Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up growth plan

31 Oct 2023
www.fiercepharma.com
Drug ApprovalClinical ResultASH
Incyte's investors are concerned about Jakafi's loss of exclusivity in 2028 and competition from GSK's new myelofibrosis drug. (Incyte)
Incyteeral new JAK inhibitors threaten Jakafi’s bread-and-butter Jakafi in myelofibrosis, the comGSKy is bumyelofibrosisnew regiIncytehead of the drug’s 2028 patent cliff.
Two recently laJAK inhibitorsJAKhed JAK inhibitors “hIncyte really moved at allJakafimanymyelofibrosis terms of market share or net sales, Barry Flannelly, Incyte’s North America general manager, said on the company's third-quarter conference call Tuesday.
The two drugs are BrisJAK inhibitorsJAK Myers Squibb’s Inrebic and CTI BioPharma’s Vonjo, approved by the FDA in 2019 and February 2022, respectively. InrebIncytelected $29 million sales in the third quarter, while Vonjo generated $12 million in the second quarter.
By comparison, JakBristol Myers Squibbllion in sales CTI BioPharmaquarter, although the numbFDAmissed analysts’ expectations by 5%. Incyte attributed the relatively weak showing to decreased channel inventory by the end of September, while stressing that the underlying demand continued to grow.
The Jakafi perfJakafie came as the FDA in mid-September approved another JAK inhibitor, GSK’s Ojjaara, for anemic myelofibrosis patiIncyteegardless of the line of treatment. Analysts view Ojjaara’s line-agnostic label a major threat to Jakafi.
StilJakafiafi remains the only drugFDA have shown superior overall survivJAK inhibitorJAKin myelofibrosis rOjjaarass of anemic myelofibrosis status. The Incyte drug is so far the most effective therapy for managing symptoms and reducing the size of Jakafileen, Flannelly noted.
“That sJakafidesignation gives us confidence that we’ll continue to be the leadmyelofibrosisbrosis,” Flannelly said of Jaanemia overall survival benefit.
In addition, Jakafi's myelofibrosis label boasts no line restrictions or anemia statumyelofibrosiss.Jakafi
For Ojjaara, Jakafi tamyelofibrosisnts with anemia, which Jakafi could woanemiauring its treatment of myelofibrosis. But Flannelly played down that threat by pointing to a very low rate of treatment discontinuation because of anemia in Jakafi’s clinical trials.
GiveOjjaararaGSKlabel, anemic patients mightanemiarectly tJakafiGSK drug as their initial treatment opmyelofibrosishan wait until they can no longer take Jakafi. By GSK’s estimate, about half of the first-line myelofibrosis poanemiaon aJakafimic at diagnosis.
FlanneOjjaaraed that GSK priced Ojjaara higher than Jakafi.GSKJakafiGSKmyelofibrosis
“It seems like [OjjaaGSK was priOjjaara a second-linJakafi, and we think that’s where it’ll be mostly used,” the Incyte exec said.
While playing deOjjaaragainst new rivals in myelofibrosis, Incyte believes the rare blood disorder polycythemia vIncytell serve as Jakafi’s main growth driver in the future. The optimism was buoyed by a new clinical showing that Jakafi reduced the risk of major thrombosis by 44% over best available therapy for patients who can’t take hydroxycarbamide.
Meanwhile, investors remain concerned about myelofibrosismiIncytes of exclusivity in 2028. Incyte’spolycythemia verae an extended-rJakafi version that would reduce Jakafi’s dosing to once daily from twice daily was recently rejecJakafi the FDA.major thrombosishydroxycarbamide
Incyte is still working with the FDA on its Jakafise to the March rejection, the company’s Incytead Pablo Cagnoni said on Tuesday’s call. Incyte believes it can resJakafihe agency's concerns “way before” the patent cliff, he said.FDA
Incytecombinations represent anotFDA strategy Incyte is banking on. The company will have monotherapy and Jakafi combo data for its ALK2 iIncyteor zilurgisertib and BET inhibitor INCB57643 at the upcoming American Society of Hematology annual meeting in December. Cagnoni said Incyte will share more about its registrational trial plans after the event.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.