Ed­i­tas CMO to ex­it as CRISPR tech gears up; Roche di­ag­nos­tics di­vi­sion CEO Roland Diggel­mann is out

Roland Diggel­mann is step­ping down as CEO of Roche’s di­ag­nos­tics di­vi­sion to “pur­sue his ca­reer out­side of the com­pa­ny.” The Swiss drug­mak­er $RHH­BY, which part­ed ways with R&D chief John Reed in re­cent months, has ap­point­ed Michael Heuer — the re­gion head of Eu­rope, Mid­dle East, Africa, and Latin Amer­i­ca — to fill the role ad in­ter­im. This year marks the 10th year of Diggel­man’s ca­reer at Roche Di­ag­nos­tics, where he pre­vi­ous­ly led the Asia Pa­cif­ic re­gion.

Bris­tol-My­ers Squibb $BMY found a re­place­ment for Mur­do Gor­don, the ex-com­mer­cial chief who re­cent­ly jumped ship to take the same reins at Am­gen. And CEO Gio­van­ni Caforio didn’t have to go far to find him. Christo­pher Boern­er, a sea­soned vet who’s been in charge of in­ter­na­tion­al sales at Bris­tol-My­ers, is get­ting the big pro­mo­tion to com­mer­cial chief and ex­ec­u­tive vice pres­i­dent. Boern­er — who’s worked at Seat­tle Ge­net­ics, Den­dreon and Genen­tech in the past — will like­ly be giv­en the chance of push­ing Bris­tol’s new PD-1 ap­proach on tu­mor mu­ta­tion bur­den in­to the mar­ket, where it will like­ly face a con­sid­er­able amount of con­fu­sion and kick­back over the tests that would be re­quired to iden­ti­fy pa­tients. But to his ad­van­tage, he knows the port­fo­lio bet­ter than most.

→ In the lat­est move in a reshuf­fle of se­nior ex­ecs among the biggest play­ers in bio­phar­ma, Gilead has tapped long­time Am­gen vet Lau­ra Hamill to head its com­mer­cial team. Hamill fills a po­si­tion va­cat­ed by the re­tire­ment of James Mey­ers, whose ca­reer tra­jec­to­ry was quite sim­i­lar to hers: He joined Gilead in 1996 as a re­gion­al sales di­rec­tor, climb­ing all the way up to EVP, com­mer­cial op­er­a­tions. Hamill had been with Am­gen since 2002, most re­cent­ly serv­ing as SVP, US busi­ness op­er­a­tions. Her new role gives her broad au­thor­ity over Gilead’s mar­ket­ing strat­egy and prod­uct launch­es around the world. Hamill joins Gilead at a time the big biotech is un­der­go­ing a ma­jor soul search­ing amidst a C-suite ex­o­dus.

Ed­i­tas Med­i­cine is search­ing for a new ex­ec to steer the first clin­i­cal tests of its CRISPR gene edit­ing tech as CMO Ger­ald Cox plans to de­part the com­pa­ny at the end of the year. Cox, a 16-year Sanofi Gen­zyme vet who joined Ed­i­tas in 2016, did not give a rea­son for his res­ig­na­tion ex­cept that it “felt like a nat­ur­al tran­si­tion point.” Cox will con­tin­ue to lead the ef­forts in sub­mit­ting Ed­i­tas’ first IND, which is ex­pect­ed in 2018.

→ Last we heard from Arc­turus Ther­a­peu­tics, CEO Joseph Payne was cel­e­brat­ing his vic­to­ry against the board of di­rec­tors that oust­ed him. Now, he’s ready to build up his own team in the af­ter­math of the bat­tle royale, putting An­drew Sas­sine — one of the new board mem­bers he brought on to re­place his old foes — in the CFO seat tem­porar­i­ly while he search­es for a per­ma­nent hire. For­mer­ly of Fi­deli­ty In­vest­ments, Sas­sine has spent the past few ears on the boards of sev­er­al life sci­ence com­pa­nies.

