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Encouraging Long-Term Data on Celgene's Otezla - Analyst Blog

Celgene Corporation ( CELG ) presented encouraging long-term data on its marketed drug Otezla at the European League Against Rheumatism Annual Congress (EULAR) in the active psoriatic arthritis indication.

The data included long-term (52-week) analyses from the PALACE 1, 2 and 3 studies in addition to a 16-week work productivity analysis from the PALACE 1 trial. The long-term analyses from the three studies revealed that treatment with Otezla resulted in significant improvements with respect to psoriatic arthritis disease activity compared to placebo at week 16. Three measures of disease activity were used − disease activity score of 28 joint counts (measured by the level of C-reactive protein), modified psoriatic arthritis response criteria and good or moderate EULAR response. The benefits of Otezla treatment at week 16 were sustained at week 52 as well, according to all three measures of disease activity. Analysis of pooled long-term safety data on Otezla revealed a consistent safety profile across the three studies over 52 weeks.

Furthermore, a work productivity analysis conducted on 261 patients from the PALACE 1 study revealed increased work productivity and improved work limitations following Otezla treatment compared with placebo at 16 weeks.

In another presentation on Otezla at the EULAR, Celgene announced encouraging long-term data from a phase III study (PALACE 4), which evaluated DMARD-naïve patients suffering from active psoriatic arthritis. Data revealed that Otezla treatment as a monotherapy resulted in significant improvements in enthesitis and dactylitis − 2 key manifestations of psoriatic arthritis − at week 16, which were also maintained at week 52. Similar encouraging results on Otezla monotherapy were observed with respect to physical function.

Celgene further stated in its press release that the long-term safety and tolerability data on Otezla from the PALACE 4 study was consistent with the findings of other PALACE studies.

The impressive long-term data on Otezla for the active psoriatic arthritis indication should augment its sales potential. We note that the drug was approved for the indication in the U.S. in March this year. Celgene is seeking FDA approval for the moderate-to-severe psoriasis indication (U.S. target date: Sep 23, 2014).

In addition, Celgene is seeking EU approval for Otezla in the combined psoriasis and psoriatic arthritis indication, with an opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use expected by Dec 31, 2014.

We expect investor focus to remain on updates regarding Otezla going forward.

Celgene carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals ( REGN ), Gilead Sciences ( GILD ) and Alexion Pharmaceuticals ( ALXN ). While Gilead and Regeneron sport a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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