Novartis Settles Short-Lived Suit Over Janssen's Psoriasis Drug Promo

Companies resolve litigation as competition in the psoriasis drug market intensifies; there are now 12 approved products in the US, with TNF-alpha inhibitors still dominating. 

Novartis AG and Janssen Pharmaceutical Cos. psoriasis drugs will continue battling it out in the US market rather than court, as the two have settled Novartis' suit seeking to halt Janssen's promotional material comparing the safety of their products.

The settlement comes less than two months after a court denied Novartis' request for a temporary restraining order and preliminary injunction to prevent distribution of material describing the results of the head-to-head ECLIPSE study of Janssen's interleukin-23 inhibitor Tremfya (guselkumab) versus Novartis' interleukin-17A inhibitor Cosentyx (secukinumab).

Novartis claimed a brochure and slide summarizing the safety findings of the study omits adverse events and suggests Tremfya is safer. (Also see "Novartis Can't Halt Janssen's Promo Comparing Their Psoriasis Drugs " - Pink Sheet, 5 Mar, 2019.)

In a 25 April court filing, the two companies noted that the case was dismissed and that they would bear their own costs and attorneys' fees.

The companies declined to provide the terms of the resolution, saying only that they settled the case "to their mutual satisfaction."

The litigation reflects how intensely competitive the psoriasis market is. Cosentyx and Tremfya are among 12 psoriasis products approved in the US, with many more in the pipeline.

TNF-Alpha Inhibitors Dominate Market

Datamonitor Healthcare issued a report last month, "Psoriasis Pricing, Reimbursement, and Access," which noted that IL-23 inhibitors have strong efficacy potential over IL-17 inhibitors. But it said the superiority data will drive physician preference rather than formulary positioning. To date, Tremfya is the only drug to demonstrate superiority against Cosentyx. (Also see "ECLIPSE: J&J's Tremfya Beats Novartis' Cosentyx For Long-Term Psoriasis Clearance" - Scrip, 12 Dec, 2018.)

The report says that despite the availability of IL inhibitors with superior efficacy, TNF-alpha inhibitors will continue to dominate first-line treatment. They include AbbVie Inc.'s Humira (adalimumab), Amgen Inc.'s Enbrel (etanercept), Janssen's Remicade (infliximab), and UCB Group's Cimzia (certolizumab pegol).

"US payers note that the savings generated from the contracts for TNF-alpha inhibitors surpass what is possible with ILs, due to the former's wide number of approved indications, while in Europe biosimilar adalimumab and etanercept present a cost-saving opportunity," the report states.

The report also includes a run down of the annual treatment costs of 12 psoriasis drugs in the US, Japan, and five major European Union markets.

Cimzia is at the top of the list in the US, with an annual treatment cost of $122,513, followed by Tremfya, which has an annual treatment cost of $70,586. Cosentyx is slightly less costly at $67,326.

Novartis' top product, Cosentyx had net sales of $791m for the first quarter of 2019 while Tremfya had worldwide sales of $217m for the first quarter. J&J touted the success of Tremfya in its quarterly earnings call, noting that it has secured a 6.9% share of the psoriasis market in the US. (Also see "J&J's Spravato's Star Power Rises While Zytiga's Sets" - Scrip, 16 Apr, 2019.)

The latest entry to the US market is AbbVie's IL-23 inhibitor Skyrizi (risankizumab-rzaa), which was approved by FDA on 23 April for moderate-to-severe psoriasis in adults. It is the third "pure" IL-23 inhibitor approved for psoriasis treatment in the US, following Tremfya and Sun Pharmaceutical's Ilumya (tildrakizumab-asmn). (Also see "AbbVie’s Humira Succession Plan Begins Taking Shape With Skyrizi US Approval" - Scrip, 24 Apr, 2019.)