Juno will pay $24M to set­tle the JCAR015 scan­dal — but don’t ex­pect that to change in­dus­try at­ti­tudes on re­port­ing sna­fus

A no­to­ri­ous string of pa­tient deaths caused by Juno Ther­a­peu­tics’ JCAR015 wound up killing the one-time CAR-T star, de­rail­ing their shot at join­ing the break­through race even­tu­al­ly won by No­var­tis and Kite. Through­out the con­tro­ver­sy, though, Juno ex­ecs fierce­ly main­tained that they had done every­thing by the book.

They nev­er budged an inch. Un­til now.

The com­pa­ny, now a sub­sidiary of Cel­gene, as well as for­mer CEO Hans Bish­op, have signed off on a $24 mil­lion pay­ment to the stock­hold­ers who brought a class ac­tion suit against the biotech based on their claims that the com­pa­ny had mis­led in­vestors by con­ceal­ing the death of the first pa­tient. 

Hans Bish­op

In the le­gal ac­tions that in­evitably fol­lowed, Juno’s ex­ecs fought fu­ri­ous­ly against the claims. And in this set­tle­ment, they still aren’t mak­ing any con­ces­sions on li­a­bil­i­ty. Ac­cord­ing to the pact, they sim­ply want to set­tle a lengthy and ex­pen­sive law­suit — avoid­ing a tri­al — with­out mak­ing con­ces­sions on their role.

The Puget Sound Busi­ness Jour­nal was the first to re­port the set­tle­ment sev­er­al days ago.

The time­line on this is im­por­tant. 

The suit not­ed that the first death caused by JCAR015 ini­tial­ly went un­men­tioned at Juno, leav­ing in­vestors vul­ner­a­ble to the stun­ning news a month lat­er that a se­ries of deaths forced in­ves­ti­ga­tors to stop the tri­al, with the FDA drop­ping a clin­i­cal hold on the pro­gram that blast­ed their stock price. Then, af­ter one of the short­est paus­es on record at the FDA, the agency lift­ed the hold days lat­er on Juno’s as­sur­ances that with­draw­ing one of the drugs used to prep the pa­tients would re­solve the safe­ty is­sues.

Once the drug was dosed again, though, more pa­tients died, even­tu­al­ly wreck­ing the ef­fort and leav­ing Juno to go on to fo­cus on its fol­lowup drug, JCAR017, which has im­pressed in clin­i­cal tri­als.

The mon­ey in the set­tle­ment amounts to lit­tle more than a speed­ing tick­et for Juno and its new own­ers at Cel­gene, which paid $9 bil­lion for the com­pa­ny. Twen­ty-four mil­lion dol­lars is a round­ing er­ror for the prin­ci­pals now in­volved.

Biotech com­pa­nies are of­ten loathe to pub­licly ac­knowl­edge pa­tient deaths trig­gered by their drugs. But you can on­ly get away with that large­ly un­scathed if you’re pri­vate. Pub­lic com­pa­nies are re­quired to stick to a more nar­row path. But mak­ing rel­a­tive­ly small con­ces­sions like this will on­ly send the wrong mes­sage to drug de­vel­op­ers with a pen­chant for keep­ing prob­lems un­der wraps as long as pos­si­ble, which al­so brings to mind Clo­vis’ re­cent will­ing­ness to set­tle a probe of its trou­bled ro­ci pro­gram with a $20 mil­lion pay­ment.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.