E-Scape Bio in­stalls per­ma­nent CEO Julie Anne Smith; Fa­ther pass­es reins to son at Al­le­gro Oph­thalmics

→ A year af­ter E-Scape Bio leapt out of stealth mode with some strong back­ing, the San Fran­cis­co up­start is ready to put its work in neu­rode­gen­er­a­tion to a clin­i­cal test. Lead­ing that charge will be Julie Anne Smith, who’s been ap­point­ed to suc­ceed Or­bimed part­ner Leon Chen as CEO. A two-time chief ex­ec­u­tive and biotech vet­er­an, Smith brings ex­pe­ri­ence in small mol­e­cule ther­a­pies and lyso­so­mal stor­age dis­or­ders from her re­cent stints at Nure­dis and Rap­tor Phar­ma. That re­sume checks all the right box­es for E-Scape: While the com­pa­ny launched with a heavy fo­cus on a ge­net­ic ap­proach to tack­ling Alzheimer’s, it has since put that project on the back­burn­er in fa­vor of an S1P5 pro­gram from Ab­b­Vie, which is slat­ed for the clin­ic in 2019.

→ Af­ter build­ing Al­le­gro Oph­thalmics from scratch over the past sev­en years, Ham­par Kara­geoz­ian de­cid­ed it’s time pres­i­dent and CMO Vick­en Kara­geoz­ian — al­so his son — steps up for the CEO role. Kara­geoz­ian Sr. will move to the ex­ec­u­tive chair­man po­si­tion, re­spon­si­ble for strat­e­gy with an eye on dis­cov­ery and R&D, while the new CEO preps the com­pa­ny for Phase III tri­als of lead drug risute­ganib in di­a­bet­ic mac­u­lar ede­ma. An oph­thalmic sur­geon by train­ing, Vick­en Kara­geoz­ian had pre­vi­ous­ly co-found­ed two oph­thal­mol­o­gy biotechs based on ther­a­peu­tics he co-in­vent­ed.

→ Over the last 11 years, Ed­ward Hu has been COO, CFO and chief in­vest­ment of­fi­cer at WuXi AppTec. Now he’s been named co-CEO, with a spe­cial re­spon­si­bil­i­ty for small mol­e­cule drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing ser­vices, drug and med­ical de­vice test­ing ser­vices, plus some. He’s re­tain­ing his CFO re­spon­si­bil­i­ties for now un­til a re­place­ment is se­lect­ed. And Hu will con­tin­ue to re­port to com­pa­ny founder Ge Li, who’s been chiefly re­spon­si­ble for the rapid growth of the big Chi­na-based com­pa­ny.

→ Ven­ture cap­i­tal­ist James Kuo sees po­ten­tial in On­co­Track­er’s bio­mark­er test­ing busi­ness — so much so that he left his 11-year role as man­ag­ing di­rec­tor of Athena Bioven­tures to pur­sue the CEO job there. “While the ini­tial fo­cus will be on build­ing a prof­itable busi­ness in the rapid­ly grow­ing mul­ti­ple myelo­ma mar­ket, we in­tend to serve a broad­er can­cer pop­u­la­tion by in­te­grat­ing nov­el im­mune ther­a­pies with com­pan­ion di­ag­nos­tics,” he said of the com­pa­ny. Bor­row­ing from his stints at Syn­thet­ic Bi­o­log­ics and Pfiz­er, he plans to ex­pand the West Hol­ly­wood, CA com­pa­ny through li­cens­ing deals like the one it had with Juno Ther­a­peu­tics.

→ Gaithers­burg, MD-based Sen­sei Bio­ther­a­peu­tics has named Ildiko Csi­ki as its chief med­ical of­fi­cer. Csi­ki most re­cent­ly worked as vice pres­i­dent of im­muno-on­col­o­gy clin­i­cal de­vel­op­ment at In­ovio Phar­ma­ceu­ti­cals. Ear­li­er she worked as clin­i­cal de­vel­op­ment lead for Mer­ck‘s Keytru­da pro­gram. Re­port­ing to John Celebi — pres­i­dent and CEO since May — her first project will in­volve mov­ing for­ward the Phase I can­cer vac­cine SNS-301.

→ Bone heal­ing spe­cial­ist Kuros Bio­sciences has ap­point­ed Pas­cal Longlade to re­place re­tired CMO Vir­ginia Jamieson. Work­ing out of the Swiss biotech’s Nether­lands site, Longlade in­her­its a pipeline of bone graft sub­sti­tute prod­ucts and surgery sealants. He has moved be­tween phar­ma, biotech and med­ical de­vice com­pa­nies, most re­cent­ly over­see­ing med­ical and reg­u­la­to­ry af­fairs for France’s D&A Phar­ma.

