Bris­tol-My­ers vet Car­o­line Loew heads up Glympse Bio; Kalei­do nabs GSK's CMO Katharine Kno­bil

Bris­tol-My­ers Squibb vet Car­o­line Loew has trad­ed an R&D strat­e­gy and plan­ning role for the top job at Glympse Bio. Af­ter a 20-year ca­reer in drug de­vel­op­ment, with stints at Mer­ck and PhRMA, Loew will now lead the Arch-backed start­up in ad­vanc­ing its in vi­vo dis­ease-mon­i­tor­ing ac­tiv­i­ty sen­sors.  

Katharine Kno­bil

Kalei­do Bio­sciences has scooped Katharine Kno­bil from Glax­o­SmithK­line to be­come its CMO and head up R&D. Found­ed by Flag­ship Pi­o­neer­ing in 2015 and boost­ed by a $101 mil­lion mega-round this year, the biotech is de­vel­op­ing a pipeline of mi­cro­bio­me-based ther­a­pies that Kno­bil is tasked with steer­ing in­to Phase II in 2019.

Thomas Can­nell has brought fel­low phar­ma vet Den­nis Kim to his team at Sesen Bio as he steers the new­ly re­named com­pa­ny through a Phase III tri­al for the blad­der can­cer treat­ment Vicini­um (VB4-845). Be­tween Ipsen, Spec­trum, No­var­tis, Bio­gen and Am­gen, the new CMO has been in­volved in the ap­proval and com­mer­cial­iza­tion of more than 10 prod­ucts in on­col­o­gy and im­munol­o­gy, the com­pa­ny says.

→ Gene ther­a­py de­vel­op­er Pre­vail Ther­a­peu­tics is shak­ing up its C-suite for the new year. Brett Ka­plan, a man­ag­ing di­rec­tor at Ever­core, is join­ing as CFO while Cel­gene vet Emi­ly Minkow gets a pro­mo­tion to chief busi­ness of­fi­cer from EVP of BD and strat­e­gy.

→ As Eiger Bio­Phar­ma­ceu­ti­cals $EIGR ral­lies for a po­ten­tial piv­ot in­to com­mer­cial stage, it’s re­cruit­ed sea­soned fi­nan­cial ex­ec Sri Ryali to its lead­er­ship. Most re­cent­ly at Aim­mune, where he helped lead an IPO, Ryali’s pre­vi­ous work ex­pe­ri­ence spans Jazz, Onyx and Am­gen. He re­places James Welch as CFO.

→ In con­junc­tion with an or­ga­ni­za­tion­al over­haul that in­volves cut­ting a quar­ter of its staff, MiMedx is al­so re­struc­tur­ing its C-suite. Chris Cash­man is out as the strug­gling biotech elim­i­nates the chief com­mer­cial of­fi­cer post that he oc­cu­pied. And then there’s the string of pro­mo­tions: Mark Landy to chief strat­e­gy of­fi­cer, David Ma­son to chief med­ical of­fi­cer (re­plac­ing Don­ald Fer­rerolf, who’s re­tir­ing); and John Har­ris to SVP, mar­ket­ing and busi­ness de­vel­op­ment.

→ On the heels of its first pos­i­tive da­ta read­out in months, Lund­beck an­nounced An­ders Gersel Ped­er­sen is re­tir­ing from his role as head of R&D af­ter 19 years with the com­pa­ny.

Thomas Wes­sel

→ Build­ing on decades of ex­pe­ri­ence in neu­ro­log­i­cal drug de­vel­op­ment — fea­tur­ing CMO stints at Acor­da and Flex Phar­maThomas Wes­sel has tak­en up a new chal­lenge to lead Swiss biotech As­ceneu­ron’s ex­pan­sion in­to the US as its CMO. He will over­see reg­u­la­to­ry and clin­i­cal de­vel­op­ment for de­men­tia treat­ment ASN120290 from the com­pa­ny’s new of­fices in Cam­bridge, MA.

→ On the verge of start­ing Phase III tri­als for reza­fun­gin, Cidara Ther­a­peu­tics $CDTX has tapped for­mer Gold­man Sachs man­ag­ing di­rec­tor James Levine as CFO. Al­so join­ing the com­pa­ny: Jes­si­ca Oien, gen­er­al coun­sel and sec­re­tary.

→ Af­ter 30 years launch­ing and mar­ket­ing drugs for the likes of Cel­gene, J&J and Bris­tol-My­ers Squibb, Mark Kre­ston is tak­ing his com­mer­cial chops Knopp Bio­sciences. As chief com­mer­cial of­fi­cer, he is tasked with de­vis­ing a glob­al strat­e­gy for the com­pa­ny’s treat­ments for in­flam­ma­to­ry and neu­ro­log­i­cal dis­eases, some of which are poised for Phase II and III stud­ies.

→ Two ex­ecs on Cel­gene’s CAR-T team have jumped to Omeros. Daniel Kir­by has been named VP and head of com­mer­cial, while Justin Mc­Cue will be­come VP of chem­istry, man­u­fac­tur­ing and con­trols, with re­spon­si­bil­i­ties over all of Omeros’ pro­grams rang­ing from eye ther­a­py to blood clot treat­ment.

→ Eye­ing an en­try in­to the clin­ic next year, Re­lay Ther­a­peu­tics has hired Mary Mad­er from Eli Lil­ly to be VP of chem­istry and Ve­rastem’s Ma­hesh Pad­val as SVP of phar­ma­ceu­ti­cal drug de­vel­op­ment.

William West­lin is the new EVP of R&D at eGe­n­e­sis, lead­ing the xeno­trans­plan­ta­tion re­search and prod­uct de­vel­op­ment work for the George Church spin­out. He pre­vi­ous­ly held sim­i­lar roles at Nim­bus Ther­a­peu­tics and Avi­la Ther­a­peu­tics, but har­vest­ing an­i­mal or­gans for hu­man use will be a new field for him.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

It’s also likely to be a much less controversial post than his board position at Pfizer, which stirred criticism from Democratic presidential candidate Elizabeth Warren.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.