Stagnant sales for Bristol Myers Squibb’s Sotyktu have raised questions about whether the tyrosine kinase 2 (TYK2) inhibitor can achieve blockbuster status, let alone the $4 billion peak sales projected by the New Jersey drugmaker.
Much will depend on how many indications the company can line up for the oral immunosuppressant beyond its 2022 FDA approval to treat moderate-to-severe plaque psoriasis.
To that end, the company has reported positive results for two phase 3 trials of Sotyktu in adult patients who have psoriatic arthritis (PsA).
Without revealing figures, BMS said that the POETYK PsA-1 and POETYK PsA-2 studies achieved their respective primary endpoints, as a significantly greater proportion of patients on Sotyktu achieved at least a 20 percent improvement in symptoms compared to those on placebo at Week 16.
BMS said it will present detailed results at an upcoming medical conference. The company’s chief of immunology, cardiovascular and neuroscience development, Roland Chen, M.D., added that BMS will discuss the results with health authorities.
The trials enrolled 670 and 730 adults, respectively. While patients in POETYK PsA-1 were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve), those in POETYK PsA-2 were either bDMARD naïve or had used a TNF blocker such as AbbVie’s Humira, Amgen’s Enbrel or Johnson & Johnson’s Remicade.
BMS is angling to make Sotyktu the first TYK2 inhibitor approved in the indication. Takeda is close behind with its TYK2 inhibitor TAK-279, which the Japanese company believes can be the best-in-class treatment. Takeda paid $4 billion to Nimbus Therapeutics to acquire TAK-279, which has achieved results in a phase 2b trial that suggest it may have an edge over Sotyktu.
More competition may be on the way as well from Johnson & Johnson, which is running a phase 3 trial pitting its novel oral IL-23R antagonist, JNJ-2113, against Sotyktu in plaque psoriasis. The trial is due for completion in February.
In 2019, BMS made a big bet on Sotyktu by deciding to keep the then-pipeline asset despite its pending acquisition of Celgene. Based on that decision, Celgene sold its mega-blockbuster Otezla to Amgen for $13.4 billion to resolve antitrust concerns surrounding its sale to BMS.
Despite its two-plus years on the market, Sotyktu has not done much to damage Otezla’s market share. While Amgen revealed sales of $564 million for Otezla in the third quarter, BMS reported Sotyktu’s sales at $66 million.
While it matched the worldwide figure year over year, it was an 18% decline in the U.S., where BMS is battling “severe payer access restrictions,” Leerink Partners said five months ago in a note to investors.