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.

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.