Eli Lil­ly vet jumps aboard Po­laris Part­ners; Mi­rati shakes up its lead­er­ship team with new hires and pro­mo­tions

Dar­ren Car­roll Po­laris

Po­laris Part­ners has snagged Eli Lil­ly vet Dar­ren Car­roll as a part­ner. Car­roll spent 22 years at Eli Lil­ly be­fore mak­ing the switch to the in­vest­ment firm’s Boston of­fice. Most re­cent­ly, Car­roll served as SVP of cor­po­rate busi­ness de­vel­op­ment at Lil­ly, where he over­saw the $8.1 bil­lion ac­qui­si­tion of Loxo On­col­o­gy and the di­vesti­ture of an­i­mal health com­pa­ny Elan­co. Car­roll is cred­it­ed with form­ing Lil­ly Asia Ven­tures and was the found­ing CEO of Lil­ly spin­out In­no­Cen­tive.

Vick­ie Reed Mi­rati

Mi­rati Ther­a­peu­tics — a keen­ly watched ri­val to Am­gen in the KRAS G12C field — has made some changes in its ex­ec­u­tive team. The biotech wel­comed for­mer Spark Ther­a­peu­tics ex­ec Daniel Fa­ga as COO and Bris­tol-My­ers Squibb vet Ben­jamin Hick­ey as CCO. In ad­di­tion, the com­pa­ny pro­mot­ed Vick­ie Reed to SVP, fi­nance and chief ac­count­ing of­fi­cer and Jes­si­ca Cor­son as VP, busi­ness de­vel­op­ment — both joined in 2013.

MBX Bio­sciences has tapped co-founder and board di­rec­tor Kent Hawry­luk to run the com­pa­ny as pres­i­dent and CEO. Hawry­luk hops over af­ter a stint as CBO of Avid­i­ty Bio­sciences, which he al­so co-found­ed. As a part­ner of Twi­light Ven­ture Part­ners, his pre­vi­ous ex­pe­ri­ence in­cludes help­ing launch Mar­ca­dia Biotech (ac­quired by Roche) and MB2 (ac­quired by No­vo Nordisk). In ad­di­tion to Hawry­luk, the com­pa­ny has brought on Greg Davis as VP, prod­uct de­vel­op­ment. Davis most re­cent­ly had a stint as VP of CMC, reg­u­la­to­ry qual­i­ty at Cal­ib­ri­um (ac­quired by No­vo Nordisk).

→ Months af­ter step­ping down as the North Amer­i­ca pres­i­dent of So­bi, Ra­mi Levin has been ap­point­ed to be CEO at San­iona — fo­cused on the treat­ment of eat­ing dis­or­ders and dis­eases of the cen­tral ner­vous sys­tem. Levin will suc­ceed Jør­gen Drejer, who will tran­si­tion to the role of CSO. Pri­or to his 5-year tenure at So­bi, Levin head­ed mar­ket­ing at Mer­ck Serono.

James Has­sard

→ J&J-part­nered Ar­row­head Phar­ma­ceu­ti­cals has tapped James Has­sard as the com­pa­ny’s first CCO to be­gin map­ping a com­mer­cial path for its RNAi ther­a­pies. Most re­cent­ly, Has­sard served as SVP of mar­ket­ing and mar­ket ac­cess at Co­herus Bio­Sciences. Pri­or to that, he held stints at Medi­va­tion, Am­gen and Scher­ing Plough.

→ As its lead ther­a­py clears a piv­otal Phase II, bring­ing it clos­er to its first BLA, ADC Ther­a­peu­tics has tapped Joseph Ca­mar­do as head of med­ical af­fairs. In his new role, Ca­mar­do will be re­spon­si­ble for en­sur­ing “op­ti­mal med­ical im­pact” for lon­cas­tux­imab tesirine (AD­CT-402) among pa­tients with B-cell non-Hodgkin lym­phoma. Ca­mar­do joins the Swiss biotech af­ter a stint as SVP of Cel­gene’s glob­al health, which fol­lowed po­si­tions at For­est Re­search In­sti­tute and Wyeth Re­search (now Pfiz­er).

