Novartis orphan drug Jakavi nabs 'blockbuster' forecasts on new data

FiercePharma File Photo

Novartis ($NVS) may have another cancer blockbuster on its hands. New Phase III data on Jakavi (ruxolitinib) has Wall Street analysts predicting that it will easily pass the $1 billion mark.

Already approved to treat the blood cancer myelofibrosis, Jakavi met its goals in a Phase III trial in certain patients with polycythemia vera, a rare and incurable cancer marked by the overproduction of blood cells. The Swiss drugmaker said Jakavi maintained the volume of red blood cells without the need for phlebotomy, which is a procedure to remove blood from the body. Spleen size also dropped by 35% or more. Now, Novartis plans to seek regulatory approval for the new use this year, Novartis Oncology chief Alessandro Riva said in a statement.

Analysts predict the approvals will start coming in next year and will ultimately push sales of Jakavi into blockbuster territory, according to Reuters. Vontobel analyst Andrew Weiss told Reuters he predicts the drug will bring in 500 million Swiss francs ($567 million) per year for each approved indication. Jakavi, which inhibits the tyrosine kinases JAK1 and JAK2, is also being tested in pancreatic cancer and other advanced malignancies.

That said, winning worldwide reimbursement for the drug has not been easy for Novartis. In February, the U.K.'s National Institute for Health and Clinical Excellence (NICE) issued a draft guidance declaring that Jakavi's price tag of £3,600 per month ($5,999) is not "a cost-effective use of resources," even though the drug could offer a survival benefit. The agency's final decision will come in June.

Novartis licensed Jakavi from Incyte ($INCY) and has full commercialization rights outside of the U.S. (where the product is known as Jakafi). The drug brought in $163 million in sales for Novartis in 2013, up from $30 million the previous year.

- here's the Novartis press release
- read more at Reuters

Special Report: Top 20 Orphan Drugs by 2018 - Jakavi

Suggested Articles

Johnson & Johnson faces a litany of problems, but executives are clearly not concerned—at least not about the company's short-term fortunes.

This week, Goldman Sachs resurrected a burning question: How can pharma companies profit from curing patients with one-time gene and cell therapies?

CMS has determined how it'll pay for Gilead's CAR-T cancer therapy, Yescarta, for outpatient use, but hasn't yet decided on Gilead's…