Jose Car­los 'JC' Gutiér­rez-Ramos hits the ex­it at Syn­log­ic; Rich Hey­man pass­es Oric reins to ex-Igny­ta CFO

Jose Car­los Gutier­rez-Ramos

→ An abrupt res­ig­na­tion by pres­i­dent and CEO Jose Car­los Gutiér­rez-Ramos has left Syn­log­ic $SYBX in the hands of CMO Aoife Bren­nan. JC Gutiér­rez-Ramos ex­its the Cam­bridge biotech al­most ex­act­ly a year af­ter he or­ches­trat­ed its re­verse merg­er on­to Nas­daq, leav­ing be­hind an op­er­a­tion with two on­go­ing Phase I stud­ies and one dis­cov­ery pact with Ab­b­Vie, all built up­on Syn­log­ic’s spe­cial­ty in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics. No rea­sons were giv­en for his de­par­ture, which comes three years af­ter he joined from Pfiz­er, where he held a high-pro­file R&D job. Pe­ter Bar­rett is step­ping in­to the ex­ec­u­tive chair­man’s role to en­sure Bren­nan can bal­ance her in­ter­im ex­ec­u­tive du­ties with all the re­search, pre­clin­i­cal ac­tiv­i­ties and clin­i­cal tri­als un­der­way. Gutiér­rez-Ramos” will serve in an ad­vi­so­ry ca­pac­i­ty as need­ed.”

→ Hav­ing led Oric Phar­ma’s tran­si­tion from re­search to de­vel­op­ment stage, se­r­i­al en­tre­pre­neur Rich Hey­man fig­ured it’s time to pass the reins to a per­ma­nent CEO. En­ter Ja­cob Chacko, the for­mer Igny­ta CFO who helped grow the com­pa­ny from a val­u­a­tion of $50 mil­lion to $1.7 bil­lion — the price at which Roche bought it out. So while this will be his first time in the chief ex­ec­u­tive role, he brings to Oric both fundrais­ing ex­pe­ri­ence and knowl­edge about an ear­ly-stage on­col­o­gy com­pa­ny. (Be­fore Igny­ta, he worked as an in­vestor for pri­vate eq­ui­ty firm TPG Cap­i­tal.) For now, his pri­or­i­ty lies in pro­gress­ing the pipeline of drugs ad­dress­ing treat­ment re­sis­tance, es­pe­cial­ly lead can­di­date ORIC-101. Hey­man, who over­saw a $50 mil­lion Se­ries C fi­nanc­ing dur­ing his one-year-plus in­ter­im term, will stay on as board chair­man.

→ A start­up try­ing to de­vel­op a stem cell cure for type 1 di­a­betes has re­cruit­ed for­mer Ma­gen­ta ex­ec­u­tive Bas­tiano San­na — a guy best known for lead­ing the de­vel­op­ment of No­var­tis’ cell-based med­i­cines — to serve as the com­pa­ny’s new CEO. Cam­bridge-based Sem­ma Ther­a­peu­tics is bring­ing San­na in to re­place its in­ter­im CEO Eliz­a­beth Ston­er. San­na comes di­rect­ly from Ma­gen­ta — an­oth­er start­up de­vel­op­ing stem cell tech — where he was chief op­er­at­ing of­fi­cer. Be­fore that, San­na was an ex­ec­u­tive at No­var­tis’ cell and gene ther­a­py di­vi­sion, over­see­ing the de­vel­op­ment of CAR-T drugs.

→ Fol­low­ing its first pub­lic ap­pear­ance with $14 mil­lion in Se­ries A cash, Austin-based TFF Phar­ma­ceu­ti­cals an­nounced that it has tapped Glenn Mattes as CEO. A J&J vet and two-time biotech CEO, Mattes has been brought in for the long haul, trust­ed to take the biotech to com­mer­cial suc­cess. In­stead of an­tivi­ral ther­a­pies or can­cer treat­ments, how­ev­er, he will now fo­cus on TFF’s dry pow­der in­haler ver­sions of pul­monary drugs gen­er­at­ed with its name­sake, the Thin Film Freez­ing tech­nol­o­gy. He takes over from Robert Mills, who is now chair­man of the board.

David Moataze­di

→ Al­ler­gan aes­thet­ics chief David Moataze­di is leav­ing to take the helm of Evo­lus, a much small­er biotech de­vel­op­ing a ri­val to Botox. Evo­lus’ new drug DWP-450 (Prabot­u­linum­tox­inA) is un­der re­view. Moataze­di not­ed: “The team at Evo­lus has done a fan­tas­tic job in bring­ing for­ward what I be­lieve will be the most ex­cit­ing new prod­uct in aes­thet­ics. I look for­ward to work­ing with this tal­ent­ed group of pro­fes­sion­als and com­plet­ing the build out of a best in class lead­er­ship team.”

