) marketed drug, Otezla, performed disappointingly in a phase III
study (POSTURE) in the ankylosing spondylitis indication. Top-line
results from the study revealed that ankylosing spondylitis
patients on being treated with Otezla did not show statistically
significant response compared to patients in the placebo arm at
week 16, thus missing the trial's primary end point.
Specifically, the primary objective of the study was to determine
the proportion of patients who achieved at least 20% reduction in
disease symptoms, according to the ASAS (Assessment of
SpondyloArthritis International Society) criteria at week 16 in
both the cohorts. Celgene said that it will present detailed safety
and efficacy results from the study at a medical conference later.
Shares Rise Despite Missing Primary Goal
Despite not meeting the primary endpoint, it was not all bad news
as far as the POSTURE study was concerned. Celgene said meaningful
efficacy was observed following 24 weeks of Otezla treatment in
early-stage patients. Moreover, the biopharmaceutical major stated
that an independent data monitoring committee recommended the
continuation of the study without making any changes. The
recommendation was based on an evaluation of the safety and
efficacy data at week 24.
Furthermore, Celgene will collect magnetic resonance imaging data
in a subgroup of patients after 52 weeks of Otezla therapy (and at
additional time points) as per protocol. Moreover, radiographs will
be conducted on the study's entire population after 104 weeks.
Celgene also intends to evaluate the candidate in another phase III
study in the same indication after further analysis of data from
the POSTURE trial. With Celgene still retaining hope for Otezla in
the above indication, investors were not too concerned by the
failure of the drug to meet the study's primary objective. Shares
of the company increased 2.1% to close the trading session on Jul 9
at $87.52 per share.
Key Action Date Coming Up for Otezla
Otezla is a new entrant to Celgene's product portfolio. The drug
was approved by the FDA for the active psoriatic arthritis
indication in March this year. Celgene is seeking FDA approval for
the moderate-to-severe plaque psoriasis indication (U.S. target
date: Sep 23, 2014). We believe investor focus will remain on
Otezla's regulatory status in the moderate-to-severe plaque
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.
Celgene carries a Zacks Rank #2 (Buy). Better-ranked stocks in the
health care sector include
). All the three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
MEDICINES CO (MDCO): Free Stock Analysis Report
CELGENE CORP (CELG): Free Stock Analysis Report
ACTELION LTD (ALIOF): Get Free Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
To read this article on Zacks.com click here.