→ Af­ter scrap­ping their Phase I pro­gram and hav­ing their CSO hit the ex­it last May, Ger­man biotech Af­fimed has brought on An­dreas Harstrick as CMO. Most re­cent­ly, Harstrick served in the same role at Mol­e­c­u­lar Part­ners. Harstrick is an alum­nus of Im­Clone, Lil­ly On­col­o­gy and Mer­ck Serono.

→ Dyve Bio­sciences has named Pfiz­er vet Chuck Har­bert as CSO — fol­low­ing the re­cent clear­ance the com­pa­ny re­ceived to be­gin a Phase II tri­al for their drug, DYV-700. Har­bert spent three decades at Pfiz­er be­fore tran­si­tion­ing to his new role. Dur­ing his time at the phar­ma gi­ant, Har­bert served as VP, US ex­plorato­ry de­vel­op­ment and strate­gic plan­ning and had roles at Pfiz­er Cen­tral Re­search. In ad­di­tion, Har­bert was the co-in­ven­tor of Zoloft.

MB Chi­nap­pa

Bio­con Bi­o­log­ics, a sub­sidiary of Bio­con, has ap­point­ed MB Chi­nap­pa as CFO. Chi­nap­pa’s ap­point­ment comes at the same time as pri­vate eq­ui­ty fund True North’s ac­qui­si­tion of 2.44% of the com­pa­ny in a deal worth $74 mil­lion. Chi­nap­pa makes the jump from one of Bio­con’s oth­er sub­sidiaries, Syn­gene, where he was pres­i­dent (fi­nance) and CFO. Chi­nap­pa led the Syn­gene’s IPO in 2015.

Mo­men­ta Phar­ma­ceu­ti­cals has added the ti­tle of CFO to the com­pa­ny’s CBO Young Kwon. Kwon joined the com­pa­ny in 2011 and pri­or to that, he worked at Bio­gen and Ad­vanced Tech­nol­o­gy Ven­tures.

AVEO — which had their drug tivozanib spurned once again by the FDA two months ago — has ap­point­ed Er­ick Lucera to the po­si­tion of CFO. Pri­or to join­ing the com­pa­ny, Lucera served in the same role at Va­ler­i­tas. Be­fore that, he was the CFO, trea­sur­er and sec­re­tary of Viven­tia Bio (ac­quired by Eleven Bio­ther­a­peu­tics and now Sesen Bio).

→ Can­del Ther­a­peu­tics — fo­cused on the de­vel­op­ment of vi­ral im­munother­a­pies for mul­ti­ple tu­mor in­di­ca­tions — has brought on Gen­zyme vet San­dra Poole as COO. Poole was most re­cent­ly COO of Log­icBio Ther­a­peu­tics, af­ter serv­ing as EVP of tech­ni­cal op­er­a­tions and com­mer­cial de­vel­op­ment at Im­muno­Gen. Dur­ing her time at Gen­zyme, Poole over­saw bi­o­log­ics man­u­fac­tur­ing.

John Chin An­ten­gene

An­ten­gene, a US-Chi­na biotech backed by Cel­gene, has snagged one of its top ex­ecs in Chi­na. John Chin, Cel­gene’s gen­er­al man­ag­er in the coun­try, has joined as chief busi­ness of­fi­cer just a few days be­fore for­mer Cel­gene CEO Mark Alles was ap­point­ed to the board of di­rec­tors. Chin’s re­sume spans Aven­tis, Bris­tol-My­ers Squibb and Mer­ck.