→ Achillion $ACHN is on a hir­ing spree un­der new CEO Joseph Tru­itt. Just a week af­ter bring­ing Leerink banker An­tho­ny Gib­ney on as chief busi­ness of­fi­cer, the biotech has scooped Steven Ze­lenkofske from uniQure to be its chief med­ical of­fi­cer. Switch­ing his fo­cus from gene ther­a­pies to com­ple­ment in­hibitors for rare dis­eases, Ze­lenkofske will lead a clin­i­cal de­vel­op­ment team along­side new VPs Lau­ra Bar­row and Marc Uk­nis. His reg­u­la­to­ry ex­pe­ri­ence will be key as Achillion hus­tles along its Phase II pro­grams and pre­pare for reg­is­tra­tional tri­als, Tru­itt said.

Ran­dall Sze has been pro­mot­ed to CFO at Athenex, tak­ing over the fi­nance and ac­count­ing de­part­ment while con­tin­u­ing to spear­head cor­po­rate de­vel­op­ment ac­tiv­i­ties. While Sze on­ly joined the com­pa­ny late last year, he’s known CEO John­son Lau and the man­age­ment team since steer­ing Athenex’s IPO $AT­NX as the lead ex­e­cu­tion banker.

Michael Garone has re­signed from Im­munomedics $IM­MU af­ter a two-year CFO run that fea­tured a brief gig as in­ter­im CEO. Chief busi­ness of­fi­cer Us­ama Ma­lik will step in to shoul­der the fi­nan­cial du­ties, while con­troller William Frick­er has been named prin­ci­pal ac­count­ing of­fi­cer. The com­pa­ny em­pha­sized that his de­par­ture “is not the re­sult of any dis­agree­ment with the com­pa­ny,” its lead­er­ship or op­er­a­tions, and not­ed that Garone will stay on as VP of fi­nance for tran­si­tion un­til May 2019, ex­act­ly one year af­ter Im­munomedics sub­mit­ted a BLA for its an­ti­body-drug con­ju­gate.

→ San Diego-based Cidara Ther­a­peu­tics $CDTX has lost CFO Matthew On­aitis to med­ical de­vice com­pa­ny Main­stay Med­ical. Jef­frey Stein, the CEO, and Brady John­son, di­rec­tor of fi­nance and con­troller, are split­ting up his re­spon­si­bil­i­ties in the in­ter­im.

Bio­gen vet Anne Marie de Jonge Schuer­mans is jump­ing to So­bi to head its tech­ni­cal op­er­a­tions — a new union of the man­u­fac­tur­ing, bi­o­log­i­cal de­vel­op­ment & sup­ply chain and en­vi­ron­ment & safe­ty units. The Swedish rare dis­ease com­pa­ny likes her skills in “putting process­es and sys­tems in place, and of dri­ving trans­for­ma­tion in cross-func­tion­al and cross-cul­tur­al set­tings.” She starts in Oc­to­ber.

→ As Si­mon Bed­son re­tires from the in­ter­na­tion­al com­mer­cial op­er­a­tions at Ver­tex $VRTX, the com­pa­ny has re­cruit­ed Lu­dovic Fe­naux from Bris­tol-My­ers Squibb to take his place in its Lon­don head­quar­ters. Fe­naux, who’s al­so worked at As­traZeneca and Glax­o­SmithK­line, joins Ver­tex amid some tough fights it’s hav­ing with sin­gle Eu­ro­pean pay­ers over cov­er­ing its cys­tic fi­bro­sis drugs.

Aerie Phar­ma­ceu­ti­cals $AERI has tapped Jef­frey White to join its R&D team as di­rec­tor, tox­i­col­o­gy and phar­ma­co­ki­net­ics. He joins from a sim­i­lar po­si­tion at Al­con, the eye care busi­ness No­var­tis is look­ing to spin out.

→ As ApoGen Biotech­nolo­gies goes pub­lic with its ex­pand­ed Se­ries A — with $11 mil­lion from the cor­po­rate ven­ture arms of Mer­ck KGaA, Ab­b­Vie, Eli Lil­ly, J&J and WuXi AppTec — it’s al­so an­nounc­ing the ap­point­ment of two new ex­ecs. Stephen Gwalt­ney, for­mer­ly of Glob­al Blood Ther­a­peu­tics and Take­da, is the new VP of chem­istry; Pe­ter de Vries joins from Fred Hutchin­son Can­cer Re­search Cen­ter to take on the se­nior di­rec­tor of bi­ol­o­gy po­si­tion. ApoGen is de­vel­op­ing ther­a­peu­tics to tack­le re­sis­tance to can­cer drugs.

→ CEO Per­ci­val Bar­ret­to-Ko is still build­ing out his ex­ec team at Astel­las, with two new pro­mo­tions this week. Ro­dri­go Fer­nan­dez, pre­vi­ous­ly ex­ec­u­tive di­rec­tor of Astel­las’ in­ter­na­tion­al busi­ness, is now VP, Latin Amer­i­ca, play­ing a su­per­vi­so­ry role across all coun­tries in the re­gion. Shon­telle Dod­son has been tapped SVP, health sys­tems, tasked with a slate of re­spon­si­bil­i­ties across pric­ing and mar­ket ac­cess.

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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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

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.
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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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