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

Joe Jimenez
Bioreg­num
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

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.