Celgene Corp., the maker of the cancer drug Revlimid, said its experimental psoriasis medicine helped quell the redness and inflammation associated with the skin disorder in a study.
The drug, apremilast, helped one-third of patients achieve a 75 reduction of symptoms, based on a standard Psoriasis Area and Severity Index measurement. That compared with 5.3 percent of those on placebo with the same score, called PASI-75, Celgene said in a statement as it presents the data at the American Academy of Dermatology meeting in Miami Beach, Florida, today.
Psoriasis is an autoimmune disease that causes red, scaly patches on the skin and affects as many as 7.5 million in the U.S., according to the National Psoriasis Foundation. The market for treatments may approach $10 billion worldwide, according to Mark Schoenebaum, an analyst with ISI Group Inc. in New York. He said investors may have been looking for at least 40 percent of patients reaching the PASI-75 metric.
“This would place apremilast slightly less effective than the biologic therapies (e.g., Enbrel, Humira, Stelara) but with a best-in-class safety profile,” Schoenebaum wrote in a Feb. 28 research note.
The data presented today were from a study called ESTEEM 1, one of two clinical trials in the third and final phase generally required for regulatory approval. Summit, New Jersey-based Celgene said in January that both ESTEEM 1 and ESTEEM 2, which together included about 1,250 patients, had met their study goals and that it plans to seek regulatory approval for apremilast in psoriasis in the second half of this year.
Celgene also has tested the drug in psoriatic arthritis, another autoimmune condition, and has plans to apply for approval in that indication in the first half of this year. It’s also running trials in ankylosing spondylitis, Behcet’s disease and rheumatoid arthritis. Apremilast may bring in $1.14 billion in revenue in 2017, according to the average of 12 analysts’ estimates compiled by Bloomberg.
Celgene today also reported that 59 percent of patients achieved a 50 percent reduction in symptoms, compared with 17 percent of those taking a placebo. The drug was generally well tolerated, with a 3.6 percent of patients on apremilast and 3.2 percent on placebo reporting severe side effects, Celgene said.
Apremilast is an oral drug that inhibits an enzyme called PDE4 that’s associated with inflammation, according to Celgene. Other drugs such as Amgen Inc. and Pfizer Inc.’s Enbrel and AbbVie Inc.’s Humira, which target the inflammatory protein TNF, and Johnson & Johnson’s Stelara, which suppresses IL-12 and IL-23, are given by injection.