Regulatory Focus™ > News Articles > 2019 > 3 > Novartis Sues Janssen Over False Advertisements for Psoriasis Drug

Novartis Sues Janssen Over False Advertisements for Psoriasis Drug

Posted 04 March 2019 | By Zachary Brennan 

Novartis Sues Janssen Over False Advertisements for Psoriasis Drug

Novartis filed a lawsuit on Friday in DC federal court claiming that Janssen has presented data on its severe plaque psoriasis drug in a false and misleading way in at least two presentations at conferences over the past several months.

Novartis, which sold $2.8 billion worth of its plaque psoriasis treatment Cosentyx (secukinumab) in 2018, directly competes with Janssen, which sold $544 million worth of Tremfya (guselkumab) in 2018.

In Janssen’s presentations, Novartis claims, the company said its Tremfya product “was both superior and noninferior” to Novartis’s Cosentyx, “but did not present key safety information. Rather, it chose to cherry-pick among the adverse events that were recorded in the [ECLIPSE] study.”

And in marketing materials presenting the results of the ECLIPSE study, Janssen “omitted the most egregious adverse events” from the trial, including malignancies and major adverse cardiac events. “In other words, these adverse events would be new information to dermatologists,” Novartis says in its complaint.

Novartis, which is requesting a trial by jury, seeks “an immediate halt to Janssen’s continued false and misleading advertising claims.”

And while claiming that Janssen’s advertising specifically violates section 43(a) of the Lanham Act, Novartis also says that the Janssen claims are continuing this week at the 2019 American Academy of Dermatology Annual Meeting in Washington, D.C.

“Janssen’s illegal false advertising is causing, and will continue to cause, massive and irreparable harm to Novartis,” the complaint says. “Novartis has sent Janssen three separate cease and desist letters in hopes of amicably – and without court intervention – solving this and associated problems in its use of ECLIPSE study data, to no avail.”
 

Categories: Regulatory News

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