Syn­er­gy CEO pass­es torch to CCO Troy Hamil­ton; Pres­i­dent Steven Kaf­ka re­signs from Foun­da­tion; Ab­b­Vie vet John Leonard to helm In­tel­lia

Troy Hamil­ton

→ Mark­ing a new phase for the biotech, Syn­er­gy Phar­ma­ceu­ti­cals $SYGP an­nounced that co-founder and Tru­lance co-in­ven­tor Gary Ja­cob is pass­ing the CEO ba­ton to Troy Hamil­ton. Join­ing Syn­er­gy in 2015, Hamil­ton was chief com­mer­cial of­fi­cer and EVP, steer­ing the launch and com­mer­cial­iza­tion of Tru­lance. The chron­ic id­io­path­ic con­sti­pa­tion drug is right up Hamil­ton’s al­ley, as he man­aged the gas­troin­testi­nal unit at Shire for nine years af­ter spend­ing much of his ca­reer at Janssen and Mc­Neil Spe­cial­ty Prod­ucts. “One of my ini­tial ar­eas of fo­cus will be to work with our CFO, Gary Gemignani, and the Syn­er­gy man­age­ment team to con­tin­ue to re­fine our busi­ness plan and fo­cus on achiev­ing cost ef­fi­cien­cies through­out the com­pa­ny while pri­or­i­tiz­ing in­vest­ments that will dri­ve sig­nif­i­cant Tru­lance growth,” Hamil­ton said in the state­ment. He al­so made sure to thank Ja­cob, who will con­tin­ue his in­volve­ment with the com­pa­ny as ex­ec­u­tive chair­man of the board.

Steven Kaf­ka

→ Pres­i­dent and COO Steven Kaf­ka has in­formed Foun­da­tion Med­i­cine $FMI of his in­ten­tion to re­sign next Feb­ru­ary, trig­ger­ing a lead­er­ship reshuf­fle that adds the pres­i­dent ti­tle to CEO Troy Cox and COO role to SVP of in­ter­na­tion­al mar­kets Kon­stan­tin Fiedler. Kaf­ka’s tenure at Foun­da­tion last­ed al­most five years, no­tice­ably longer than his stints at oth­er biotechs in­clud­ing Mil­len­ni­um Phar­ma­ceu­ti­cals and Aileron Ther­a­peu­tics. Cox and Fiedler are both rel­a­tive­ly new to the biotech, but each had spent time at some big name com­pa­nies be­fore land­ing here.

→ Cam­bridge, MA-based start­up Dis­arm Ther­a­peu­tics has lured Pe­ter Keller to join as chief busi­ness of­fi­cer af­ter sev­en years at Se­lec­ta Bio­sciences. Keller hasn’t al­ways worked in biotech — he was a man­age­ment con­sul­tant for a decade — but while in the in­dus­try, he has been in­volved in an ac­qui­si­tion, a big IPO and a bil­lion-dol­lar deal. While we haven’t heard much about where Dis­arm’s ax­on­al de­gen­er­a­tion-pre­vent­ing tech is head­ed, we now know Keller will be shap­ing part of it.

Joe Jimenez

→ As Joe Jimenez con­tin­ues to search for his next big break af­ter No­var­tis (ide­al­ly in Sil­i­con Val­ley), he will spend some time in Cincin­nati as a mem­ber of Proc­ter & Gam­ble’s board of di­rec­tors. Con­sumer busi­ness is fa­mil­iar turf for Jimenez, who worked top jobs at Heinz be­fore tak­ing the reins of the Swiss phar­ma gi­ant.

→ In a clear sig­nal that CRISPR/Cas9 play­er In­tel­lia Ther­a­peu­tics is piv­ot­ing to a Phase I, John Leonard, found­ing chief med­ical of­fi­cer, is be­ing kicked up to the CEO’s of­fice. Hav­ing led the biotech $NT­LA through a quick and suc­cess­ful IPO in 2016, At­las part­ner Nes­san Berming­ham will re­turn to biotech ven­ture cap­i­tal. The R&D trek will like­ly be long, with ri­vals Ed­i­tas and CRISPR Ther­a­peu­tics — who are still fight­ing over the IP — de­ter­mined to have a slice of the mar­ket. The board is putting its faith in Leonard, the for­mer top sci­en­tist at Ab­b­Vie who worked on HIV and HCV while tak­ing a lead role on Hu­mi­ra dur­ing his 22-year tenure.

Gen­zyme vet Marc Beck­er will be Con­cert Phar­ma’s new CFO, af­ter a brief stint at CRISPR Ther­a­peu­tics. The Lex­ing­ton, MA-based biotech $CNCE is prepar­ing to broad­en its pipeline of deu­teri­um chem­istry prod­uct can­di­dates — a pipeline where four out of five pro­grams are cur­rent­ly part­nered — and Beck­er will be very much in­volved in that, ac­cord­ing to a state­ment.

