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Celgene's new drug for psoriasis may not be that g

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Post# of 72446
Posted On: 11/13/2012 4:31:59 PM
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Posted By: BigJeff

Celgene's new drug for psoriasis may not be that good after all. Good news for CTIX . . .

Nov 13 (Reuters) - Celgene Corp's experimental treatment for psoriatic arthritis, apremilast, proved to be modestly effective compared with leading treatments in a late-stage study, and it showed fewer side effects, according to data released by the company on Tuesday,



Data released at the annual meeting of the American College of Rheumatology showed that 41 percent of patients who took 30 milligrams of apremilast twice daily achieved a 20 percent improvement in symptoms after 16 weeks, compared with 19.4 percent who took a placebo.


"While these efficacy results might be acceptable in a disease like psoriasis, we don't view them as sufficient for a disease characterized by ongoing joint destruction and progressive disability," said Geoffrey Porges, an analyst at Sanford Bernstein, in a recent research report based on an initial summary of the data.


A table compiled by Porges shows that between 50 percent and 57 percent of patients taking standard biologics achieved a 20 percent improvement in symptoms after 24 weeks in clinical trials.


Only 20 percent of patients taking apremilast in the study experienced a 50 percent improvement in symptoms, and only 11 percent saw in improvement of 70 percent or more after 16 weeks. Those figures are also lower than those seen with the biologics.


Celgene expects to file for U.S. approval of the drug in treating psoriatic arthritis in the first half of 2013.


The most common side effects with apremilast, which is also being tested as a treatment for psoriasis, were gastrointestinal disturbances such as nausea and diarrhea.


Celgene expects to begin reporting data from two late-stage studies of the drug in psoriasis by the end of this year and to file for marketing approval in the second half of next year.



In Europe, the company has said it plans to file for both the psoriasis and psoriatic arthritis indications together in the second half of the year.





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