Te­va boots its R&D chief; Iron­wood grows the C-suite and In­ter­cept taps new EVP of re­search

Michael Hay­den

→ In the first ma­jor C-suite over­haul un­der new CEO Kåre Schultz, trou­bled Te­va is part­ing ways with R&D chief Michael Hay­den, Glob­al Spe­cial­ty Med­i­cines head Rob Ko­re­mans, and Glob­al Gener­ic Med­i­cines Group leader Di­pankar Bhat­tachar­jee by the end of the year. A num­ber of staffers are be­ing pro­mot­ed to fill the va­can­cies, in­clud­ing Michael Mc­Clel­lan, who will be­come CFO, and Hafrun Fridriks­dot­tir, the new EVP of glob­al R&D.

Gi­na Con­syl­man

→ Cam­bridge, MA-based Iron­wood Phar­ma­ceu­ti­cals $IR­WD — the de­vel­op­er of Linzess and Zu­rampic — has just grown its C-suite by two mem­bers. William Huyett is the new chief op­er­a­tion of­fi­cer, while Gi­na Con­syl­man has been pro­mot­ed to CFO and SVP, of­fi­cial­ly tak­ing a po­si­tion that she has oc­cu­pied since Tom Graney left for Ver­tex. Hav­ing con­sult­ed life sci­ence com­pa­nies at McK­in­sey, where he worked for 30 years, Huyett’s list of re­spon­si­bil­i­ties in­cludes fi­nance, cor­po­rate strat­e­gy, de­vel­op­ment, glob­al op­er­a­tions, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions func­tions. Mean­while Con­syl­man, a Bio­gen vet, will build up­on the work that she has done for Iron­wood since join­ing in 2014.

Joseph Kel­ly, a long­time No­vo Nordisk sales ex­ec­u­tive, is jump­ing ship to run sales and mar­ket­ing at Ra­dius Health, re­plac­ing out­go­ing chief com­mer­cial of­fi­cer David Snow. Join­ing him on the SVP rank is Aman­da Mott, who will take charge of mar­ket ac­cess. These lead­er­ship changes come not long af­ter the sur­prise ap­point­ment of Jes­per Høi­land, al­so a No­vo Nordisk vet, who was re­cruit­ed specif­i­cal­ly to steer Ra­dius’ $RDUS launch of its de­but drug, Tym­los, for os­teo­poro­sis.

Megan Schoeps is re­sign­ing from her po­si­tion as Bellerophon’s con­troller and prin­ci­pal fi­nan­cial of­fi­cer to pur­sue oth­er ca­reer in­ter­ests. The SEC fil­ing notes that she will stay in her role while the com­pa­ny $BLPH, which tack­les car­diopul­monary dis­eases, un­til around Jan­u­ary 2018.

→ Hop­ing to up its game in T cell en­gi­neer­ing and man­u­fac­tur­ing, CAR-T con­tender Juno has ap­point­ed Ann Lee as EVP of tech­ni­cal op­er­a­tions and Patrick Yang as EVP, se­nior ad­vi­sor to the CEO. Yang was the in­ter­im leader of tech­ni­cal op­er­a­tions be­fore Lee came on board. Both have spent time at Roche/Genen­tech and Mer­ck & Co, and their ex­per­tise will like­ly be key as Juno looks to make a come­back and strides to­wards com­mer­cial­iza­tion.

Chris­t­ian Wey­er

→ Liv­er dis­ease play­er In­ter­cept Phar­ma­ceu­ti­cals $ICPT has ap­point­ed Chris­t­ian Wey­er as EVP of re­search and de­vel­op­ment. “Build­ing on a strong sci­en­tif­ic foun­da­tion with com­pelling clin­i­cal ev­i­dence, In­ter­cept is lead­ing the in­dus­try’s most ad­vanced clin­i­cal de­vel­op­ment pro­gram in NASH, a preva­lent and se­ri­ous dis­or­der with glob­al health-eco­nom­ic im­pact and no cur­rent­ly avail­able phar­ma­co­log­i­cal treat­ment op­tions,” Wey­er said in a state­ment. In case you’re won­der­ing, David Shapiro, who used to jug­gle that job with chief med­ical of­fi­cer du­ties, will con­tin­ue serv­ing as CMO.