→ Paris-based Ac­ti­cor Biotech has tapped Yan­nick Plé­tan as its first chief med­ical of­fi­cer. A spin­off from the French Na­tion­al In­sti­tute of Health and Med­ical Re­search, the 4-year-old com­pa­ny is de­vel­op­ing an an­tithrom­bot­ic agent for the acute phase of is­chemic stroke. Plé­tan’s clin­i­cal and med­ical ex­pe­ri­ence at Roche and Pfiz­er will be im­por­tant as Ac­ti­cor nav­i­gates the next tri­al phase for its lead can­di­date ACT017.

Ra­jesh Shrotriya, the 15-year chair­man and CEO of Spec­trum Phar­ma­ceu­ti­cals, has been fired, the com­pa­ny an­nounced Sun­day. The ter­mi­na­tion trig­gered a chain of lead­er­ship changes: cur­rent pres­i­dent and COO Joseph Tur­geon is now pres­i­dent and CEO, as well as a board of di­rec­tor mem­ber; di­rec­tor Stu­art Krass­ner fills the chair­man seat; and Thomas Riga (EVP, CCO and head of busi­ness de­vel­op­ment) be­comes COO. Tur­geon is an Am­gen vet who used to over­see com­mer­cial ac­tiv­i­ties for Spec­trum.

→ For­est Labs vet Charles Ryan will take the CEO’s job at Neu­rotrope $NTRP fol­low­ing the res­ig­na­tion of Su­sanne Wilke.

→ In line with CEO George Scan­gos’ vi­sion for Vir Biotech­nol­o­gy to be a sci­ence-dri­ven com­pa­ny, im­mu­nol­o­gist An­to­nio Lan­za­vec­chia has been brought on as SVP and se­nior re­search fel­low. His main charge is to pro­vide sci­en­tif­ic lead­er­ship for Vir’s tech­ni­cal pro­grams look­ing in­to se­ri­ous in­fec­tious dis­eases. While do­ing that for the San Fran­cis­co up­start, he will con­tin­ue his roles as di­rec­tor of the In­sti­tute for Re­search in Bio­med­i­cine in Bellinzona, Switzer­land and as pro­fes­sor at the Uni­ver­sità del­la Svizzera ital­iana.

→ Fol­low­ing No­vem­ber’s IPO, Apel­lis Phar­ma­ceu­ti­cals $APLS has ap­point­ed Tim­o­thy Sul­li­van, for­mer­ly a VC firm part­ner, as CFO. Sul­li­van has spent the past three years as an ob­serv­er on Apel­lis’ board of di­rec­tors, as the Ken­tucky biotech took its Soliris ri­val drug and age-re­lat­ed mac­u­lar de­gen­er­a­tion ther­a­py fur­ther along the pipeline, rais­ing mon­ey even af­ter a foiled first IPO at­tempt. Now Apel­lis is ready to en­ter Phase III tri­als for both pro­grams in 2018, and in his new role, Sul­li­van will lead the de­vel­op­ment of its fi­nanc­ing and growth strat­e­gy.

→ Long­time EVP and CFO Ryan May­nard is re­sign­ing from South San Fran­cis­co-based Rigel Phar­ma­ceu­ti­cals $RIGL for undis­closed rea­sons (but cer­tain­ly not due to a dis­pute or dis­agree­ment with the com­pa­ny, ac­cord­ing the to SEC fil­ing). Nel­son Ca­bat­u­an, cur­rent VP of fi­nance, will step in as the in­ter­im prin­ci­pal ac­count­ing of­fi­cer while the biotech search­es for a re­place­ment ahead of its lead drug’s PDU­FA date.

Bellerophon Ther­a­peu­tics $BLPH has qui­et­ly hired a new CFO, As­saf Ko­rner, to re­place Megan Schoeps, who re­signed a cou­ple weeks ago. Ko­rner has worked a slate of fi­nan­cial jobs at med­ical de­vice and con­sumer prod­uct com­pa­nies such as Syneron Med­ical, Ilu­mi­nage Beau­ty and KP­MG.

→ Af­ter wow­ing in­vestors with its BC­MA-tar­get­ing CAR-T at ASH, blue­bird bio $BLUE turned to its in­ter­nal op­er­a­tions and named Ko­ry Went­worth VP of fi­nance and prin­ci­pal ac­count­ing of­fi­cer. A vet­er­an of big pub­lic ac­count­ing firms, Went­worth cut his teeth in biotech con­troller­ship dur­ing his 9-year run at Alex­ion. He fills the shoes of Jef­frey Walsh, the biotech’s chief fi­nan­cial and strat­e­gy of­fi­cer, who will con­tin­ue to serve in the prin­ci­pal fi­nan­cial role.

→ British dis­cov­ery and de­vel­op­ment ser­vice provider Con­cept Life Sci­ences has hired An­drew Scott as head of bioas­say de­vel­op­ment and screen­ing, and Ma­g­a­lie Fer­bach as busi­ness de­vel­op­ment di­rec­tor for South­ern and Cen­tral Eu­rope. Scott has ex­pe­ri­ence span­ning phar­ma, biotech and CRO, while Fer­bach’s back­ground is in agro­chem­i­cals. These ap­point­ments wrap up Con­cept’s ex­pand­ing year, marked by the ac­qui­si­tion of Aquila Bio­med­ical in Ed­in­burgh and open­ing of new lab­o­ra­to­ry space at Alder­ly Park.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Michel Vounatsos, Getty Images

UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.