Ru­bius Ther­a­peu­tics has ap­point­ed au­toim­mu­ni­ty and trans­la­tion­al im­munol­o­gy ex­pert Lau­rence Tur­ka as the biotech’s first CSO, join­ing its mis­sion to pi­o­neer a new class of med­i­cines called red cell ther­a­peu­tics. Tur­ka hops over to the com­pa­ny from Rheos Med­i­cines, where he was a co-founder and CSO. Tur­ka was an en­tre­pre­neur-in-res­i­dence at Third Rock Ven­tures, turn­ing to the VC life af­ter an aca­d­e­m­ic ca­reer that put him at the head of the Amer­i­can So­ci­ety of Trans­plan­ta­tion and a pro­fes­sor at Har­vard Med­ical School and Mass­a­chu­setts Gen­er­al Hos­pi­tal.

Abeona Ther­a­peu­tics — which had some good news last month when the FDA lift­ed its hold on the com­pa­ny’s but­ter­fly dis­ease ther­a­py — is part­ing ways with its ex­ec­u­tive chair­man Steven Rouhan­deh, re­vealed in an SEC fil­ing.

Eiger Bio­Phar­ma­ceu­ti­cals has ap­point­ed El­don May­er as EVP and CCO. May­er joins just as the com­pa­ny has ini­ti­at­ed an NDA for its drug ion­a­farnib to treat Hutchin­son-Gil­ford prog­e­ria syn­drome (HG­PS or prog­e­ria) and progeroid laminopathies. May­er had the same job at Rigel Phar­ma­ceu­ti­cals. Pre­vi­ous­ly, May­er was the SVP of com­mer­cial op­er­a­tions at Quest­cor Phar­ma­ceu­ti­cals (ac­quired by Mallinck­rodt).

→ Can­cer-fo­cused Cel­lec­tar Bio­sciences has named Ig­or Grachev as CMO. Grachev pre­vi­ous­ly served as glob­al de­vel­op­ment leader and head of in­no­v­a­tive clin­i­cal tri­als ini­tia­tive, R&D for TE­VA Phar­ma­ceu­ti­cals. His pri­or em­ploy­ers in­clude GE Health­care, No­var­tis, GSK, Mer­ck, Scher­ing PLough, Sanofi-Aven­tis and Bio­Clin­i­ca.

Michael Cooke IFM

→ The im­munol­o­gy ex­perts at IFM Ther­a­peu­tics — who brought in $55.5 mil­lion in new ven­ture back­ing last month — has wooed Michael Cooke from Ma­gen­ta Ther­a­peu­tics as CSO. Be­fore Ma­gen­ta, Cooke was a found­ing sci­en­tist at the Ge­nomics In­sti­tute of the No­var­tis Re­search Foun­da­tion.

→ An­ti-ede­ma ther­a­pies-fo­cused Aeromics has brought on Joseph Schindler as its first CMO. Schindler is an as­so­ciate pro­fes­sor of neu­rol­o­gy and of neu­ro­surgery at Yale Uni­ver­si­ty School of Med­i­cine, where he is the clin­i­cal chief of the di­vi­sion of vas­cu­lar neu­rol­o­gy. He is al­so the di­rec­tor of the com­pre­hen­sive stroke pro­gram and tele­stroke ser­vices at Yale New Haven Hos­pi­tal.

→ In­dia’s Vy­ome Ther­a­peu­tics — which back in 2016 raised $14 mil­lion for its R&D work on skin dis­eases — has named Craig Tooman COO and CFO. Pri­or to join­ing Vy­ome, Tooman served as the CEO of Aratana Ther­a­peu­tics. In ad­di­tion, Tooman has served as founder and CEO of Avan­zar Med­ical and CFO at Ikaria and En­zon Phar­ma­ceu­ti­cals.

