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.
Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.