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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.