ing as chair­man at Karuna, stepped down near the be­gin­ning of the year as CEO of Voy­ager, the gene ther­a­py start­up he co-found­ed.

→ Strug­gling to shed a bad rep for a string of ethics scan­dals capped by the ex­plo­sive ac­cu­sa­tions of sev­er­al US Sen­a­tors that com­pa­ny ex­ecs re­cent­ly mis­rep­re­sent­ed the cozy re­la­tion­ship be­tween for­mer CEO Joe Jimenez and Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis is once again look­ing to clean up its act. CEO Vas Narasimhan has re­cruit­ed a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts.

Klaus Moos­may­er will now be charged with keep­ing the com­pa­ny clear of any new ethics scan­dals, which have come fast and fre­quent­ly at the phar­ma gi­ant. The lawyer has spent the past few years as chief com­pli­ance of­fi­cer at Siemens and chairs the An­ti-Cor­rup­tion Task­force of the Busi­ness and In­dus­try Ad­vi­so­ry Com­mit­tee at the Or­ga­ni­za­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment. Moos­may­er is tak­ing the place of Shan­non Thyme Klinger, new­ly pro­mot­ed to group gen­er­al coun­sel in the wake of Fe­lix Ehrat’s abrupt res­ig­na­tion dur­ing the cri­sis that hit No­var­tis as it strug­gled with rev­e­la­tions about their $1.2 mil­lion in pay­ments to Co­hen.

→ The ex­o­dus of top ex­ecs out of a high-per­form­ing Gilead is con­tin­u­ing. The biotech not­ed Tues­day night that Chief Med­ical Of­fi­cer An­drew Cheng is leav­ing the com­pa­ny “to pur­sue an­oth­er op­por­tu­ni­ty.” As of now, we don’t know what that oth­er op­por­tu­ni­ty is, but Gilead $GILD has re­cent­ly seen the de­par­ture of chief R&D ex­ec Nor­bert Bischof­berg­er (to a start­up) as well as the an­nounced ex­its of CEO John Mil­li­gan and long­time com­pa­ny ex­ec John Mar­tin, ex­ec­u­tive chair­man.

Cheng plans to stay on to Sep­tem­ber 7 to help with the tran­si­tion, ac­cord­ing to Gilead. Mean­while Gregg Al­ton has been ap­point­ed to the new­ly cre­at­ed po­si­tion of chief pa­tient of­fi­cer while Di­ana Brainard was pro­mot­ed to Se­nior Vice Pres­i­dent, HIV and Emerg­ing Vi­ral In­fec­tions. Cheng joined Gilead 19 years ago to lead the com­pa­ny’s de­vel­op­ment-stage pro­grams in HIV/AIDS. He was named Ex­ec­u­tive Vice Pres­i­dent in 2015 and CMO in March.

→ Af­ter tak­ing off the past 7 months to trav­el the world and spend time with fam­i­ly, for­mer Foun­da­tion Med­i­cine ex­ec Steve Kaf­ka is join­ing the start­up foundry Third Rock Ven­ture as their lat­est ven­ture part­ner. Kaf­ka has spent the bulk of his ca­reer in fi­nance and op­er­a­tions at var­i­ous bio­phar­ma out­fits, most re­cent­ly serv­ing as pres­i­dent and COO of Foun­da­tion. This will be Kaf­ka’s first post in the VC world, but that’s not un­usu­al for Third Rock part­ners, which prides it­self on op­er­at­ing like a “start­up stu­dio.” “For me, the ear­ly-stage com­pa­ny build is the best part,” Kaf­ka told us. “To be able to go do that again — and again and again — sounds so in­cred­i­bly fun and im­pact­ful to me.”

