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

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

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.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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Samsung Biologics has entered an agreement with South Korean biotech GreenLight BioSciences to manufacture its mRNA Covid-19 vaccine at commercial scale, the two companies announced.

Samsung Biologics, one of the fastest growing manufacturers in the world right now, will use its vaccine manufacturing expertise to help patients in lower-income countries, CEO John Rim said in a press release. This will help expand their capabilities from drug substance to aseptic fill-finish and all the way to commercial release from one site.

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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GenScript, Suzhou Abogen, and Walvax Biotechnology have announced the three companies will be collaborating on a Covid-19 mRNA vaccine project dubbed ABO-O28M.

WalVax will submit a BLA for the project, and GenScript will provide exclusive manufacturing services, according to Asia One.

The project stems form an agreement between Abogen, the  Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax, which gained clinical trial approval in June 2020. It was one of the first vaccine projects approved by China’s government, and GenScript used its plasmid GMP manufacturing to accelerate into clinical trials.

Lisa Deschamps, AviadoBio CEO

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

‘So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,” he told Endpoints News. 

Amgen’s blockbuster Otezla just racked up another Phase III win as it looks to continue expanding on its multibillion-dollar revenue stream.

The drug hit the primary endpoint in a trial researching its use in moderate to severe genital psoriasis, Amgen announced in the topline readout Wednesday afternoon. On top of that, all secondary endpoints were hit, demonstrating ‘meaningful and significant improvements,’ the company said.
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