7. Stelara

Stelara
J&J's immunology mainstay Stelara benefited from its fourth approval, to treat ulcerative colitis. (Johnson & Johnson)

Stelara
Company:
Johnson & Johnson
2020 sales: $7.94 billion
Diseases: plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis

Armed with a fourth indication in ulcerative colitis, J&J's immunology mainstay Stelara bucked pandemic sales trends in 2020. FDA safety warnings on a pair of JAK inhibitor rivals helped, but with competition mounting, J&J had to slash the price of its IL-12/23 inhibitor to stay competitive.

Despite the challenges, Stelara pulled in $7.94 billion last year, an increase of nearly 20% over 2019. Stelara's approval in ulcerative colitis gave J&J access to roughly 910,000 U.S. patients each year in the booming GI market.

But it wasn’t long before a potential challenger emerged. In early June, Bristol Myers Squibb posted data showing a daily regimen of its multiple sclerosis med Zeposia bested placebo at increasing the number of patients who achieved remission from ulcerative colitis symptoms at 10 weeks. The sphingosine-1-phosphate (S1P) receptor modulator, which BMS is advancing as an oral therapy, also helped maintain remission for a year during the phase 3 trial.

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Ulcerative colitis was a crowded market to begin with, but Stelara saw a slight reprieve in July after the FDA slapped Pfizer’s immunology rival Xeljanz with a black box warning of an increased risk of blood clots and potential death with the JAK inhibitor’s 10 mg twice-daily dose. The drug is now approved for patients who do not respond to or are unsuitable for other meds.

The JAK-inhibitor safety scare hit AbbVie’s rheumatoid arthritis med Rinvoq, too, with the FDA in August warning of an increased risk of serious infections, malignancy and thrombosis. The drug isn’t approved for ulcerative colitis, but the GI disease is one of many potential indications on AbbVie’s radar.

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Stelara fared well in a pandemic year that challenged sales of other drugs, but competition and government crackdowns on drug prices have sent the med’s price tag tumbling.

Both Stelara and J&J’s plaque psoriasis med Tremfya “reported double digit [year-over-year] decline in pricing, suggesting the need to discount the products to retain share,” Bernstein analyst Ron Gal wrote to clients in October, shortly after J&J posted its third-quarter results.

The blockbuster’s “implied price” fell 19% versus 2019’s third quarter and was flat versus the second quarter of 2020, Gal’s team calculated. At the time, J&J said it expected pricing pressure would bleed into 2021 because of high unemployment rates and government efforts to curb drug pricing.

Meanwhile, Stelara’s steep price tag cost it an endorsement from England’s National Institute for Health Care Excellence in ulcerative colitis early last year. “The cost-effectiveness estimates vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources,” NICE’s January 2020 guidance read. The organization opened up a comment period for J&J to make its case—or consent to a discount—after which it said it would reconsider the evidence and make its final call.

7. Stelara