Al­ler­gan $AGN has re­cruit­ed top can­cer ex­ec­u­tive Charles Hugh-Jones, the guy who’s been lead­ing Pfiz­er On­col­o­gy as CMO, to serve as the phar­ma gi­ant’s new se­nior vice pres­i­dent and chief med­ical of­fi­cer. The move comes just 16 months af­ter Hugh-Jones joined Pfiz­er’s on­col­o­gy arm. Be­fore that, he was a long timer at Sanofi in New Jer­sey, where he held sev­er­al ex­ec­u­tive roles, end­ing up at chief med­ical of­fi­cer in North Amer­i­ca. The move to Al­ler­gan will take Hugh-Jones back to New Jer­sey, as the new gig is at Al­ler­gan’s US head­quar­ters in Madi­son. There, he’ll be re­port­ing to ex­ec­u­tive vice pres­i­dent and chief R&D of­fi­cer David Nichol­son.

→ Af­ter walk­ing away from a long ca­reer in Big Phar­ma last year — on­ly to bail from his start­up of choice on­ly 10 months lat­er — ex-Pfiz­er ex­ec Geno Ger­mano is back on the move. The re­spect­ed bio­phar­ma chief has joined New York-based Elu­ci­da On­col­o­gy, a tiny Cor­nell spin­out work­ing on some fas­ci­nat­ing nanopar­ti­cle tech with ap­pli­ca­tions in can­cer. At Elu­ci­da, Ger­mano will serve as pres­i­dent and CEO — the first full-time post he’s tak­en up since his ab­bre­vi­at­ed stint at In­trex­on, the flashy syn­thet­ic bio start­up he ex­it­ed from last No­vem­ber.

At Pfiz­er, he cul­ti­vat­ed a $14 bil­lion op­er­a­tion and over­saw a port­fo­lio of drugs span­ning sev­er­al ther­a­peu­tics ar­eas. He al­so worked at the top of Pfiz­er’s on­col­o­gy and spe­cial­ty care busi­ness units and di­rect­ed the in­te­gra­tion of in­dus­try gi­ant Wyeth af­ter the mas­sive $68 bil­lion ac­qui­si­tion.

→ As Sig­ilon CEO Paul Wot­ton leaves the post to han­dle a fam­i­ly health is­sue, the com­pa­ny is putting Roge­rio Vi­val­di — a for­mer se­nior ex­ec at Biover­a­tiv ahead of the Sanofi buy­out ear­li­er this year — in his place at the helm. It will be Vi­val­di’s job now to get the start­up in the clin­ic, look­ing to move the up­start’s stem cell ther­a­py pipeline be­yond its ini­tial for­ays in­to di­a­betes, he­mo­phil­ia and lyso­so­mal stor­age dis­or­ders. An en­docri­nol­o­gist by train­ing, Vi­val­di had been ex­ec­u­tive vice pres­i­dent, chief glob­al ther­a­peu­tic op­er­a­tions of­fi­cer at Biover­a­tiv. Vi­val­di al­so co-found­ed and helmed Min­er­va Ther­a­peu­tics.

→ Af­ter ris­ing up the ranks at British T cell re­cep­tor biotech Im­muno­core, Namir Has­san is mov­ing to Nor­way for his next gig in TCR. As chief sci­en­tif­ic of­fi­cer of Oslo-based Zel­lu­na Im­munother­a­py, Has­san is re­spon­si­ble for both man­ag­ing the ex­ist­ing port­fo­lio and lead­ing ef­forts to ex­pand it, all the while build­ing out the re­search team and fa­cil­i­ties. Im­muno­core, a biotech uni­corn not­ed for scor­ing a stun­ning $320 mil­lion Se­ries A, had seen the de­par­tures of CEO Eliot Forster and CFO Paul Fry in the past few months.

→ Now that Pfenex $PFNX looks set to file an NDA for its For­teo me-too, chief med­ical and sci­en­tif­ic of­fi­cer Hu­bert Chen is turn­ing in his no­tice. The San Diego-based com­pa­ny said that while they are search­ing for a suc­ces­sor, his de­par­ture will not af­fect the tra­jec­to­ry of PF708 as they be­lieve their lead as­set al­ready has the FDA’s bless­ing. Be­sides, he will re­main as an ad­vi­sor, sup­port­ing Pfenex’s reg­u­la­to­ry in­ter­ac­tions. Be­sides PF708, Jazz-part­nered Pfenex is de­vel­op­ing a hodge­podge of “ther­a­peu­tic equiv­a­lents,” biosim­i­lars and vac­cines.