→ Six months in­to Daniel O’Con­nor’s tenure at On­cosec $ONCS, Punit Dhillon is phas­ing out even more from the biotech he co-found­ed and once helmed. In a con­sol­i­da­tion, O’Con­nor will now serve as both CEO and pres­i­dent — a role that for­mer­ly be­longed to Dhillon. Dhillon will, how­ev­er, re­main on the board.

→ In­di­cat­ing its dri­ve to gain mar­ket share in the gene en­gi­neer­ing ser­vices space, Hori­zon Dis­cov­ery has pro­mot­ed its head of com­mer­cial op­er­a­tions Ter­ry Pizzie to CEO, fill­ing a va­can­cy left by the de­par­ture of Dar­rin Dis­ley three months ago. Richard Vel­la­cott, who’s been shoul­der­ing most of the re­spon­si­bil­i­ties, will go back to just be­ing CFO. Be­fore join­ing Cam­bridge, UK-based Hori­zon last year and start­ing to build out its team, Pizzie had led com­mer­cial op­er­a­tions for Genetix and Bi­a­core.

Michael Stocum is step­ping down from Ini­va­ta, the liq­uid biop­sy com­pa­ny he’s led for four years, to make way for a new CEO “with a dif­fer­ent set of skills” as the Uni­ver­si­ty of Cam­bridge spin­out en­ters its “next stage of growth.” Stocum, for­mer­ly of GSK, found­ed and con­tin­ues to run a strat­e­gy con­sult­ing busi­ness called Per­son­al­ized Med­i­cine Part­ners.

→ A se­nior glob­al R&D leader at Genen­tech is leav­ing the biotech gi­ant for a new post at South San Fran­cis­co’s Atara Bio­ther­a­peu­tics. Di­et­mar Berg­er will join Atara $ATRA as glob­al head of R&D, tak­ing the com­pa­ny’s al­lo­gene­ic T cell treat­ments through the clin­ic. Berg­er is best known for his re­cent role at Genen­tech/Roche, where he’d been work­ing as se­nior vice pres­i­dent and glob­al head of prod­uct de­vel­op­ment with­in the com­pa­ny’s hema­tol­ogy and on­col­o­gy unit since 2014. There, he led med­ical strat­e­gy for Genen­tech’s port­fo­lio of can­cer med­i­cines, in­clud­ing glob­al fil­ings of ap­proved drugs like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. At Atara, he will man­age a slate of R&D pro­grams, in­clud­ing a CAR-T part­ner­ship with Juno co-founder Michel Sade­lain an­nounced just a day af­ter his ap­point­ment.

→ In the af­ter­math of a de­ci­sive PhII fail­ure for one in­di­ca­tion of its sole drug, Men­lo Ther­a­peu­tics $MN­LO has reshuf­fled its C-suite to divvy up ear­ly- and late-stage clin­i­cal re­spon­si­bil­i­ties. Paul Kwon, a Genen­tech vet who’s been CMO for the last two years, will now take on the role of CSO, iden­ti­fy­ing po­ten­tial new in­di­ca­tions for ser­lop­i­tant and run­ning ear­ly-stage tri­als. Mary Spell­man, pre­vi­ous­ly SVP of clin­i­cal de­vel­op­ment, has been tapped to man­age the plan­ning and ex­e­cu­tion of late-stage clin­i­cal pro­grams as CMO. The new ap­point­ments for Kwon and Spell­man, both of whom are der­ma­tol­o­gists, un­der­scores Men­lo’s con­vic­tion for its drug in the pruri­go nodu­laris itch and pso­ri­a­sis itch in­di­ca­tions, though it does have Phase II da­ta for its re­frac­to­ry cough pro­gram com­ing up lat­er this year.

Au­dentes Ther­a­peu­tics COO Na­tal­ie Holles is adding “pres­i­dent” to her ti­tle. Her new man­date cov­ers day-to-day op­er­a­tions of the com­pa­ny $BOLD, in­clud­ing R&D, man­u­fac­tur­ing, pro­gram man­age­ment and cor­po­rate de­vel­op­ment. For Au­dentes, this marks an evo­lu­tion in their lead­er­ship struc­ture, part of a quest to bring gene ther­a­py for rare dis­eases to the mar­ket.

→ As Third Rock-backed Tan­go Ther­a­peu­tics be­gins to trans­late its CRISPR-based dis­cov­ery plat­form in­to next-gen im­muno-on­col­o­gy ther­a­peu­tics, it has pro­mot­ed a found­ing staffer to the C-suite and brought in an­oth­er ex­ec from No­var­tis. New CSO Alan Huang and SVP of phar­ma­ceu­ti­cal sci­ences Charles Davis share roots in No­var­tis In­sti­tutes for Bio­Med­ical Re­search; Huang lat­er went on to be­come a con­sul­tant at Third Rock. To­geth­er with Davis, a GSK vet of 20 years, he will work to build a pipeline for the young biotech.

