Mer­ck vet Thomas Can­nell takes the reins at Sesen Bio; Post-tur­bu­lence, Rock­well Med­ical ap­points new CEO

→ It’s been a year of change for Sesen Bio — or, un­til three months ago, Eleven Bio — and they are now adding a new CEO to that list. Mer­ck vet Thomas Can­nell is step­ping in to steer the com­pa­ny through a Phase III tri­al they hope will take their blad­der can­cer treat­ment, Vicini­um (VB4-845), to reg­u­la­to­ry sub­mis­sion in 2019. Can­nell jumps from a stint as COO and pres­i­dent of glob­al com­mer­cial prod­ucts at Orex­i­gen, the bank­rupt di­et pill mak­er that just sold to Nal­pro­pi­on. He re­places Stephen Hurly, the for­mer CEO of Viven­tia Biotech who took the reins when Sesen ac­quired Viven­tia and switched its fo­cus from oph­thal­mol­o­gy to on­col­o­gy. Mark­ing the be­gin­ning of the new era, two board di­rec­tors — Third Rock part­ner Ab­bie Cel­niker and eye dis­ease ex­pert Paul Chaney — are al­so leav­ing their role.

→ Re­mem­ber when Rock­well Med­ical CEO Robert Chioi­ni un­fired him­self af­ter get­ting oust­ed by the board? Af­ter weeks un­der the radar, it seems like the De­troit biotech $RMTI is ready to turn a new leaf with the ap­point­ment of Stu­art Paul to the top job. A court had barred Chioi­ni, a founder of the com­pa­ny, from any con­tact with his for­mer col­leagues out­side of me­di­a­tion. Now Paul, a life sci­ences vet with stints at Bax­ter, Gam­bro, Quest Di­ag­nos­tics and Ab­bott Lab­o­ra­to­ries, has the tall or­der of putting the com­mer­cial op­er­a­tion back on track. “While there re­mains sig­nif­i­cant work ahead to strength­en the busi­ness and en­hance val­ue, I be­lieve the Com­pa­ny ben­e­fits from a unique mar­ket po­si­tion due to its two in­no­v­a­tive re­nal drug ther­a­pies,” he said, re­fer­ring to Trifer­ic and Cal­citri­ol.

Glax­o­SmithK­line CEO Em­ma Walm­s­ley is reach­ing in­to the glob­al bank­ing world to fin­ish round­ing out the top team she ex­pects to re­verse the phar­ma gi­ant’s steady ero­sion over the past decade. HS­BC’s Iain Mack­ay will grad­u­al­ly take the CFO reins by next spring, when he’ll be slow­ly re­plac­ing the de­part­ing Si­mon Dinge­mans. Walm­s­ley, CEO now since April, 2017, said this about Mack­ay in a state­ment: “As a proven CFO of a com­plex, reg­u­lat­ed glob­al or­ga­ni­za­tion, he brings tremen­dous fi­nance ex­pe­ri­ence and will be a great ad­di­tion to the team. He is a strong leader with a track record of dri­ving cost, cash and cap­i­tal al­lo­ca­tion dis­ci­pline to de­liv­er strat­e­gy. These ca­pa­bil­i­ties will be vi­tal as we con­tin­ue to im­ple­ment our in­no­va­tion, per­for­mance and trust pri­or­i­ties for the ben­e­fit of pa­tients and share­hold­ers.”

→ Boul­der, CO-based i2 Phar­ma­ceu­ti­cals has tapped David Stover to lead its nascent op­er­a­tion. Not much is out there about i2’s an­ti­body-based im­muno-on­col­o­gy as­sets, but chair­man Bruce Eaton said Stover’s ar­rival co­in­cides with a “strate­gic growth-phase.” While this will be Stover’s first time as CEO, he brings ex­pe­ri­ence head­ing an Astel­las af­fil­i­ate called Agen­sys, which al­so fo­cused on an­ti­body and an­ti­body drug con­ju­gate de­vel­op­ment.

