Peer Re­view: Ru­bius re­cruits BD chief; Epizyme hires No­var­tis vet as CFO

Kris Elverum

Ru­bius Ther­a­peu­tics — clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny de­vel­op­ing a new class of med­i­cines called red cell ther­a­peu­tics — made the ad­di­tion of Kris Elverum to its se­nior lead­er­ship team as SVP of busi­ness de­vel­op­ment and strat­e­gy. Elverum joins the com­pa­ny from Turn­stone Bi­o­log­ics and has pre­vi­ous­ly served at SQZ Biotech, No­var­tis and McK­in­sey & Co

→ As Epizyme preps a tran­si­tion to the com­mer­cial stage — which could come as ear­ly as next Jan­u­ary if the FDA comes through — it’s in­stalling Pao­lo Tombe­si as CFO. A No­var­tis vet, Tombe­si has over­seen a sim­i­lar tran­si­tion for In­smed, help­ing launch a sub­sidiary in Japan and bring­ing in more than $1 bil­lion by Epizyme’s count. Aside for the sar­co­ma ap­pli­ca­tion, now un­der pri­or­i­ty pre­view, a sec­ond NDA for tazeme­to­stat is slat­ed for lat­er this year, he added.

Jim Wil­son and Steve Squin­to has en­list­ed two more ex­ecs to their lean team at Pas­sage Bio in pur­suit of AAV gene ther­a­pies to treat rare mono­genic cen­tral ner­vous sys­tem dis­eases. Jill Quigley, who’s cred­it­ed for ad­vice and ne­go­ti­a­tions in the Shire/NPS and Gilead/Phar­mas­set ac­qui­si­tions, has been tapped as COO and gen­er­al coun­sel, while Bio­gen vet Alex Fo­topou­los is com­ing on board as CTO. Hav­ing over­seen tech­ni­cal op­er­a­tions at Ul­tragenyx’s gene ther­a­py unit (ac­quired from Di­men­sion), Fo­topou­los will now lead the buildup of Pas­sage’s man­u­fac­tur­ing ca­pa­bil­i­ties as it ad­vances lead pro­grams in GM1 gan­gliosi­do­sis, fron­totem­po­ral de­men­tia and Krabbe dis­ease in­to the clin­ic in 2020.”

Alex Fo­topou­los

Cor­bus Phar­ma­ceu­ti­cals — a Phase III clin­i­cal-stage com­pa­ny fo­cused on the de­vel­op­ment and com­mer­cial­iza­tion of ther­a­peu­tics to treat in­flam­ma­to­ry and fi­brot­ic dis­eases — re­cent­ly hired Kaizar Lehri as head of glob­al sup­ply chain. Lehri joins the com­pa­ny as their lead prod­uct can­di­date, lenaba­sum — a syn­thet­ic, oral, se­lec­tive cannabi­noid re­cep­tor type 2 (CB2) ag­o­nist —  is cur­rent­ly be­ing eval­u­at­ed in sys­temic scle­ro­sis, cys­tic fi­bro­sis, der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus. Lehri has had stints as as­so­ciate di­rec­tor, sup­ply chain process op­ti­miza­tion and ef­fec­tive­ness at Bio­gen and di­rec­tor, sup­ply chain op­er­a­tions at Re­gen­eron.

→ Since seal­ing a deal for Avi­ra­gen Ther­a­peu­tics to serve as Vaxart’s shell in a re­verse merg­er, Joseph Pat­ti has re­treat­ed to the back bench­es. But he’s jump­ing back to the front lines now as CEO of Ag­ilVax, tak­ing a stab at an­ti­body-based can­cer ther­a­pies. He suc­ceeds Fed­er­i­ca Per­i­cle, who is leav­ing the Al­bu­querque-based biotech for an­oth­er op­por­tu­ni­ty. Ag­ilVax prod­ucts go af­ter xCT, an amino-acid trans­porter over­ex­pressed in sev­er­al can­cers and sus­pect­ed to play a role in metas­ta­sis. Pat­ti — a sci­en­tif­ic co-founder of Bris­tol-My­ers Squibb ac­quired In­hib­i­tex — is tasked with steer­ing the two lead drugs in­to clin­i­cal tri­als, in com­bi­na­tion with chemo, check­point or KRAS in­hibitors. 

→ Five months af­ter leav­ing Vivek Ra­maswamy’s rare dis­ease off­shoot En­zy­vant, Alvin Shih has land­ed his next CEO job at Dis­arm Ther­a­peu­tics. In­cu­bat­ed out of At­las Ven­ture’s Cam­bridge, MA hatch­ing grounds, the biotech is ze­ro­ing in on SARM1 in hopes of dis­rupt­ing the process of ax­on­al de­gen­er­a­tion. Shih’s ex­pe­ri­ence with rare neu­ro­log­i­cal dis­eases preps him for the chal­lenge of ap­ply­ing this tech­nol­o­gy to a broad range of dis­eases in­clud­ing mul­ti­ple scle­ro­sis and ALS to pe­riph­er­al neu­ropathies, Dis­arm said.

