Three se­nior Chimerix ex­ecs to hold the fort to re­place de­part­ing CEO Berrey

Michelle Berrey — the woman who re­placed Chimerix CEO Ken­neth Moch in 2014 af­ter the com­pa­ny no­to­ri­ous­ly de­nied a dy­ing child com­pas­sion­ate use of its ex­per­i­men­tal treat­ment — has stepped down for undis­closed rea­sons, the Durham, North Car­oli­na-based drug de­vel­op­er said on Wednes­day.

Berrey, who served as the com­pa­ny’s chief med­ical of­fi­cer pri­or to be­com­ing CEO, came to Chimerix from Phar­mas­set where she was al­so CMO un­til the com­pa­ny was swal­lowed by Gilead in 2012, en­abling the lat­ter to gen­er­ate bil­lions in hep C drug sales. She steered the ship at Chimerix as the com­pa­ny sought to spin set­back af­ter set­back in the late-stage de­vel­op­men­tal pro­gram of its oral an­tivi­ral drug, brin­cid­o­fovir, for the pre­ven­tion of cy­tomegalovirus (CMV) dis­ease in kid­ney trans­plant pa­tients.

Gar­rett Nichols

Even­tu­al­ly, the com­pa­ny ter­mi­nat­ed de­vel­op­ing the drug in that in­di­ca­tion and shift­ed fo­cus to test­ing the drug for small­pox, among oth­er pa­tient pop­u­la­tions. Da­ta from two piv­otal small­pox stud­ies in rab­bits and mice are ex­pect­ed this year, and if pos­i­tive will form the ba­sis of a mar­ket­ing ap­pli­ca­tion. Mean­while, an IV ver­sion of brin­cid­o­fovir is al­so in de­vel­op­ment.

Over the last three years, the com­pa­ny has kept a rel­a­tive­ly low-pro­file. On Wednes­day, Chimerix said a new­ly cre­at­ed of­fice of the CEO — en­cap­su­lat­ing three se­nior ex­ec­u­tives Gar­rett Nichols, Tim­o­thy Trost and Michael Al­rutz — will man the fort while a re­place­ment for Berrey is found.

Michael Al­rutz

The three will al­so con­tin­ue to serve in their orig­i­nal posts: Nichols as CMO; Trost as CFO, se­nior VP and cor­po­rate sec­re­tary; and Al­rutz as se­nior VP, gen­er­al coun­sel.

Chimerix de­clined to com­ment on Berrey’s de­par­ture.

The com­pa­ny went pub­lic in 2013 un­der Moch — who quick­ly found a way to tem­per the firestorm of pub­lic crit­i­cism that emerged in re­sponse to the re­jec­tion of the com­pas­sion­ate use re­quest in 2014 — by en­rolling the child Josh Hardy in a small open-la­bel tri­al set up in agree­ment with the FDA.

Moch, who is cur­rent­ly CEO of Cog­ni­tion Ther­a­peu­tics in an emailed state­ment told End­points News: “Ac­tu­al­ly, I no­to­ri­ous­ly got Josh Hardy the drug in 120 hours af­ter our med­ical de­part­ment (led by Michelle Berry) turned down the re­quest from the Hardy fam­i­ly.”


Im­age: Michelle Berrey. CHIMERIX

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

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.

John Hood [file photo]

UP­DAT­ED: 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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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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