Big day loom­ing, No­var­tis' new CEO Vas Narasimhan read­ies his jump in­to a mar­ket­ing melee

Joe Jimenez
The view from John Car­roll

Next week, No­var­tis CEO Joe Jimenez will of­fi­cial­ly hand over the reins to Vas Narasimhan, a top ex­ec­u­tive at the multi­na­tion­al com­pa­ny that has scored some stand­out ap­provals dur­ing his two-year stretch run­ning the D side of R&D. And much of his near-term grades on the big test to come will sit square­ly on the fate await­ing his top picks for Phase III de­vel­op­ment projects.

To­day, No­var­tis gen­er­al­ly sat­is­fied an­a­lysts with a Q4 record that in­di­cat­ed its big woes with Gleevec copy­cats are be­ing man­aged as a set of new drugs — par­tic­u­lar­ly Cosen­tyx , Kisqali and En­tresto — gains mar­ket trac­tion as their pi­o­neer­ing CAR-T Kym­ri­ah be­gins to get es­tab­lished. That’s al­lowed the com­pa­ny to look for­ward to some mod­est growth again, trig­ger­ing a sharp 4% spike in the stock price Wednes­day morn­ing.

This year No­var­tis will jock­ey a set of drugs in a race that in­cludes the first CGRP mi­graine drug ap­proval for erenum­ab, al­lied with Am­gen and a near cer­tain win­ner at the FDA, with lots of com­pe­ti­tion bit­ing on their heels.

Kym­ri­ah will al­so al­most cer­tain­ly ex­pand its port­fo­lio of in­di­ca­tions, go­ing head-to-head with an ag­gres­sive group of play­ers at Gilead on DL­B­CL soon.

RTH258 (brolu­cizum­ab) is be­ing po­si­tioned to carve out some block­buster mar­ket ter­ri­to­ry from Re­gen­eron’s key Eylea fran­chise, some­thing that biotech is al­ready prep­ping for as Re­gen­eron hunts an OK for a quar­ter­ly in­jec­tion of Eylea, look­ing to kick back against what will be a big ad­van­tage for No­var­tis with 12-week dos­ing. Re­gen­eron, though, has al­so been ham­pered by the fail­ure of its next-gen com­bos.

Ap­provals with­out sig­nif­i­cant rev­enue in the bal­ance won’t get cel­e­brat­ed at No­var­tis un­der Narasimhan. Acute­ly aware of the chal­lenges pay­ers throw in the face of ex­pen­sive new heart meds, the com­pa­ny is po­si­tion­ing canakinum­ab — the big sur­prise in the pipeline — for a par­tic­u­lar slice of the tough car­dio mar­ket that is like­ly to ben­e­fit the most pa­tients and have the least trou­ble get­ting the drug cov­ered.

And Cosen­tyx is be­ing po­si­tioned for new in­di­ca­tions, which will al­so be chal­lenged by some heavy­weights in that mar­ket.

In every sin­gle case, the star per­form­ers in No­var­tis’ late-stage pipeline will face ei­ther di­rect, head-to-head chal­lenges or pay­er kick­backs — or both — ei­ther on the day they hit the mar­ket or what amounts to the day af­ter.

So now Narasimhan, who put the com­pa­ny in this po­si­tion as de­vel­op­ment chief, will have to prove that he can lead the mar­ket­ing team to­ward their block­buster goals in de­liv­er­ing new rev­enue from in­no­v­a­tive prod­ucts.

And then there’s 2019 and all the oth­er years that the new, young CEO plans to stay at the top.

He’s off to a sol­id start. And no one un­der­stands the pipeline strat­e­gy at No­var­tis bet­ter than Vas Narasimhan. That’s some­thing few new Big Phar­ma chiefs have been able to boast of over the past decade, a time of steadi­ly shrink­ing ROI on multi­bil­lion dol­lar R&D gam­bles. And as a re­sult, ex­pec­ta­tions are run­ning very high.

Vas Narasimhan at a Jan­u­ary 2018 news con­fer­ence in Basel. Geor­gios Ke­falas/Key­stone via AP

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

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.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

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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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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