Novartis slaps J&J with Tremfya lawsuit, claiming it 'cherry-picked' safety stats

Tremfya One-Press
J&J won approval last week for its new self-injected form of psoriasis drug Tremfya. (J&J)

Aiming to protect its blockbuster psoriasis drug Cosentyx, Novartis slapped Johnson & Johnson with a lawsuit claiming it's using "cherry-picked" safety stats to promote its rival therapy Tremfya. And it's demanding an injunction to stop those promos, stat.

Novartis asked for a temporary restraining order and injunction in U.S. District Court in Washington, D.C., citing J&J marketing materials that it says omit key information from a December head-to-head study between the two drugs.

In that study, dubbed Eclipse, the J&J drug bested Cosentyx by clearing up more patients' skin, as measured by the Psoriasis Area Severity Index. Almost 85% of Tremfya patients had hit 90 or above on that index after 48 weeks, compared with only 70% of Cosentyx patients.

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Other results in the Eclipse study showed little statistical difference between the two drugs or Novartis superior in some measurements, the lawsuit said.

Now, J&J is citing other data from that study to make Tremfya look better than Cosentyx, the Novartis lawsuit claims. A “Safety Profile” circulated in a slideshow presentation at the American Academy of Dermatology conference last week omitted some of the adverse effects that cropped up in Tremfya patients and painted the J&J drug as safer to use than Cosentyx, the lawsuit states.

J&J's Janssen unit "has selectively ‘cherry-picked’ the safety data so as to provide a utterly false impression that Tremfya is actually safer than Cosenytx,” the suit read.

In a declaration filed with the suit, Novartis VP Victor Bulto said Tremfya’s profile in that slide left out a number of adverse effects found in the Eclipse study. The slide did include, however,  a small-print disclaimer saying it did not include Tremfya’s risks of malignancy and major adverse cardiac events.

“In my personal experience, dermatologists are particularly sensitive to safety information and in particular to malignancies, including skin cancer,” Bulto said. “Misleading information like this negatively affects the dermatology community in their search for reliable safety information.”

Novartis alleged that Tremfya’s advertising directly harmed Cosentyx by marketing it as unsafe in comparison, according to court documents. 

In a separate declaration, Nicholas J. Senior, director of regulatory advertising and promotion at Novartis, said leaving out side effects could mislead patients and harm public health. Omitting the cancer and CV risks “may misleadingly imply that these adverse events do not occur nor are they a risk of treatment with the appropriate use of these products,” Senior said. 

Novartis requested a temporary restraining order that would prevent J&J from publishing any new marketing material comparing Cosentyx and Tremfya using the Eclipse study. It would also require J&J to delete all previous material using the study as a point of comparison between the two drugs.

The lawsuit comes at a time when drugmakers in the psoriasis field are looking for ways to challenge competitors—or, in Novartis' case, fend off newer competition. Cosentyx has led the next-gen psoriasis market since it won approval in 2015—and it grew 36% to $2.8 billion last year—but with every new approval, the threat multiplies. Eli Lilly’s Taltz, Valeant’s Siliq and Sun's Ilumya piled in after Cosentyx, and J&J has high hopes for latecomer Tremfya.

Although Johnson & Johnson entered the field late, Tremfya is gaining share; it grew last year to $544 million in worldwide sales from just $63 million in 2017. And with FDA approval last week for its One-Press single-dose injector for Tremfya, J&J is hoping the convenience factor can position the drug for an even bigger leap this year.

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