Bay­er, Ori­on prostate can­cer drug de­lays spread of dis­ease in PhI­II, but can it make a mark in a crowd­ed mar­ket?

Bay­er and Fin­land’s Ori­on (ORN­BV: $FH) on Wednes­day said their prostate can­cer drug, daro­lu­tamide, met the main goal in a late-stage tri­al, lift­ing Ori­on’s shares up in Helsin­ki by near­ly 10%. But the two drug­mak­ers may be late to the par­ty, with oth­er such an­dro­gen re­cep­tor (AR) in­hibitors such as Pfiz­er’s $PFE Xtan­di as well as J&J’s $JNJ new­er Er­lea­da al­ready on the mar­ket.

The tri­al test­ed daro­lu­tamide against a place­bo in more than 1,500 pa­tients with non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (nm­CR­PC) that were al­ready on stan­dard-of-care an­dro­gen de­pri­va­tion ther­a­py, and were at risk of the dis­ease spread­ing.  Da­ta showed the drug met the pri­ma­ry end­point of metas­ta­sis-free sur­vival, as it thwart­ed the can­cer from spread­ing over the course of the study. De­tailed re­sults will be pre­sent­ed at an up­com­ing sci­en­tif­ic meet­ing, the com­pa­nies said.

The Ger­man drug­mak­er agreed to de­vel­op daro­lu­tamide with Ori­on in 2014, the same year the Phase III ARAMIS tri­al com­menced.

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high lev­el AR func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

AR in­hibitors are a class of drugs de­signed to block the growth of can­cer cells by bind­ing to the an­dro­gen re­cep­tor and in­hibit­ing its func­tion. How­ev­er, oth­er biotechs such as Arv­inas $ARVN are hop­ing to go one step fur­ther to help pa­tients that progress de­spite AR in­hibitor ther­a­py by de­vel­op­ing drugs to de­grade the AR, po­ten­tial­ly re­sult­ing in more pro­found an­ti-can­cer ef­fects and dif­fer­en­tial bi­ol­o­gy, ver­sus in­hi­bi­tion.

Bay­er, which al­ready sells Xofi­go for metasta­t­ic prostate can­cer, said it plans to dis­cuss ARAMIS da­ta with health reg­u­la­tors re­gard­ing mar­ket­ing au­tho­riza­tion. The drug has al­ready se­cured fast-track sta­tus with FDA as a treat­ment for nm­CR­PC. If ap­proved, Ori­on will be in charge of man­u­fac­tur­ing and Bay­er will have the right to sell the drug glob­al­ly, al­though Ori­on has the op­tion of co-pro­mot­ing the prod­uct in Eu­rope. Up­on the first sale in the Unit­ed States, Ori­on is el­i­gi­ble to re­ceive €45 mil­lion; the num­bers are €20 mil­lion in Eu­rope and €8 mil­lion in Japan.

An­oth­er tri­al eval­u­at­ing daro­lu­tamide in pa­tients with metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC) is on­go­ing, and is ex­pect­ed to be com­plet­ed in 2022.

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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Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

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.

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.