→ On the brink of mov­ing its fi­bro­sis drugs in­to the clin­ic, Pli­ant Ther­a­peu­tics has brought in Éric Lefeb­vre from Al­ler­gan to lead de­vel­op­ment strat­e­gy and clin­i­cal op­er­a­tions for its prod­uct can­di­dates. As CMO, over time, Lefeb­vre is ex­pect­ed to chan­nel the many skills he’s ac­crued at To­bi­ra, Janssen and GSK — rang­ing from de­vel­op­ment and med­ical af­fairs to com­mer­cial­iza­tion. He will do all this un­der the lead­er­ship of new­ly in­stalled board chair­man Hoy­oung Huh, a for­mer McK­in­sey part­ner and vet­er­an board di­rec­tor who will guide the man­age­ment team on high-lev­el busi­ness strat­e­gy.

Flex­ion Ther­a­peu­tics $FLXN has found a suc­ces­sor for re­tir­ing CFO Fred­er­ick Driscoll in David Arkowitz. Be­tween Vis­ter­ra, AM­AG Phar­ma and Mer­ck, Arkowitz has served in COO, CBO and con­troller roles in ad­di­tion to be­ing the top fi­nan­cial per­son. Ex­ecs al­so liked his com­mer­cial ex­pe­ri­ence, giv­en that Flex­ion is still rel­a­tive­ly new in the mar­ket­ing game for its in­jectable drug for os­teoarthri­tis-re­lat­ed knee pain.

→ Look­ing to bring its cell-based im­plant to the US, Cana­da’s Ser­no­va has hired Sean Hod­gins to as­sist the CEO in ex­e­cut­ing the com­pa­ny’s busi­ness de­vel­op­ment and cap­i­tal mar­ket strate­gies. The new CFO man­aged a cou­ple of Nas­daq IPOs while work­ing in the US and has han­dled sev­er­al Cana­di­an list­ings and CFO jobs since then. He re­places Scott Langille.

→ Tap­ping what they see as a boom in stem cell-based re­gen­er­a­tive med­i­cine, Tel Aviv-based Cel­lect Biotech­nol­o­gy $APOP is open­ing a US cen­ter of op­er­a­tions and wooed a for­mer GE Health­care ex­ec to lead it. An­drew Sabati­er’s of­fi­cial ti­tle will be chief busi­ness of­fi­cer, in which he will lever­age his pre­vi­ous ex­pe­ri­ence mar­ket­ing raw ma­te­ri­als to a gen­er­a­tion of biotechs de­vel­op­ing new ther­a­pies.

→ Mov­ing from one women’s health bio­phar­ma to the next, John Fair has tak­en a CBO job at Daré Bio­science $DARE. The San Diego com­pa­ny is de­vel­op­ing a non-hor­mon­al con­tra­cep­tive and a drug for fe­male sex­u­al arousal dis­or­der us­ing the ac­tive in­gre­di­ent in Vi­a­gra; Fair will be seek­ing part­ner­ships for these and oth­er re­pro­duc­tive prod­uct can­di­dates in the works.

→ Fol­low­ing a four-month search, Sy­neos Health con­clud­ed that its in­ter­im CFO Ja­son Meg­gs is the best per­son for the job left be­hind by Greg Rush. For­mer­ly an EVP and CFO of com­mer­cial so­lu­tions, Meg­gs joined INC Re­search back be­fore it merged with In­Ven­tiv Health, cre­at­ing an in­te­grat­ed com­pa­ny $SYNH with both con­tract re­search and con­tract com­mer­cial­iza­tion ca­pa­bil­i­ties.

Adare Phar­ma­ceu­ti­cals’ Prince­ton, NJ head­quar­ters is bub­bling with ac­tiv­i­ty. En­do Phar­ma vet Robert Rush is join­ing as VP, fi­nance and CFO; Ajay Damani has left Lon­za to lead Adare’s phar­ma­ceu­ti­cal tech­nolo­gies busi­ness unit as a VP; and Giuseppe Di Vin­cen­zo has been pro­mot­ed to VP, strat­e­gy. To­geth­er, they will help bal­ance an op­er­a­tion that fea­tures both in-house R&D and clin­i­cal ser­vices. Joseph Del Buono, who used to have Rush’s job, has re­signed to pur­sue oth­er op­por­tu­ni­ties.

→ Leav­ing be­hind a clin­i­cal pro­gram lead po­si­tion at Bris­tol-My­ers Squibb’s vi­rol­o­gy unit, Stephanie Noviel­lo is now the VP of clin­i­cal de­vel­op­ment at an­tibi­otics mak­er Mo­tif Bio. Noviel­lo will stay — at least ini­tial­ly — laser-fo­cused on the EMA sub­mis­sion for Mo­tif Bio’s Phase III Gram-pos­i­tive bac­te­r­i­al in­fec­tion drug iclaprim.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.