→ Fol­low­ing a deal spree, Ad­lai Nortye has wooed Lars Birg­er­son from Bris­tol-My­ers Squibb to guide clin­i­cal de­vel­op­ment for its beefed up pipeline of can­cer treat­ments. As pres­i­dent and CEO of the Chi­nese biotech’s US op­er­a­tions, as well as its chief de­vel­op­ment of­fi­cer, Birg­er­son in­her­its a port­fo­lio that in­cludes an im­muno-on­colyt­ic virus and a PI3K drug cast-off from No­var­tis.

→ Af­ter help­ing dri­ve Agios’ two acute myeloid leukemia drugs — Id­hi­fa and Tib­so­vo — through the clin­ic to ap­provals, Samuel Agres­ta is start­ing fresh at In­fin­i­ty Phar­ma­ceu­ti­cals, where he’s been named CMO. Agres­ta is tasked with over­see­ing glob­al clin­i­cal de­vel­op­ment and reg­u­la­to­ry af­fairs for the Cam­bridge, MA-based com­pa­ny, which is still in ear­ly-stage stud­ies for its sole as­set IPI-549. The drug is be­ing test­ed as both a monother­a­py and in com­bi­na­tion with Bris­tol-My­ers’ Op­di­vo.

→ BioX­cel Ther­a­peu­tics has brought in a for­mer Pfiz­er di­rec­tor to lead the com­pa­ny’s neu­ro­science ef­forts. Michael De Vi­vo will serve as vice pres­i­dent of neu­ro­science, aid­ing the com­pa­ny’s CSO Frank Yoc­ca in ex­e­cut­ing BioX­cel’s neu­ro­science strat­e­gy. De Vi­vo was di­rec­tor of neu­ro­science at Pfiz­er, where he led trans­la­tion­al re­search and pre­clin­i­cal stud­ies, and over­saw a Parkin­son’s dis­ease project, ac­cord­ing to BioX­cel’s state­ment.

Robert Lee has been pro­mot­ed to pres­i­dent at Par­ti­cle Sci­ences af­ter 10 years at the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion. 

→ Bel­gium’s CAR-T cell ther­a­py play­er Celyad $CYAD has tapped Wells Far­go in­vest­ment banker Fil­ip­po Pet­ti to fill the CFO seat va­cat­ed by Patrick Jean­mart.

→ As On­copep­tides moves be­yond its Stock­holm base to ex­pand its or­ga­ni­za­tion in­to Eu­rope and the US, Bir­git­ta Ståhl is pass­ing the CFO ba­ton to An­ders Mar­tin-Löf, for­mer­ly of Wil­son Ther­a­peu­tics and medtech com­pa­ny Ray­search. Ståhl, who helped pre­pare and ex­e­cute the can­cer drug­mak­er’s re­cent IPO, will con­tin­ue to work in the com­pa­ny.

→ Cas­ma Ther­a­peu­tics has re­cruit­ed two new ex­ec­u­tives: Jef­frey Saun­ders as se­nior vice pres­i­dent of drug dis­cov­ery, and Daniel Ory as se­nior vice pres­i­dent of trans­la­tion­al med­i­cine. Saun­ders comes from Nu­va­lent Ther­a­peu­tics, where he worked as vice pres­i­dent of chem­istry. Ory is join­ing from Wash­ing­ton Uni­ver­si­ty School of Med­i­cine, where he served as a pro­fes­sor of med­i­cine, cell bi­ol­o­gy, phys­i­ol­o­gy and car­di­ol­o­gy.

→ Por­to­la Phar­ma­ceu­ti­cals has hired Ernie Mey­er, a for­mer Cel­gene HR ex­ec, to serve as the com­pa­ny’s vice pres­i­dent and chief hu­man re­sources of­fi­cer. At Cel­gene, Mey­er most re­cent­ly served as VP of hu­man re­sources and cor­po­rate ser­vices.

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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