Al­lo­gene Ther­a­peu­tics has en­list­ed an­oth­er es­teemed bio­phar­ma ex­ec in its am­bi­tious plan to bring the first al­lo­gene­ic CAR-T can­cer ther­a­pies to mar­ket. Named chief de­vel­op­ment of­fi­cer, Susie Jun is tasked with ac­cel­er­at­ing clin­i­cal de­vel­op­ment of Al­lo­gene’s pre­clin­i­cal as­sets by lever­ag­ing her ex­pe­ri­ence in trans­la­tion­al re­search. Well versed in hema­tol­ogy and on­col­o­gy, Jun had di­rect­ed clin­i­cal re­search at Am­gen and Gilead be­fore land­ing at her most re­cent role in Ab­b­Vie-Stem­cen­trx.

→ Hav­ing seen through Ar­mo Bio­sciences’ promis­ing im­muno-on­col­o­gy drug all the way to an ac­qui­si­tion by Eli Lil­ly, Joseph Lev­eque has found his next stop at Syn­thorx. While his deep I/O ex­per­tise — honed dur­ing stints at Bris­tol-My­ers Squibb and Mer­ck KGaA where he took a front-row seat in the de­vel­op­ment of Op­di­vo, Yer­voy and Baven­cio — made him a stand­out for the job, the new CMO will al­so be re­spon­si­ble for dri­ving the au­toim­mune ap­pli­ca­tions of Syn­thorx’s par­tial­ly syn­thet­ic bi­o­log­ics. The start­up, based in San Diego, builds its tech on a syn­thet­ic DNA base pair en­gi­neered by Scripps pro­fes­sor Floyd Romes­berg that has the po­ten­tial to tweak pro­teins by in­tro­duc­ing nov­el amino acids.

→ Long­time in­vest­ment banker An­tho­ny Gib­ney is jump­ing to the CBO seat at Achillion $ACHN for a change. Hav­ing ob­served the com­pa­ny from the oth­er side of the ta­ble as co-head of the biotech team at Leerink, Gib­ney will now be in­volved in cor­po­rate strat­e­gy, busi­ness de­vel­op­ment, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Bri­an Di­Do­na­to, an­oth­er for­mer banker, has been hired to work un­der Gib­ney.

Car­ol Suh is the lat­est mem­ber of the biotech in­vest­ment team at Arch Ven­ture Part­ners, where she’s worked as a con­sul­tant/in­tern since Feb­ru­ary. Fresh out of Stan­ford’s busi­ness school, the 28-year-old has pre­vi­ous­ly worked on Ma­gen­ta Ther­a­peu­tics’ launch and, be­fore that, served as an in­no­va­tion fel­low at Glax­o­SmithK­line spe­cial­iz­ing in stem cell and re­gen­er­a­tive med­i­cines.

→ We now know where Alan Mus­so is go­ing af­ter Bel­licum. Pelo­ton Ther­a­peu­tics has tapped the sea­soned fundrais­er as its first CFO. The Dal­las-based com­pa­ny, which is de­vel­op­ing what it hopes will be a first-in-class can­cer drug, is al­so count­ing on Mus­so for in­vestor re­la­tions, ac­count­ing, hu­man re­sources, in­for­ma­tion sys­tems, and op­er­a­tions.

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D re­or­ga­ni­za­tion in­side Sanofi is con­tin­u­ing, more than a year af­ter the phar­ma gi­ant brought in John Reed to head the re­search arm of the Paris-based com­pa­ny.

Sanofi said in a state­ment that it is cut­ting its re­search ranks by 466 in France and Ger­many while drop­ping new, in-house car­di­ol­o­gy drug re­search. Ex­ist­ing car­dio pro­grams will go for­ward, says Sanofi, but the pipeline is be­ing cut off at the dis­cov­ery source. The phar­ma gi­ant, long known as a lag­gard in R&D, in­tends to com­mit more of its re­sources to the 4 re­main­ing R&D fo­cus­es: can­cer, im­munol­o­gy, rare dis­eases and vac­cines.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.