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.

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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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.