When Celgene won FDA approval for its psoriasis pill Otezla in 2014, the company was entering a hugely competitive market that would become home to both established therapies and biotech newcomers from the likes of Eli Lilly, Novartis and Merck. But the company had a plan: It would continue investing in R&D around the product in the hopes of getting it approved for relieving inflammatory conditions that most other rival products can’t claim to be able to treat.
That plan may finally be producing results. On Monday, Celgene announced that a phase 3 study of Otezla in scalp psoriasis met its primary endpoint. If the FDA expands the product’s label to include that indication, it could bring the company closer to meeting analysts’ initial expectations for peak Otezla sales of $2 billion—provided, of course, its marketing team can come up with a good strategy for dealing with a raft of challenges including payer pushback and competition from biosimilar versions of older drugs.
In the scalp psoriasis trial, patients taking Otezla experienced a statistically significant improvement in symptoms at week 16 compared with those taking a placebo, the company said. The trial also met its secondary endpoint of reducing the “whole body itch numeric rating scale.”
Terrie Curran, president of Celgene’s inflammation and immunology unit, said in a statement that scalp psoriasis affects about 80% of patients. “The area is difficult to treat with topical therapies, and clinical data from systemic therapies are limited,” Curran said.
But whether the data will be enough to persuade payers and physicians to embrace Otezla is still an open question. During Celgene’s second-quarter conference call, Curran said the product is on track to reach $1.5 billion in sales for this year, and that sales of the drug in the U.S. were up 21% over the same period a year ago.
She added that future growth could come not only from the scalp psoriasis indication but also from “multiple studies underway,” including trials of the product in mild to moderate plaque psoriasis and a rare inflammatory blood vessel disorder called Behçet’s disease.
Still, in the second quarter, global sales of Otezla rose just 5% year over year to $375 million, despite 62% growth overseas that was driven by strong uptake in France and Japan. Otezla underperformance last year contributed to Celgene knocking its 2020 sales guidance down from $20 billion to $19 billion.
Competition isn’t helping matters. Celgene has struggled to make Otezla stand out from such players as Novartis’ Cosentyx and Eli Lilly’s Taltz, even though Otezla’s pill formulation offers convenience over rival injectables. And recent FDA approvals of biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Enbrel threaten to steal market share from the newer entrants.
As for the scalp psoriasis indication, Celgene will have to wrestle Novartis for attention from patients and physicians in that market, too. Novartis got the FDA’s blessing to add scalp psoriasis to Cosentyx’s label in February.