→ As the PDU­FA date for Ve­rastem On­col­o­gy’s PI3K drug ap­proach­es, it has re­cruit­ed Robert Gagnon to han­dle its fi­nances as CFO. A for­mer chief ac­count­ing of­fi­cer at Bio­gen, Gagnon has since worked in two CFO roles at an in­dus­tri­al ser­vices com­pa­ny and a life sci­ence re­search tools provider. It will on­ly be weeks be­fore we know whether du­velis­ib, an Ab­b­Vie castoff with a no­madic past, will fi­nal­ly get an OK at the FDA de­spite mixed re­sults.

→ Toron­to-based top­i­cal cream de­vel­op­er De­liv­ra has pro­mot­ed Pas­cal At­tard to CFO af­ter two years as VP of fi­nance.

Longeveron, a Mi­a­mi-based com­pa­ny de­vel­op­ing stem cell ther­a­pies for age-re­lat­ed dis­eases, has named Arin Maer­cks chief com­mer­cial of­fi­cer. With their lead prod­uct for ag­ing frailty in Phase II, ex­ecs be­lieve Maer­cks’ ex­pe­ri­ence guid­ing growth in a slate of in­dus­tries — from med­ical de­vice to point of care tech­nol­o­gy — will come in­to play. Oth­er pro­grams in the pipeline in­clude an Alzheimer’s treat­ment.

→ The hir­ing spree at Al­lo­gene Ther­a­peu­tics is con­tin­u­ing with the ap­point­ment of David Tillet as SVP, head of qual­i­ty. Tillet shares the same Am­gen roots with Al­lo­gene’s new chief tech­ni­cal of­fi­cer, Al­li­son Moore, though he’s been work­ing as a con­sul­tant in the past few years — Al­lo­gene be­ing one of his clients. “I look for­ward to build­ing and over­see­ing the qual­i­ty func­tion and be­ing a part of this ex­cit­ing time at Al­lo­gene,” he said in a state­ment, as the up­start looks to claim the fron­trun­ner po­si­tion in CAR-T with a pipeline of cell ther­a­pies from Pfiz­er.

→ Look­ing to up its IT game, Ei­sai has tapped Stephen Davies to over­see its glob­al tech­nol­o­gy in­fra­struc­ture and app de­vel­op­ment as well as the IT func­tion for its Amer­i­c­as re­gion. Jump­ing from a re­search di­rec­tor role at ad­vi­so­ry firm Gart­ner’s life sci­ence di­vi­sion, Davies’ of­fi­cial ti­tle will be VP, Ei­sai strat­e­gy in­for­ma­tion sys­tems.

Chi-Chang Wung is the new di­rec­tor of an­a­lyt­i­cal de­vel­op­ment at UPM Phar­ma­ceu­ti­cals. Pri­or to the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion, he’s worked at Alk­er­mes and Siga Tech­nolo­gies.

→ Af­ter a stint at gener­ics mak­er Lupin Phar­ma, Mer­ck vet Jef­fery Palmer has land­ed at Tris Phar­ma. As VP of qual­i­ty and com­pli­ance, he will build up a qual­i­ty team as the com­pa­ny looks to piv­ot to com­mer­cial­iza­tion with a pair of cold meds.

→ Cana­da’s Tetra Bio-Phar­ma has hired Steeve Neron to strate­gize mar­ket­ing for its cannabi­noid-based drug can­di­dates. The new VP jumps from Bausch Health Cana­da — bet­ter known by its for­mer iden­ti­ty as Valeant.

→ Not­ed CAR-T in­ves­ti­ga­tor Michel Sade­lain is lend­ing his cell ther­a­py ex­per­tise to the plat­form builders at Berke­ley Lights, where he’s the lat­est mem­ber of its strate­gic sci­en­tif­ic ad­vi­so­ry board.

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.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.