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Novartis sees five new $1bn-plus launches in next two years

CEO defends likely high price of Zolgensma

Novartisn

Novartis is entering one of its most productive R&D periods, with 25 potential blockbusters in the pipeline, including five new molecules which reach the market in the next two years.

That was the message delivered by CEO Vas Narasimhan at the company’s annual R&D update, as Novartis showcased a pipeline with more than 200 projects in clinical development, and 60 major submissions planned in before the end of 2021.

With psoriasis drug Cosentyx (secukinumab) and heart failure therapy Entresto (sacubitril/valsartan) already gathering momentum, Novartis is now anticipating five more billion dollar-plus launches.

That includes Mayzent (siponimod) for secondary progressive multiple sclerosis – approved by the FDA in March – as well as gene therapy Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy, brolucizumab for age-related macular degeneration (AMD), ofatumumab for relapsing MS and fevpiprant for asthma.

Vas

Vas Narasimhan

“I can't remember a time at Novartis where year after year after year we have these significant medicines getting launched,” Narasimhan told CNBC in an interview.

Among these, the one that is generating the most column inches is Zolgensma, which looks likely to become the first gene therapy blockbuster assuming it is approved for marketing, expected later this month.

Narasimhan took some time to discuss the price that might be charged for the one-shot treatment for SMA, a muscle-wasting disease, against a backdrop of earlier remarks by Novartis that it could be cost-effective at a price of $4m-$5m.

He said the price would be far lower than that, but would be set at “a fraction” of the current cost of care – which is in the $4m-$5m range over 10 years. Analysts think the eventual price will be close to $2m, while the influential Institute for Clinical and Economic Review (ICER) has suggested it should cost no more than $1.5m.

That came after it evaluated first-to-market SMA gene therapy Spinraza (nusinersen) from Biogen and concluded that the drug is overpriced. Spinraza has been on the US market since 2016, and comes in at a list price $750,000 for the initial year and $375,000 per year thereafter, a price tag that helped it reach $1.7bn in sales last year.

Novartis’ near-term pipeline has plenty more to deliver this year, including a possible approval for new breast cancer drug alpelisib (BYL719), which has bucked the trend of disappointing clinical results among PI3K inhibitors.

There will also be pivotal trial readouts for Novartis’ PD-1 inhibitor spartalizumab-based combination in melanoma, crizanlizumab for sickle cell disease, and oral CRTH2 antagonist fevpiprant in asthma.

The pipeline is poised to deliver “sustained, accretive growth”, said Narasimhan, adding: “We are developing and launching medicines that can change the standard of care in devastating diseases.”

Article by
Phil Taylor

24th May 2019

From: Marketing

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