Celgene bolsters case for closely watched arthritis drug with Ph3 data

Celgene and most analysts have never met eye-to-eye on the future prospects of the psoriasis drug apremilast, which the biotech heavyweight ($CELG) expects could become a blockbuster seller. Yet at least one analyst argues that new data from a late-stage study of the oral treatment in patients with psoriatic arthritis could lift sales expectations for apremilast among his peers.

Industry watchers have been quick to highlight that efficacy scores from studies of apremilast fall short of those on injected anti-TNF therapies such as AbbVie's ($ABBV) Humira. However, the 52-week results from the PALACE-1 study of apremilast show improvements in symptoms that fall in the ballpark with injected biologics, The Street's contributor David Sobek writes. And though Celgene aims to avoid direct competition with the big anti-TNF therapies, the company's investigators have noted the relatively benign side effect profile of the oral treatment. Many patients forgo anti-TNF therapy because of the side effects.

Celgene, which has already filed for FDA approval of apremilast in psoriatic arthritis this year, previously reported 16-week results from the late-stage Palace-1 trial and this week its investigators revealed potentially more impressive numbers from patients in the same study after a year. For example, 31.3% of patients on a twice-daily 20 mg dose of apremilast saw at least a 20% reduction in pain and other symptoms at week 16. At week 52, 63% of patients had achieved this benefit. Yet some patients from the placebo group had crossed over into treatment arms after weeks 16 and 24 of the study. The 504 patients in the study had previously taken anti-TNF drugs or other disease-modifying agents.

"Over the course of their disease patients with psoriatic arthritis may take a variety of treatment regimens over extended periods of time. Durability of response is therefore important," Investigator Dr. Arthur Kavanaugh, Professor of Medicine at the University of California, San Diego, stated. "This relatively large study suggests that apremilast has sustained efficacy and tolerability over a year among patients previously treated with DMARDs and/or biologic agents."

Many analysts disagree with Celgene's $2 billion revenue projection for apremilast yet expect the drug to gain regulatory approvals. Later this year, Celgene expects to file for approval of the drug for psoriasis and seek a green light from European regulators for both psoriasis and psoriatic arthritis. About 30% of patients with the skin condition psoriasis get psoriatic arthritis, which happens when the immune system attacks hit their joints.

Celgene CEO Bob Hugin has included apremilast, which blocks the phosphodiesterase 4 enzyme involved in inflammation, on a short list of therapies in his company's pipeline with major sales potential over the next several years as he and the company seek rapid revenue growth beyond the big Revlimid franchise.

- here's the release
- check out The Street's article
- and a report from Reuters

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