Novartis' Enbrel beater nears a soon-to-crowd psoriasis market

Novartis' ($NVS) in-development drug secukinumab beat out the blockbuster Enbrel in improving symptoms of psoriasis in Phase III, improving the company's odds of success in what promises to be a competitive race among next-generation therapies for the autoimmune disease.

In two studies, more than half of the patients on secukinumab reported skin clearance rates of 90% or more, compared to just 20.7% of patients taking Amgen's ($AMGN) Enbrel, an anti-TNF drug that brought in about $8.8 billion last year. Novartis' drug works by blocking the cytokine interleukin-17A (IL-17A), a key factor in the body's autoimmune response.

The studies, published in The New England Journal of Medicine today, are part of Novartis' 3,300-patient Phase III effort for secukinumab. The company has already filed applications in the U.S. and Europe to treat moderate-to-severe plaque psoriasis, expecting final word from the FDA in January and a European Medicines Agency committee recommendation by year's end.

If and when Novartis' autoimmune drug wins approval, it'll have to contend with an incoming class of psoriasis contenders poised to expand the market. Celgene's ($CELG) oral apremilast, already approved for psoriatic arthritis, is first up with a September FDA decision date for its psoriasis application, followed by Amgen ($AMGN) and AstraZeneca ($AZN), developers of an IL-17A inhibitor called brodalumab that charted excellent Phase III results in May. Eli Lilly ($LLY) is working through Phase III with the similar ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) guselkumab.

Sales estimates for Novartis' secukinumab hover around $600 million, but the company believes it can make more noise in the autoimmune market if a few late-stage studies come up positive. Novartis is running a head-to-head trial comparing secukinumab to J&J's fast-growing Stelara, and still to come are data on the drug's affects on psoriatic arthritis and ankylosing spondylitis.

And there's plenty at stake: Annual sales for biological psoriasis treatments sit at about $4.8 billion, Novartis said, and the company expects that figure to grow 10% a year through 2020.

- read the statement

Editor's note: An earlier version of this story misstated apremilast's approved indication. We regret the error.