Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thurs­day marks No­var­tis’ an­nu­al R&D day, and with it comes CEO Vas Narasimhan’s at­tempt to spot­light the com­pa­ny’s pipeline strat­e­gy and emerg­ing stars.

The biggest ques­tion en­ter­ing Thurs­day’s pre­sen­ta­tion dealt with how the big bio­phar­ma will make up rev­enues from up­com­ing gener­ic com­pe­ti­tion — No­var­tis says with­in the next five years, gener­ics will eat away rough­ly $9 bil­lion in sales. To off­set this, Narasimhan out­lined a strat­e­gy for 4% growth or high­er un­til 2026, fo­cus­ing on six key med­i­cines he be­lieves will see multi­bil­lion dol­lar prof­its dur­ing this time.

Top­ping the list are ap­proved drugs Cosen­tyx and En­tresto, which have al­ready proved big mon­ey-mak­ers for No­var­tis. The com­pa­ny ex­pects Cosen­tyx to bring in peak sales of more than $7 bil­lion, up from an an­nu­al­ized $5 bil­lion cur­rent pro­jec­tion, and En­tresto to top $5 bil­lion, up from $3.7 bil­lion an­nu­al­ized third quar­ter sales.

No­var­tis al­so ex­pects more growth out of Zol­gens­ma, the one-time gene ther­a­py that’s earned the du­bi­ous ti­tle of most ex­pen­sive drug in the world. At more than $2 mil­lion a pop, Zol­gens­ma had seen flag­ging sales due to a two-year FDA hold on tri­als for an in­trathe­cal de­liv­ery method, caus­ing No­var­tis to shut­ter a man­u­fac­tur­ing fa­cil­i­ty and lay off 400 staffers.

There’s ad­di­tion­al fo­cus on two new­er med­i­cines No­var­tis hopes can break in­to the block­buster ranks: Kisqali and Kes­imp­ta. Though Kisqali was first ap­proved four years ago, No­var­tis saw sig­nif­i­cant growth this past quar­ter and now ex­pects it should ap­proach the $1 bil­lion sales mark this year.

Round­ing out the top six, how­ev­er, is a drug that’s seen its fair share of set­backs: in­clisir­an. Af­ter ac­quir­ing the drug in its $9.7 bil­lion ac­qui­si­tion of Med­Co, No­var­tis re­ceived a sur­prise CRL in late 2020, throw­ing the drug’s launch in­to ques­tion. No­var­tis is now tar­get­ing a Jan. 1 PDU­FA date and has since seen in­clisir­an ap­proved in al­most 50 oth­er coun­tries.

For the longer term, No­var­tis high­light­ed a horde of mid-to-late stage pipeline as­sets that it thinks could one day al­so be big sales dri­vers. Among such drugs is the ra­di­oli­gand can­di­date Lu-PS­MA-617, ac­quired for $2 bil­lion and cur­rent­ly ex­pect­ed to launch in 2022, No­var­tis says. Ear­li­er this year, the com­pa­ny showed off “ground­break­ing: da­ta for the pro­gram at #AS­CO21.

No­var­tis grouped Lu-PS­MA-617 in its “high strength” ev­i­dence um­brel­la, sig­ni­fy­ing it’s ex­pect­ing big things as the ra­dio­phar­ma mar­ket be­gins to take shape in earnest.

Al­so in this group are oth­er fil­ings for its ap­proved med­i­cines, ip­ta­co­pan and lige­lizum­ab. Narasimhan high­light­ed both of these can­di­dates dur­ing last year’s R&D day as like­ly slam dunks of fu­ture growth, and both ap­pear on track to re­main that way in No­var­tis’ pro­jec­tions. Ip­ta­co­pan is ex­pect­ed to be a star kid­ney drug while No­var­tis has po­si­tioned lige­lizum­ab as a suc­ces­sor to Xo­lair.

Where No­var­tis sees on­ly “mod­er­ate” strength of ev­i­dence are two pro­grams that were once ex­pect­ed to pro­vide sol­id foot­ing, though. Narasimhan clas­si­fied pelacarsen and canakinum­ab as drugs that could see multi­bil­lion-dol­lar sales num­bers but are a bit riski­er. Pelacarsen is an an­ti­sense oligonu­cleotide be­ing de­vel­oped for the re­duc­tion of lipopro­tein(a), where­as canakinum­ab, an IL-1 in­hibitor, saw its fu­ture thrown in­to ques­tion af­ter fail­ing a lung can­cer study in Oc­to­ber.

And No­var­tis didn’t project any sort of rev­enue for an­oth­er oft-tout­ed pro­gram in is­cal­imab af­ter scut­tling a tri­al in Sep­tem­ber for the can­di­date once thought to be a leader in the com­pa­ny pipeline.

Last­ly, Narasimhan out­lined his three “Wild Card” picks — down from five last year — that are risky but po­ten­tial­ly huge­ly re­ward­ing pro­grams. All three were list­ed in 2020 as Wild Cards, and they are:

  • LNA043, an os­teoarthri­tis can­di­date. It’s cur­rent­ly in Phase IIb stud­ies and No­var­tis ex­pects a fil­ing here in 2026.
  • NIS793, a pro­gram go­ing af­ter the TGF-be­ta path­way in­hi­bi­tion and mi­croen­vi­ron­ment mod­u­la­tion in sol­id tu­mors, al­so list­ed as a 2020 Wild Card. This can­di­date, in Phase II/III stud­ies right now, has po­ten­tial as a first-line pan­cre­at­ic can­cer drug, No­var­tis says. Fil­ings are ex­pect­ed as ear­ly as 2025.
  • CSJ117, an in­haled TSLP in­hibitor. No­var­tis touts this drug as pos­si­bly the first in­haled bi­o­log­ic di­rect­ly tar­get­ing air­ways at the site of TSLP ex­pres­sion. A Phase II read­out is ex­pect­ed in 2023, an os­ten­si­ble de­lay from last year’s 2022 pro­jec­tion.
Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

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Teresa Graham, incoming Roche Pharmaceuticals CEO

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Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

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