Alvin Shih

→ France’s Im­Check Ther­a­peu­tics has put Re­cep­tos alum Paul Frohna in charge of its im­mune mod­u­la­tor pro­grams across can­cer and au­toim­mune dis­eases. As the com­pa­ny’s first CMO, Frohna will lead an an­tic­i­pat­ed en­try in­to the clin­ic by ear­ly 2020. He brings some fresh ex­pe­ri­ence from the same role at Bion­iz, a biotech in Irvine, Cal­i­for­nia he’d helped cre­ate. In­stead of cy­tokines, though, his new niche will be g9d2 T cells and a nov­el fam­i­ly of im­munomod­u­la­tors dubbed bu­ty­rophilins. 

→ With a num­ber of pro­grams for eye and neu­rode­gen­er­a­tive dis­eases in mid-stage stud­ies, Alka­h­est is ap­par­ent­ly con­fi­dent enough about its an­ti-ag­ing plat­form to be­gin scout­ing part­ner­ships. Robert Klein will be head­ing up that ef­fort as its new­ly-mint­ed CBO, lever­ag­ing his back­ground in neu­ro­science drug de­vel­op­ment as well as re­cent ex­po­sure to busi­ness de­vel­op­ment. Re­cent stints in­clude CEO at iKaryos Di­ag­nos­tics and CSO at Amnestix. Alka­h­est al­ready has an al­liance with Spain’s Gri­fols, an ear­ly be­liev­er in its pro­tein prod­ucts de­rived from blood plas­ma.

NeuBase Ther­a­peu­tics wel­comed Danith Ly aboard as their CSO. Ly is cred­it­ed as the pri­ma­ry in­ven­tor of the com­pa­ny’s pep­tide nu­cle­ic acid (PNA) an­ti­sense oligonu­cleotide (PA­TrOL) plat­form tech­nol­o­gy. Pri­or to join­ing the com­pa­ny, Ly co-found­ed PNA In­no­va­tions (now Tru­code Gene Re­pair) and held stints as a sci­en­tif­ic ad­vi­so­ry board mem­ber at He­lixBind and a mem­ber of the board of di­rec­tors of Karuna Com­mune En­ter­prise. He is a found­ing di­rec­tor of the Bio­mol­e­c­u­lar De­sign and Dis­cov­ery In­sti­tute (BDI) at Carnegie Mel­lon Uni­ver­si­ty. In ad­di­tion to his role at NeuBase, Dr. Ly will main­tain his fac­ul­ty ap­point­ment as pro­fes­sor of chem­istry at Carnegie Mel­lon Uni­ver­si­ty’s Mel­lon Col­lege of Sci­ence.

Verb Sur­gi­cal — the ro­bot­ic surgery joint ven­ture from Ver­i­ly and J&J —  tapped Kurt Azarbarzin as its pres­i­dent and CEO. Azarbarzin joins the com­pa­ny from his la­paro­scop­ic surgery start­up, SurgiQuest — known for its FDA-ap­proved AirSeal de­vice. Azarbarzin was CEO of SurgiQuest un­til its ac­qui­si­tion in 2015 by Con­med, where he then be­came Con­med’s chief tech­nol­o­gy of­fi­cer.

Joseph Pa­pan­drea

Joseph Pa­pan­drea hopped to Zynex — a com­pa­ny that sells elec­trother­a­py med­ical de­vices used for pain man­age­ment, such as Neu­ro­Move — as their COO. Pri­or to jump­ing aboard Zynex, Pa­pan­drea was the vice pres­i­dent of op­er­a­tions at Ar­row Elec­tron­ics — a glob­al provider of elec­tron­ic com­po­nents and en­ter­prise com­put­ing so­lu­tions. Pa­pan­drea has al­so held var­i­ous stints in Aus­tralia, Sin­ga­pore, Ger­many, the UK, Chile and the US in a va­ri­ety of se­nior lead­er­ship roles. 

KE­PRO ap­points John Malanows­ki as chief peo­ple of­fi­cer. In this new role, Malanows­ki will be in charge of tal­ent man­age­ment, lead­er­ship de­vel­op­ment and com­pen­sa­tion and ben­e­fits. Malanows­ki re­cent­ly served as the in­ter­im chief hu­man re­source of­fi­cer for Virence Health Tech­nolo­gies and Uni­ver­si­ty of Texas, South­west­ern Med­ical Cen­ter. 

Ar­cis Biotech­nol­o­gy — a nu­cle­ic acid sam­ple prepa­ra­tion provider — has tapped pro­fes­sor Steve How­ell as non-ex­ec­u­tive chair­man to suc­ceed Paul Foul­ger, who was serv­ing as the in­ter­im chair­man on be­half of the board. How­ell joins the com­pa­ny af­ter their re­cent an­nounce­ments of strate­gic dis­tri­b­u­tion and li­cens­ing agree­ments with Open­trons and Mir­nax Biosens re­spec­tive­ly. How­ell found­ed In­no­va Part­ner­ships in 2006, where he helped cre­ate over a dozen life sci­ence start-ups and raised in ex­cess £100M in fi­nanc­ing. How­ell has al­so held po­si­tions at Unilever, Alere and Uni­path. In 2015, he was made vis­it­ing pro­fes­sor of com­mer­cial in­no­va­tion at King’s Col­lege, Lon­don.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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