Evan Loh climbs the lad­der to be­come CEO at Paratek Phar­ma­ceu­ti­cals; Co­di­ak's Doug Williams takes chair­man's role at AC Im­mune

Evan Loh Paratek

De­ter­mined to be the good sto­ry that the an­tibi­otics field so des­per­ate­ly needs, Paratek Phar­ma­ceu­ti­cals $PRTK is reshuf­fling its top-lev­el man­age­ment to han­dle a grow­ing com­mer­cial op­er­a­tion. Evan Loh has be­come CEO af­ter climb­ing the lad­der over the past sev­en years (from CMO to pres­i­dent and COO) while Michael Bigham claims the new­ly cre­at­ed po­si­tion of ex­ec­u­tive chair­man. They will over­see life cy­cle ex­pan­sion ini­tia­tives for Nuzyra with chief com­mer­cial of­fi­cer Adam Woodrow, who’s been pro­mot­ed to pres­i­dent. Mean­while, Randy Bren­ner will take up ad­di­tion­al re­spon­si­bil­i­ties in med­ical af­fairs af­ter lead­ing the reg­u­la­to­ry ef­forts for Paratek.

Doug Williams, the CEO at Co­di­ak, is tak­ing the chair­man’s po­si­tion at Swiss biotech AC Im­mune, which has spent years pur­su­ing new ther­a­pies for Alzheimer’s dis­ease. Williams was a top ex­ec at Bio­gen with George Scan­gos’ crew be­fore he left well ahead of the big biotech’s cur­rent tra­vails with Alzheimer’s.

Yaky Yanay Linkedin

→ Is­raeli biotech Pluris­tem has of­fi­cial­ly phased out its co-CEO struc­ture, in­stalling Yaky Yanay as the sole chief and pres­i­dent. Za­mi Aber­man will be­come ex­ec­u­tive chair­man, with a man­date to shape cor­po­rate de­vel­op­ment and busi­ness strat­e­gy. The tran­si­tion comes as the com­pa­ny wraps up its Phase III and be­gins pon­der­ing com­mer­cial­iza­tion of its pla­cen­ta-based cell ther­a­pies, which treat crit­i­cal limb is­chemia and hip frac­ture among oth­er dis­eases. 

Mar­garet Olinger Linkedin

Amy­lyx Phar­ma­ceu­ti­cals has laid rel­a­tive­ly low since break­ing out six years ago with sup­port from the late Hen­ri Ter­meer. But the young founders are now con­fi­dent enough in their Phase II work in amy­otroph­ic lat­er­al scle­ro­sis and Alzheimer’s dis­ease to re­cruit some sea­soned ex­ecs to their team. Patrick Yerami­an, who’s been con­sult­ing with the Cam­bridge, MA-based com­pa­ny, joins as the full-time CMO; Alex­ion vet Mar­garet Olinger is the new chief com­mer­cial of­fi­cer; and Tom Holmes jumps from Bio­gen to head the sup­ply chain.

→ Mov­ing fast and plan­ning way ahead have been cen­tral tenets at Ar­cus Bio­sciences, and it is once again show­ing in their ap­point­ment of a chief com­mer­cial of­fi­cer long be­fore en­ter­ing late-stage stud­ies. Er­ic Hoe­fer, an I/O vet who’s cred­it­ed for help­ing launch Imfinzi at As­traZeneca, is tasked with ad­vis­ing the team on iden­ti­fy­ing key pa­tient pop­u­la­tions, mar­ket op­por­tu­ni­ties and po­ten­tial ap­proach­es to ac­cel­er­ate de­vel­op­ment. Ar­cus’ most ad­vanced pro­gram com­bines AB928, a dual adeno­sine re­cep­tor an­tag­o­nist, and AB122, a cheap PD-1 drug li­censed from WuXi.

Mor­phoSys has re­cruit­ed ex-Syn­tim­mune chief Jean-Paul Kress to take the helm as Si­mon Mo­roney makes his planned ex­it from the C-suite. Mo­roney steps down at the be­gin­ning of Sep­tem­ber. Kress helped arrange the sale of Syn­tim­mune to Alex­ion.

Er­ic Hoe­fer Twit­ter

In the fi­nal lead-up to its all-im­por­tant BLA sub­mis­sion slat­ed for Q3, DBV Tech­nolo­gies has raid­ed Mil­len­do Ther­a­peu­tics for a new CMO. Phar­is Mo­hideen will work close­ly with CSO Hugh Samp­son, who’s been dou­bling in the med­ical role ad in­ter­im. Aside from their peanut al­ler­gy prod­uct, the French biotech is al­so de­vel­op­ing a non-in­va­sive way to de­liv­er bi­o­log­i­cal­ly ac­tive com­pounds to the im­mune sys­tem through the skin.

→ Long­time in­vest­ment banker Pe­ter Col­lum is mak­ing the leap to the in­dus­try as CFO and CBO at Pharnext, a French com­pa­ny he’s got­ten to know in the past five years. Its pleother­a­py plat­form iden­ti­fies the ide­al com­bi­na­tion of avail­able med­i­cines to fight tar­gets un­der­ly­ing, of­ten rare, dis­ease. 

