Roche ex­pands its PhI­II pro­gram for Eylea ri­val as long-act­ing da­ta back its block­buster con­tender faricimab

Roche’s Genen­tech has notched an­oth­er suc­cess on its way to chal­leng­ing Re­gen­eron — as well as the oth­er Big Phar­ma con­tender No­var­tis — for the block­buster crown now worn by Eylea.

Re­searchers at the big sub say that their bis­pe­cif­ic Ang-2/VEGF drug faricimab (you once knew it as RG7716) came up with an im­proved pro­file over their fran­chise play­er Lu­cen­tis as a long-act­ing drug for wet AMD. And they scored on long act­ing 16-week da­ta, while Re­gen­eron $REGN and No­var­tis $NVS have been duk­ing it out over the 12-week niche.

Here’s the lat­est da­ta from their Phase II STAIR­WAY study, which dosed faricimab 6.0 mg every 16 weeks or every 12 weeks, com­pared to ranibizum­ab (Lu­cen­tis) 0.5 mg every four weeks:

At week 24 (three months af­ter the last of four load­ing dos­es), pa­tients ran­dom­ized to faricimab every 16 weeks were switched to 12-week dos­ing if they were shown to have ac­tive dis­ease, per pre-de­fined cri­te­ria. At week 24, 65 per­cent (n=36/55) of peo­ple treat­ed with faricimab had no ac­tive dis­ease, high­light­ing the po­ten­tial of 16-week dos­ing in near­ly two-thirds of pa­tients. Ini­tial vi­sion gains, as mea­sured by Best Cor­rect­ed Vi­su­al Acu­ity (BC­VA), were ful­ly main­tained through to week 52 with 16- and 12-week dos­ing reg­i­mens. Peo­ple treat­ed with faricimab dosed every 16 weeks ex­pe­ri­enced a mean im­prove­ment of 11.4 chart let­ters from base­line, com­pared to 10.1 let­ters in pa­tients treat­ed with faricimab dosed every 12 weeks and 9.6 let­ters in pa­tients treat­ed with ranibizum­ab (Lu­cen­tis) 0.5 mg dosed every four weeks. 

Eylea has been the mas­ter of this mar­ket, giv­ing Re­gen­eron the lu­cra­tive fran­chise mar­ket it needs to build the com­pa­ny’s pipeline and new prod­uct of­fer­ings. No­var­tis, mean­while, has been mak­ing a mark with brolu­cizum­ab (RTH258), which it has pre­sent­ed as a ma­jor late-stage con­tender.

For Re­gen­eron, Eylea re­mains wor­thy of a vig­or­ous de­fense, even though its own next-gen drug failed to make a mark. Re­searchers for the com­pa­ny have been fight­ing back against its ma­jor league ri­vals with their own longterm da­ta aimed at pro­tect­ing its rep and bil­lions of an­nu­al rev­enue.

Roche, mean­while, is push­ing ahead in­to late-stage work — with Phase II­Is that will take con­sid­er­able time for a read­out. They’re al­ready deep in­to di­a­bet­ic mac­u­lar ede­ma and now plan to add wet AMD to the late-stage ros­ter.

Re­gen­eron has plen­ty of sup­port for its ag­gres­sive de­fense strat­e­gy, though. Leerink’s Ge­of­frey Porges, in par­tic­u­lar, has wad­ed in­to the melee, ready to de­fend the ti­tle that Re­gen­eron won ear­ly. But this fight has a ways to go, with ri­vals ready to duke it out in ways that are like­ly to play out in pa­tients’ fa­vor — one way or an­oth­er.

Levi Garraway. Broad Institute via Youtube

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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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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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.