→ Bal­ti­more-based start­up Wind­MIL Ther­a­peu­tics — spun out of John Hop­kins — has named Bris­tol-My­ers vet Karen LaRochelle as SVP, cor­po­rate & busi­ness de­vel­op­ment and pro­mot­ed Patrick Dougher­ty to SVP, strat­e­gy, plan­ning & op­er­a­tions. LaRochelle pre­vi­ous­ly served as CBO of PsiOxus Ther­a­peu­tics and dur­ing her time at BMS served as glob­al head of ne­go­ti­a­tions and head of busi­ness de­vel­op­ment in Chi­na. Pri­or to his time at Wind­MIL, Dougher­ty served as chief of staff to the SVP R&D pipeline for phar­ma­ceu­ti­cals R&D at GSK.

Vor Bio­phar­ma — the biotech co-found­ed by Sid­dhartha Mukher­jee to pi­o­neer a new type of can­cer cell ther­a­py — has made two new ad­di­tions to its team. Amy Mendel joins as chief le­gal of­fi­cer and Tania Philipps joins as VP of peo­ple. Mendel was the VP & as­so­ciate gen­er­al coun­sel for Zio­pharm On­col­o­gy while Philipps was the VP and head of hu­man re­sources at Tan­go Ther­a­peu­tics.

Ye­mi On­akun­le Se­lex­is

→ JSR life sci­ences com­pa­ny Se­lex­is has pro­mot­ed Ye­mi On­akun­le to the po­si­tion of CBO. On­akun­le joined the com­pa­ny in 2012 from Diosynth RTP, where he was the di­rec­tor of com­mer­cial de­vel­op­ment. His oth­er stints in­clude roles at Lon­za Cus­tom Man­u­fac­tur­ing and Bachem Amer­i­c­as.

Howard Kauf­man Im­muneer­ing

Im­muneer­ing — whose cur­rent pipeline fo­cus­es on dis­eases such as can­cer cachex­ia and metas­ta­sis — has brought on Howard Kauf­man as head of re­search and de­vel­op­ment. Kauf­man, the for­mer pres­i­dent of the So­ci­ety for Im­munother­a­py of Can­cer (SITC), was most re­cent­ly CMO at Replimune Group. Kauf­man’s hir­ing comes a few weeks af­ter the ap­point­ment of Scott Bar­rett to CMO at Im­muneer­ing.

→ CAR-T-fo­cused In­no­v­a­tive Cel­lu­lar Ther­a­peu­tics (ICT) has wel­comed Christo­pher Bal­las on­board as SVP of man­u­fac­tur­ing. Bal­las’ ca­reer has brought him to Rock­et Phar­ma­ceu­ti­cals, Cook Med­ical and WuXi AppTec.

Al­lu­ri­on Tech­nolo­gies has re­cruit­ed Whit­ney Cypes, for­mer se­nior di­rec­tor of mar­ket­ing for In­sulet Cor­po­ra­tion, as VP of glob­al mar­ket­ing and Chris Aron­son, for­mer­ly of Restora­tion Ro­bot­ics, as VP of North Amer­i­can sales. In ad­di­tion, Benoit Chardon was pro­mot­ed to EVP of com­mer­cial.

Eliot Forster-led can­cer biotech F-star Ther­a­peu­tics has ap­point­ed Ed­ward Benz, the pres­i­dent and CEO emer­i­tus of the Dana-Far­ber Can­cer In­sti­tute, and Min­er­va ex­ec Ge­off Race to the board of di­rec­tors.

Elias Zer­houni 

Elias Zer­houni, the for­mer R&D head at Sanofi and ex-NIH di­rec­tor, has tak­en up a seat at Way­point Cap­i­tal’s board. The Gene­va firm is led by Swiss bil­lion­aire and for­mer Serono chief Ernesto Bertarel­li and de­vised an $832 mil­lion buy­out deal to take al­ler­gy drug­mak­er Stal­ler­genes Greer pri­vate.

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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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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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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UP­DAT­ED: 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 dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Tri­fec­ta of sick­le cell dis­ease ther­a­pies ex­tend life ex­pectan­cy, but are not cost-ef­fec­tive — ICER

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.