Qrons has tapped John Bon­figlio to spear­head IND ac­tiv­i­ties sur­round­ing its hy­dro­gel for trau­mat­ic brain in­juries. As COO, Bon­figlio will op­er­ate from the biotech’s New York head­quar­ters and co­or­di­nate with the sci­en­tif­ic team in Is­rael. Be­fore start­ing his own con­sult­ing group, he helmed sev­er­al drug de­vel­op­ment com­pa­nies in­clud­ing TapIm­mune, Or­a­gen­ics and Pere­grine.

Paul Fos­ter Xen­cor

→ CMO and se­nior vice pres­i­dent of Xen­cor — a com­pa­ny fo­cused on de­vel­op­ing en­gi­neered mon­o­clon­al an­ti­bod­ies for the treat­ment of var­i­ous dis­eases and ill­ness­es — Paul Fos­ter will be step­ping out the door and in­to re­tire­ment ef­fec­tive Oc­to­ber 31, 2019, af­ter a decade of ser­vice. While at the com­pa­ny, Fos­ter ad­vanced a di­verse pipeline of XmAb bis­pe­cif­ic an­ti­bod­ies in­to ear­ly-stage clin­i­cal de­vel­op­ment. The com­pa­ny has ini­ti­at­ed a search for a suc­ces­sor. 

→ Mel­bourne, Aus­tralia-based Propanc Bio­phar­ma wel­comed Car­lo Campi­ciano to the ranks as CFO of the com­pa­ny. For over a decade, Campi­ciano has served as an ex­ter­nal ad­vi­sor for the com­pa­ny while al­so serv­ing as CFO of a start­up — which grew from an an­nu­al turnover of $2 mil­lion to $40 mil­lion, run­ning a pri­vate ac­count­ing prac­tice for over 30 years and serv­ing as a lec­tur­er for 12 years at Swin­burne Uni­ver­si­ty.

→ Ahead of its Phase III de­vel­op­ment of en­sifen­trine, Verona Phar­ma — a com­pa­ny fo­cused on res­pi­ra­to­ry dis­eases — added Ni­na Church and Nan­cy Her­je to the fold. GSK vet Church will serve as ex­ec­u­tive di­rec­tor of glob­al clin­i­cal de­vel­op­ment and Her­je will join as se­nior di­rec­tor of clin­i­cal op­er­a­tions. Dur­ing her 25 years at GSK, Church was in­volved in the de­vel­op­ment of Ad­vair, Anoro, Flovent, Serevent and Ven­tolin. She joins Verona from Par­i­on Sci­ences where she served as ex­ec­u­tive di­rec­tor, clin­i­cal op­er­a­tions. Pri­or to join­ing Verona, Her­je was a se­nior clin­i­cal sci­en­tist at Ex­e­cuPharm. She has had pre­vi­ous stints at Chimerix, Ae­ro­crine, In­spire and GSK

Nan­cy Her­je Linkedin

Abeona Ther­a­peu­tics — a com­pa­ny de­vel­op­ing cell and gene ther­a­pies — has strength­ened its lead­er­ship board with the ad­di­tion of Vic­tor Paulus as se­nior vice pres­i­dent of reg­u­la­to­ry af­fairs and Jodie Gillon as vice pres­i­dent of pa­tient ad­vo­ca­cy and clin­i­cal af­fairs. 

Pri­or to join­ing Abeona, Paulus served as vice pres­i­dent and glob­al head of reg­u­la­to­ry af­fairs at Hookipa Phar­ma. He’s al­so served at No­var­tis com­pa­ny, Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, where he se­cured or­phan des­ig­na­tions and prod­uct ap­provals for Gal­li­um Ga68 dotatate and Lutetium Lu177 dotatate and has held stints at GSK and Dr. Red­dy’s

Jodie Gillon Linkedin

Gillon has had over a decade of ex­pe­ri­ence at Pfiz­er — where she was the glob­al med­ical lead for pa­tient en­gage­ment. She’s al­so pre­vi­ous­ly served at Achillion Phar­ma­ceu­ti­cals, As­traZeneca, No­var­tis and Orid­ion

Im­pel Neu­roPhar­ma — fo­cused on ther­a­pies to treat pa­tients with cen­tral ner­vous sys­tem dis­or­ders, such as INP104 (POD-DHE) for acute mi­graine headaches — has tapped John Lea­man as CFO. Most re­cent­ly, Lea­man served at Se­lec­ta Bio­sciences in the same role and has served in oth­er lead­er­ship po­si­tions at Med­gen­ics, Shire and De­von Park Bioven­tures.

Vi­a­Cyte — a stem cell play­er who fu­eled up with $105 mil­lion for its next big at­tack on di­a­betes last No­vem­ber — has en­list­ed San­dra E. Poole to its board of di­rec­tors. Most re­cent­ly, Poole served as the COO of genome edit­ing com­pa­ny, Log­icBio Ther­a­peu­tics. Poole’s has held stints at Im­muno­Gen and Gen­zyme (now Sanofi Gen­zyme). Poole cur­rent­ly serves on the board of di­rec­tors of Retrophin and the su­per­vi­so­ry board of Val­ne­va, SE — a France-based vac­cine com­pa­ny. 

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.