→ Af­ter pre­sent­ing stel­lar da­ta on NK­TR-214 at SITC, Nek­tar Ther­a­peu­tics $NK­TR has el­e­vat­ed some of the staffers in­volved in the pro­gram to se­nior po­si­tions. Stephen Dober­stein, for­mer­ly head of the dis­cov­ery team, is now chief re­search & de­vel­op­ment of­fi­cer and SVP of R&D; Mary Tagli­a­fer­ri, who of­fered strate­gic lead­er­ship as VP of clin­i­cal de­vel­op­ment, is be­ing pro­mot­ed to chief med­ical of­fi­cer and SVP of clin­i­cal de­vel­op­ment; Jonathan Za­levsky is now chief sci­en­tif­ic of­fi­cer and SVP of re­search. As VP of bi­ol­o­gy and pre­clin­i­cal de­vel­op­ment, Za­levsky ad­vanced NK­TR-262, a small mol­e­cule TLR ag­o­nist be­ing de­vel­oped in com­bi­na­tion with NK­TR-214.

Herb Cross is serv­ing as Ar­mo Bio­sciences’ first chief fi­nan­cial of­fi­cer fol­low­ing stints at Bal­ance Ther­a­peu­tics and Kalo­Bios Phar­ma­ceu­ti­cals. Mean­while, the im­muno-on­col­o­gy com­pa­ny’s CEO, Pe­ter Van Vlas­se­laer, has been named chair­man of the board at Dutch bio­phar­ma TM3 Ther­a­peu­tics.

Acte­lion co-founder Thomas Wid­mann has been ap­point­ed to the board of Can­cer Ge­net­ics In­cor­po­rat­ed $CGIX, a di­ag­nos­tic and dis­cov­ery ser­vice provider fo­cused on pre­ci­sion med­i­cine.

Shire’s Flem­ming Orn­skov has re­cruit­ed An­dreas Busch as his new R&D chief and chief sci­en­tif­ic of­fi­cer, hand­ing him the reins for the pipeline as the CEO com­pletes a mis­sion to re­make Shire in­to a rare dis­ease spe­cial­ist. That comes im­me­di­ate­ly af­ter Bay­er an­nounced that Busch, the for­mer head of dis­cov­ery, is leav­ing as the phar­ma melds its ear­ly re­search and de­vel­op­ment op­er­a­tions un­der one of­fice oc­cu­pied by cur­rent de­vel­op­ment chief Jo­erg Moeller. Al­so hap­pen­ing at Shire $SH­PGThomas Dit­trich has been tapped to re­place cur­rent CFO Jeff Poul­ton, who is leav­ing at the end of this year. Where­as his most re­cent stint was at an in­dus­tri­al en­gi­neer­ing firm, Dit­trich had pre­vi­ous­ly worked in fi­nance roles at Am­gen for al­most a decade. 

Bio­gen has re­cruit­ed Jeff Capel­lo as CFO and ex­ec­u­tive vice pres­i­dent, fill­ing the po­si­tion a few months af­ter los­ing Paul Clan­cy to Alex­ion. Capel­lo, whose slate of pre­vi­ous em­ploy­ers spans Or­tho Clin­i­cal Di­ag­nos­tics, Boston Sci­en­tif­ic Cor­po­ra­tion and Perkin Elmer, jumps ship from Bea­con Health Op­tions, where he held the same roles. His fi­nan­cial ex­pe­ri­ence will like­ly be cru­cial for the big biotech {$BI­IB} as it ex­e­cutes a plan to “stream­line” op­er­a­tions.

