R&D

Novartis CEO Vas Narasimhan lines up his late-stage blockbuster contenders — mixing old favorites and add-ons

Every Big Pharma company is judged by its late-stage pipeline and the number of prospective blockbusters in play. Novartis CEO Vas Narasimhan is giving his pivotal strategy top marks today as the giant player reviews its development game plan in the wake of a couple of key setbacks.

Adding it all up, Novartis is using its R&D review to highlight a tally of 26 blockbusters in the pipeline, 13 projects in what is now grouped into cell, gene and radioligand work — adding radiopharmaceuticals to the group — while aiming for 60 “major” regulatory submissions from 2019-2022. And it’s already lining up promised approvals for next year, betting that they can shoot for key regulatory OKs based on the data in hand.

The move to ease concerns about the company’s future revenues comes after Novartis reported that the FDA had rejected its big application to sell canakinumab for heart disease, wiping out one of their earlier boasts, with a decision on the generics side of the business to throw in the towel on a Rituxan copycat rather than try to make a mark as a runner-up in that heavily contested field.

Of all the Big Pharma players, Novartis has been one of the least reluctant to promote the scale of its in-house work, with lots of big numbers when it comes to future opportunities for drugs that can earn $1 billion or more per year. Even in late-stage development, though, the odds of success can be daunting — and Novartis will find plenty of challenges in getting these drugs to market.

Keep in mind, Novartis is one of the top spenders in R&D, with a budget of close to $9 billion last year — just behind Roche and Merck. And that raises the bar considerably on their performance in an era of steadily dwindling ROI for the top companies in drug development.

Here are the top drugs now spotlighted in late-stage development at Novartis:

  • AVXS101, which Novartis says should be good to go for a marketing approval in H1 of next year. Back in April, Narasimhan made his biggest bet yet with his $8.7 billion deal to buy AveXis and expand the company’s profile in gene therapy. It was a bold move, and there are plenty of great expectations on the line after this program delivered some impressive results for spinal muscular atrophy. This could be a big headache for Biogen, which has been racking up big sales for its SMA drug Spinraza — which also highlights Novartis’ opportunity.
  • Mayzent (siponimod) should launch in Q1 for multiple sclerosis, says Novartis. Company officials described this drug’s latest results as “pretty much the first and only study in secondary progressive MS that showed meaningful results.” Novartis needs this one badly as its $3.2 billion franchise for Gilenya is about to get hit. Analysts have offered a $3 billion peak sales projection to help out.
  • Arzerra — OMB157 (ofatumumab) — has caused plenty of headaches for Novartis this year. They were forced to pull it off the market outside the US as competition heated up for the leukemia drug. Novartis thinks it can repurpose this drug, though, for MS, calling it a “next generation B-cell depletor with a potentially favorable safety profile from faster b-cell repletion and preserved immunity, and with a convenient monthly sub-cutaneous dosing.”  
  • Novartis has a CRTh2 receptor antagonist for moderate to severe asthma called QAW039 (fevipiprant) which is being lined up for a pitch. Novartis has insisted for years this oral therapy is a potential blockbuster, but it hasn’t been in the spotlight as much as you might expect for a would-be top contender.
  • RTH258 (brolucizumab) is slated to be the big Regeneron rival to Eylea that can slice away a chunk of the blockbuster franchise with an easier dosing regimen. It’s been a top contender at Novartis for some time, but analysts have begun to raise doubts as Regeneron came on with its own new dosing strategy and Roche jumped in as well with its own contender, faricimab, which has 16-week data to boast about.
  • Novartis has had plenty of issues with being a little later to the game than planned, and that has been on display with its sickle cell disease drug SEG101 (crizanlizumab). The therapy has demonstrated a doubling of the response rate over placebo in preventing a painful vaso-occlusive crisis for patients. But after initially inking in a 2018 filing timeline, Novartis has shifted back to 2019.
  • Just a couple of weeks ago Novartis acknowledged that regulators had batted back its application to market ACZ885 (canakinumab) for cardio risk reduction, but company execs immediately pivoted to their work in cancer, with 3 Phase lll trials in adjuvant NSCLC, 1st line NSCLC, and 2nd line NSCLC. Novartis says it has a shot at becoming the “standard of care in these settings,” but they often hype prospects.

Not all of these drugs will make it, but they do help raise the bar for R&D performance in this sector as other Big Pharma rivals angle in with their own development strategies. Novartis has also shown that it’s capable of surprise, so don’t expect this tally to remain static through 2019.


Image: Vas Narasimhan. AP IMAGES


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