Novartis expects a parade to blockbusterland, with Entresto leading the way

Novartis pharma chief Paul Hudson said alternative models for SMA gene therapy AVXS-101 would be ready at launch point mid-2019. (Novartis)

It's been a long slog through a sluggish launch, but Novartis' highly anticipated heart drug Entresto has finally reached blockbuster status.

For 2018, Entresto sales hit $1.03 billion, thanks to 76% year-over-year growth in its fourth-quarter haul of $318 million. And Novartis is counting on the large-scale Paragon-HF trial to boost sales further. That trial, which compares Entresto with Diovan in terms of cardiovascular death or hospitalization rates, is expected to read out in 2019.

Entresto also posted clear benefits in patients with heart failure with reduced ejection fraction. In a trial dubbed Pioneer-HF, it achieved a 46% reduction in serious clinical outcomes, reducing death and heart failure rehospitalization compared to common heart failure therapy enalapril.

“The type of performance of Entresto in the Pioneer study is a real marker in the sand to show what's possible,” pharma chief Paul Hudson said on the Swiss drugmaker's fourth-quarter earnings call.

Entresto wasn't alone in crossing the blockbuster threshold in 2018. In Novartis' oncology portfolio, platelet therapy Promacta and BRAF-MEK combo therapy Tafinlar and Mekinist also achieved blockbuster status on 30%-plus growth in 2018.

And more blockbusters are on the way, executives said on Wednesday. On the earnings call, they laid out plans for 11 blockbuster launches—including new indications for approved drugs—by 2020.

A key focus is spinal muscular atrophy drug zolgensma, previously known as AVXS-101, which was the centerpiece of Novartis’ $8.7 billion acquisition of AveXis in 2018 to build its gene therapy platform on top of rights to Spark Therapeutics’ Luxturna. Pharmaceutical intelligence house EvaluatePharma previously predicted the candidate  could reach $1.56 billion in 2024 sales.

But with the FDA slated to deliver a verdict in May, all eyes are on how Novartis plans to price the drug. AveXis President Dave Lennon previously hinted at a price in the range of $4 million to $5 million. On Wednesday’s call, Hudson stressed that the company hasn’t finalized the sticker. But he also pointed to recent draft guidance (PDF) from drug cost watchdog the Institute for Clinical and Economic Review (ICER) and suggested that zolgensma would be cost-effective at up to $5 million.

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“I can assure you that constructive conversations with both regulators and payers have brought us to a position where we feel we will be able to deliver on the scientific and clinical promise, and find the best way that through the price or the ability to pay over a period of time to give the patients the best possible access,” he said.

Meanwhile, not all of Novartis' new rollouts are performing well. Breast cancer drug Kisqali and CAR-T therapy Kymriah are still dragging with fourth-quarter sales of $60 million and $28 million, respectively.

Overall, for 2018, psoriasis blockbuster Cosentyx, Entresto and several cancer therapies helped the Swiss drugmaker’s innovative medicines business grow sales by 8% to reach $34.9 billion.

Cosentyx’s fourth-quarter sales of $806 million were $56 million better than the previous quarter. In the U.S., total prescriptions jumped 29% in dermatology and 49% in rheumatology year over year, and the company expects to see demand keep increasing, Hudson said. 

Moving into 2019, after Novartis' Alcon and Aurobindo deals are factored out, Novartis expects sales to grow by a mid-single-digit percentage at constant exchange rates. That prediction is largely in line with consensus estimates of $53.1 billion, according to ODDO BHF analyst Pierre Corby's Wednesday note to investors.