→ A month ago George Scan­gos blazed through a biotech buy­out, two bil­lion-dol­lar drug de­vel­op­ment deals and more than $500 mil­lion in fi­nanc­ing to build a pipeline of new ther­a­pies for in­fec­tious dis­eases at his start­up biotech Vir. Now he’s se­lect­ed Her­bert “Skip” Vir­gin as R&D chief and CSO. Vir­gin is join­ing Vir from Wash­ing­ton Uni­ver­si­ty School of Med­i­cine in St. Louis, Mis­souri, where he has served as the Ed­ward Mallinck­rodt Pro­fes­sor and Chair of the De­part­ment of Pathol­o­gy & Im­munol­o­gy since 2006.

→ An­oth­er round of lead­er­ship changes is tak­ing place at In­trex­on {$XON}: re­tired lieu­tenant gen­er­al Thomas Bo­stick is slat­ed to re­place COO An­drew Last; Te­va vet Nir Nim­ro­di has been pro­mot­ed as chief busi­ness of­fi­cer; and He­len Sabze­vari is tak­ing the helm of Pre­ci­gen as pres­i­dent of the sub­sidiary. This marks the lat­est move by hands-on bil­lion­aire backer and CEO Ran­dal “RJ” Kirk, af­ter the high pro­file de­par­ture of then-pres­i­dent Gene Ger­mano in March. “A more stream­lined se­nior man­age­ment struc­ture is in line with our tran­si­tion to a group of re­lat­ed and in­creas­ing­ly com­mer­cial­ly ori­ent­ed en­ter­pris­es,” Kirk said in a state­ment.

→ Biotech vet­er­an Shao-Lee Lin will start at Hori­zon Phar­ma ear­ly next year as ex­ec­u­tive vice pres­i­dent, re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer. In this new po­si­tion, Lin joins CMO Jef­frey Sher­man in man­ag­ing the com­pa­ny’s grow­ing pipeline. As Hori­zon $HZNP gains a larg­er pres­ence in the or­phan drug field while and builds on its port­fo­lio of mar­ket­ed drugs, it could like use Lin’s ex­pe­ri­ence at Ab­b­Vie, Gilead and Am­gen lead­ing drug de­vel­op­ment across im­munol­o­gy, vi­rol­o­gy, in­flam­ma­tion and res­pi­ra­to­ry ther­a­peu­tics. Said Lin in a state­ment: “I’m im­pressed by Hori­zon’s rapid growth and its strat­e­gy for evo­lu­tion from pri­ma­ry care, with a fo­cus on mar­ket­ed med­i­cines, to di­ver­si­fy­ing in­to rare dis­eases and rheuma­tol­ogy and now com­mit­ted to the next stage in its trans­for­ma­tion of build­ing a ro­bust and sus­tain­able re­search and de­vel­op­ment port­fo­lio.”

→ Pere­grine Phar­ma­ceu­ti­cals re­cent­ly an­nounced it was scrap­ping its old busi­ness and tran­si­tion­ing in­to a con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion (CD­MO). The com­pa­ny is al­so toss­ing the Pere­grine name, and do­ing busi­ness in­stead as Avid Bioser­vices (a for­mer “side busi­ness” of Pere­grine that now em­ploys most of its peo­ple and earns the ma­jor­i­ty of its rev­enue). As part of that re­or­ga­ni­za­tion, Roger Lias was brought on to lead Avid as pres­i­dent of the com­pa­ny. Lias was pre­vi­ous­ly at Al­ler­gan, where he worked as head of glob­al bi­o­log­ics busi­ness de­vel­op­ment.

→ CRO Bio­Clin­i­ca has named David Her­ron as the com­pa­ny’s in­com­ing CEO, ef­fec­tive Jan­u­ary 2, 2018. The ap­point­ment comes as Bio­Clin­i­ca’s cur­rent CEO John Hub­bard is re­tir­ing ear­ly next year. Hub­bard will stay on as a non-ex­ec­u­tive di­rec­tor on the CRO’s board. Her­ron has been at Bio­Clin­i­ca for the past 10 years, most re­cent­ly lead­ing the med­ical imag­ing busi­ness and its tech-fo­cused eHealth seg­ment.

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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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.

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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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.

Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

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