As­traZeneca spins out 6 drugs and an R&D group in­to Viela Bio, which emerges with a piv­otal pro­gram and $250M

As­traZeneca $AZN has culled its pipeline of pre­clin­i­cal through mid-stage an­ti-in­flam­ma­to­ry/au­toim­mune drugs at its big Med­Im­mune sub­sidiary in Gaithers­burg, MD and spun out six pro­grams in­to a new start­up called Viela Bio.

Viela springs in­to ex­is­tence to­day with the sup­port of a group of three mar­quee Chi­nese in­vestors who have put up $250 mil­lion to get the com­pa­ny es­tab­lished and keep all its pro­grams mov­ing for­ward un­in­ter­rupt­ed. And As­traZeneca is re­tain­ing the largest sin­gle mi­nor­i­ty stake in the com­pa­ny as it bids farewell to a group of in­ves­ti­ga­tors who have di­rect­ed this work in­side Med­Im­mune for years.

Bing Yao, the head of Med­Im­mune’s Res­pi­ra­to­ry, In­flam­ma­tion & Au­toim­mu­ni­ty In­no­v­a­tive Med­i­cines unit, is tak­ing the helm as CEO. An­oth­er As­traZeneca vet in the RIA unit, Jorn Drap­pa, will be the new chief med­ical of­fi­cer and R&D chief.

Bahi­ja Jal­lal

Yao told me in a pre­view of to­day’s an­nounce­ment that they’re still in the process of re­view­ing who at Med­Im­mune will come along. But Med­Im­mune chief Bahi­ja Jal­lal — who em­pha­sized the phar­ma gi­ant’s com­mit­ment to as­sist­ing the biotech ecosys­tem in Mary­land — says there will be no lay­offs, with some mak­ing the jump to Viela and the rest of the peo­ple at­tached to these pro­grams be­ing as­signed to oth­er projects.

“We al­ways run lean here,” says Jal­lal, so there’s no short­age of work for those who re­main. The de­part­ing group have plen­ty on their plate as well.

“It’s a rich pipeline,” says Yao, cit­ing a lead drug — inebi­lizum­ab — that’s in a po­ten­tial­ly reg­is­tra­tional Phase IIb study for a rare con­di­tion called neu­romyelitis op­ti­ca. Both the FDA and the EMA have en­dorsed the work with or­phan drug sta­tus. The oth­er two clin­i­cal pro­grams are ME­DI4920, an an­ti-CD40L-Tn3 fu­sion pro­tein for an in­flam­ma­to­ry con­di­tion called pri­ma­ry Sjö­gren’s syn­drome, and ME­DI7734 for myosi­tis.

The con­sor­tium of in­vestors in­cludes Boyu Cap­i­tal, 6 Di­men­sions Cap­i­tal and Hill­house Cap­i­tal, which all met Yao’s cri­te­ria: Deep pock­ets, a longterm view of things and a big ap­petite for biotech. Boyu is an in­flu­en­tial pri­vate eq­ui­ty group that al­so backed Greg Ver­dine’s LifeM­ine. And Wuxi Health­care Ven­tures threw in with Front­line BioVen­tures to cre­ate 6 Di­men­sions in a merg­er last year.

In the long run, says the new­ly mint­ed CEO, these are the kind of back­ers that will help build a staff of 100 over the next few years, while al­so as­sist­ing as Viela be­gins the ear­ly work of scout­ing the com­mer­cial prospects of its lead ther­a­py. Viela, he says, can go all the way in be­com­ing a ful­ly in­te­grat­ed biotech com­pa­ny.

As­traZeneca has been shed­ding as­sets for years now as it con­cen­trates its R&D cash around three key fields: On­col­o­gy first and fore­most fol­lowed by car­dio/meta­bol­ics and res­pi­ra­to­ry. The clin­i­cal stage drugs be­ing spun out to­day have been list­ed with the re­main­der of the neu­ro­sciences pro­grams as the “oth­er” cat­e­go­ry of work be­ing done at As­traZeneca, and ex­ecs em­pha­sized that they’re re­tain­ing the Phase III lu­pus drug an­i­frol­um­ab, where they have high hopes of suc­cess.

A spin­out like this, says Jal­lal, is a nat­ur­al re­sult when you have a rich pipeline like As­traZeneca’s, where there are more drugs to de­vel­op than it can han­dle alone.

 

 

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.